Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy

NCT07658326 | Recruiting

• 1 other identifier: 2021-A01707-34
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

Orthopedic surgery of the limbs presents a unpredictable postoperative course, which can be more or less lengthy in terms of functional recovery and resumption of personal or professional activities. Not uncommon, convalescence can require many months with dramatic personal and/or socio-professional consequences (disability, unemployment, etc.), particularly in the postoperative development of complex regional pain syndrome (CRPS) and/or adhesive capsulitis. Among the suspected contributing factors, the existence of an unfavorable preoperative psychological context in patients is often mentioned. This research is based on the hypothesis that a high level of preoperative stress in patients could contribute to the occurrence of more significant postoperative complications in patients who have undergone shoulder surgery. The main objective is to measure the level of preoperative stress in patients undergoing surgery for rotator cuff tendinopathy.

Conditions

Stress; Tendinopathy Rotator Cuff

Outcome Measures

Primary Outcomes (1)

• Stress will be assessed using the MSP9 score.

  This score ranges from 9 to 72 based on a rating scale of 1 to 8 (reversed for positive items): * 9-26 - Very low stress level * 27-44 - Low stress level * 45-54 - Moderate stress level * 55-63 - High stress level * 64-72 - Very high stress level

  Preoperation

Study Arms (1)

patient undergoing surgery for rotator cuff tendinopathy

Other: Questionnaires

Interventions

Questionnaires OTHER

MSP9 score Cungi scale EVA scale

patient undergoing surgery for rotator cuff tendinopathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the orthopedic surgery department of the centers (Clinique de l'Union, Clinique la Croix du sud and Clinique des Cèdres).

You may qualify if:

• Patient, male or female, over 18 years of age
• First-line surgery for rotator cuff tendinopathy (torn and untorn)
• Subject affiliated with or covered by a social security scheme
• Collection of the patient's non-opposition to participate in the study

You may not qualify if:

• Patients with medical history of adhesive capsulitis or complex regional pain syndrome (CRPS)
• Patients with a history of diabetes or thyroid dysfunction
• Patients with a history of fibromyalgia
• Patients with a history of mental illness (PMD, schizophrenia)
• Patients taking antidepressants or similar medications
• Patients participating in another clinical trial
• Protected patients: adults under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision;
• Pregnant, breastfeeding, or parturient women;
• Patients hospitalized without their consent.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (3)

Clinique des Cèdres

Cornebarrieu, 31700, France

RECRUITING

Clinique la croix du sud

Quint-Fonsegrives, 31130, France

RECRUITING

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Jean-François Oudet

CONTACT

0033683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 22, 2026
• Study Start: September 28, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

FR (3)