Clinical trial NCT06893900: Assessing Shoulder Pathways Involving the Cuff
Official title: Description of Care Pathways in Non-Traumatic Rotator Cuff Related Shoulder Pain Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders
Rotator Cuff Related Shoulder Pain
Keywords: rotator cuff
health economics
cost utility
incapacity
shoulder
non-traumatic
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK)
name: GIRCI Auvergne Rhône-Alpes
First posted: 2025-03-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the French general population

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.


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)

Primary outcomes:
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: 1 year
Secondary outcomes:
measure: Total number of different healthcare pathways and their description
timeFrame: 1 year
measure: Number and proportion of patient in each healthcare pathway
timeFrame: 1 year
measure: Delay for the first secondary care consultation
timeFrame: 1 year
measure: Number and nature of adverse event
timeFrame: 1 year
measure: Shoulder Pain And Disability Index (SPADI)
timeFrame: baseline, 2 weeks, 2, 4, 6 and 9 months
measure: Pain Self-Efficacy Questionnaire-Fr
timeFrame: baseline, 6 and 12 months
measure: Patient belief in the efficacy of rehabilitation
timeFrame: Baseline, 6 and 12 months
measure: Visual Analog Pain Scale
timeFrame: 1 year
measure: Tampa Scale of Kinesiophobia 11-item
timeFrame: Baseline and 6 and 12 months
measure: Fear and Avoidance Belief Questionnaire (FABQ)
timeFrame: baseline and 6 months
measure: EQ5D-5L
timeFrame: Baseline, 2, 4, 6, 9, 12 months
measure: Direct costs
timeFrame: 2, 4, 6, 12 months
measure: Indirect costs
timeFrame: 2, 4, 6 and 12 months
measure: Referrals
timeFrame: 2, 4, 6, 9 and 12 months
measure: Patient satisfaction
timeFrame: 1 year
measure: Patient preferences and motivation regarding a surgical or conservative pathway
timeFrame: baseline, 2, 4, 6, 9 and 12 months
measure: Dominant upper limb and involved upper limb
timeFrame: Baseline
measure: Quick DASH
timeFrame: At baseline and 12 months
measure: PASS
timeFrame: 12 months
measure: Anchor-based MCID
timeFrame: Baseline, 2, 4, 6, 9 and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Thomas LATHIERE, PT, PhDc
role: PRINCIPAL_INVESTIGATOR
References: