Rotator Cuff Shoulder Syndrome and Allied DisordersASPICNCT06893900
Assessing Shoulder Pathways Involving the Cuff
An observational study of Rotator Cuff Shoulder Syndrome and Allied Disorders and Rotator Cuff Related Shoulder Pain, run by University Hospital, Grenoble.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Shoulder Syndrome and Allied Disorders, Rotator Cuff Related Shoulder Pain
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2025to 27 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from the French general population
Who may be able to join
- Rotator cuff related shoulder pain
- Consultation with a general practitionner for this disorder in the 6 weeks prior to the inclusion
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Beatrice GENOUX, MSc contact
About this study
Official title: 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).
Read more
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.
- Keywords
- rotator cuff, health economics, cost utility, incapacity, shoulder, non-traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain And Disability Index (SPADI)
The SPADI is a patient reported outcome measure assessing pain and function in the shoulder.
Measured: 1 year
Secondary outcomes (20)
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".
Measured: 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.
Measured: 1 year
Delay for the first secondary care consultation
Delay between the GP referall and the consultation with a physiotherapist or a surgeon.
Measured: 1 year
Number and nature of adverse event
Number and nature of adverse event in each pathway
Measured: 1 year
Shoulder Pain And Disability Index (SPADI)
Pain and function shoulder PROM
Measured: baseline, 2 weeks, 2, 4, 6 and 9 months
Pain Self-Efficacy Questionnaire-Fr
PROM assessing pain self-efficacy
Measured: 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.'"
Measured: Baseline, 6 and 12 months
Visual Analog Pain Scale
Self administered pain assessment
Measured: 1 year
Tampa Scale of Kinesiophobia 11-item
PROM assessing kinesiophobia
Measured: Baseline and 6 and 12 months
Fear and Avoidance Belief Questionnaire (FABQ)
PROM assessing fear and avoidance beliefs
Measured: baseline and 6 months
EQ5D-5L
PROM assessing quality of life
Measured: Baseline, 2, 4, 6, 9, 12 months
Direct costs
Healthcare ressource consumption (Patient healthcare provider consultations, imaging, prescribed drugs, surgeries).
Measured: 2, 4, 6, 12 months
Indirect costs
Sick leaves
Measured: 2, 4, 6 and 12 months
Referrals
Number and types of referrals to other healthcare professionals
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline
Quick DASH
The sort version of the "disability of the arm, the shoulder and the hand" patient reported outcome measure.
Measured: 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.
Measured: 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"
Measured: Baseline, 2, 4, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start12 May 2025 (estimated)
- Primary completion27 Mar 2027 (estimated)
- Study completion27 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Shoulder Syndrome and Allied DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK), GIRCI Auvergne Rhone-Alpes
- Responsible party
- Sponsor
- Investigators
- Thomas LATHIERE, PT, PhDc, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893900
- Sponsor's protocol ID
- 2024-A01019-38
- Acronym
- ASPIC
- Status last verified
- Apr 2025
- First submitted
- 15 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Care Pathways in Non-Traumatic Rotator Cuff Related Shoulder Pain Syndrome
- ClinicalTrials.gov ID
- NCT06893900
- Acronym / sponsor ID
- ASPIC / 2024-A01019-38
- Keywords
- rotator cuff, health economics, cost utility, incapacity, shoulder, non-traumatic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK), GIRCI Auvergne Rhone-Alpes
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 27 Mar 2027 (estimated)
- Study completion
- 27 Mar 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the French general population
Key inclusion criteria (2 listed)
- Rotator cuff related shoulder pain
- Consultation with a general practitionner for this disorder in the 6 weeks prior to the inclusion
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Shoulder Pain And Disability Index (SPADI)
Time frame: 1 year
The SPADI is a patient reported outcome measure assessing pain and function in the shoulder.
20 secondary outcomes
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
Indirect costs
Time frame: 2, 4, 6 and 12 months
Referrals
Time frame: 2, 4, 6, 9 and 12 months
Patient satisfaction
Time frame: 1 year
Patient preferences and motivation regarding a surgical or conservative pathway
Time frame: baseline, 2, 4, 6, 9 and 12 months
Dominant upper limb and involved upper limb
Time frame: Baseline
Quick DASH
Time frame: At baseline and 12 months
PASS
Time frame: 12 months
Anchor-based MCID
Time frame: Baseline, 2, 4, 6, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice GENOUX, MSc contact
Thomas LATHIERE, PT, PhDc principal investigator
Grenoble Alpes University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Shoulder Syndrome and Allied Disorders and Rotator Cuff Related Shoulder Pain, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas LATHIERE, PT, PhDc (+33457041225, thomas.lathiere@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain And Disability Index (SPADI) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.