Chronic pain, a condition defined by persistent pain lasting longer than 3 months [1], affects upward of 50 million US adults [2] and is rising in prevalence every year [3]. One-third of individuals with chronic pain report experiencing severe pain [4], about one-third have pain in multiple locations [5], and more than a third have activity-limiting pain [6], indicating a significant toll on life [4]. Indeed, for millions of adults, chronic pain results in reduced productivity, poor quality of life, difficulties with interpersonal relationships, and disability [7,8]. These disturbances are costly to both the individual and the nation, resulting in the loss of billions of dollars each year in health care expenditures and lost productivity [3].

Historically, opioids were often prescribed to treat chronic pain, though prescribing trends have decreased sharply since 2016. For instance, the US national trend analysis of 2014 data revealed that the majority of people taking prescription opioids (79.4%) at that time were taking them long-term [9], a period defined as 90 days or longer. The risk for overdose, misuse, and development of opioid use disorder (OUD) became a growing concern following the declaration of the opioid epidemic as a national public health emergency in 2017 [10]. From 2019 to 2022, the total number of opioid prescriptions decreased by 14.2% (153.6 million in 2019 to 131.8 million in 2022) [11]. Yet, overdose deaths involving prescription opioids remained high, with 8.5 million individuals in the United States reporting opioid misuse in 2022 [12]. While some patients gain durable analgesic benefits from prescription opioids for chronic pain [13], there remains a clear need to provide patients access to the lowest risk pain treatment options.

Nonpharmacologic treatment options have gained substantial clinical attention to optimize pain care at lowest risk. Psychological treatment for chronic pain encompasses a wide variety of interventions focusing on the ability to self-manage pain, pain-related worry, and distress [14]. Multisession cognitive behavioral therapy (CBT), the gold standard psychological therapy for chronic pain [15], has been shown to be effective in reducing pain intensity, pain interference [16], and improving quality of life [17]. Other multisession therapies, such as 8-session acceptance and commitment therapy and 8-session mindfulness-oriented recovery enhancement (MORE), offer slight strategic variations from 8-session CBT and are similarly applied in the management of chronic pain. These pain psychology treatments have shown equivalent effects on pain-related outcomes measures [18] and compatible treatment satisfaction ratings [19,20]. Although MORE was not designed for chronic pain and comorbid OUD, MORE has notably shown effectiveness in reducing opioid craving [21,22]. However, the availability of psychological treatments for chronic pain is limited by a lack of clinicians trained in pain management, time and cost required, and health insurance barriers [3,23]. Furthermore, patients taking medication for OUD (MOUD), including either buprenorphine or methadone, are of specific interest because of their risk for unmanaged pain-triggering relapse. Indeed, patients taking MOUD often have difficulty accessing nonpharmacological treatments and many report unmanaged pain as the primary reason for opioid relapse [24].

Empowered Relief (ER) is a single-session group-based pain relief skills intervention that was developed to reduce treatment burden and increase accessibility to effective low-risk pain care. Results from a randomized controlled 3-arm clinical trial conducted in 263 patients with chronic low back pain revealed that ER was comparable with 8 sessions of CBT [25] in improving pain catastrophizing, pain intensity, pain interference, pain bothersomeness, sleep disturbance, anxiety, depression, and fatigue at 3 months post treatment, with benefits being clinically meaningful. A second randomized controlled trial tested a live-instructor, web-based ER compared with usual care in 105 patients with mixed etiology chronic pain. Results revealed that at 3 months post treatment, ER was superior and significantly reduced pain catastrophizing, pain intensity, pain bothersomeness, anxiety, and sleep disturbance [26]. Digital versions of ER have been used in 2 randomized controlled surgical studies with results showing that it was associated with reduced opioid use after breast cancer surgery [27] and reduced pain up to 3 months after orthopedic trauma surgery [28]. While the collective ER trials are promising, the intervention has not yet been tested as a web-based treatment for people who may have a history of OUD or current OUD, or for people taking medications commonly prescribed for these circumstances. This study is designed to examine whether web-based ER is a plausible and accessible pain treatment option for patients with any chronic pain condition who are receiving methadone or buprenorphine (commonly prescribed medications) for OUD in various clinics in the United States.

This study aims to conduct a single-arm uncontrolled trial to assess the feasibility and preliminary efficacy of a web-based single-session pain education class to participants with chronic pain conditions who are taking methadone or buprenorphine in the United States. We have 3 primary hypotheses. First, we hypothesize that patients with chronic pain who take methadone or buprenorphine will report overall acceptable satisfaction with the brief web-based intervention. Second, we hypothesize that web-based ER will reduce pain metrics (catastrophizing, pain intensity, and pain bothersomeness) as well as sleep disturbance and opioid craving at 1 month post treatment (primary end point) and 3 months post treatment (secondary end point).

