All trial procedures involved in this study were approved by the medical research ethics review committee of the General Hospital of Ningxia Medical University (approval number KYLL-2025-0083, Yinchuan, China, date: January 24, 2025) and prospectively registered at the International Traditional Medicine Clinical Trial Registration platform (registration number ITMCTR2025001377) [19]. The trial will follow the CONSORT (Consolidated Standards of Reporting Trials) guidelines and fulfill the requirements of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist (Checklist 1). All interested participants will be required to sign the written informed consent form with a clear understanding of the study before participation and clearly understand all the contents and processes of the study.

This is a single-center, randomized, controlled, parallel-group, assessor- and analyst-blinded, superiority trial comparing Tuina therapy versus ESWT in patients with NNP. The trial will be conducted at the General Hospital of Ningxia Medical University. Eligible participants will be randomly assigned in a 1:1 ratio to either the Tuina group or the ESWT group. Both groups will receive their respective intervention in addition to standardized exercise therapy over a 4-week treatment period, followed by a 4-week follow-up (total study duration: 8 wk). The flowchart of the trial process is shown in Figure 2, and the trial period is shown in Figure 3.

Any important protocol modifications will be submitted to the Medical Ethics Committee for approval prior to implementation. Amendments will be updated in the clinical trial registry and communicated to all study personnel through meetings or written notifications. If modifications affect the rights, safety, or willingness of participants to continue, the informed consent form will be updated and participants will be reconsented.

All participants will be recruited through hospital social network media (WeChat) information, hospital posters, and the outpatient department of rehabilitation medicine. According to the diagnostic criteria, inclusion criteria, and exclusion criteria, patients with NNP were screened out.

Diagnosis of NNP was based on the 2014 Canadian evidence-based guidelines for chiropractic therapy in the treatment of adult neck pain and the consensus plan for clinical diagnosis and treatment of NNP through muscle massage (2024 edition) [20,21]: (1) pain located in the anatomical region of the cervical spine; (2) no specific cause such as trauma, infection, tumor, or neuropathy; (3) may or may not be accompanied by headache, restricted cervical motion, or stiffness in one or more directions.

Participants will be eligible if they meet all of the following criteria: (1) meet the above diagnostic criteria; (2) age 18 to 60 years old, gender unlimited; (3) 3 points ≤ visual analog scale (VAS) ≤ 5 points; (4) pain duration for more than 3 weeks (ie, beyond the acute phase as defined by the DEGAM S3 [German Society of General Practice and Family Medicine] guideline), which classifies acute neck pain as 0 to 3 weeks [22]; and (5) voluntary participation with signed informed consent.

Participants will be excluded if they have any of the following conditions: (1) history of neck trauma, surgery, or tumor; (2) severe cardiac, cerebral, renal, hepatic, or other major organ diseases, mental or behavioral disorders, or inability to cooperate; (3) receipt of Tuina, ESWT, opioid analgesics, antispasmodic analgesics, or anti-inflammatory analgesics within 3 months before enrollment; (4) a confirmed history of infection or familial genetic disease; and (5) pregnant or breastfeeding women.

Participants will be withdrawn if they (1) have incomplete treatment or missing data, (2) experience serious adverse events (SAEs) that prevent further intervention, and (3) show worsening of the condition or are diagnosed with another serious illness during the study period.

A computer-generated random allocation sequence will be prepared by an independent statistician using IBM SPSS 26.0. We will use randomly permuted blocks of varying sizes (2, 4, and 6) to ensure balance between the 2 groups over time and to reduce predictability. A total of 58 subjects will be randomized in a 1:1 ratio to the Tuina group or the ESWT group.

Allocation concealment will be achieved using sequentially numbered, opaque, sealed envelopes. The envelopes will be prepared by an independent statistician who generates the sequence and will be stored in a locked cabinet accessible only to a designated research coordinator who is not involved in participant recruitment, intervention delivery, or outcome assessment. After a participant completes the baseline assessment and signs informed consent, the next sequentially numbered envelope will be opened by the coordinator to reveal the group assignment. The use of envelopes with identical appearances and sequential numbering prevents any foreknowledge of upcoming allocations. Owing to the nature of the interventions, it is not feasible to blind participants or the therapists delivering Tuina and ESWT. This unavoidably introduces the potential for performance bias and expectation bias in self-reported outcomes. To mitigate these risks, we will implement the following measures:

After the trial, data will be entered into the database according to subject codes, and the database will be locked after verification. Unblinding will be performed by the project administrator only after all data analyses are completed, at which point the group codes will be revealed.

All interventions will be delivered over a 4-week treatment period, with follow-up assessments conducted 4 weeks after treatment completion. Both groups will receive the same standardized exercise therapy and self-stretching relaxation program. The Tuina group will additionally receive 3-step Tuina therapy, and the ESWT group will additionally receive ESWT. All procedures take place in the treatment room of the Department of Rehabilitation Medicine, General Hospital of Ningxia Medical University. In order to improve the compliance of the subjects, the subjects will receive treatment and related assessment and examination free of charge.

Participants will receive enrollment education on the importance of treatment compliance, appointment reminders 24 hours before each session, flexible scheduling with transportation subsidies, and a treatment log cosigned by the participant and practitioner after each session. Adherence will be monitored through (1) treatment logs cosigned by participant and practitioner after each session, (2) attendance recorded in case report forms, (3) home exercise logs reviewed weekly, and (4) appointment reminders sent 24 hours before each session. Nonadherence thresholds are predefined: participants missing more than 20% of scheduled sessions (ie, ≥3 Tuina sessions or ≥2 ESWT sessions) or completing less than 70% of the prescribed home exercise program will be classified as nonadherent. A per-protocol analysis will be conducted in addition to the intention-to-treat (ITT) analysis. Treatment parameters in the ESWT group will be randomly audited every 2 weeks to ensure protocol consistency.

