Chronic Pain, Chronic Pain Syndrome, Repetitive Stress Injury
Conditions
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.
Interventions
BEHAVIORALMind-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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) | 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
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Function Scale | Baseline, 4 weeks, 8 weeks, 13 weeks | The Upper Extremity Function Scale is an alternative instrument to the DASH which contains both common and unique evaluation questions. |
| Brief Pain Inventory Questionnaire (Short Form) | Baseline, 4 weeks, 8 weeks, 13 weeks | The Brief Pain Inventory questionnaire will be utilized to gauge pain intensity during the duration of the study. |
| Pain Anxiety Symptom Scale (short form 20) | Baseline, 4 weeks, 8 weeks, 13 weeks | The short form Pain Anxiety Symptom Scale (PASS-20) is a 20 question survey assessing cognitive, avoidance, fear, and physiological anxiety due to pain. |
| Somatic Symptom Score (SSS-8) | Baseline, 4 weeks, 8 weeks, 13 weeks | 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. |
Countries
United States
Contacts
CONTACTAshley Scafetta
CONTACTMichael Donnino, MD
PRINCIPAL_INVESTIGATORMichael Donnino, MD
Beth Israel Deaconess Medical Center
Outcome results
None listed