Clinical trial NCT06903962: Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)
Official title: Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Chronic Pain Syndrome
Repetitive Stress Injury
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
Secondary outcomes:
measure: Upper Extremity Function Scale
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: Brief Pain Inventory Questionnaire (Short Form)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: Pain Anxiety Symptom Scale (short form 20)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
measure: Somatic Symptom Score (SSS-8)
timeFrame: Baseline, 4 weeks, 8 weeks, 13 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Michael Donnino, MD
role: PRINCIPAL_INVESTIGATOR
References: