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

NCT ID: NCT06903962

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-28
• Study Completion Date: 2027-06-01

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.

Conditions

Chronic Pain; Chronic Pain Syndrome; Repetitive Stress Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Mind-body Intervention

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

Group Type: EXPERIMENTAL

Mind-Body Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Donnino

Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Donnino, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Samuel Kukler

Role: CONTACT

skukler@bidmc.harvard.edu

617-754-2882

Michael Donnino, MD

Role: CONTACT

mdonnino@bidmc.harvard.edu

617-754-2882

Facility Contacts

Samuel Kukler

Role: primary

skukler@bidmc.harvard.edu

617-754-2882

Other Identifiers

2023P000579

Identifier Type: -

Identifier Source: org_study_id