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Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.

ABSTRACT: Chronic 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 12month 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.Potential 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.This 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.ClinicalTrials.gov registry, NCT02620579 (Registered on November 13, 2015).

SUBMITTER: George SZ

PROVIDER: S-EPMC5484407 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.

George Steven Z SZ Staud Roland R Borsa Paul A PA Wu Samuel S SS Wallace Margaret R MR Greenfield Warren H WH Mackie Lauren N LN Fillingim Roger B RB

Contemporary clinical trials 20170314

<h4>Background</h4>Chronic 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 12month post-operatives pain intensity ratings (in a clinical ...[more]

PMID: 28315479

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Project description:UnlabelledChronic pain is influenced by biological, psychological, social, and cultural factors. The current study investigated potential roles for combinations of genetic and psychological factors in the development and/or maintenance of chronic musculoskeletal pain. An exercise-induced shoulder injury model was used, and a priori selected genetic (ADRB2, COMT, OPRM1, AVPR1 A, GCH1, and KCNS1) and psychological (anxiety, depressive symptoms, pain catastrophizing, fear of pain, and kinesiophobia) factors were included as predictors. Pain phenotypes were shoulder pain intensity (5-day average and peak reported on numerical rating scale), upper extremity disability (5-day average and peak reported on the QuickDASH), and shoulder pain duration (in days). After controlling for age, sex, and race, the genetic and psychological predictors were entered as main effects and interaction terms in separate regression models for the different pain phenotypes. Results from the recruited cohort (N = 190) indicated strong statistical evidence for interactions between the COMT diplotype and 1) pain catastrophizing for 5-day average upper extremity disability and 2) depressive symptoms for pain duration. There was moderate statistical evidence for interactions for other shoulder pain phenotypes between additional genes (ADRB2, AVPR1 A, and KCNS1) and depressive symptoms, pain catastrophizing, or kinesiophobia. These findings confirm the importance of the combined predictive ability of COMT with psychological distress and reveal other novel combinations of genetic and psychological factors that may merit additional investigation in other pain cohorts.PerspectiveInteractions between genetic and psychological factors were investigated as predictors of different exercise-induced shoulder pain phenotypes. The strongest statistical evidence was for interactions between the COMT diplotype and pain catastrophizing (for upper extremity disability) or depressive symptoms (for pain duration). Other novel genetic and psychological combinations were identified that may merit further investigation.

Project description:Shoulder surgery is a primary intervention for shoulder pain, yet many individuals experience persistent postoperative pain. Previously, we found individuals categorized as having a high-risk phenotype (comprised of COMT variation and pain catastrophizing) had approximately double the chance of not reaching a 12-month pain recovery criterion. As a means to better understand the development of persistent postoperative shoulder pain, this study advanced our previous work by examining temporal ordering of postoperative shoulder recovery based on potential mediating factors, and expansion of outcomes to include movement-evoked pain and shoulder active range of motion. Before surgery, individuals were categorized as either high-risk (high pain catastrophizing, COMT-genotype linked to low enzyme activity [n = 41]) or low-risk (low pain catastrophizing, COMT-genotype linked to normal enzyme activity [n = 107]). We then compared potential mediating variables at 3, 6, and 12 months postoperatively 1) endogenous pain modulation defined by a conditioned pain modulation paradigm; and 2) and emotion factors such as anxiety, fear of movement, and depressive symptoms. At 3 months, the high-risk subgroup had higher fear and movement-evoked pain, and causal mediation analysis confirmed the direct effect of risk subgroup on 12-month movement evoked pain. However, baseline to 12-month change in depressive symptoms were found to mediate 53% of the total effect of risk subgroup on 12-month movement-evoked pain. This study introduces potential temporal components and relationships to the development of persistent postoperative shoulder pain, which future studies will confirm and assess for potential therapeutic targets. PERSPECTIVE: This study expands upon postoperative shoulder recovery measures to include movement-evoked pain and depressive symptoms, and provides preliminary indication of temporal ordering to postoperative shoulder recovery for a preidentified high-risk subgroup. Future studies will distinguish temporal components of shoulder surgery that may optimize treatment targets of postoperative recovery.

Project description:IntroductionLifetime prevalence of shoulder pain is 70%, and approximately 50% of people with shoulder pain will experience pain for more than a year. Rotator cuff-related shoulder pain (RCRSP) is the most common shoulder condition and the main non-surgical intervention is exercise therapy. For approximately 30% of people with RCRSP, this approach does not lead to a significant reduction in symptoms. This may be due to an inappropriate dosage or choice of exercises. The aim of this investigation is to compare the short, mid and long-term effects, in terms of symptoms, functional limitations, kinesiophobia and pain catastrophising, of three different shoulder rehabilitation approaches (education, strengthening, motor control) in adults with RCRSP.Methods and analysisIn this single-blind (assessor), parallel-group, randomised clinical trial, 123 adults presenting with RCRSP will take part in a 12-week rehabilitation programme. They will be randomly assigned to one of three groups (education only, strengthening approach or motor control-focused approach). Abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire, the primary outcome, Western Ontario Rotator Cuff Index and Brief Pain Inventory will evaluate symptoms and functional limitations, while Tampa Scale of Kinesiophobia and Pain Catastrophizing Scale will evaluate pain-related fear and catastrophising at baseline and at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral distances and tendon thickness will be assessed at baseline and 12 weeks. Intervention groups will be compared on outcomes with intention-to-treat analyses using two-way repeated measures analysis of variance if the data are normally distributed or non-parametric analysis of longitudinal data if they are not.Ethics and disseminationEthics approval was obtained from the Sectorial Rehabilitation and Social Integration Research Ethics Committee of the Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale Nationale (CIUSSS-CN). Results will be disseminated through international publications in peer-reviewed journals, in addition to international conference presentations.Trial registration numberNCT03892603; pre-results.

Project description:Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Such musculoskeletal pain - which is often associated with restricted range of motion and loss of muscle strength - is one of the most common conditions treated by physical therapists. The exact mechanism of neck pain is rarely revealed by clinical examination and the treatment has varied from passive rest to active treatments. Active treatments have often been divided into either training of the painful area or the surrounding musculature avoiding direct training of the painful area. Our study investigates the effect of the latter approach.A randomized controlled trial of 10 weeks duration is currently being conducted. Employed office workers with severe neck-shoulder pain are randomized to 3 × 20 min shoulder function training with training supervision or to a reference group receiving advice to stay physically active. Shoulder function training primarily focuses on the serratus anterior and lower trapezius muscle with only minimal activation the upper trapezius.An announcement was sent to the administrative section of the university including jobs characterized by intensive computer work. The first 100 positive replies entered the study. Among these inclusion criteria were pain intensity in the neck/shoulder of at least 3 on a 0-9 scale. Exclusion criteria were cardiovascular disease, trauma, hypertension, or serious chronic disease. Before and after the intervention period the participants replied to a questionnaire about musculoskeletal disorders and work disability, and underwent a standardized clinical examination of the neck and shoulder girdle. Further, on a weekly basis the participants log pain intensity of the neck and shoulder during the previous week.The primary outcome measure is pain in the neck and shoulders at week 10 based on the weekly pain registration and results from the clinical examination. Secondary outcomes are strength and work disability.ClinicalTrials (NCT): NCT01205542.

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Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.

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Biopsychosocial influence on shoulder pain: Rationale and protocol for a pre-clinical trial.

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