Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

NCT ID: NCT05817578

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-02
• Study Completion Date: 2024-09-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Quantitative Sensory Testing / Dynamometry / Goniometry

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

Intervention Type: DEVICE

Other Intervention Names

Dynamometry; Goniometry

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Achilleas Paliouras

Principal Investigator, Physiotherapist, MSc, PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ELENI KAPRELI, PT, PROF

Role: STUDY_DIRECTOR

University of Thessaly

Central Contacts

ACHILLEAS PALIOURAS, PT, MSc

Role: CONTACT

apaliouras@uth.gr

6975768673 ext. +30

Other Identifiers

9

Identifier Type: -

Identifier Source: org_study_id