We are conducting a single-arm, uncontrolled feasibility clinical trial for patients with chronic pain conditions taking methadone or buprenorphine anywhere in the United States (Figures 1 and 2). All study procedures are performed over the phone or internet (ie, Zoom) and no in-person visits are required. All enrolled participants will attend a web-based ER session. Participants will be assessed for 3 months following the class via web-based surveys. Participants will be surveyed during an initial phone screening; immediately after treatment; 2 weeks; and 1, 2, and 3 months after the class. For clinical outcomes, the primary end point is 1 month (short-term outcomes) and the secondary end point is 3 months (delayed outcomes) post treatment. The primary aim of the study is to report the feasibility of web-based ER using a quantitative treatment satisfaction survey administered immediately post treatment (all participants) and an in-depth qualitative interview with about 10 participants to enhance understanding of patient preferences. The secondary aim is to examine the preliminary efficacy of web-based ER. The secondary outcomes are pain catastrophizing, pain intensity, pain bothersomeness, and sleep disturbance at 1 month and 3 months post treatment. The tertiary outcomes include pain interference, mood, physical function, global impression of change, and cravings at 1 month and 3 months post treatment.

The protocol for this trial has been approved by Stanford institutional review board (IRB; 60855). This research adheres to the Helsinki Declaration’s ethical standards for research involving human subjects. Informed consent will be obtained from all participants prior to study enrollment. Participants are also notified that they can revoke their consent at any time for any reason without any repercussions. Data access will be exclusively limited to the research team members. After data collection is complete and the results have been published, deidentified data will be preserved. Consequently, any future requests for data access will be limited to this deidentified information, implemented after request approval and conducted in accordance with all IRB regulations. Participants will be compensated up to US $145 in the form of Amazon gift cards ranging from US $10 to US $45 each for successful completion of study surveys with prorated compensation possible. Participants who agreed to participate in the 30-minute qualitative interview will be compensated with an additional US $20 Amazon gift card.

Data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data capture tools hosted at Stanford University [29,30]. REDCap is a secure, HIPAA (Health Insurance Portability and Accountability Act) compliant, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture, (2) audit trails for tracking data manipulation and export procedures, (3) automated export procedures for seamless data downloads to common statistical packages, and (4) procedures for data integration and interoperability with external sources. All study measures will be completed using a web-based survey platform unless a participant requests paper-based or telephonic format. All web-based surveys will be completed directly by the participants and sent by email through a secure, participant-specific link.

Participants will be recruited nationally through pain and addiction clinics by patient referral from physicians and clinic staff briefed on the treatment research opportunity. This study invites patients with any chronic pain conditions who are also taking methadone or buprenorphine; we will recruit at least 45 participants completing study measures at the primary end point. Interested individuals will be scheduled to complete a brief phone screening interview with study staff to assess eligibility. Individuals who meet the eligibility criteria will be contacted by phone to complete informed consent and study enrollment. Enrolled participants will complete an assessment of OUD symptoms at this time.

Eligibility criteria include ongoing body pain for more than half of the days for ≥3 months, taking either methadone or buprenorphine, 18 years of age or older, having access to a device with video call capabilities, and verbal English fluency (written English fluency is not required because participants may choose 1 of 3 survey options: web-based, paper, or research coordinator–assisted phone surveys). Furthermore, internet or computer access is not required if referring clinics can accommodate the Zoom (Zoom Technologies Inc) ER group meeting for 2 hours. Individuals who are pregnant or have previously received ER will be excluded for this feasibility study to minimize the incompletion of research tasks during the 3-month study period and maintain the homogeneity of the sample.

ER was developed in 2013 at the Stanford University Division of Pain Medicine with clinician certification workshops initiating at Stanford University in 2019 [29,31]. ER provides an accessible, low-risk ntervention for pain management. The didactic 2-hour class may be delivered to large groups of patients. A certified instructor uses a structured PowerPoint slide deck and instructor manual to deliver content that includes pain neuroscience education, experiential and interactive exercises, 3 core pain management skills, and a guided binaural relaxation audio application that participants download onto their smartphone or other device. Instructors assist participants with the creation of a personalized plan that uses the skills presented in the course and can be implemented outside of the class. ER has been shown as multidimensional benefits to participants with chronic pain conditions with both short-term and long-term effects.

For this study, the ER class will be offered once monthly to small groups that consist of 5-20 participants each. The class is hosted through the Zoom platform. To ensure participant confidentiality, participants’ cameras are off and they are asked to display only first names. Furthermore, the classes are not recorded. Participants can receive the study materials via email or mail and can receive the guided binaural relaxation audio file by direct app download or by email.

Prior research has documented no ER study–related adverse events [25,26]. For this study, participants are asked to report any adverse events or new problems they have experienced since their last survey at each survey time point. The adverse event forms are reviewed by the study staff and a determination is made regarding event severity and whether the event is related to the study or not. Any reported adverse event cases will be discussed in team meetings and reported to the IRB annually. All serious adverse event cases will be evaluated by the study staff and principal investigator (DY) within 24 hours of acknowledgment of the incident and immediately reported to the Stanford IRB.