Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

Sponsor
Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05817578
Collaborator
(none)
100
18

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Profiling the Rotator Cuff - Related Shoulder Pain (RCRSP) Patient: a Pain Phenotype Classification Algorithm
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Numeric Pain Rating Scale (NPRS) [Once - Baseline]

    Obtain a measurement of pain

  2. Western Ontario Rotator Cuff Index (WORC) [Once - Baseline]

    Assess the self-reported functional ability of participants

  3. The Self-Report Leeds Assessment of Neuropathic Symptoms & Signs (SLANSS) [Once - Baseline]

    Identify possible participants with neuropathic type of pain

  4. Central Sensitisation Inventory (CSI) [Once - Baseline]

    Identify participants suspicious of central sensitisation symptoms

  5. Pain Drawings (PD) [Once - Baseline]

    Capture painful body locations for participants with the spectrum of pathologies

  6. Nociplastic Pain Flow Chart by IASP [Once - Baseline]

    Identification of Predominant Pain Mechanism, especially participants with possible nociplastic pain

  7. Quantitative Sensory Testing (QST) [Once - Baseline]

    Assessment of Pressure Pain Threshold, Conditioned Pain Modulation & Temporal Summation

  8. Range of Motion (ROM) [Once - Baseline]

    Assess Range of motion of the movements of interest

  9. Dynamometry [Once - Baseline]

    Assess strength and explore pain provocation in participants

  10. Posterior Shoulder Endurance Test (PSET) [Once - Baseline]

    Assess the endurance of the Rotator Cuff myotendinous unit

  11. Hospital Anxiety & Depression Scale (HADS) [Once - Baseline]

    Obtain a score of Anxiety & Depression among participants

  12. Pain Catastrophising Scale (PCS) [Once - Baseline]

    Explore how the pain experience is perceived by the individual

  13. Tampa Scale of Kinesiophobia (TSK) [Once - Baseline]

    Explore fear of movement and avoidance of participants

  14. Pain Self-Efficacy Questionnaire (PSEQ) [Once - Baseline]

    Assess the ability of the participant to cope with a spectrum of activities

  15. Allostatic Index-5 (ALI-5) [Once - Baseline]

    Investigate psychosocial stressors reflective of chronc adaptive states for 'wear & tear' of the human body

  16. EuroQol-5Dimension (EQ-5D) [Once - Baseline]

    Investigate quality of life levels of participants

  17. Pittsburgh Sleep Quality Index (PSQI) [Once - Baseline]

    Assess sleep quality of participants

  18. Modified Baecke Physical Activity Questionnaire (MBPAQ) [Once - Baseline]

    Evaluate Physical Activity levels of participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Achilleas Paliouras, Physiotherapist, MSc, PhD candidate, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
ClinicalTrials.gov Identifier:
NCT05817578
Other Study ID Numbers:
  • 9
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Achilleas Paliouras, Physiotherapist, MSc, PhD candidate, Clinical Exercise Physiology and Rehabilitation Reasearch Laboratory
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023