Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial

Background Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck pain. Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues, and muscle with the intent to mechanically disrupt tissue without the use of an anesthetic. Dry needling is emerging as a treatment modality that is widely used clinically to address a variety of musculoskeletal conditions. Recent studies of dry needling in mechanical neck pain suggest potential benefits, but do not utilize methods typical to clinical practice and lack long-term follow-up. Therefore, a clinical trial with realistic treatment time frames and methods consistent with clinical practice is needed to examine the effectiveness of dry needling on reducing pain and enhancing function in patients presenting to physical therapy with mechanical neck pain. Objective The aim of this trial will be to examine the short- and long-term effectiveness of dry needling delivered by a physical therapist on pain, disability, and patient-perceived improvements in patients with mechanical neck pain. Methods We will conduct a randomized, double-blind, placebo-controlled trial in accordance with the CONSORT guidelines. A total of 76 patients over the age of 18 with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy will be enrolled after meeting the eligibility criteria. Subjects will be excluded if they have previous history of surgery, whiplash in the last 6 weeks, nerve root compression, red flags, or contraindications to dry needling or manual therapy. Participants will be randomized to receive (1) dry needling, manual therapy, and exercise or (2) sham dry needling, manual therapy, and exercise. Participants will receive seven physical therapy treatments lasting 45 minutes each over a maximum of 4 weeks. The primary outcome will be disability as measured by the Neck Disability Index. Secondary outcomes include the following: pain, patient-perceived improvement, patient expectations, and successful blinding to the needling intervention. Outcome measures will be assessed at 4 weeks, 6 months, and 12 months by an assessor who is blind to the group allocation of the participants to determine the short- and long-term treatment effects. We will examine the primary aim with a two-way, repeated-measures analysis of variance with treatment group as the between-subjects variable and time as the within-subjects variable. The hypothesis of interest will be the two-way group by time interaction. An a priori alpha level of .05 will be used for all analyses. Results Recruitment is currently underway and is expected to be completed by the end of 2017. Data collection for long-term outcomes will occur throughout 2017 and 2018. Data analysis, preparation, and publication submission is expected to occur throughout the final three quarters of 2018. Conclusions The successful completion of this trial will provide evidence to demonstrate whether dry needling is effective for the management of mechanical neck pain when used in a combined treatment approach, as is the common clinical practice. Trial Registration ClinicalTrials.gov NCT02731014; https://clinicaltrials.gov/ct2/show/NCT02731014 (Archived by WebCite at http://www.webcitation.org/6ujZgbhsq)


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if ooine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. 1 2 3 4 5 subitem not at all important essential https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…=en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "Neck Pain" is in title 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions NPT extension: Description of experimental treatment, comparator, care providers, centers, and blinding status.

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT
Mention key features/functionalities/components of the intervention and comparator in the abstract. If possible, also mention theories and principles used for designing the site. Keep in mind the needs of systematic reviewers and indexers by including important synonyms. (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Participants will be randomized to receive 1) dry needling, manual therapy, and exercise or 2) sham dry needling, manual therapy and exercise. Participants will receive 7 physical therapy treatments lasting 45 minutes each over a maximum of 4 weeks.

1b-ii) Level of human involvement in the METHODS section of the ABSTRACT
Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Participants will receive 7 physical therapy treatments lasting 45 minutes each over a maximum of 4 weeks. " All physical therapy treatment will be provided by licensed physical therapists.

1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT
Mention how participants were recruited (online vs. ooine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials). Note: In traditional ooine trials, an open trial (open-label trial) is a type of clinical trial in which both the researchers and participants know which treatment is being administered. To avoid confusion, use "blinded" or "unblinded" to indicated the level of blinding instead of "open", as "open" in web-based trials usually refers to "open access" (i.e. participants can self-enrol). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 1b-iii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "76 patients over the age of 18 with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy will be enrolled after meeting the eligibility criteria. "

1b-iv) RESULTS section in abstract must contain use data
Report number of participants enrolled/assessed in each group, the use/uptake of the intervention (e.g., attrition/adherence metrics, use over time, number of logins etc.), in addition to primary/secondary outcomes.

