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

NCT06903962 | Recruiting

• 1 other identifier: 2023P000579
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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. 2.To determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants.
3. 3.To tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.

Conditions

Chronic Pain; Chronic Pain Syndrome; Repetitive Stress Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Upper Extremity Function Scale

  Baseline, 4 weeks, 8 weeks, 13 weeks

• Brief Pain Inventory Questionnaire (Short Form)

  Baseline, 4 weeks, 8 weeks, 13 weeks

• Pain Anxiety Symptom Scale (short form 20)

  Baseline, 4 weeks, 8 weeks, 13 weeks

• Somatic Symptom Score (SSS-8)

  Baseline, 4 weeks, 8 weeks, 13 weeks

Study Arms (1)

Experimental: Mind-body Intervention

EXPERIMENTAL

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

Behavioral: Mind-Body Intervention

Interventions

Mind-Body Intervention BEHAVIORAL

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.

Experimental: Mind-body Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sprains and Strains; Wounds and Injuries

Study Officials

• Michael Donnino, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Scafetta

CONTACT

617-754-2882; ascafett@bidmc.harvard.edu

Michael Donnino, MD

CONTACT

617-754-2882; mdonnino@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Model Details: This is a cohort study in which all participants will receive the mind-body intervention. We will not modify participant medication regimens and no pain or other medication prescriptions will be issued by the research team at any time

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 1, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)