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Biopsychosocial Influence on Shoulder Pain (BISP)

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Duke University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT02620579
First received: November 13, 2015
Last updated: May 3, 2017
Last verified: May 2017
  Purpose

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.


Condition Intervention Phase
Shoulder Pain Drug: Propranolol LA (60 mg) Drug: Placebo Behavioral: Shoulder Anatomy Education Behavioral: Pain Processing Education Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Biopsychosocial Influence on Shoulder Pain: a Randomized, Pre-clinical Trial

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Brief Pain Inventory (BPI) for pain duration [ Time Frame: Daily until recovery criterion met, approximately 5-15 days ]
    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). This measure 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.

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) [ Time Frame: Daily until recovery criterion met, approximately 5-15 days ]
    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.

  • Brief Pain Inventory (BPI) for peak shoulder pain intensity (highest daily pain intensity rating) recorded during recovery. [ Time Frame: Daily until recovery criterion met, approximately 5-15 days ]
    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 highest pain intensity rating during that time period will be recorded as the Peak Shoulder Pain Intensity.


Secondary Outcome Measures:
  • Pain Catastrophizing Scale (PCS) [ Time Frame: Daily for 5 days ]
    The PCS is a 13-item instrument which instruction participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification and helplessness. The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52. The PCS subscales are computed by summing the responses to the following items: Rumination: Sum of items 8, 9, 10, 11 Magnification: Sum of items 6, 7, 13 Helplessness: Sum of items 1, 2, 3, 4, 5, 12

  • Tampa Scale of Kinesiophobia (TSK-11) [ Time Frame: Daily for 5 days ]
    The TSK-11 is a 11-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury. The total score ranges between 11 and 44. A higher value on the TSK indicates a high degree of kinesiophobia.

  • Fear of Pain Questionnaire (FPQ) [ Time Frame: Daily for 5 days ]
    The Fear of Pain Questionnaire (FPQ) is a self-report measure of pain-related fear containing 3 subscales. We will be using a shortened 9 item version in this study. Participants rate their anticipation of fear on a 5-point Likert scale ranging from 1 (not at all) to 5 (extreme). The 3 FPQ subscales are summed to create one total score. Higher scores indicate a greater pain-related fear and the lower scores indicate a lesser degree of fear. The overall scores range from 9 - 45.

  • Suprathreshold heat pain responses [ Time Frame: Daily for 5 days ]
    Suprathreshold heat pain response measures will be completed using the Pathway ATS/CHEPS Model (Medoc, Durham NC) unit or the TSA Neurosensory Analyzer (Medoc, Durham NC). The pain responses will be acquired with a VAS response to each stimulus. The VAS will consist of a 10 cm line whose endpoints are designated as 'no pain sensation' and 'the most intense pain sensation imaginable'. Stimuli will be applied to both arms.

  • Pressure pain threshold [ Time Frame: Daily for 5 days ]
    Pressure pain threshold response measures are done using a pressure algometer. A research assistant will apply pressure at 1kg/second through a application tip at the following anatomical locations: deltoid (local) and tibialis anterior (remote). The pressure pain sensitivity will be determined by recording the kg/cm2 when pain is first reported at each location. Trials will be repeated to ensure consistency.

  • Conditioned pain modulation [ Time Frame: Daily for 5 days ]
    The conditioning stimulus will be cold water applied to the right arm for up to 60 seconds, and the testing stimulus will be pressure applied to the tibialis anterior opposite the side of fatigue.

  • Molecular and inflammatory measures [ Time Frame: Daily for 5 days ]
    These measures will capture relevant inflammatory biomarkers. Thus, we plan to perform assays for IL1B, IL6, IL8, and TNFα at baseline, immediately after the exercise-induced injury, and at regular daily intervals. Additional inflammatory or pain regulatory markers may be assessed depending on updates from other ongoing studies.


Estimated Enrollment: 448
Study Start Date: January 2016
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personalized Pharmaceutical and Education
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)
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
Behavioral: Pain Processing Education
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
Placebo Comparator: Placebo Pharmaceutical, General Education
This group will have the placebo pharmaceutical administered orally and receive general shoulder anatomy education modules as the interventions for this arm.
Drug: Placebo
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
Behavioral: Shoulder Anatomy Education
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
Active Comparator: Placebo Pharmaceutical, Personalized Education
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
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
Behavioral: Pain Processing Education
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
Active Comparator: Personalized Pharmaceutical, General Education
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)
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
Behavioral: Shoulder Anatomy Education
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02620579

Contacts
Contact: Warren H. Greenfield, III, MS 352-273-8964 whgiii@phhp.ufl.edu

Locations
United States, Florida
University of Florida Clinical and Translational Science Institute Recruiting
Gainesville, Florida, United States, 32610
Contact: Jason Haugh    352-273-8157    jhaugh@ufl.edu   
Sponsors and Collaborators
Duke University
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Mark Bishop, PhD University of Florida
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02620579     History of Changes
Other Study ID Numbers: Pro00078287
2R01AR055899 ( U.S. NIH Grant/Contract )
Study First Received: November 13, 2015
Last Updated: May 3, 2017

Keywords provided by Duke University:
Personalized Pharmaceutical
Personalized Education

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 21, 2017