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Biopsychosocial Influence on Shoulder Pain (BISP)

Primary Purpose

Shoulder Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Propranolol LA (60 mg)

Placebo

Shoulder Anatomy Education

Pain Processing Education

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Personalized Pharmaceutical, Personalized Education

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Florida Clinical and Translational Science Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Personalized Pharmaceutical and Education

Placebo Pharmaceutical, General Education

Placebo Pharmaceutical, Personalized Education

Personalized Pharmaceutical, General Education

Arm 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.

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Brief Pain Inventory (BPI) for Pain Duration

The Brief Pain Inventory (BPI) consists of rating pain intensity on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain intensity imaginable). BPI will be recorded daily and the recovery criterion used for this study will be a BPI rating of current pain 0/10 and worst pain rating of less than 2/10. The pain duration is number of days from the date of induced pain to date of recovery. The longer the duration means a worse outcome.

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

The Brief Pain Inventory (BPI) which consists of rating pain intensity on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain intensity imaginable). Participants will rate their current, best, and worst pain intensity on the BPI. This measure will be recorded daily through study completion, an average of 5 days. The worst pain intensity rating at Day 2 (when participants usually had the Peak Shoulder Pain Intensity) is reported.

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

The abridged version of the DASH (the QuickDASH) which consists of 11 functional items, with total scores ranging from 0 (not disability) to 100 (complete disability) will be used to assess upper-extremity disability. The primary outcome will be the highest DASH score recorded during the pain intensity recovery period.

Full Information

NCT ID

NCT02620579

First Posted

November 13, 2015

Last Updated

December 20, 2022

Sponsor

Duke University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02620579

Brief Title

Biopsychosocial Influence on Shoulder Pain

Acronym

BISP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

November 5, 2021 (Actual)

Study Completion Date

November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shoulder Pain

Keywords

Personalized Pharmaceutical, Personalized Education

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

264 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Personalized Pharmaceutical and Education

Arm Type

Experimental

Arm 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.

Arm Title

Placebo Pharmaceutical, General Education

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Placebo Pharmaceutical, Personalized Education

Arm Type

Active Comparator

Arm Description

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

Arm Title

Personalized Pharmaceutical, General Education

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Propranolol LA (60 mg)

Other Intervention Name(s)

Personalized Pharmaceutical

Intervention 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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo Pharmaceutical

Intervention 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.

Intervention Type

Behavioral

Intervention Name(s)

Shoulder Anatomy Education

Other Intervention Name(s)

General Education

Intervention 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.

Intervention Type

Behavioral

Intervention Name(s)

Pain Processing Education

Other Intervention Name(s)

Personalized Education

Intervention 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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Approximately 6 days

Secondary Outcome Measure Information:

Title

Brief Pain Inventory (BPI) for Pain Duration

Description

Time Frame

Daily until recovery criterion met, approximately 5-15 days

Title

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

Description

Time Frame

Day 2 value of the worst pain intensity is reported

Title

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

Description

Time Frame

Daily until recovery criterion met, approximately 5-15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Bishop, PhD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida Clinical and Translational Science Institute

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28315479

Citation

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.

Results Reference

background

PubMed Identifier

30425562

Citation

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.

Results Reference

background

PubMed Identifier

29505689

Citation

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.

Results Reference

background

PubMed Identifier

35604152

Citation

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.

Results Reference

derived

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/28315479

Description

Abstract for citation and access to paper

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Biopsychosocial Influence on Shoulder Pain

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