Web-TIRELESS for Arm Pain

Overseen By Kozbi B Cliff, BS

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new web-based program to manage arm pain and risky substance use. The program, called Web-TIRELESS, combines mind-body techniques to determine its effectiveness for people with ongoing arm pain not caused by an injury. Participants will be divided into two groups: one will try the Web-TIRELESS program, while the other will receive online educational materials and coping strategies. Suitable candidates have non-traumatic arm pain with a pain level above 4 and engage in risky use of substances like alcohol or cannabis. As an unphased trial, this study provides a unique opportunity to explore innovative pain management strategies and contribute to valuable research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if your psychotropic medications (like antidepressants) have changed in the past 3 months, you may not be eligible to participate.

What prior data suggests that this web-based intervention is safe for patients with arm pain and substance use issues?

Research shows that Web-TIRELESS, an online program focusing on mind and body, is being tested for safety and effectiveness in managing pain and substance use. The program aims to build resilience and assist with long-term pain management. Researchers monitor participants for side effects and assess their progress at various intervals, including immediately after the program and six months later. So far, studies suggest that Web-TIRELESS is well-tolerated, with most participants experiencing no serious problems. While the program remains under study, past research on similar online pain management programs has shown promising results in reducing pain and improving overall well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Web-TIRELESS is unique because it offers a 4-session, web-based mind-body intervention specifically designed to manage arm pain and substance use asynchronously. Unlike traditional treatments that often involve in-person therapy or medication, Web-TIRELESS allows users to engage with the program at their own pace and convenience. Researchers are excited about this approach because it combines pain management with substance use support, potentially addressing both issues simultaneously. This innovative method could offer a more holistic and accessible solution for individuals struggling with these challenges.

What evidence suggests that this trial's treatments could be effective for arm pain?

This trial will compare the Web-TIRELESS program with the Web-MEUC program. Studies have shown that mind-body programs like Web-TIRELESS can enhance resilience and reduce pain. Web-TIRELESS is an online program that teaches skills to manage pain and substance use. Early research suggests that such programs can significantly aid those with chronic pain. Although specific results for Web-TIRELESS are still being collected, it is based on proven methods used in similar pain management programs. This suggests it could be effective for individuals with painful upper-extremity conditions and risky substance use. ^{1 2 6 7 8}

Who Is on the Research Team?

Jafar Bakhshaie, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Risky substance use based on WHO-ASSIST scores (alcohol >10 and <27, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette >3 and <27)

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11667126/

A Web-Based Mind-Body Intervention to Improve Resilience ... We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain ...

2. withpower.com withpower.com/trial/web-tireless-for-arm-pain-4c360

Web-TIRELESS for Arm Pain Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, post-program, and 6-month follow-up. 6 months. 3 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06483035

Treatment of Phantom Limb Pain by Intensive Visual ... The primary aim of the study is to investigate if IVS treatment is superior to usual care in reducing phantom limb pain intensity after 2 months of treatment ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6280998/

Pain Phenotypes and Associated Clinical Risk Factors ... Results. A majority of enrolled patients (64.5%) reported clinically significant pain (pain score ≥3 averaged over previous week). 61% experienced residual limb ...

5. scholars.northwestern.edu scholars.northwestern.edu/en/publications/benchmarking-residual-limb-pain-and-phantom-limb-pain-in-amputees-2

Benchmarking Residual Limb Pain and Phantom ... Background: More than 75% of major limb amputees experience chronic pain; however, data on severity and experience of pain are inconsistent.

6. withpower.com withpower.com/trial/phase-substance-related-disorders-6-2024-b45c7

Web-Based Mind-Body Program for Arm Problems and ... This N/A medical study run by Jafar Bakhshaie is evaluating whether Web-TIRELESS will have tolerable side effects & efficacy for patients with ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06804239

Improving Activity in Adults With Chronic Pain With Online ... Outcomes of interest include measures of activity, sleep, pain and level of use of the online pain-management resource.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37051894/

Online pain management programs for chronic ... This systematic review assessed the effects of online pain management programs in chronic, widespread musculoskeletal conditions on pain measurements.