Ireland
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Recruiting Observational

PETRA: Pictorial Assessment of Task Occurrence and Upper Limb Avoidance Behaviors

NCT07031791 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-06-27
Last updated
2026-10-13

Condition(s) studied

Thoraco-brachial Outlet SyndromeADAP-shoulder ScalePETRA

Investigational drug(s) / intervention(s)

PETRA questionnaire

PETRA questionnaire: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult, * Person referred for suspected TDSB Exclusion Criteria: * 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.) Exclusion criteria for the reproducibility study phase: * 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.

Primary outcome measure(s)

  • PETRA questionnaire — 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.

Trial sites (1)

FacilityCityRegionStatus
Angers University hospital Angers France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07031791 on ClinicalTrials.gov ↗ ← All trials in France