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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05934734
Other study ID # 09876543
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2023
Est. completion date May 16, 2024

Study information

Verified date June 2024
Source Ahram Canadian University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate the relationship between the severity of thoracic outlet syndrome and upper extremity function, as well as neural integrity.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date May 16, 2024
Est. primary completion date May 16, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age 18-65 years - Diagnosed with thoracic outlet syndrome - Willing and able to provide informed consent Exclusion Criteria: - History of upper extremity surgery unrelated to thoracic outlet syndrome - Other upper extremity disorders unrelated to thoracic outlet syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This is an observational cross-sectional study. No intervention will be provided. Participants will be assessed and stratified into four cohorts based on self-reported symptom severity of thoracic outlet syndrome using a visual analog scale (VAS) to investigate the relationship between symptom severity and upper extremity function/neural integrity.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of Motion (ROM) of the Shoulder joint Active and passive ROM will be measured using a standard goniometer. Baseline
Primary Range of Motion (ROM) of the Elbow joint Active and passive ROM will be measured using a standard goniometer. Baseline
Primary Range of Motion (ROM) of the Wrist joint Active and passive ROM will be measured using a standard goniometer. Baseline
Primary Isometric Muscle Strength of shoulder Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer. Baseline
Primary Isometric Muscle Strength of elbow Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer. Baseline
Primary Isometric Muscle Strength of wrist Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer. Baseline
Primary Self-reported upper extremity function The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, developed by the Institute for Work and Health, is used to measure patient-reported functional outcomes. The DASH questionnaire consists of 30 questions regarding limitations to complete physical activities due to upper extremity pain/impairment. Participants will be asked to respond to each question based on their experiences over the preceding week according to a 5-point Likert scale ranging from 1 (no difficulty) to 5 (unable to do). Responses will be scored out of 5 and averaged to produce a score out of 100 with higher scores representing greater disability. Baseline
Primary Nerve Conduction Studies of ulnar nerve Nerve conduction studies will assess the function/integrity of the ulnar nerve. Baseline
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