Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

Study Overview
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Brief Summary
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The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management

Detailed Description
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This study will be conducted at a hospital environment by recruiting people that will seek help for their shoulder pain by a specialist upper- limb Orthopaedic Surgeon at the Department of Hand & Upper Limb Microsurgery of the 'KAT General Hospital' in Athens, Greece. Participants that will be diagnosed with RCRSP by the orthopaedic surgeon and fulfil the eligibility criteria will undergo a series of one-off measurements. Written consent will have to be obtained before a sum of self-reported outcome measures and objective testing will take place. The main categories for which outcome measures will be used are: pain, function, psychosocial and lifestyle factors.

Official Title
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Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm

Conditions
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Rotator Cuff Syndrome, Rotator Cuff Tears, Rotator Cuff Tendinosis, Rotator Cuff Impingement, Rotator Cuff Tear or Rupture, Not Specified as Traumatic

Intervention / Treatment
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* Device: Quantitative Sensory Testing / Dynamometry / Goniometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-65 Pain: >3 months, non-traumatic, unilateral or bilateral of anterolateral location ROM: >50% all planes, AROM painful in forward flexion and/or abduction Provocation testing: Hawkins-Kennedy, Neer, Painful Arc, Resisted ER, Empty Can (3 or more out of the 5 +ve) Exclusion Criteria: Pain < 3months History of neck or shoulder trauma Radicular signs, shoulder pain reproduced with neck movements GH OA Frozen Shoulder Tears >C3 according to Snyder Classification Fibromyalgia Neurological, systemic local or autoimmune inflammatory conditions Clinical depression No injected corticosteroids or physiotherapy the last 3/12

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Quantitative Sensory Testing / Dynamometry / Goniometry|Testing procedures that follow previously used protocols of the literature for all the Quantitative Sensory Testing, Dynamometry & Goniometry|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Pain Rating Scale (NPRS) | Obtain a measurement of pain Score: 0-10 Higher scores indicate more pain | Once - Baseline | 
| Western Ontario Rotator Cuff Index (WORC) | Assess the self-reported functional ability of participants Score: 0-100 % Higher scores indicate higher functional status | Once - Baseline | 
| The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS) | Identify possible participants with neuropathic type of pain Score: 0-24 Score >12 indicates neuropathic pain | Once - Baseline | 
| Central Sensitisation Inventory (CSI) | Identify participants suspicious of central sensitisation symptoms Score: 0-100 Score>40 indicates central sensitisation | Once - Baseline | 
| Pain Drawings (PD) | Capture painful body locations for participants with the spectrum of pathologies | Once - Baseline | 
| Nociplastic Pain Flow Chart by IASP | Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain | Once - Baseline | 
| Quantitative Sensory Testing (QST) | Assessment of Pressure Pain Threshold, Conditioned Pain Modulation & Temporal Summation | Once - Baseline | 
| Range of Motion (ROM) | Assess Range of motion of the movements of interest | Once - Baseline | 
| Dynamometry | Assess strength and explore pain provocation in participants | Once - Baseline | 
| Posterior Shoulder Endurance Test (PSET) | Assess the endurance of the Rotator Cuff myotendinous unit | Once - Baseline | 
| Hospital Anxiety & Depression Scale (HADS) | Obtain a score of Anxiety & Depression among participants Score: 0-42 (Two scales between 0 & 21 each - one for anxiety and 1 for depression) Higher Scores indicate higher anxiety & depression | Once - Baseline | 
| Pain Catastrophising Scale (PCS) | Explore how the pain experience is perceived by the individual Scale: 0-52 Higher scores indicate higher levels of catastrophising | Once - Baseline | 
| Tampa Scale of Kinesiophobia (TSK) | Explore fear of movement and avoidance of participants Score: 17-68 Higher scores indicate higher levels of Kinesiophobia, cut-off point: scores >37 are indicative of kinesiophobia | Once - Baseline | 
| Pain Self-Efficacy Questionnaire (PSEQ) | Assess the ability of the participant to cope with a spectrum of activities Score: 0-60 Lower scores indicate less self-efficacy | Once - Baseline | 
| Allostatic Index-5 (ALI-5) | Investigate psychosocial stressors reflective of chronc adaptive states for 'wear & tear' of the human body Score: 0-5 Higher score indicating higher allostatic load | Once - Baseline | 
| EuroQol-5Dimension (EQ-5D) | Investigate quality of life levels of participants Score: 5-likert with no problem, slight, moderate, severe and extreme in each of the dimensions plus the 0-100 VAS as a global rating of self-perceived health with higher scores indcating better health | Once - Baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | Assess sleep quality of participants Score: 0-21 Higher scores indicate worse sleep quality | Once - Baseline | 
| Modified Baecke Physical Activity Questionnaire (MBPAQ) | Evaluate Physical Activity levels of participants Score: low - moderate - high Higher scores indicate higher activity levels | Once - Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Related Shoulder Pain, Chronic Pain