Biopsychosocial Influence on Shoulder Pain

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the investigators identified a genetic and psychological subgroup that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study the investigator proposes to test how interventions tailored to the high risk subgroup affect pain responses in a pre-clinical cohort.

The optimal theorized match for the identified high-risk subgroup is a combination of personalized pharmaceutical and education interventions. This combined personalized intervention versus a placebo pharmaceutical and general education intervention group is the primary comparison of interest. Also, an evaluation of the individual effect of personalized pharmaceutical and educational interventions will be part of the study. Such comparisons will provide important information on what the active portion of the combined personalized intervention may be.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University; University of Florida
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Institutes of Health (NIH)
• Treatments: Propranolol

Criteria

Inclusion Criteria:

• English speaking

Exclusion Criteria:

• chronic pain (> 3 months) in any area,

• currently experiencing neck or shoulder pain,

• previous history of neck or shoulder pain (operationally defined as experiencing neck or shoulder pain for longer than 48 hours or seeking medical treatment for neck or shoulder pain),

• neurological impairment of the in the upper-extremity (determined by loss of sensation, muscle weakness, and reflex changes),

• regular participation in upper-extremity weight training,

• currently or regular use of pain medication, and

• previous history of upper-extremity surgery.

Additional exclusion criteria for propranolol administration are reported history of or presence of any of the following cardiovascular conditions:

• clinically significant abnormal 12-lead ECG,

• sinus bradycardia (resting heart rate below 55 beats per minute),

• greater than first degree heart block,

• cardiac failure,

• coronary artery disease,

• uncontrolled hypertension (resting systolic blood pressure above 140 mm Hg), or hypotension (resting systolic blood pressure below 90 mm Hg),

• Wolff-Parkinson-White syndrome.

Non-cardiovascular reasons for study exclusion include:

• bronchial asthma,

• nonallergic bronchospasm,

• history of recent major surgery requiring general anesthesia,

• diabetes,

• pregnancy,

• major depression.