Thoraco-brachial Outlet SyndromePETRANCT07031791
PETRA: Pictorial Assessment of Task Occurrence and Upper Limb Avoidance Behaviors
An observational study of Thoraco-brachial Outlet Syndrome and ADAP-shoulder Scale, run by University Hospital, Angers at 1 site in France.
Trial summary
The clinical evaluation of patients suspected of having thoracic brachial outlet syndrome (TBS) is not standardized, as it may be for the lower limbs. Assessment of symptoms and functional impact is based on questionnaires (Disability of the Arm, Shoulder and Hand: DASH, Short Form 36: SF36, Mobility of the Arm and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoraco-brachial Outlet Syndrome, ADAP-shoulder Scale, PETRA
- What is being tested?
- PETRA questionnaire
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2025to Jun 2027
- 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 referred for thoraco-brachial outlet syndrome
Who may be able to join
- Adult,
- Person referred for suspected TDSB
Who cannot join
- Person unwilling to complete questionnaire and participate,
- Person unable to understand the objectives of the study. -- For the reproducibility study phase: planned or modified treatment within 14 days following the consultation (surgery, changes to medication, physical therapy, etc.)
- Patients whose treatment plan was modified between the consultation and the completion of the second questionnaire (administered 7 to 14 days after the consultation and for whom surgery, a change in medication, or a change in physical therapy, etc., occurred),
- Patients who did not complete the second PETRA questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Angers University hospital
Angers
Simon LECOQ, MD, + 33 2 41 35 36 89 ext. + 33, Simon.Lecoq@chu-angers.fr
About this study
The clinical evaluation of patients suspected of having thoracic brachial outlet syndrome (TBS) is not standardized, as it may be for the lower limbs. Assessment of symptoms and functional impact is based on questionnaires (Disability of the Arm, Shoulder and Hand: DASH, Short Form 36: SF36, Mobility of the Arm and Shoulder: MASC, Thoracic and Upper limb ischemia Pain: TULIP), which are complex to complete, sometimes non-lateralized, and do not take into account the frequency of occurrence of certain gestures or the avoidance behaviours adopted by patients.
For avoidance behaviors, a recent tool has been proposed in the form of the Avoidance Daily Activities Photo Scale (ADAP shoulder scale). However, this questionnaire has not been translated into French and does not reflect the frequency with which patients are confronted with the different tasks proposed.
Read more
The aim of this study is to test the feasibility of a new questionnaire (PETRA), derived from the ADAP-shoulder scale, which is simple for patients to complete, quick to analyze and calculable directly by the doctor, and suitable for the general population, whether for initial assessment or follow-up.
The PETRA aims to assess avoidance behaviours in the face of daily tasks, but also the frequency of occurrence of these tasks in order to evaluate a disabling score that weights the avoidance index according to the degree of exposure to the proposed tasks.
The investigators hypothesize that the PETRA questionnaire could eventually be used routinely.
- Conditions
- Thoraco-brachial Outlet Syndrome, ADAP-shoulder Scale, PETRA
- Being tested
- PETRA questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETRA questionnaireOther
The questionnaire is given to the patient to complete in the waiting room. The completed questionnaire is given to the doctor at the end of the consultation.
To test the questionnaire's reproducibility, a subgroup of patients (N = 30) was asked to complete the same questionnaire a second time between the 7th and 14th day following their initial visit.
| Study group | Role | What they receive |
|---|---|---|
| Patient with thoraco-brachial outlet syndrome | PETRA questionnaire Receives: Other: PETRA questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
PETRA questionnaire
The questionnaire enables patients to indicate the extent to which they avoid performing everyday tasks, based on 15 questions taken from the ADAP Shoulder Scale, to which have been added five questions on the ability to pull an object, throw an object and dry oneself. Each question is on a numerical scale from 0 to 10.
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start27 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoraco-brachial Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031791
- Sponsor's protocol ID
- 49RC25_0163
- Acronym
- PETRA
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PETRA: Pictorial Assessment of Task Occurrence and Upper Limb Avoidance Behaviors
- ClinicalTrials.gov ID
- NCT07031791
- Acronym / sponsor ID
- PETRA / 49RC25_0163
- Conditions
- Thoraco-brachial Outlet Syndrome, ADAP-shoulder Scale, PETRA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jun 2025 (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.
The clinical evaluation of patients suspected of having thoracic brachial outlet syndrome (TBS) is not standardized, as it may be for the lower limbs. Assessment of symptoms and functional impact is based on questionnaires (Disability of the Arm, Shoulder and Hand: DASH, Short Form 36: SF36, Mobility of the Arm and Shoulder: MASC, Thoracic and Upper limb ischemia Pain: TULIP), which are complex to complete, sometimes non-lateralized, and do not take into account the frequency of occurrence of certain gestures or the avoidance behaviours adopted by patients.
For avoidance behaviors, a recent tool has been proposed in the form of the Avoidance Daily Activities Photo Scale (ADAP shoulder scale). However, this questionnaire has not been translated into French and does not reflect the frequency with which patients are confronted with the different tasks proposed.
The aim of this study is to test the feasibility of a new questionnaire (PETRA), derived from the ADAP-shoulder scale, which is simple for patients to complete, quick to analyze and calculable directly by the doctor, and suitable for the general population, whether for initial assessment or follow-up.
The PETRA aims to assess avoidance behaviours in the face of daily tasks, but also the frequency of occurrence of these tasks in order to evaluate a disabling score that weights the avoidance index according to the degree of exposure to the proposed tasks.
The investigators hypothesize that the PETRA questionnaire could eventually be used routinely.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with thoraco-brachial outlet syndrome | – | Other: PETRA questionnairePETRA questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred for thoraco-brachial outlet syndrome
Key inclusion criteria (2 listed)
- Adult,
- Person referred for suspected TDSB
Key exclusion criteria (4 listed)
- Person unwilling to complete questionnaire and participate,
- Person unable to understand the objectives of the study. -- For the reproducibility study phase: planned or modified treatment within 14 days following the consultation (surgery, changes to medication, physical therapy, etc.)
- Patients whose treatment plan was modified between the consultation and the completion of the second questionnaire (administered 7 to 14 days after the consultation and for whom surgery, a change in medication, or a change in physical therapy, etc., occurred),
- Patients who did not complete the second PETRA questionnaire.
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 |
|---|---|---|
| PETRA questionnaireThe questionnaire is given to the patient to complete in the waiting room. The completed questionnaire is given to the doctor at the end of the consultation. To test the questionnaire's reproducibility, a subgroup of patients (N = 30) was asked to complete the same questionnaire a second time between the 7th and 14th day following their initial visit. | Other | Patient with thoraco-brachial outlet syndrome |
Primary outcome
PETRA questionnaire
Time frame: Inclusion
The questionnaire enables patients to indicate the extent to which they avoid performing everyday tasks, based on 15 questions taken from the ADAP Shoulder Scale, to which have been added five questions on the ability to pull an object, throw an object and dry oneself. Each question is on a numerical scale from 0 to 10.
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 13 Oct 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoraco-brachial Outlet Syndrome and ADAP-shoulder Scale, run by University Hospital, Angers at 1 site 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 2 inclusion and 4 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Simon LECOQ, MD (+33 2 41 35 36 89 ext. + 33, Simon.Lecoq@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PETRA questionnaire (time frame: Inclusion). 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 13 Oct 2026.