Biopsychosocial Influence on Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Intervention: Propranolol LA (60 mg); Placebo; Shoulder Anatomy Education; Pain Processing Education
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.; 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.
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Personalized Pharmaceutical; Personalized Education

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.
    

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.