Web-TIRELESS for Arm Pain

Overseen By Nadine Levey, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jafar Bakhshaie

Must not be taking: Psychotropic medications

Disqualifiers: Serious mental illness, Suicidal ideation, Pregnancy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jafar Bakhshaie, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with non-traumatic upper-extremity pain who also use substances in a risky manner. Participants should be willing to engage with web-based programs aimed at improving resilience and managing pain.

Inclusion Criteria

I am 18 years old or older.

I have a painful arm condition not caused by injury.

I am an adult seeking care for my hand or arm.

Exclusion Criteria

My psychotropic medication has not changed in the last 3 months.

Serious untreated mental illness (e.g., Schizophrenia)

Suicidal ideation with intent or plan

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

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.

5 weeks

Asynchronous online access

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, post-program, and 6-month follow-up.

6 months

3 assessment points (self-report surveys)

Treatment Details

Interventions

• Web-MEUC
• Web-TIRELESS

Trial Overview The study compares two online interventions: Web-TIRELESS, which is a mind-body program designed to help manage pain and substance use, versus Web-MEUC, which offers basic care information. The goal is to see how feasible and helpful these programs are.

Participant Groups

Group I: Web-TIRELESS Experimental Treatment 1 Intervention

A 4-session, asynchronous, web-based mind-body pain and substance use management intervention.

Group II: Web-MEUC Active Control 1 Intervention

Open access to a web-based pamphlet containing brief, educational information and coping techniques.

Who Is Running the Clinical Trial?

Jafar Bakhshaie

Lead Sponsor

Trials

1

Recruited

10+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+