Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)

Not Applicable

Recruiting

• Conditions: Chronic Pain; Chronic Pain Syndrome; Repetitive Stress Injury

• Registration Number: NCT06903962
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

The goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow).

1. To determine if a mind-body intervention improves upper extremity functional capacity (ie., Disability of Arm Shoulder Hand - DASH) among people with chronic wrist, elbow, and shoulder pain

2. To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.

3. To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Study Start: 2025-03-28
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Adult (≥ 18 years of age)
2. A disability score ≥ 40 as per the QuickDASH survey
3. Presence of pain and perceived disability for a minimum of 3 months
4. Willing to engage in a Mind-Body intervention
5. Positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain)

Exclusion Criteria

1. Clear organic diagnosis of pain (e.g., cancer, infection, etc...) not inclusive of non-specific findings on imaging studies (e.g., mild arthritis)
2. Age greater than 60 years (due to an increased risk of there being an organic/physical cause for their pain and confounding results)
3. Diagnosis of cognitive impairment or dementia
4. Active addiction disorder, e.g. cocaine or IV heroin use, that would interfere with study participation
5. Major psychiatric comorbidity (e.g., schizophrenia). Anxiety and mild-moderate depression are not considered in this category

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)	Baseline, 4 weeks, 8 weeks, 13 weeks	The DASH is a commonly used and validated 38 question survey self-report survey assessing the effects of upper extremity disabling conditions on functional activity, pain, sleep, and other parameters

Secondary Outcome Measures

Name	Time	Method
Upper Extremity Function Scale	Baseline, 4 weeks, 8 weeks, 13 weeks	The Upper Extremity Function Scale is an alternative instrument to the DASH which contains both common and unique evaluation questions.
Brief Pain Inventory Questionnaire (Short Form)	Baseline, 4 weeks, 8 weeks, 13 weeks	The Brief Pain Inventory questionnaire will be utilized to gauge pain intensity during the duration of the study.
Pain Anxiety Symptom Scale (short form 20)	Baseline, 4 weeks, 8 weeks, 13 weeks	The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain.
Somatic Symptom Score (SSS-8)	Baseline, 4 weeks, 8 weeks, 13 weeks	The 8 question SSS-8 is an abbreviated version of the 15 question Patient Health Questionnaire (PHQ)-15. SSS-8 survey questions pertain to pain, the gastrointestinal system, fatigue, and cardiovascular complaints.

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States