Thoracic Outlet SyndromeTEMPUSNCT05441176
TULIP et MASC : Premiers Usages
A study testing Questionnaires in people with Thoracic Outlet Syndrome, run by University Hospital, Angers at 1 site in France.
Trial summary
The aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2022to 18 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Suspicion of Thoracic Outlet Syndrome
Who cannot join
- Non applicable
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up.
The TULIP questionnaire aims to characterize the symptoms suggestive of Thoracic Outlet Syndrome (TOS). The MASC questionnaire aims to assess the functional maintenance of TOS in a simpler way (fewer questions) than the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and in a lateralized way.
Read the detailed description
Two questionnaires the TULIP and the MASC are submitted (self completion) to patients suspected of TOS.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Questionnaires
- Keywords
- suspicion of arterial TOS and/or veinous TOS, DASH questionnaire, TULIP and MASC questionnaires
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Scoring of the DASH is performed according to references.
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicion of TOS | Experimental | Patients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of both questionnaires : percentage of questionnaires correctly completed
Estimation of the percentage of questionnaires correctly completed. "correctly completed" means a questionnaire without physician's correction.
Measured: 1 day
Secondary outcomes (3)
TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation
Determine the diagnostic performance of each response according to the presence or absence of vascular compression of the arm considered.
We evaluate the correlation between each response of TULIP's items and vascular investigation results (positive ultrasound or/and angiography)
Measured: 1 day
MASC : Concording with DASH questionnaire
Correlation coefficient with the DASH questionnaire
Measured: 1 day
MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH
Comparison of correlation coefficient with the DASH questionnaire and of correlation coefficient with the Quick-DASH questionnaire.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start12 Sep 2022
- Primary completion18 Sep 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441176
- Sponsor's protocol ID
- 2022-A01451-42
- Acronym
- TEMPUS
- Status last verified
- Jun 2024
- First submitted
- 23 Jun 2022
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TULIP et MASC : Premiers Usages
- ClinicalTrials.gov ID
- NCT05441176
- Acronym / sponsor ID
- TEMPUS / 2022-A01451-42
- Conditions
- Thoracic Outlet Syndrome
- Keywords
- suspicion of arterial TOS and/or veinous TOS, DASH questionnaire, TULIP and MASC questionnaires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 18 Sep 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 1 Jul 2022 (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 aim of this work is to propose two new questionnaires (TULIP and MASC) which are simple to complete by the patient, quick to analyze and can be calculated directly by the physician, adapted to the general population, whether during an initial evaluation or for follow-up.
The TULIP questionnaire aims to characterize the symptoms suggestive of Thoracic Outlet Syndrome (TOS). The MASC questionnaire aims to assess the functional maintenance of TOS in a simpler way (fewer questions) than the Disability of the Arm, Shoulder and Hand (DASH) questionnaire and in a lateralized way.
Detailed description
Two questionnaires the TULIP and the MASC are submitted (self completion) to patients suspected of TOS.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspicion of TOS | Experimental | Other: QuestionnairesPatients coming for a visit to diagnostic TOS and submitted TULIP and MASC questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspicion of Thoracic Outlet Syndrome
Key exclusion criteria (1 listed)
- Non applicable
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 |
|---|---|---|
| QuestionnairesScoring of the DASH is performed according to references. | Other | Patients with suspicion of TOS |
Primary outcome
Feasibility of both questionnaires : percentage of questionnaires correctly completed
Time frame: 1 day
Estimation of the percentage of questionnaires correctly completed. "correctly completed" means a questionnaire without physician's correction.
3 secondary outcomes
TULIP : Diagnostic performance of vascular TOS by concordance between each response and vascular investigations results evaluation
Time frame: 1 day
MASC : Concording with DASH questionnaire
Time frame: 1 day
MASC : Comparison between concordance MASC/DASH and concordance MASC/Quick DASH
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Thoracic Outlet Syndrome, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of both questionnaires : percentage of questionnaires correctly completed (time frame: 1 day). 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 11 Jun 2024.