Mind Body Intervention for Chronic Upper Extremity Pain (Repetitive Stress Injury)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeth Israel Deaconess Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Mind-Body Intervention
BehavioralThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experimental: Mind-body InterventionExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeksSecondary outcomes
1
Upper Extremity Function Scale
The Upper Extremity Function Scale is an alternative instrument to the DASH which contains both common and unique evaluation questions.
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeks2
Brief Pain Inventory Questionnaire (Short Form)
The Brief Pain Inventory questionnaire will be utilized to gauge pain intensity during the duration of the study.
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeks3
Pain Anxiety Symptom Scale (short form 20)
The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain.
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeks4
Somatic Symptom Score (SSS-8)
The 8 question SSS-8 is an abbreviated version of the 15 question Patient Health Questionnaire (PHQ)-15. SSS-8 survey questions pertain to pain, the gastrointestinal system, fatigue, and cardiovascular complaints.
Time frame
Baseline, 4 weeks, 8 weeks, 13 weeksSponsors and contacts
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Source ClinicalTrials.gov