Web-based program for managing upper extremity pain and substance use

Feasibility Open Pilot of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Nontraumatic Painful Upper Extremity Conditions and Comorbid Risky Substance Use

This study is testing a new online program to help adults with upper body pain and substance use issues learn ways to manage their pain and reduce risky behaviors.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06366633 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the feasibility and acceptability of a web-based mind-body intervention called Web-TIRELESS for adults suffering from non-traumatic painful upper-extremity conditions and risky substance use. Participants will engage in four on-demand video sessions that teach cognitive-behavioral strategies, pain management techniques, and psychoeducation about the relationship between pain and substance use. The study will also include baseline and post-test assessments, along with virtual exit interviews to gather feedback for future improvements. The goal is to refine the program and methodology in preparation for a larger randomized control trial.

Who should consider this trial

Good fit: Ideal candidates are adults with non-traumatic painful upper-extremity conditions and risky substance use who are seeking outpatient care.

Not a fit: Patients currently engaged in specialized substance abuse treatment or practicing mindfulness extensively may not benefit from this program.

Why it matters

Potential benefit: If successful, this program could provide patients with effective strategies to manage pain and reduce substance use.

How similar studies have performed: While similar mind-body interventions have shown promise, this specific approach is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Outpatient adults seeking care in the Hand and Arm Center
2. Diagnosed with a non-traumatic painful upper-extremity condition (NPUC)
3. Pain score \> 4 on the Numerical Rating Scale (NRS)
4. 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 \[WHO-ASSIST\])
5. Owns a smartphone, laptop, or computer with internet access
6. Age ≥18yr
7. English fluency
8. Ability and willingness to participate in a live video focus group and the following asynchronous Web-based intervention

Exclusion Criteria:

1. Participation in mind-body or specialized substance abuse treatment in the past 3 months
2. Practice of mindfulness \>45 minutes/week in the past 3 months
3. Psychotropic medications (e.g. antidepressants) changed in the past 3 months
4. Serious untreated mental illness (e.g., Schizophrenia)
5. Suicidal ideation with intent or plan
6. Pregnancy
7. Secondary gains that may bias motivation (e.g., pending disability claim),
8. Moderate to severe cognitive impairment (score ≥4 on the Short Portable Mental Status Questionnaire (SPMSQ))
9. History of surgery for the presented NPUC within the past 6 months

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Jafar Bakhshaie, MD, PhD — Massachusetts General Hospital
• Study coordinator: Jafar Bakhshaie, MD, PhD

Conditions: Orthopedic Disorder, Nontraumatic Injury, Substance Use, Upper Extremity Problem, Upper Extremity Condition, Risky substance Use, Mindfulness, Nontraumatic conditions