Assessing Shoulder Pathways Involving the Cuff

NCT06893900 | Not Yet Recruiting

• 1 other identifier: 2024-A01019-38
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

rotator cuff; health economics; cost utility; incapacity; shoulder; non-traumatic

Outcome Measures

Primary Outcomes (1)

• Shoulder Pain And Disability Index (SPADI)

  The SPADI is a patient reported outcome measure assessing pain and function in the shoulder.

  1 year

Secondary Outcomes (20)

• Total number of different healthcare pathways and their description

  1 year

• Number and proportion of patient in each healthcare pathway

  1 year

• Delay for the first secondary care consultation

  1 year

• Number and nature of adverse event

  1 year

• Shoulder Pain And Disability Index (SPADI)

  baseline, 2 weeks, 2, 4, 6 and 9 months

Study Arms (1)

Primary care non-traumatic shoulder pain

Patients will be enrolled if they receive care in France for non-traumatic shoulder disorder, that is related to the rotator cuff.

Eligibility Criteria

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

Study Population

Patients will be recruited from the French general population

You may qualify if:

• Rotator cuff related shoulder pain

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK): collaborator
• GIRCI Auvergne Rhône-Alpes: collaborator

Study Officials

• Thomas LATHIERE, PT, PhDc

  Grenoble Alpes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas LATHIERE, PT, PhDc

CONTACT

+33457041225; thomas.lathiere@univ-grenoble-alpes.fr

Beatrice GENOUX, MSc

CONTACT

bgenoux@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: March 25, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): March 27, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04