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Recruiting NCT06903962

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

No phase Interventional Chronic Pain Chronic Pain Syndrome Repetitive Stress Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mind-Body Intervention.
Who it may be relevant to
Registry conditions: Chronic Pain, Chronic Pain Syndrome, Repetitive Stress Injury. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
Secondary outcome measures (4)
  • Upper Extremity Function Scale [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • Brief Pain Inventory Questionnaire (Short Form) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • Pain Anxiety Symptom Scale (short form 20) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]
  • Somatic Symptom Score (SSS-8) [Time frame: Baseline, 4 weeks, 8 weeks, 13 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Beth Israel Deaconess Medical Center — Boston

Identifiers

NCT: NCT06903962 · 2023P000579

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