Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05817578
• Other study ID #: 9
• Status: Not yet recruiting
• Start date: September 2, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2023
• Source: Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
• Contact: ACHILLEAS PALIOURAS, PT, MSc
• Phone: 6975768673
• Email: apaliouras[@]uth.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Rotator Cuff Impingement
• Rotator Cuff Injuries
• Rotator Cuff Syndrome
• Rotator Cuff Tear or Rupture, Not Specified as Traumatic
• Rotator Cuff Tears
• Rotator Cuff Tendinosis
• Rupture
• Shoulder Impingement Syndrome
• Tendinopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory

Outcome

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