Biopsychosocial Influence on Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Propranolol LA (60 mg); Placebo; Shoulder Anatomy Education; Pain Processing Education
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 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.; 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.; 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.; 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 intervention name(s): Personalized Pharmaceutical; Placebo Pharmaceutical; General Education; Personalized Education
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Personalized Pharmaceutical; Personalized Education