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Assessing Shoulder Pathways Involving the Cuff

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06893900
Acronym
ASPIC
Enrollment
160
Registered
2025-03-25
Start date
2025-05-12
Completion date
2027-03-27
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Sponsors

Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK)
CollaboratorUNKNOWN
GIRCI Auvergne Rhône-Alpes
CollaboratorUNKNOWN
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Shoulder Pain And Disability Index (SPADI)1 yearThe SPADI is a patient reported outcome measure assessing pain and function in the shoulder.

Secondary

MeasureTime frameDescription
Number and proportion of patient in each healthcare pathway1 yearNumber and proportion of patient in each healthcare pathway that patients go through after having had a first general practitioner consultation for a first or new episode of non-traumatic rotator cuff related shoulder pain.
Delay for the first secondary care consultation1 yearDelay between the GP referall and the consultation with a physiotherapist or a surgeon.
Number and nature of adverse event1 yearNumber and nature of adverse event in each pathway
Shoulder Pain And Disability Index (SPADI)baseline, 2 weeks, 2, 4, 6 and 9 monthsPain and function shoulder PROM
Pain Self-Efficacy Questionnaire-Frbaseline, 6 and 12 monthsPROM assessing pain self-efficacy
Patient belief in the efficacy of rehabilitationBaseline, 6 and 12 monthsMultiple choice question : You believe that shoulder rehabilitation: 'allows for full recovery,' 'allows for partial recovery,' or 'does not allow for recovery.'
Visual Analog Pain Scale1 yearSelf administered pain assessment
Tampa Scale of Kinesiophobia 11-itemBaseline and 6 and 12 monthsPROM assessing kinesiophobia
Fear and Avoidance Belief Questionnaire (FABQ)baseline and 6 monthsPROM assessing fear and avoidance beliefs
Total number of different healthcare pathways and their description1 yearNumber and nature of different healthcare pathways that patients go through after having had a first general practitioner consultation for a first or new episode of non-traumatic rotator cuff related shoulder pain. E.g. : surgical pathway, rheumatology pathway, conservative pathway.
Direct costs2, 4, 6, 12 monthsHealthcare ressource consumption (Patient healthcare provider consultations, imaging, prescribed drugs, surgeries).
Indirect costs2, 4, 6 and 12 monthsSick leaves
Referrals2, 4, 6, 9 and 12 monthsNumber and types of referrals to other healthcare professionals
Patient satisfaction1 yearPlease respond to the statements below by circling the answer that best reflects your opinion regarding the care you received. (5 points likert scale for each item : Not at all satisfied - Not satisfied - Neutral - Satisfied - Completely satisfied and a Not Concerned option). The dimensions assessed are : 1. Respect for my values, preferences, and needs 2. Coordination and integration of the care I received 3. Information, communication, and education about my condition 4. Physical comfort during care 5. Emotional support, relief of my fears and anxiety 6. Involvement of my family and close relatives in my care 7. Transition and continuity of care 8. Accessibility of care
Patient preferences and motivation regarding a surgical or conservative pathwaybaseline, 2, 4, 6, 9 and 12 monthsSemi-guided interviews with patients from each identified pathway at different points in time.
Dominant upper limb and involved upper limbBaselineDominant upper limb: left, right, or neither Affected upper limb: left, right, or both
Quick DASHAt baseline and 12 monthsThe sort version of the disability of the arm, the shoulder and the hand patient reported outcome measure.
PASS12 monthsPatient Acceptable Symptom State : Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory? - Dichotomic answer.
Anchor-based MCIDBaseline, 2, 4, 6, 9 and 12 monthsPatients are asked : Since the last questionnaire, my shoulder pain and function has : * Significantly improved * Improved, but not really changed * Neither improved nor deteriorated * Worsened, but not really changed * Significantly worsened
EQ5D-5LBaseline, 2, 4, 6, 9, 12 monthsPROM assessing quality of life

Contacts

Primary ContactThomas LATHIERE, PT, PhDc
thomas.lathiere@univ-grenoble-alpes.fr+33457041225
Backup ContactBeatrice GENOUX, MSc
bgenoux@chu-grenoble.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026