Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial
Affiliation:
1. Duke Clinical Research Institute, Department of Orthopaedic Surgery, Duke University, Durham, NC 27715, USA;2. Department of Medicine, Univ. of Florida, Gainesville, FL 32610, USA;3. Applied Physiology and Kinesiology, Univ. of Florida, Gainesville, FL 32611, USA;4. Biostatistics, Univ. of Florida, Gainesville, FL 32610, USA;5. Molecular Genetics and Microbiology, UF Genetics Institute, Univ. of Florida, Gainesville, FL 32610, USA;6. Department of Physical Therapy, Univ. of Florida, Gainesville, FL 32610, USA;7. School of Medicine, Saint Louis University, St. Louis, MO 63104, USA;8. Pain Research & Intervention Center of Excellence, Univ. of Florida, Gainesville, FL 32610, USA;1. Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands;2. Interuniversity Cardiology Institute of the Netherlands, Utrecht, The Netherlands;3. Haga Hospital, The Hague, The Netherlands;4. Department of Cardiology, Leiden Medical Center, Leiden, The Netherlands;5. Department of Vascular Medicine, Academic Medical Center, Amsterdam, The Netherlands;6. Department of Cardiology, University Medical Center Groningen, The Netherlands;7. Department of Cardiology, Radboud University Medical Center, The Netherlands;8. Department of Cardiology, University Medical Center Utrecht, The Netherlands;9. Department of Cardiology, VU University Medical Center, Medical Center, The Netherlands;10. Department of Vascular Medicine, Academic Medical Center Amsterdam, The Netherlands;11. Department of Clinical Epidemiology and Biostatistics, Academic Medical Center, Amsterdam, The Netherlands
Abstract:
BackgroundChronic musculoskeletal pain conditions are a prevalent and disabling problem. Preventing chronic musculoskeletal pain requires multifactorial treatment approaches that address its complex etiology. Prior cohort studies identified a high risk subgroup comprised of variation in COMT genotype and pain catastrophizing. This subgroup had increased chance of heightened pain responses (in a pre-clinical model) and higher 12 month post-operatives pain intensity ratings (in a clinical model). This pre-clinical trial will test mechanisms and efficacy of personalized pain interventions matched to the genetic and psychological characteristics of the high-risk subgroup.MethodsPotential participants will be screened for high risk subgroup membership, appropriateness for exercise-induced muscle injury protocol, and appropriateness for propranolol administration. Eligible participants that consent to the study will then be randomized into one of four treatment groups; 1) personalized pharmaceutical and psychological education; 2) personalized pharmaceutical and general education; 3) placebo pharmaceutical and psychological education; 4) placebo pharmaceutical and psychological education. Over the 5-day study period participants will complete an exercise-induced muscle injury protocol and receive study interventions. Pain and disability assessments will be completed daily, with primary outcomes being duration of shoulder pain (number of days until recovery), peak shoulder pain intensity, and peak shoulder disability. Secondary outcomes include inflammatory markers, psychological mediators, and measures of pain sensitivity regulation.ConclusionThis pre-clinical trial builds on prior cohort studies and its completion will provide foundational data supporting efficacy and mechanisms of personalized interventions for individuals that may be at increased risk for developing chronic shoulder pain.Trial registrationClinicalTrials.gov registry, NCT02620579 (Registered on November 13, 2015).