All interventions will be performed by qualified practitioners. Tuina manipulations will be delivered by practitioners holding a Physician Qualification Certificate and a Physician Practice License in Traditional Chinese Medicine, Acupuncture-Tuina, or Rehabilitation Medicine, with at least 3 years of clinical experience in Tuina. ESWT will be administered by practitioners holding a Physician Qualification Certificate and a Physician Practice License or a nationally recognized rehabilitation therapist certificate, who have completed specialized shock wave training and possess at least 1 year of clinical experience in shock wave therapy. Prior to study initiation, all intervention providers will undergo standardized training on the study protocol and pass a competency assessment. Ongoing quality monitoring will be conducted quarterly throughout the study.

Patients can choose to withdraw from the study at any time. Any significant improvement or deterioration in the condition of a participant, including adverse events (AEs), will be monitored throughout the trial. AEs will be reported to the principal investigator (PI), who will monitor the affected participants and investigate the potential causes.

To ensure comparability, the exercise therapy and self-stretching relaxation training are fully standardized across both groups. The program consists of (1) cervical isometric exercises (flexion, extension, lateral flexion, and rotation, each held for 10 s, 10 repetitions per direction); (2) upper trapezius and levator scapulae self-stretching (30 s per muscle, 3 repetitions each); and (3) postural reeducation. This session is performed at each treatment visit and prescribed as a daily home program. Adherence to the home program is recorded in a self-reported log. Because the exercise component is identical for both groups, any between-group differences observed at the end of the trial can be attributed to the added Tuina or ESWT rather than to the exercise itself. In the primary analysis, group allocation will be the independent variable, and the exercise protocol is considered part of the standard background care that is balanced by randomization.

The most commonly used methods for the treatment of NNP were loosening tendons, pulling tendons, and smoothing tendons. The treatment was performed 3 times a week for a total of 4 weeks. The operation time and key points of each technique are shown in Table 1.

The 3 manipulations are applied with distinct depth and force characteristics:

The force ranges are based on published biomechanical data on cervical Tuina. The end point of force application is the patient’s subjective sensation of soreness and distension (deqi-like sensation) without sharp pain. Each session lasts approximately 20 to 30 minutes, including brief rest intervals between techniques.

ESWT will be performed using a Swiss Storz extracorporeal shock wave therapeutic apparatus (MP50). The MP50 device delivers radial (dispersive) shock waves, characterized by a divergent wave pattern that distributes energy over a broader, more superficial tissue area. Each session will deliver 2000 shocks at a pressure of 1.5 to 2.0 bar and a frequency of 10 to 12 Hz, with moderate handle pressure. Based on the pressure range and radial wave characteristics, the estimated energy flux density ranges from 0.10 to 0.20 mJ/mm², which falls within the medium-energy category as defined by international consensus guidelines (medium estimated energy flux density: 0.08‐0.28 mJ/mm²). The therapy will target tender points and the surrounding soft tissues. Treatment will be administered on days 1, 5, 10, 15, 20, 25, and 30.

The efficacy of the intervention will be evaluated using the improvement rates of the VAS for pain intensity and the NDI for functional status. The percentage improvement for both measures will be calculated as (baseline score−posttreatment score)/baseline score×100%. Clinical response will be classified into 3 categories based on simultaneous satisfaction of both criteria: markedly effective (VAS improvement ≥50% and NDI improvement ≥50%), effective (VAS improvement ≥30% and <50%, NDI improvement ≥30% and <50%), and ineffective (VAS improvement <30% and NDI improvement <30%). If a patient meets different classification levels across the 2 measures, the lower classification will be assigned. The overall clinical effective rate will be calculated as (number of markedly effective cases+number of effective cases)/total number of eligible cases×100%. The threshold of 30% improvement represents the minimum clinically important difference established for both VAS and NDI in patients with neck pain, while the 50% threshold represents substantial clinical benefits, indicating a truly successful outcome [23-25].

Data will be collected using printed case report forms and entered into an electronic case report form by independent researchers in a timely manner. Paper case report forms will be stored in a locked cabinet in the researcher’s office, and the electronic dataset will be deidentified and locked. Access to these records will be limited to authorized data administrators and statisticians. All study documents will be retained for at least 5 years after publication.

Following the ITT principle, all randomized participants will be included in the final analysis. For participants who discontinue the intervention or deviate from the protocol, primary and secondary outcome data will still be collected at scheduled time points whenever possible, AEs will be continuously monitored, and detailed reasons for discontinuation or deviation will be documented.

The sample size was calculated using G*Power (version 3.1.9.7; Heinrich Heine University Düsseldorf). The primary outcome is the change in VAS score from baseline to week 4. Based on published literature, the minimal clinically important difference for VAS is 1.5 points, with a pooled SD of 1.8 points, yielding an effect size (Cohen d) of 0.83 [26,27]. Using a 2-independent-samples t test with a 2-sided significance level of α=.05 and power (1-β)=0.80, the required sample size is 24 per group (48 in total), with an actual power of 81.2%. Allowing for a 15% dropout rate, the final sample size is set at 29 per group (58 in total).