2a-i) Problem and the type of system/solution
Describe the problem and the type of system/solution that is object of the study: intended as stand-alone intervention vs. incorporated in broader health care program? Intended for a particular patient population? Goals of the intervention, e.g., being more cost-effective to other interventions, replace or complement other solutions? (Note: Details about the intervention are provided in "Methods" under 5) 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 2a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "With the high prevalence of neck pain and its contribution to prolonged disability in patients, it is essential to identify optimal treatment approaches. Therefore, the aim of this randomized clinical trial is to examine the longterm effects of a combination of manual therapy, exercises, and dry needling to the cervicothoracic region on pain and disability in individuals with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy." Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Therefore, the aim of this randomized clinical trial is to examine the long-term effects of a combination of manual therapy, exercises, and dry needling to the cervicothoracic region on pain and disability in individuals with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy.

2a-ii) ScientiUc background, rationale: What is known about the (type of) system
We hypothesize that patients who receive dry needling, manual therapy, and exercise will achieve greater reductions in pain and disability in the short (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry needling, manual therapy, and exercise." METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Once the baseline examination is complete equal numbers of patients will be randomly assigned to 1 of 2 groups" 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Not applicable as this is a protocol paper.

3b-i) Bug Uxes, Downtimes, Content Changes
Bug Uxes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug Uxes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have inpuenced study design such as staff changes, system failures/downtimes, etc. [2].

Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable as this is a protocol paper.

4a) Eligibility criteria for participants
Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "A combination of physical examination and self-report measures will be used to assess the patient's potential eligibility to participate. Inclusion criteria for the study include age 18 years or older, a primary complaint of neck pain, and a Neck Disability Index > 10 points=20%.
[48] Patient exclusion criteria include: red flags (i.e. tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms), use of blood thinners, history of whiplash injury within the past six weeks, evidence of central nervous system involvement (to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clariUed.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Not applicable as not E-Health study.

4a-ii) Open vs. closed, web-based vs. face-to-face assessments:
Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. ooine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasianonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email conUrmation, phone calls) were used to detect/prevent these.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Each physical therapy clinic upon receiving a patient referral for neck pain attempts to schedule the patient with the therapists that have agreed to assess and treat participants in the trial. Upon arrival for their initial assessments, patients are informed about the potential opportunity to participate in the study if they meet inclusion/ exclusion criteria."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Each physical therapy clinic upon receiving a patient referral for neck pain attempts to schedule the patient with the therapists that have agreed to assess and treat participants in the trial. Upon arrival for their initial assessments, patients are informed about the potential opportunity to participate in the study if they meet inclusion/ exclusion criteria. " "If a patient is determined to have met inclusion/ exclusion criteria they will be asked if they would like to participate in the study. If they choose to provide informed consent each patient will complete the baseline questionnaires as well as the baseline outcome assessments. " 4b) Settings and locations where the data were collected Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Consecutive subjects presenting to Concord Hospital physical therapy clinics (Concord NH, USA), and Franciscan, ST.Francis Health physical therapy clinics (Indianapolis IN, USA) with mechanical neck pain will be screened for eligibility criteria. "

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full not in the ms, or briepy explain why the item is not applicable/relevant for your study No online questionnaires were used. All were paper and were either completed in the clinic or mailed back.
"All outcome assessments will be performed by an individual blind to group assignment and will be at baseline, 4 weeks, 6 months and 1 year. The latter two assessments will be mailed to the patients to improve return rate."

4b-ii) Report how institutional a.liations are displayed
Report how institutional atliations are displayed to potential participants [on ehealth media], as atliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 5) The interventions for each group with sutcient details to allow replication, including how and when they were actually administered

5-i) Mention names, credential, a.liations of the developers, sponsors, and owners
Mention names, credential, atliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conpict of interest" section or mentioned elsewhere in the manuscript).
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Author information and recruitment sites are clearly written. "We will conduct a randomized double blind placebo controlled trial according to the CONSORT guidelines ( Figure 1

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Treatment is standardized for protocol and has not changed.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.

Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "To ensure that the clinicians involved in administering the treatment are familiar with the procedures of the study, they will be required to participate in a two-hour training session. During the training session the manual therapy, exercise, and dry needling techniques will be reviewed to ensure treatments are applied in a standardized manner consistent with the treatment algorithm outlined below. The majority of the training time (1 hour) will be dedicated to ensuring standardization of the application of the dry needling and sham needling techniques. The second hour will be spent reviewing the manual therapy techniques, therapeutic exercises, and algorithms to help standardize their prescription, as well as data collection procedures. Due to the pragmatic nature of this study design even when the treatment algorithm is followed for manual therapy and exercise there will likely be some variation in the interventions selected by each therapist based on each patient's relevant examination findings. As this is a pragmatic trial designed to mimic usual clinical practice, this individualization of a patient's treatment is acceptable and expected. All therapists applying all interventions will be licensed physical therapists who have also completed the required post-graduate training that enables them by their state practice act to utilize dry needling, and who regularly use the technique in practice."

5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing ^owcharts of the algorithms used
Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing powcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientiUc reporting.

Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Treatment Algorithms are included in protocol paper.

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speciUc group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "We will provide a small financial reimbursement for patients as incentive for completion of the 4 week, 6 months, and 1 year follow up in order to assist with compliance and reduce the numbers lost to follow up." subitem not at all important essential Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Patients in both groups will attend physical therapy for 7 treatments over a maximum of 4 weeks. Each treatment session will last for a total of 45 minutes of one on one treatment time with the treating physical therapist. "

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum. Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Patients in both groups will attend physical therapy for 7 treatments over a maximum of 4 weeks. Each treatment session will last for a total of 45 minutes of one on one treatment time with the treating physical therapist." "Manual therapy: 15 minutes, Exercise: 15 minutes, Dry needling: 15 minutes, or Sham dry needling: 15 minutes."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).

Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Patients in both groups will attend physical therapy for 7 treatments over a maximum of 4 weeks. Each treatment session will last for a total of 45 minutes of one on one treatment time with the treating physical therapist."

5-xi) Report any prompts/reminders used
Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability). Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Each patient will be provided with a home exercise log that includes pictures as well as descriptions of all exercises. This exercise log will be used to encourage patient compliance.
The patient will be instructed to maintain usual activity levels within the limits of pain. Advice to maintain usual activity has been found to assist in recovery from neck pain. Patients will be instructed to do all activities that do not increase symptoms, and avoid activities, which aggravate symptoms."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study No co-interventions were utilized.
6a) Completely deUned pre-speciUed primary and secondary outcome measures, including how and when they were assessed Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full on patient's perceived level of functioning and disability.[52-55]" "All outcome assessments will be performed by an individual blind to group assignment and will be at baseline, 4 weeks, 6 months and 1 year. The latter two assessments will be mailed to the patients to improve return rate (Table 1).
[59]" Table 1 outlines when each outcome tool was administered during the trial.

6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed
If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].

Copy and paste relevant sections from manuscript text
None were online surveys.

6a-ii) Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored
Describe whether and how "use" (including intensity of use/dosage) was deUned/measured/monitored (logins, logUle analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. "Each patient will be provided with a home exercise log that includes pictures as well as descriptions of all exercises. This exercise log will be used to encourage patient compliance." Exercise log will be used to help determine dosage of exercise outside of therapy sessions. Dosage of exercise, dry needling and manual therapy is standardized in the treatment protocol at 15 minutes each.

6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained
Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text No qualitative feedback will be asked for.
6b) Any changes to trial outcomes after the trial commenced, with reasons Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA, Protocol paper.
7a) How sample size was determined https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full NPT: When applicable, details of whether and how the clustering by care provides or centers was addressed

7a-i) Describe whether and how expected attrition was taken into account when calculating the sample size
Describe whether and how expected attrition was taken into account when calculating the sample size.

