Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

Not yet recruiting

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

• Registration Number: NCT05817578
• Lead Sponsor: University of Thessaly

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-18
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-19
• Last Update Posted: 2023-06-22
• Study Start: 2023-09-02
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	Once - Baseline	Obtain a measurement of pain; Score: 0-10; Higher scores indicate more pain
Range of Motion (ROM)	Once - Baseline	Assess Range of motion of the movements of interest
Quantitative Sensory Testing (QST)	Once - Baseline	Assessment of Pressure Pain Threshold, Conditioned Pain Modulation \& Temporal Summation
Western Ontario Rotator Cuff Index (WORC)	Once - Baseline	Assess the self-reported functional ability of participants; Score: 0-100 %; Higher scores indicate higher functional status
Pain Drawings (PD)	Once - Baseline	Capture painful body locations for participants with the spectrum of pathologies
Posterior Shoulder Endurance Test (PSET)	Once - Baseline	Assess the endurance of the Rotator Cuff myotendinous unit
Hospital Anxiety & Depression Scale (HADS)	Once - Baseline	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
Pittsburgh Sleep Quality Index (PSQI)	Once - Baseline	Assess sleep quality of participants; Score: 0-21; Higher scores indicate worse sleep quality
Modified Baecke Physical Activity Questionnaire (MBPAQ)	Once - Baseline	Evaluate Physical Activity levels of participants; Score: low - moderate - high; Higher scores indicate higher activity levels
The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS)	Once - Baseline	Identify possible participants with neuropathic type of pain; Score: 0-24; Score \>12 indicates neuropathic pain
Pain Catastrophising Scale (PCS)	Once - Baseline	Explore how the pain experience is perceived by the individual; Scale: 0-52; Higher scores indicate higher levels of catastrophising
EuroQol-5Dimension (EQ-5D)	Once - Baseline	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
Dynamometry	Once - Baseline	Assess strength and explore pain provocation in participants
Pain Self-Efficacy Questionnaire (PSEQ)	Once - Baseline	Assess the ability of the participant to cope with a spectrum of activities; Score: 0-60; Lower scores indicate less self-efficacy
Allostatic Index-5 (ALI-5)	Once - Baseline	Investigate psychosocial stressors reflective of chronc adaptive states for 'wear \& tear' of the human body; Score: 0-5; Higher score indicating higher allostatic load
Central Sensitisation Inventory (CSI)	Once - Baseline	Identify participants suspicious of central sensitisation symptoms; Score: 0-100; Score\>40 indicates central sensitisation
Nociplastic Pain Flow Chart by IASP	Once - Baseline	Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain
Tampa Scale of Kinesiophobia (TSK)	Once - Baseline	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