Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06903962
NCT06903962RecruitingNot Applicable

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

Beth Israel Deaconess Medical Center1 site in 1 country40 target enrollmentStarted: March 28, 2025Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
40
Locations
1
Primary Endpoint
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Arms & Interventions

Experimental: Mind-body Intervention

Experimental

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

Intervention: Mind-Body Intervention (Behavioral)

Outcomes

Primary Outcomes

Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Donnino

Professor of Emergency Medicine

Beth Israel Deaconess Medical Center

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Mind Body Intervention for Long COVID-19Long COVIDPost-Acute Sequelae of COVID-19COVID Long-Haul
NCT06045338Beth Israel Deaconess Medical Center180
Recruiting
Not Applicable
Mind-body Medicine for Patients With Malignant Hematological DiseasesHematologic Neoplasms
NCT03735992Universität Duisburg-Essen94
Completed
Phase 2
Mind-Body Therapy for Pain in Ehlers-Danlos SyndromeEhlers-Danlos SyndromePain
NCT00001966National Human Genome Research Institute (NHGRI)40
Completed
Phase 3
Mind Body Intervention for Chronic Lower Back PainChronic Lower Back Pain
NCT01894282Canandaigua VA Medical Center4
Completed
Not Applicable
Live Video Mind-body Treatment to Prevent Persistent Symptoms Following mTBIAnxietyMTBI - Mild Traumatic Brain Injury
NCT05524402Massachusetts General Hospital50