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Not yet recruiting NCT06893900

Assessing Shoulder Pathways Involving the Cuff

Observational Rotator Cuff Shoulder Syndrome and Allied Disorders Rotator Cuff Related Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders, Rotator Cuff Related Shoulder Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Description of Care Pathways in Non-Traumatic Rotator Cuff Related Shoulder Pain Syndrome

Overview

New recommendations regarding care pathways for the management of shoulder pain syndromes have recently been published. We aim to analyze and compare the existing care pathways and identify the most appropriate approaches for different patient profiles. Our primary objective is to compare pain levels and shoulder function one year after your initial consultation with your general practitioner for this episode. We also seek to assess which healthcare professionals you consult for your shoulder management, the treatments you receive (e.g., analgesics), and any imaging studies you undergo (if prescribed). We will send you notifications to remind you of the survey completion schedule and provide the link to access the questionnaire. Participation in this study requires your commitment and adherence to the timeline, as missing data may compromise the analysis of results. Non-participation in the study will not affect your current medical care.

Primary outcome measures

  • Shoulder Pain And Disability Index (SPADI) [Time frame: 1 year]
Secondary outcome measures (12)
  • Total number of different healthcare pathways and their description [Time frame: 1 year]
  • Number and proportion of patient in each healthcare pathway [Time frame: 1 year]
  • Delay for the first secondary care consultation [Time frame: 1 year]
  • Number and nature of adverse event [Time frame: 1 year]
  • Shoulder Pain And Disability Index (SPADI) [Time frame: baseline, 2 weeks, 2, 4, 6 and 9 months]
  • Pain Self-Efficacy Questionnaire-Fr [Time frame: baseline, 6 and 12 months]
  • Patient belief in the efficacy of rehabilitation [Time frame: Baseline, 6 and 12 months]
  • Visual Analog Pain Scale [Time frame: 1 year]
  • Tampa Scale of Kinesiophobia 11-item [Time frame: Baseline and 6 and 12 months]
  • Fear and Avoidance Belief Questionnaire (FABQ) [Time frame: baseline and 6 months]
  • EQ5D-5L [Time frame: Baseline, 2, 4, 6, 9, 12 months]
  • Direct costs [Time frame: 2, 4, 6, 12 months]

Eligibility criteria

Inclusion criteria

  • Rotator cuff related shoulder pain
  • Consultation with a general practitionner for this disorder in the 6 weeks prior to the inclusion

Exclusion criteria

  • History of upper limb trauma associated with the current episode of shoulder pain
  • Neurologic or rheumatismal shoulder disorder
  • Frozen shoulder (current or past)
  • History of advanced glenohumeral athritis
  • History of shoulder surgery (on the affected side)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06893900 · 2024-A01019-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