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

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 Overview

• Status: Recruiting
• Conditions: Thoraco-brachial Outlet Syndrome; ADAP-shoulder Scale; PETRA
• Intervention / Treatment: Other: PETRA questionnaire

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Simon LECOQ, MD; Phone Number: + 33 +33 2 41 35 36 89; Email: Simon.Lecoq@chu-angers.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • Angers University Hospital
    • Contact: Simon LECOQ, MD; Phone Number: + 33 + 33 2 41 35 36 89; Email: Simon.Lecoq@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients referred for thoraco-brachial outlet syndrome

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient with thoraco-brachial outlet syndrome; PETRA questionnaire	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 4, 2025
• First Submitted That Met QC Criteria: June 12, 2025
• First Posted (Actual): June 22, 2025

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 49RC25_0163

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
• IPD Sharing Access Criteria: The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No