Biopsychosocial Influence on Shoulder Pain

NCT02620579 | Completed Phase 2 Results

• 2 other identifiers: Pro000782872R01AR055899
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Personalized Pharmaceutical; Personalized Education

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity

  The outcome has a range between 0 and 1, the higher scores mean a better outcome. Successful recovery was determined based on meeting the recovery criterion for shoulder pain intensity by at least 6 days. Specifically, recovery (Yes or No) was defined using Brief Pain Inventory (BPI) ratings as a current pain intensity rating of 0/10 and a worst pain intensity rating of less than 2/10.

  Approximately 6 days

Secondary Outcomes (3)

• Brief Pain Inventory (BPI) for Pain Duration

  Daily until recovery criterion met, approximately 5-15 days

• Brief Pain Inventory (BPI) for Worst Shoulder Pain Intensity (Highest Daily Pain Intensity Rating) Recorded During Recovery.

  Day 2 value of the worst pain intensity is reported

• Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)

  Daily until recovery criterion met, approximately 5-15 days

Study Arms (4)

Personalized Pharmaceutical and Education

EXPERIMENTAL

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.

Drug: Propranolol LA (60 mg); Behavioral: Pain Processing Education

Placebo Pharmaceutical, General Education

PLACEBO COMPARATOR

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

Drug: Placebo; Behavioral: Shoulder Anatomy Education

Placebo Pharmaceutical, Personalized Education

ACTIVE COMPARATOR

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

Drug: Placebo; Behavioral: Pain Processing Education

Personalized Pharmaceutical, General Education

ACTIVE COMPARATOR

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

Drug: Propranolol LA (60 mg); Behavioral: Shoulder Anatomy Education

Interventions

Propranolol LA (60 mg) DRUG

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.

Also known as: Personalized Pharmaceutical

Personalized Pharmaceutical and Education; Personalized Pharmaceutical, General Education

Placebo DRUG

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.

Also known as: Placebo Pharmaceutical

Placebo Pharmaceutical, General Education; Placebo Pharmaceutical, Personalized Education

Shoulder Anatomy Education BEHAVIORAL

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.

Also known as: General Education

Personalized Pharmaceutical, General Education; Placebo Pharmaceutical, General Education

Pain Processing Education BEHAVIORAL

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.

Also known as: Personalized Education

Personalized Pharmaceutical and Education; Placebo Pharmaceutical, Personalized Education

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking

You may not qualify if:

• 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.
• 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.
• bronchial asthma,

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Florida Clinical and Translational Science Institute

Gainesville, Florida, 32610, United States

Location

Related Publications (4)

• George SZ, Staud R, Borsa PA, Wu SS, Wallace MR, Greenfield WH, Mackie LN, Fillingim RB. Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial. Contemp Clin Trials. 2017 May;56:9-17. doi: 10.1016/j.cct.2017.03.005. Epub 2017 Mar 14.

  PMID: 28315479 BACKGROUND

• Borsa PA, Parr JJ, Wallace MR, Wu SS, Dai Y, Fillingim RB, George SZ. Genetic and psychological factors interact to predict physical impairment phenotypes following exercise-induced shoulder injury. J Pain Res. 2018 Oct 23;11:2497-2508. doi: 10.2147/JPR.S171498. eCollection 2018.

  PMID: 30425562 BACKGROUND

• Butera KA, George SZ, Borsa PA, Dover GC. Prolonged Reduction in Shoulder Strength after Transcutaneous Electrical Nerve Stimulation Treatment of Exercise-Induced Acute Muscle Pain. Pain Pract. 2018 Nov;18(8):954-968. doi: 10.1111/papr.12690. Epub 2018 Apr 6.

  PMID: 29505689 BACKGROUND

• George SZ, Bishop MD, Wu SS, Staud R, Borsa PA, Wallace MR, Greenfield WH 3rd, Dai Y, Fillingim RB. Biopsychosocial influence on shoulder pain: results from a randomized preclinical trial of exercise-induced muscle injury. Pain. 2023 Feb 1;164(2):305-315. doi: 10.1097/j.pain.0000000000002700. Epub 2022 May 23.

  PMID: 35604152 DERIVED

Related Links

• Abstract for citation and access to paper

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This trial did not include participants with a clinical conditions. Instead, participants were recruited into this trial and shoulder pain was induced via exercise-induced muscle injury. We then randomly assigned them to 4 different arms, and tested for differences in recovery.

Results Point of Contact

• Title: Dr. Samuel S. Wu
• Organization: University of Florida

samwu@biostat.ufl.edu

3522945910

Study Officials

• Mark Bishop, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2016
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: January 13, 2023
• Results First Posted: January 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)