Biopsychosocial Influence on Shoulder Pain

Biopsychosocial Influence on Shoulder Pain: a Randomized, Pre-clinical Trial

Sponsors

Lead Sponsor: Duke University

Collaborator: National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Source Duke University
Brief 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.

Detailed Description

Potential subjects will be screened and those meeting the high-risk criteria based on COMT genotype for high pain sensitivity and pain catastrophizing questionnaire score will be eligible for randomization into intervention groups (stratified by sex). Exercise induced shoulder injury will serve as the pain generating mechanism on Day 1 and participants will receive pharmaceutical and education interventions over Days 1-4, and Days 2-4 respectively. Statistical analysis will determine whether the combined personalized intervention group experienced shorter shoulder pain duration, lower peak pain intensity, or decreased upper-extremity disability and determine which molecular, psychological, and pain sensitivity regulation mechanisms are associated with pain relief. A preliminary analysis is planned after the first 300 subjects are equally randomized to the 4 intervention groups. The comparison of interest for the preliminary analysis is the combined personalized intervention group with the placebo and general education group for the primary outcome. Depending on the results of this preliminary analysis the randomization pattern may change, with details of these changes available in the protocol paper.

Overall Status Recruiting
Start Date January 2016
Completion Date April 2021
Primary Completion Date April 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Brief Pain Inventory (BPI) for pain duration Daily until recovery criterion met, approximately 5-15 days
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) Daily until recovery criterion met, approximately 5-15 days
Brief Pain Inventory (BPI) for peak shoulder pain intensity (highest daily pain intensity rating) recorded during recovery. Daily until recovery criterion met, approximately 5-15 days
Secondary Outcome
Measure Time Frame
Pain Catastrophizing Scale (PCS) Daily for 5 days
Tampa Scale of Kinesiophobia (TSK-11) Daily for 5 days
Fear of Pain Questionnaire (FPQ) Daily for 5 days
Suprathreshold heat pain responses Daily for 5 days
Pressure pain threshold Daily for 5 days
Conditioned pain modulation Daily for 5 days
Molecular and inflammatory measures Daily for 5 days
Enrollment 448
Condition
Intervention

Intervention Type: Drug

Intervention Name: Propranolol LA (60 mg)

Description: Long-acting propranolol (Propranolol LA) 60 mg to be administered orally daily for Days 1 (before exercise induced muscle injury) and Days 2-4 following exercise induced muscle injury.

Other Name: Personalized Pharmaceutical

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo capsules will be prepared by the University of Florida Investigational Drug Service to be visually indistinguishable from the active medication and delivered orally. Placebo administration will be done in the same fashion as propranolol - administered on Days 1 (before exercise induced muscle injury) and the Days 2-4 after the exercise induced muscle injury.

Other Name: Placebo Pharmaceutical

Intervention Type: Behavioral

Intervention Name: Shoulder Anatomy Education

Description: Shoulder anatomy education modules will be administered Days 2-4 (after exercised induced muscle injury) following exercise enhance injury with the goal of participant understanding shoulder anatomy and injury while reviewing: a) structure and arthrokinematics of the shoulder joint; b) muscle anatomy of the shoulder with emphasis on the rotator cuff; and c) potential shoulder pain generators from the exercise-induced injury. This education component will be devoid of information related to pain signaling and cognitive restructuring that characterizes Pain Processing Education modules. These education modules will be scripted and structured so they are provided in a standardized manner for all subjects.

Other Name: General Education

Intervention Type: Behavioral

Intervention Name: Pain Processing Education

Description: Pain processing education modules will be administered Days 2-4 (after exercised induced muscle injury) following exercise enhance injury with the goal of better understanding of pain processing and psycho-education. This information will encourage shoulder activation by: a) reducing the threat of muscle injury; b) encouraging normal use of the shoulder and arm; and c) addressing specific concerns expressed by the subject (e.g. pain with shoulder motion is a sign of re-injury). This education component will be devoid of detailed information on shoulder anatomy, movement, and injury that characterizes the Shoulder Anatomy Education modules. These education modules will be scripted and structured so they are provided in a standardized manner for all subjects.

Other Name: Personalized Education

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Mark Bishop, PhD Principal Investigator University of Florida
Overall Contact

Last Name: Warren H. Greenfield, III, MS

Phone: 352-273-8964

Email: [email protected]

Location
Facility: Status: Contact: University of Florida Clinical and Translational Science Institute Jason Haugh 352-273-8157 [email protected]
Location Countries

United States

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Personalized Pharmaceutical and Education

Type: Experimental

Description: This group will have propranolol (Propranolol LA) 60 mg administered orally and receive the pain processing education modules as the combined intervention for this arm.

Label: Placebo Pharmaceutical, General Education

Type: Placebo Comparator

Description: This group will have the placebo pharmaceutical administered orally and receive general shoulder anatomy education modules as the interventions for this arm.

Label: Placebo Pharmaceutical, Personalized Education

Type: Active Comparator

Description: This group will have the placebo pharmaceutical administered orally and receive the pain processing education modules as the combined intervention for this arm.

Label: Personalized Pharmaceutical, General Education

Type: Active Comparator

Description: This group will have propranolol (Propranolol LA) 60 mg administered orally and receive general shoulder anatomy education modules as the interventions for this arm.

Acronym BISP
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov