Mind-Body Intervention for Repetitive Stress Injury

Overseen By Michael Donnino, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Cancer, Infection, Dementia, Addiction, Schizophrenia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a mind-body approach can help individuals with ongoing pain in their wrists, elbows, or shoulders, often caused by repetitive stress. The study aims to determine if this treatment can improve arm function, reduce pain and anxiety about pain, and lessen overall discomfort. Eligible participants have experienced pain and difficulty using their upper limbs for at least three months and can imagine pain when thinking about performing tasks. Participants will learn mind-body techniques through sessions that include lectures and group discussions. As an unphased trial, this study offers participants the chance to explore innovative techniques that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mind-body intervention is safe for treating upper extremity pain?

Research has shown that mind-body techniques are generally safe for most people. These methods can reduce stress and pain without causing serious side effects. For instance, one study found that about 65% of participants completed the program, indicating it was well-received.

Occasionally, minor issues arose, such as the need for more medication with certain relaxation practices, but these are uncommon. Overall, mind-body practices like yoga and relaxation are considered low-risk and helpful for managing pain and stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mind-body intervention for repetitive stress injury because it focuses on holistic healing rather than conventional medical treatments like medications or physical therapy. This approach uses techniques taught in lectures and group discussions to promote mental and physical wellness, aiming to address both the mind and body simultaneously. Unlike other treatments that primarily target the physical symptoms, this method may help reduce stress and enhance overall well-being, potentially leading to improved recovery and resilience against future injuries.

What evidence suggests that this mind-body intervention is effective for repetitive stress injury?

Research has shown that mind-body practices can help reduce stress and anxiety, benefiting people with arm or hand pain. In past studies, participants felt less depressed and stressed after engaging in mind-body activities, with noticeable improvements. Other studies suggest these practices can also ease work-related stress, especially through activities like yoga. While results can differ, longer programs have shown positive effects on physical health, such as lowering heart rate and blood pressure. This trial will evaluate a mind-body intervention specifically for repetitive stress injuries, aiming to improve pain and movement based on these promising findings. ^{3 6 7 8 9}

Who Is on the Research Team?

Michael Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals experiencing chronic pain in the upper extremities, such as wrist, elbow, or shoulder pain often related to repetitive stress injuries. Participants should be interested in exploring mind-body interventions to alleviate their condition.

Inclusion Criteria

I have been in pain and unable to do some activities for at least 3 months.

I am open to trying mind-body therapy.

Positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain)

Exclusion Criteria

Diagnosis of cognitive impairment or dementia

My pain is due to a clear medical condition like cancer.

Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mind-body intervention techniques taught in lectures and group discussion sessions

13 weeks

Lectures and group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mind-Body Intervention

Trial Overview The study tests a mind-body intervention aimed at improving functional capacity of the arm and reducing pain intensity, anxiety related to pain, and somatic complaints among those with chronic upper extremity pain.

How Is the Trial Designed?

Group I: Experimental: Mind-body Intervention Experimental Treatment 1 Intervention

Mind body techniques for the intervention will be taught in lectures and group discussion sessions

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11172229/

A Pilot Pre-Post Interventional Study - PMC A significantly larger proportion of participants reported no depression or stress post-intervention compared with pre-intervention (p < 0.001, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06903962?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(Repetitive%20Motion%20Disorders))&rank=5

Mind Body Intervention for Chronic Upper Extremity Pain ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-11437-7

Comparing the effectiveness of mind–body practices (MBPs ... Our study suggested MBPs may be the most effective intervention to improve the occupational stress of HCWs. Furthermore, yoga is likely to be the most optimal ...

4. chan.usc.edu chan.usc.edu/msop/research/completed/mbht

Completed Research Mind-Body Interventions in Hand Therapy Results. For all intervention types, anxiety and stress decreased across the treatment session (p < 0.001); no statistically significant changes were noted in ...

5. journals.plos.org journals.plos.org/mentalhealth/article?id=10.1371/journal.pmen.0000332

Physiological outcomes from mind-body resiliency programs ... Longer mind-body programs (8–12 weeks) generally improved resting heart rate and blood pressure while having inconsistent effects on heart rate variability.

6. trialx.com trialx.com/clinical-trials/listings/306648/mind-body-intervention-for-chronic-upper-extremity-pain-repetitive-stress-injury/

Mind Body Intervention for Chronic Upper Extremity Pain ... The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8305779/

Effectiveness of Mind–Body Intervention for Inflammatory ... Attrition from the intervention program was 19%, with 65% of MBI patients and 71% of TAU patients completing the outcome assessments. After 12 ...

8. mdpi.com mdpi.com/2227-9067/8/5/358

Adverse Events of Mind-Body Interventions in Children Relaxation had five adverse events associated with it, including four instances of increased betamimetic medication use [38] and an increase in ...

9. bmjopen.bmj.com bmjopen.bmj.com/content/13/7/e064758

a systematic review and meta-analysis This is the first systematic review of mind-body exercise interventions as a possible means of prevention for post-traumatic stress disorder. We performed a ...