Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity

The Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity: A Cross-Sectional Study

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Outlet Syndrome
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

A total of 100 individuals (n=25 per cohort), aged 18-65 years, diagnosed with thoracic outlet syndrome will be recruited for this study. Participants will be recruited from local physical therapy clinics and physician offices. Participants will be screened for eligibility prior to being enrolled in the study and stratified into one of four cohorts based on the severity of self-reported symptoms using a visual analog scale: mild (scores 1-3), moderate (scores 4-6), severe (scores 7-9) and very severe (score 10). Exclusion criteria include a history of upper extremity surgery or other upper extremity disorders not related to thoracic outlet syndrome. All participants will provide written informed consent prior to participating in the study assessments.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 (Mild); Participants with mild self-reported thoracic outlet syndrome symptoms (visual analog scale score 1-3).	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.
Cohort 2 (Moderate); Participants with moderate self-reported thoracic outlet syndrome symptoms (visual analog scale score 4-6). No intervention will be provided.	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.
Cohort 3 (Severe); participants with severe self-reported thoracic outlet syndrome symptoms (visual analog scale score 7-9). No intervention will be provided	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.
Cohort 4 (Very Severe); Participants with very severe self-reported thoracic outlet syndrome symptoms (visual analog scale score 10). No intervention will be provided.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion (ROM) of the Shoulder joint	Active and passive ROM will be measured using a standard goniometer.	Baseline
Range of Motion (ROM) of the Elbow joint	Active and passive ROM will be measured using a standard goniometer.	Baseline
Range of Motion (ROM) of the Wrist joint	Active and passive ROM will be measured using a standard goniometer.	Baseline
Isometric Muscle Strength of shoulder	Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer.	Baseline
Isometric Muscle Strength of elbow	Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer.	Baseline
Isometric Muscle Strength of wrist	Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer.	Baseline
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
Nerve Conduction Studies of ulnar nerve	Nerve conduction studies will assess the function/integrity of the ulnar nerve.	Baseline

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2023
• Primary Completion (Actual): May 16, 2024
• Study Completion (Actual): May 16, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 1, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome
• Other Study ID Numbers: 09876543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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