- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07658326
Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy (Tendistress)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marie-Hélène Barba
- Email: mh.barba@ecten.eu
Study Contact Backup
- Name: Jean-François Oudet
- Phone Number: 0033683346567
- Email: jf.oudet@ecten.eu
Study Locations
-
-
-
Cornebarrieu, France, 31700
- Recruiting
- Clinique des Cèdres
-
Contact:
- Jacques-Emmanuel AYEL, Dr
- Phone Number: 00333562133175
- Email: je.ayel@free.fr
-
Quint-Fonsegrives, France, 31130
- Recruiting
- Clinique la croix du sud
-
Contact:
- Nicolas Lapie, Dr
- Phone Number: 0033679599344
- Email: nicolas.lapie@ramsaysante.fr
-
Saint-Jean, France, 31240
- Recruiting
- Clinique de l'Union
-
Contact:
- Régis Guinand, Dr
- Phone Number: 0033661818222
- Email: regis.guinand@epaule-toulouse.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patient undergoing surgery for rotator cuff tendinopathy
|
MSP9 score Cungi scale EVA scale
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress will be assessed using the MSP9 score.
Time Frame: Preoperation
|
This score ranges from 9 to 72 based on a rating scale of 1 to 8 (reversed for positive items):
|
Preoperation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A01707-34
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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