Orthopedic DisorderNCT06991205
Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain
A study testing Web-TIRELESS and Web-MEUC in people with Orthopedic Disorder and Nontraumatic Injury, run by Jafar Bakhshaie at 1 site in United States.
Trial summary
The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopedic Disorder, Nontraumatic Injury, Upper Extremity Pain
- What is being tested?
- Web-TIRELESS and Web-MEUC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatient adults seeking care in the Hand and Arm Center
- Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
- Pain score > 4 on the Numerical Rating Scale (NRS)
- Risky substance use (scores >10 and <27 for alcohol, and >3 and <27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette on The World Health Organization's - Alcohol, Smoking and Substance Involvement Screening Test [WHO-ASSIST])
- Owns a smartphone, laptop, or computer with internet access
- Age ≥18yr
- English fluency
- Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention
Who cannot join
- Participation in mind-body or specialized substance abuse treatment in the past 3 months
- Practice of mindfulness >45 minutes/week in the past 3 months
- Psychotropic medications (e.g. antidepressants) changed in the past 3 months
- Serious untreated mental illness (e.g., Schizophrenia)
- Suicidal ideation with intent or plan
- Pregnancy
Show all 9Show fewer
- Secondary gains that may bias motivation (e.g., pending disability claim),
- Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
- History of surgery for the presented NPUC within the past 6 months OR future plans for surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Principal Investigator, 617-643-7641, jbakhshaie@mgh.harvard.edu
About this study
Official title: Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use
The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use.
Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, and other study materials. [2] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.
Read the detailed description
Aim: Conduct a feasibility randomized controlled trial (RCT) (N=50) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC)-both of which are web-based-among patients with painful nontraumatic upper extremity conditions and comorbid risky substance use (N=50), to demonstrate the feasibility of recruitment procedures and data collection; and the feasibility, credibility, and acceptability (adherence, retention, fidelity, and satisfaction) of Web-TIRELESS and Web-MEUC. We will use this mixed-methods information to assess the primary outcomes and optimize both programs and study methodology in preparation for research.
Participants are randomized to either Web-TIRELESS or Web-MEUC and given access to the respective program for approximately 5 weeks to review and complete the assigned material. Both groups are given education material to help improve pain and substance use urge coping. There are 3 assessment points consisting of self-report surveys: baseline, post-program, and 6-month follow-up.
- Being tested
- Web-TIRELESS, Web-MEUC
- Keywords
- Upper Extremity Problem, Risky substance use, Randomized Controlled Trial (RCT), Mindfulness, Nontraumatic conditions, Chronic pain, Psychiatry, Feasibility
- Medical subject headings
- Musculoskeletal Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-TIRELESSBehavioural
This is a self-administered web-based intervention that consists of 4 on-demand sessions, each ~30 minutes long, that teach mind-body skills, cognitive-behavioral strategies (e.g., reframing, pain and substance use urge surfing), activity pacing, acceptance and commitment skills, and psychoeducation on the association between substance use and pain. The program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive substance use behaviors.
Web-MEUCOther
An educational information web-based pamphlet, containing brief, summarized information tailored for the respective patient population that follows topics including the trajectory of pain and adaptation after non-traumatic painful upper extremity conditions, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living.
| Study group | Role | What they receive |
|---|---|---|
| Web-TIRELESS | Experimental | A 4-session, asynchronous, web-based mind-body pain and substance use management intervention. Receives: Behavioral: Web-TIRELESS |
| Web-MEUC | Active comparator | Open access to a web-based pamphlet containing brief, educational information and coping techniques. Receives: Other: Web-MEUC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Credibility and Expectancy Questionnaire (CEQ)
Assesses the degree to which one believes the intervention will effectively manage their condition, substance use, and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Measured: Baseline (0 Weeks)
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
Participants' satisfaction with treatment received after completion. The score range is 0-12. Higher scores indicate greater satisfaction.
Measured: Post-Test (5 Weeks)
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.
Measured: Post-Test (5 Weeks)
The percent of patients that agree to participate to assess feasibility of recruitment
The percent of eligible patients approached that agree to participate.
Measured: Baseline (0 Weeks)
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
The proportion of Web-TIRELESS participants who complete > or = 3 of 4 sessions.
Measured: Post-Test (5 Weeks)
Adherence to homework
Rate of Web-TIRELESS participant's completion of homework assigned throughout the study.