Does your paper address subitem 7a-i?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Sample size and power calculations were performed using G Power statistical software based on the minimal clinical improvement of 12 points on the NDI [55, 72], assuming a standard deviation of 16 points, two-tailed, and an alpha level equal to (P=.05). This requires a minimum sample size of 29 subjects per group. A total of 76 patients with a primary compliant of neck pain who meet the inclusion/exclusion criteria and consent to participate will be enrolled into the study. This sample size will yield greater than 80% power to detect both statistically significant and clinically meaningful changes in the NDI, additionally this will control for drop-outs prior to the 4-week follow-up."

7b) When applicable, explanation of any interim analyses and stopping guidelines
Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "The randomization procedure will be conducted prior to the initiation of the study using a computer program randomizer by an individual not involved in patient recruitment. The randomization will be concealed according to the following procedure. The group assignment will be recorded on a label that will be placed inside an envelope, and the envelope will be sealed. After the baseline examination is complete, the randomization envelope will be handed to a treating therapist and treatment will begin according to group assignment." 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Equal numbers of patients will be randomly assigned to 1 of 2 groups: 1.) dry needling, manual therapy, and exercise (MTEX-Needle group) or 2.) sham dry needling, manual therapy and exercise (MTEX-Sham group). A random number generator will be used to conduct the randomization. The randomization procedure will be conducted prior to the initiation of the study using a computer program randomizer by an individual not involved in patient recruitment. " 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "The randomization will be concealed according to the following procedure. The group assignment will be recorded on a label that will be placed inside an envelope, and the envelope will be sealed. After the baseline examination is complete, the randomization envelope will be handed to a treating therapist and treatment will begin according to group assignment. " 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "The randomization procedure will be conducted prior to the initiation of the study using a computer program randomizer by an individual not involved in patient recruitment." 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment

11a-i) Specify who was blinded, and who wasn't
Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).

2 3 4 5 subitem not at all important essential
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full not in the ms, or briepy explain why the item is not applicable/relevant for your study to which group they were enrolled. An outcome assessing the blinding will be performed upon completion of the treatment. "Patient perception about the intervention to determine whether the sham was an effective placebo: Patient will be asked for their perceptions on the dry needling intervention they received in order to determine if they felt they received genuine treatment. The following questions will be asked: What did you think of the dry needling intervention? Would you be willing to have the dry needling intervention again if you were attending physical therapy? Do you think you received the real dry needling intervention?" 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".

Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study Informed consent is very clear what the item was the intervention of choice (dry needling), vs the comparator (sham needling).

11b) If relevant, description of the similarity of interventions
(this item is usually not relevant for ehealth trials as it refers to similarity of a placebo or sham intervention to a active medication/intervention) Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full same fashion as in the MTEX-needling group by the physical therapist after assessment. Therapists will be asked to sham needle at least 6 sites up to a maximum of 10 but the muscles that are (sham) treated will be left at the discretion of the physical therapist. The number of sites and specific muscles (sham) treated will be recorded by the therapist. Only posterior muscles of the cervical spine and upper thoracic spine, the same muscles targeted in the dry needling group, will be treated in order to ensure patients will be blinded to whether they received the real or sham needling." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Descriptive statistics, including frequency counts for categorical variables and measures of central tendency and dispersion for continuous variables will be calculated to summarize the data. Baseline demographic data will be compared across treatment groups to assess the adequacy of the randomization. We will compare baseline variables between groups by using independent t-tests or Mann-Whitney U tests for continuous data and chi-square tests of independence for categorical data. An intention-to-treat analysis will be utilized, in which all participants will be analyzed in the group to which they were originally assigned. All drop-outs and the reason for dropping out of the study will be reported. An a priori alpha level of 0.05 will be used for all analyses. All data will be checked to ensure they meet the assumptions for the inferential statistical analyses described below. If they do not meet the necessary assumptions, appropriate non-parametric procedures will be utilized. We will examine the primary aim with a 2-way repeatedmeasures analysis of variance (ANOVA) with treatment group (manual therapy, exercise and dry needling vs. manual therapy, exercise, and sham dry needling) as the between subjects independent variables and time (baseline, 4 weeks, 6 months, 12 months) as the within-subjects independent variable. The hypothesis of interest is the 2-way group * time interaction. Bonferroni-corrected post-hoc tests will be used to determine difference between group means."

