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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Chronic Pain Syndrome; Repetitive Stress Injury
• Intervention / Treatment: Behavioral: Mind-Body Intervention

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Donnino, MD; Phone Number: 617-754-2882; Email: mdonnino@bidmc.harvard.edu
• Study Contact Backup: Name: Ashley Scafetta; Phone Number: 617-754-2882; Email: ascafett@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Contact: Ashley Scafetta; Phone Number: 617-754-2882; Email: ascafett@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Mind-body Intervention; Mind body techniques for the intervention will be taught in lectures and group discussion sessions	Behavioral: Mind-Body Intervention; The mind-body intervention will include regular approximate 2 hour educational sessions and didactics learning mind body techniques. The sessions will be twice per week for the first 4 weeks and then subsequently once per week for a total of 13 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)	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	Baseline, 4 weeks, 8 weeks, 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Function Scale	The Upper Extremity Function Scale is an alternative instrument to the DASH which contains both common and unique evaluation questions.	Baseline, 4 weeks, 8 weeks, 13 weeks
Brief Pain Inventory Questionnaire (Short Form)	The Brief Pain Inventory questionnaire will be utilized to gauge pain intensity during the duration of the study.	Baseline, 4 weeks, 8 weeks, 13 weeks
Pain Anxiety Symptom Scale (short form 20)	The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain.	Baseline, 4 weeks, 8 weeks, 13 weeks
Somatic Symptom Score (SSS-8)	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.	Baseline, 4 weeks, 8 weeks, 13 weeks

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Michael Donnino, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 1, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Sprains and Strains; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Cumulative Trauma Disorders
• Other Study ID Numbers: 2023p000579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No