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NCT Number: NCT06893900

Assessing Shoulder Pathways Involving the Cuff

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Total number of different healthcare pathways and their description

    Time frame: 1 year

    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".

  2. Number and proportion of patient in each healthcare pathway

    Time frame: 1 year

    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.

  3. Delay for the first secondary care consultation

    Time frame: 1 year

    Delay between the GP referall and the consultation with a physiotherapist or a surgeon.

  4. Number and nature of adverse event

    Time frame: 1 year

    Number and nature of adverse event in each pathway

  5. Shoulder Pain And Disability Index (SPADI)

    Time frame: baseline, 2 weeks, 2, 4, 6 and 9 months

    Pain and function shoulder PROM

  6. Pain Self-Efficacy Questionnaire-Fr

    Time frame: baseline, 6 and 12 months

    PROM assessing pain self-efficacy

  7. Patient belief in the efficacy of rehabilitation

    Time frame: Baseline, 6 and 12 months

    Multiple choice question : "You believe that shoulder rehabilitation: 'allows for full recovery,' 'allows for partial recovery,' or 'does not allow for recovery.'"

  8. Visual Analog Pain Scale

    Time frame: 1 year

    Self administered pain assessment

  9. Tampa Scale of Kinesiophobia 11-item

    Time frame: Baseline and 6 and 12 months

    PROM assessing kinesiophobia

  10. Fear and Avoidance Belief Questionnaire (FABQ)

    Time frame: baseline and 6 months

    PROM assessing fear and avoidance beliefs

  11. EQ5D-5L

    Time frame: Baseline, 2, 4, 6, 9, 12 months

    PROM assessing quality of life

  12. Direct costs

    Time frame: 2, 4, 6, 12 months

    Healthcare ressource consumption (Patient healthcare provider consultations, imaging, prescribed drugs, surgeries).

  13. Indirect costs

    Time frame: 2, 4, 6 and 12 months

    Sick leaves

  14. Referrals

    Time frame: 2, 4, 6, 9 and 12 months

    Number and types of referrals to other healthcare professionals

  15. Patient satisfaction

    Time frame: 1 year

    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

  16. Patient preferences and motivation regarding a surgical or conservative pathway

    Time frame: baseline, 2, 4, 6, 9 and 12 months

    Semi-guided interviews with patients from each identified pathway at different points in time.

  17. Dominant upper limb and involved upper limb

    Time frame: Baseline

    Dominant upper limb: left, right, or neither Affected upper limb: left, right, or both

  18. Quick DASH

    Time frame: At baseline and 12 months

    The sort version of the "disability of the arm, the shoulder and the hand" patient reported outcome measure.

  19. PASS

    Time frame: 12 months

    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.

  20. Anchor-based MCID

    Time frame: Baseline, 2, 4, 6, 9 and 12 months

    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"

Study contacts

Contact information is provided by the study sponsor or research team.

Beatrice GENOUX, MSc

CONTACT

[email protected]

Thomas LATHIERE, PT, PhDc

CONTACT

[email protected]

+33457041225

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Conseil National de l'Ordre des Masseur Kinésithérapeutes (CNOMK)
  • GIRCI Auvergne Rhone-Alpes

Registry information

Official study title

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

Acronym: ASPIC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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