NCT02620579: BISP

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

Completed Phase 2 Results posted Last updated 20 December 2022

What this trial tests

Phase 2 trial testing Propranolol LA (60 mg) in Shoulder Pain in 264 participants. Completed in 5 November 2021.

Timeline

1 January 2016

Primary endpoint
5 November 2021

5 November 2021

Quick facts

Lead sponsor	Duke University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	264
Start date	1 January 2016
Primary completion	5 November 2021
Estimated completion	5 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Propranolol LA (60 mg) — full drug profile →
• Placebo
• Shoulder Anatomy Education
• Pain Processing Education

Conditions studied

• Shoulder Pain — all drugs for Shoulder Pain →

Sponsor

Duke University

Who can join

Adults 18 to 64, any sex, with Shoulder Pain. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants Who Met the Recovery Criterion for Shoulder Pain Intensity
  Time frame: Approximately 6 days
  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.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Plasma Concentrations of Select Inflammatory Cytokines Predicts Pain Intensity 48 Hours Post-Shoulder Muscle Injury.
   Hedderson WC, Borsa PA, Fillingim RB, Coombes SA, et al · · 2020 · cited 10× · PMID 32675582 · DOI 10.1097/ajp.0000000000000861
2. Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.
   George SZ, Staud R, Borsa PA, Wu SS, et al · · 2017 · cited 9× · PMID 28315479 · DOI 10.1016/j.cct.2017.03.005
3. Biopsychosocial influence on shoulder pain: results from a randomized preclinical trial of exercise-induced muscle injury.
   George SZ, Bishop MD, Wu SS, Staud R, et al · · 2023 · cited 5× · PMID 35604152 · DOI 10.1097/j.pain.0000000000002700
4. Circulating Inflammatory Biomarkers Predict Pain Change Following Exercise-Induced Shoulder Injury: Findings From the Biopsychosocial Influence on Shoulder Pain Preclinical Trial.
   Simon CB, Bishop MD, Wallace MR, Staud R, et al · · 2023 · cited 4× · PMID 37178095 · DOI 10.1016/j.jpain.2023.04.001
5. Pain and Disability Following Exercise-Induced Injury in Prognostic and Intervention Studies: The Why May Be More Important Than the How.
   Bishop MD, George SZ. · · 2023 · cited 1× · PMID 36827192 · DOI 10.1097/ajp.0000000000001097
6. Impact of Propranolol and Psychologically Informed Intervention on Pain Sensitivity: Secondary Analysis from the Biopsychosocial Influence on Shoulder Pain Preclinical Randomized Trial.
   Bishop MD, Simon CB, Huo Y, Wallace MR, et al · · 2025 · PMID 40206234 · DOI 10.2147/jpr.s500140