Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

NCT05817578 | Unknown DMC

• 1 other identifier: 9
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (18)

• Numeric Pain Rating Scale (NPRS)

  Obtain a measurement of pain Score: 0-10 Higher scores indicate more pain

  Once - Baseline

• 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

• 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

• Central Sensitisation Inventory (CSI)

  Identify participants suspicious of central sensitisation symptoms Score: 0-100 Score\>40 indicates central sensitisation

  Once - Baseline

• Pain Drawings (PD)

  Capture painful body locations for participants with the spectrum of pathologies

  Once - Baseline

• Nociplastic Pain Flow Chart by IASP

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

  Once - Baseline

• Quantitative Sensory Testing (QST)

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

  Once - Baseline

• Range of Motion (ROM)

  Assess Range of motion of the movements of interest

  Once - Baseline

• Dynamometry

  Assess strength and explore pain provocation in participants

  Once - Baseline

• Posterior Shoulder Endurance Test (PSET)

  Assess the endurance of the Rotator Cuff myotendinous unit

  Once - Baseline

• 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

• 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

• 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

• 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

• 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

• 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

• Pittsburgh Sleep Quality Index (PSQI)

  Assess sleep quality of participants Score: 0-21 Higher scores indicate worse sleep quality

  Once - Baseline

• Modified Baecke Physical Activity Questionnaire (MBPAQ)

  Evaluate Physical Activity levels of participants Score: low - moderate - high Higher scores indicate higher activity levels

  Once - Baseline

Interventions

Quantitative Sensory Testing / Dynamometry / Goniometry DEVICE

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

Also known as: Dynamometry, Goniometry

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome; Rupture; Chronic Pain

Interventions

Arthrometry, Articular

Condition Hierarchy (Ancestors)

Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Range of Motion, Articular; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• ELENI KAPRELI, PT, PROF

  University of Thessaly

  STUDY DIRECTOR

Central Study Contacts

ACHILLEAS PALIOURAS, PT, MSc

CONTACT

6975768673; apaliouras@uth.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Physiotherapist, MSc, PhD candidate

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 18, 2023
• Study Start: September 2, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06