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Recruiting NCT07658326

Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy

Observational Stress Tendinopathy Rotator Cuff

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaires.
Who it may be relevant to
Registry conditions: Stress, Tendinopathy Rotator Cuff. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Questionnaires
    MSP9 score Cungi scale EVA scale

Primary outcome measures

  • Stress will be assessed using the MSP9 score. [Time frame: Preoperation]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • Clinique des Cèdres — Cornebarrieu
  • Clinique la croix du sud — Quint-Fonsegrives
  • Clinique de l'Union — Saint-Jean

Identifiers

NCT: NCT07658326 · 2021-A01707-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