Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear or Rupture, Not Specified as Traumatic; Rotator Cuff Tears; Rotator Cuff Tendinosis; Rotator Cuff Syndrome; Rotator Cuff Impingement
• Intervention / Treatment: Device: Quantitative Sensory Testing / Dynamometry / Goniometry

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: ACHILLEAS PALIOURAS, PT, MSc; Phone Number: +30 6975768673; Email: apaliouras@uth.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People in the 18-65 spectrum that have a gradual onset of shoulder pain without being able to recall any injuries to the area and pain to be present for at least three months

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
• Investigators: Study Director: ELENI KAPRELI, PT, PROF, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory

Study record dates

Study Major Dates

• Study Start (Estimated): September 2, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Pain; Rotator Cuff Related Shoulder Pain
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Tendinopathy; Rupture; Shoulder Impingement Syndrome
• Other Study ID Numbers: 9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No