12a-i) Imputation techniques to deal with attrition / missing values
Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation techniques such as LOCF may also be problematic [4]).
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "An intention-to-treat analysis will be utilized, in which all participants will be analyzed in the group to which they were originally assigned. All drop-outs and the reason for dropping out of the study will be reported. " 12b) Methods for additional analyses, such as subgroup analyses and adjusted analyses Does your paper address CONSORT subitem 12b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA X26) REB/IRB Approval and Ethical Considerations [recommended as subheading under "Methods"] (not a CONSORT item)

X26-i) Comment on ethics committee approval
1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full "Approval of both the Institutional Review Board (IRB) at Concord Hospital (Concord NH, USA) where the trial will be performed and the University of Newcastle Human Research Ethics Committee (Callaghan Australia) where author EG is currently enrolled as a PhD candidate have been obtained."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained ooine or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.

Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "If a patient is determined to have met inclusion/ exclusion criteria they will be asked if they would like to participate in the study. If they choose to provide informed consent each patient will complete the baseline questionnaires as well as the baseline outcome assessments. "

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full Not currently included in the manuscript.

RESULTS
13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 13b) For each group, losses and exclusions after randomisation, together with reasons

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

16-i) Report multiple "denominators" and provide deUnitions
Report multiple "denominators" and provide deUnitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speciUc pre-deUned time points of interest (in absolute and relative numbers per group). Always clearly deUne "use" of the intervention.

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational deUnitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is deUned (e.g., timeout after idle time) [1] (report under item 6a).

Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full NA 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-speciUed from exploratory Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2].

Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA DISCUSSION 22) Interpretation consistent with results, balancing beneUts and harms, and considering other relevant evidence NPT: In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group

22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use)
Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).

Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events. https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full 1 2 3 4 5 subitem not at all important essential Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study assignment, which may influence the verbal and non-verbal interaction with subjects. To try to manage this limitation all therapists will be trained to maximize the consistency with which the dry needling intervention and the sham intervention will be performed.
We have chosen to allow therapists to perform individualized dry needling treatment specific to each patient within the outlined treatment algorithm to be consistent with clinical practice and improve external generalizability. We believe that by providing treatment specific to the patient's presentation will improve outcomes. We understand this may be seen as a limitation as it may lead to variation in the treatments that will be applied by therapists, which may mask the difference between groups. However, individualized treatment better reflects clinical practice.
Another potential limitation is that we are not including physical measures such as range of motion or pain pressure threshold in our analyses. We have chosen to limit our outcomes to validated questionnaires in an effort to decrease loss to follow-up, especially at the long-term tie points." 21) Generalisability (external validity, applicability) of the trial Undings NPT: External validity of the trial Undings according to the intervention, comparators, patients, and care providers or centers involved in the trial

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations 1 2 3 4 5 subitem not at all important essential

Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 21-ii) Discuss if there were elements in the RCT that would be different in a routine application https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
1 2 3 4 5 subitem not at all important essential Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study

23) Registration number and name of trial registry
Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study NA 25) Sources of funding and other support (such as supply of drugs), role of funders Does your paper address CONSORT subitem 25? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study "Funding Organization: Orthopaedic Section of the American Physical Therapy Association "

X27-i) State the relation of the study team towards the system being evaluated
In addition to the usual declaration of interests (Unancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.

Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briepy explain why the item is not applicable/relevant for your study https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_Oim…en_US&formkey=dGlKd2Z2Q1lNSGQ0THl1azM5MS1aWWc6MA&rm=full No conflicts of interest.

About the CONSORT EHEALTH checklist
As a result of using this checklist, did you make changes in your manuscript? * yes, major changes yes, minor changes no What were the most important changes you made as a result of using this checklist?
More clear data on methods.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript * 90 minutes.
As a result of using this checklist, do you think your manuscript has improved? * yes no Other: Would you like to become involved in the CONSORT EHEALTH group?