Measured: Throughout intervention completion, an average of 1 month
Rate of participant's completion of self-report measures to assess feasibility of assessments
Investigators will report number of patients who complete assessments at each time-point.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks)
Adverse Events
Any self-reported or observed negative events related to participation.
Measured: Throughout intervention completion, an average of 1 month
Secondary outcomes (11)
Graded Chronic Pain Scale (GCPS)
Assesses pain severity and pain-related disability. Total scores range from 0 to 10, with higher scores indicating worse pain severity.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Disabilities of the Arm, Shoulder and Hand (DASH)
A 30-item measure that assesses disability severity. Scores range from 0 to 100 with higher scores indicating greater disability.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8a v1.0
An 8-item measure assessing symptoms of depression. Scores range from 8 to 40 with higher scores indicating greater symptom severity
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0
An 8-item measure assessing symptoms of anxiety. Scores range from 8 to 40, with higher scores indicating greater symptom severity.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Pain Catastrophizing Scale (PCS)
Assesses magnification, helplessness, and rumination about pain. Scores range from 0 to 52. Higher scores indicate greater pain catastrophizing.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Pain Anxiety Symptoms Scale - Short Form (PASS-20)
Assesses fear and anxiety related to pain. Scores range from 0 to 100. Higher scores indicate greater pain-related fear and anxiety.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Pain Vigilance and Awareness Questionnaire (PVAQ)
Assesses preoccupation with or attention to pain. Scores range from 16 to 96. Higher scores indicate greater pain vigilance.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Brief Experiential Avoidance Questionnaire (BEAQ)
This measure assesses tendencies to avoid unpleasant internal experiences. Scores range from 15 to 90. Higher scores suggest greater avoidance behaviors.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Current Opioid Misuse Measure (COMM)
Assesses risk for aberrant medication-related behavior in persons with chronic pain. Scores range from 0 to 68. Higher scores indicate greater risk for opioid misuse.
Measured: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
The Timeline Follow Back (TLFB)
Assesses daily estimates of alcohol, cannabis, cigarette, and other drug use during the past week. The range is 0 to 7 days, with higher scores indicating more severe use.
Measured: Throughout intervention completion, an average of 1 month
Numerical Rating Scale (NRS)
Severity of participant's average ans worse pain over the last 3 months using a Likert scale with 0 being no pain and 10 being worst possible pain.
Measured: Eligibility Screening (-1 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start15 Sep 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jafar Bakhshaie
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor-investigator, Jafar Bakhshaie, Massachusetts General Hospital
- Investigators
- Jafar Bakhshaie, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991205
- Sponsor's protocol ID
- 2025P001335
- Other IDs
- 5K23AT012364-03
- Status last verified
- Mar 2026
- First submitted
- 19 May 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility RCT of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Painful Nontraumatic Upper-extremity Conditions and Commorbid Risky Substance Use
- ClinicalTrials.gov ID
- NCT06991205
- Acronym / sponsor ID
- 2025P001335
- Keywords
- Upper Extremity Problem, Risky substance use, Randomized Controlled Trial (RCT), Mindfulness, Nontraumatic conditions, Chronic pain, Psychiatry, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jafar BakhshaieUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator aims to conduct a feasibility randomized controlled trial (RCT) (N=50) to test the feasibility, acceptability, and credibility of an asynchronous web-based mind-body intervention (Toolkit for Resilient Life beyond Pain and Substance Use; Web-TIRELESS) versus web-based minimally enhanced usual care (Web-MEUC) among adult patients with a painful non-traumatic upper-extremity condition(s) (PNUC) and commorbid risky substance use.
Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, and other study materials. [2] Assess the feasibility, acceptability, and credibility of Web-TIRELESS and Web-MEUC in preparation for future research.
Detailed description
Aim: Conduct a feasibility randomized controlled trial (RCT) (N=50) of Web-TIRELESS versus Minimally Enhanced Usual Care (Web-MEUC)-both of which are web-based-among patients with painful nontraumatic upper extremity conditions and comorbid risky substance use (N=50), to demonstrate the feasibility of recruitment procedures and data collection; and the feasibility, credibility, and acceptability (adherence, retention, fidelity, and satisfaction) of Web-TIRELESS and Web-MEUC. We will use this mixed-methods information to assess the primary outcomes and optimize both programs and study methodology in preparation for research.
