Clinical trial NCT05817578: Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Official title: Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rotator Cuff Syndrome
Rotator Cuff Tears
Rotator Cuff Tendinosis
Rotator Cuff Impingement
Rotator Cuff Tear or Rupture, Not Specified as Traumatic
Keywords: Rotator Cuff Related Shoulder Pain
Chronic Pain
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Once - Baseline
measure: Western Ontario Rotator Cuff Index (WORC)
timeFrame: Once - Baseline
measure: The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS)
timeFrame: Once - Baseline
measure: Central Sensitisation Inventory (CSI)
timeFrame: Once - Baseline
measure: Pain Drawings (PD)
timeFrame: Once - Baseline
measure: Nociplastic Pain Flow Chart by IASP
timeFrame: Once - Baseline
measure: Quantitative Sensory Testing (QST)
timeFrame: Once - Baseline
measure: Range of Motion (ROM)
timeFrame: Once - Baseline
measure: Dynamometry
timeFrame: Once - Baseline
measure: Posterior Shoulder Endurance Test (PSET)
timeFrame: Once - Baseline
measure: Hospital Anxiety & Depression Scale (HADS)
timeFrame: Once - Baseline
measure: Pain Catastrophising Scale (PCS)
timeFrame: Once - Baseline
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Once - Baseline
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Once - Baseline
measure: Allostatic Index-5 (ALI-5)
timeFrame: Once - Baseline
measure: EuroQol-5Dimension (EQ-5D)
timeFrame: Once - Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Once - Baseline
measure: Modified Baecke Physical Activity Questionnaire (MBPAQ)
timeFrame: Once - Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Thessaly
name: ELENI KAPRELI, PT, PROF
role: STUDY_DIRECTOR
References: