StressTendistressNCT07658326
Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy
An observational study of Stress and Tendinopathy Rotator Cuff, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Tendinopathy Rotator Cuff
- What is being tested?
- Questionnaires
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Sep 2023to Sep 2026
- 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 orthopedic surgery department of the centers (Clinique de l'Union, Clinique la Croix du sud and Clinique des Cèdres).
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France3 sites, 3 recruiting
- Recruiting
Clinique des Cèdres
Cornebarrieu, 31700
Jacques-Emmanuel AYEL, Dr, 00333562133175, je.ayel@free.fr
- Recruiting
Clinique la croix du sud
Quint-Fonsegrives, 31130
Nicolas Lapie, Dr, 0033679599344, nicolas.lapie@ramsaysante.fr
- Recruiting
Clinique de l'Union
Saint-Jean, 31240
Régis Guinand, Dr, 0033661818222, regis.guinand@epaule-toulouse.com
About this study
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.
Read more
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
- Being tested
- Questionnaires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
MSP9 score Cungi scale EVA scale
| Study group | Role | What they receive |
|---|---|---|
| patient undergoing surgery for rotator cuff tendinopathy | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start28 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658326
- Sponsor's protocol ID
- 2021-A01707-34
- Acronym
- Tendistress
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Stress Assessment in Patients Undergoing Surgery for Rotator Cuff Tendinopathy
- ClinicalTrials.gov ID
- NCT07658326
- Acronym / sponsor ID
- Tendistress / 2021-A01707-34
- Conditions
- Stress, Tendinopathy Rotator Cuff
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jun 2026 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient undergoing surgery for rotator cuff tendinopathy | – | Other: Questionnaires |
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 orthopedic surgery department of the centers (Clinique de l'Union, Clinique la Croix du sud and Clinique des Cèdres).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesMSP9 score Cungi scale EVA scale | Other | patient undergoing surgery for rotator cuff tendinopathy |
Primary outcome
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): * 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
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 16 Jul 2026.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Marie-Hélène Barba contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress and Tendinopathy Rotator Cuff, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 3 sites in France.
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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jean-François Oudet (0033683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress will be assessed using the MSP9 score. (time frame: Preoperation). 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 16 Jul 2026.