Rotator Cuff Tears Clinical Trial
Official title:
Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm
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
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Pain Rating Scale (NPRS) | Obtain a measurement of pain
Score: 0-10 Higher scores indicate more pain |
Once - Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | Central Sensitisation Inventory (CSI) | Identify participants suspicious of central sensitisation symptoms
Score: 0-100 Score>40 indicates central sensitisation |
Once - Baseline | |
Primary | Pain Drawings (PD) | Capture painful body locations for participants with the spectrum of pathologies | Once - Baseline | |
Primary | Nociplastic Pain Flow Chart by IASP | Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain | Once - Baseline | |
Primary | Quantitative Sensory Testing (QST) | Assessment of Pressure Pain Threshold, Conditioned Pain Modulation & Temporal Summation | Once - Baseline | |
Primary | Range of Motion (ROM) | Assess Range of motion of the movements of interest | Once - Baseline | |
Primary | Dynamometry | Assess strength and explore pain provocation in participants | Once - Baseline | |
Primary | Posterior Shoulder Endurance Test (PSET) | Assess the endurance of the Rotator Cuff myotendinous unit | Once - Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Pittsburgh Sleep Quality Index (PSQI) | Assess sleep quality of participants
Score: 0-21 Higher scores indicate worse sleep quality |
Once - Baseline | |
Primary | Modified Baecke Physical Activity Questionnaire (MBPAQ) | Evaluate Physical Activity levels of participants
Score: low - moderate - high Higher scores indicate higher activity levels |
Once - Baseline |
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