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Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05817578
Enrollment
100
Registered
2023-04-18
Start date
2023-09-02
Completion date
2024-09-30
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Rotator Cuff Related Shoulder Pain, Chronic Pain

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.

Interventions

DEVICEQuantitative Sensory Testing / Dynamometry / Goniometry

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

Sponsors

University of Thessaly
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Contacts

Primary ContactACHILLEAS PALIOURAS, PT, MSc
apaliouras@uth.gr6975768673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026