Participants are randomized to either Web-TIRELESS or Web-MEUC and given access to the respective program for approximately 5 weeks to review and complete the assigned material. Both groups are given education material to help improve pain and substance use urge coping. There are 3 assessment points consisting of self-report surveys: baseline, post-program, and 6-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-TIRELESS | Experimental | Behavioral: Web-TIRELESSA 4-session, asynchronous, web-based mind-body pain and substance use management intervention. |
| Web-MEUC | Active comparator | Other: Web-MEUCOpen access to a web-based pamphlet containing brief, educational information and coping techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatient adults seeking care in the Hand and Arm Center
- Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
- Pain score > 4 on the Numerical Rating Scale (NRS)
- Risky substance use (scores >10 and <27 for alcohol, and >3 and <27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette on The World Health Organization's - Alcohol, Smoking and Substance Involvement Screening Test [WHO-ASSIST])
- Owns a smartphone, laptop, or computer with internet access
Key exclusion criteria (9 listed)
- Participation in mind-body or specialized substance abuse treatment in the past 3 months
- Practice of mindfulness >45 minutes/week in the past 3 months
- Psychotropic medications (e.g. antidepressants) changed in the past 3 months
- Serious untreated mental illness (e.g., Schizophrenia)
- Suicidal ideation with intent or plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-TIRELESSThis is a self-administered web-based intervention that consists of 4 on-demand sessions, each ~30 minutes long, that teach mind-body skills, cognitive-behavioral strategies (e.g., reframing, pain and substance use urge surfing), activity pacing, acceptance and commitment skills, and psychoeducation on the association between substance use and pain. The program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive substance use behaviors. | Behavioural | Web-TIRELESS |
| Web-MEUCAn educational information web-based pamphlet, containing brief, summarized information tailored for the respective patient population that follows topics including the trajectory of pain and adaptation after non-traumatic painful upper extremity conditions, the role of relaxation strategies to manage pain, and the importance of returning to engagement in activities of daily living. | Other | Web-MEUC |
Primary outcome
Credibility and Expectancy Questionnaire (CEQ)
Time frame: Baseline (0 Weeks)
Assesses the degree to which one believes the intervention will effectively manage their condition, substance use, and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.
Client Satisfaction Questionnaire to assess satisfaction with/acceptability of treatment
Time frame: Post-Test (5 Weeks)
Participants' satisfaction with treatment received after completion. The score range is 0-12. Higher scores indicate greater satisfaction.
The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
Time frame: Post-Test (5 Weeks)
This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.
The percent of patients that agree to participate to assess feasibility of recruitment
Time frame: Baseline (0 Weeks)
The percent of eligible patients approached that agree to participate.
Rate at which program was accepted, measured by attendance to assess acceptability of treatment
Time frame: Post-Test (5 Weeks)
The proportion of Web-TIRELESS participants who complete > or = 3 of 4 sessions.
Adherence to homework
Time frame: Throughout intervention completion, an average of 1 month
Rate of Web-TIRELESS participant's completion of homework assigned throughout the study.
Rate of participant's completion of self-report measures to assess feasibility of assessments
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks)
Investigators will report number of patients who complete assessments at each time-point.
Adverse Events
Time frame: Throughout intervention completion, an average of 1 month
Any self-reported or observed negative events related to participation.
11 secondary outcomes
Graded Chronic Pain Scale (GCPS)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress - Depression-Short Form 8a v1.0
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
PROMIS Emotional Distress - Anxiety-Short Form 8a v1.0
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Pain Anxiety Symptoms Scale - Short Form (PASS-20)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Pain Vigilance and Awareness Questionnaire (PVAQ)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Brief Experiential Avoidance Questionnaire (BEAQ)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
Current Opioid Misuse Measure (COMM)
Time frame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (6 Months)
The Timeline Follow Back (TLFB)
Time frame: Throughout intervention completion, an average of 1 month
Numerical Rating Scale (NRS)
Time frame: Eligibility Screening (-1 Weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jafar Bakhshaie, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-TIRELESS and Web-MEUC in people with Orthopedic Disorder and Nontraumatic Injury, run by Jafar Bakhshaie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jafar Bakhshaie, MD, PhD (617-643-7641, jbakhshaie@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Credibility and Expectancy Questionnaire (CEQ) (time frame: Baseline (0 Weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.