Recruiting at 1 site No phase Orthopedic Disorder

Orthopedic Disorder study: Web-TIRELESS vs Web-MEUC

Official title Web-based Mind-body Program to Improve Resilience Among Risky Substance Users With Persistent Upper Extremity Pain

ClinicalTrials.gov ID: NCT06991205

What this study is testing

What it's testing
This study is testing whether a web‑based mind‑body program is doable and helpful for people with arm pain and risky substance use.
Who it's for
You may be able to join if you are an adult with ongoing arm pain that isn’t from an injury and you use substances in a risky way.
What's involved
You will use a web program that teaches mind‑body skills. You will also get a basic web‑based care plan. You will fill out online surveys and share your thoughts about the program.
Time commitment
The study lasts about 8 weeks. You will have a few online check‑ins and complete surveys during that time.
  • Time commitment: about 5 weeks
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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 \ 3 and \<27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids...
  • Owns a smartphone, laptop, or computer with internet access

You likely can't join if

  • 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
See the full eligibility criteria
Who can 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 \ 3 and \<27 for cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, tobacco products, and e-cigarette on The World Health Organization's -...
  • 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
What rules you out
  • 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
  • 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.

The study team makes the final eligibility decision.

Where it is enrolling

  • Boston, Massachusetts, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.

How long does this study last?

The study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.