Assessing Shoulder Pathways Involving the Cuff (ASPIC)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Shoulder Syndrome and Allied Disorders; Rotator Cuff Related Shoulder Pain

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Thomas LATHIERE, PT, PhDc; Phone Number: +33457041225; Email: thomas.lathiere@univ-grenoble-alpes.fr
• Study Contact Backup: Name: Beatrice GENOUX, MSc; Email: bgenoux@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the French general population

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain And Disability Index (SPADI)	The SPADI is a patient reported outcome measure assessing pain and function in the shoulder.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of different healthcare pathways and their description	Number 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".	1 year
Number and proportion of patient in each healthcare pathway	Number 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.	1 year
Delay for the first secondary care consultation	Delay between the GP referall and the consultation with a physiotherapist or a surgeon.	1 year
Number and nature of adverse event	Number and nature of adverse event in each pathway	1 year
Shoulder Pain And Disability Index (SPADI)	Pain and function shoulder PROM	baseline, 2 weeks, 2, 4, 6 and 9 months
Pain Self-Efficacy Questionnaire-Fr	PROM assessing pain self-efficacy	baseline, 6 and 12 months
Patient belief in the efficacy of rehabilitation	Multiple choice question : "You believe that shoulder rehabilitation: 'allows for full recovery,' 'allows for partial recovery,' or 'does not allow for recovery.'"	Baseline, 6 and 12 months
Visual Analog Pain Scale	Self administered pain assessment	1 year
Tampa Scale of Kinesiophobia 11-item	PROM assessing kinesiophobia	Baseline and 6 and 12 months
Fear and Avoidance Belief Questionnaire (FABQ)	PROM assessing fear and avoidance beliefs	baseline and 6 months
EQ5D-5L	PROM assessing quality of life	Baseline, 2, 4, 6, 9, 12 months
Direct costs	Healthcare ressource consumption (Patient healthcare provider consultations, imaging, prescribed drugs, surgeries).	2, 4, 6, 12 months
Indirect costs	Sick leaves	2, 4, 6 and 12 months
Referrals	Number and types of referrals to other healthcare professionals	2, 4, 6, 9 and 12 months
Patient satisfaction	Please 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 : Respect for my values, preferences, and needs; Coordination and integration of the care I received; Information, communication, and education about my condition; Physical comfort during care; Emotional support, relief of my fears and anxiety; Involvement of my family and close relatives in my care; Transition and continuity of care; Accessibility of care	1 year
Patient preferences and motivation regarding a surgical or conservative pathway	Semi-guided interviews with patients from each identified pathway at different points in time.	baseline, 2, 4, 6, 9 and 12 months
Dominant upper limb and involved upper limb	Dominant upper limb: left, right, or neither Affected upper limb: left, right, or both	Baseline
Quick DASH	The sort version of the "disability of the arm, the shoulder and the hand" patient reported outcome measure.	At baseline and 12 months
PASS	Patient 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.	12 months
Anchor-based MCID	Patients 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"	Baseline, 2, 4, 6, 9 and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: GIRCI Auvergne Rhone-Alpes; Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK)
• Investigators: Principal Investigator: Thomas LATHIERE, PT, PhDc, Grenoble Alpes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 12, 2025
• Primary Completion (Estimated): March 27, 2027
• Study Completion (Estimated): March 27, 2027

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: shoulder; cost utility; rotator cuff; health economics; incapacity; non-traumatic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Disease; Arthralgia; Syndrome; Shoulder Pain
• Other Study ID Numbers: 2024-A01019-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No