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

NCT05934734 | Completed

• 1 other identifier: 09876543
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

Cohort 1 (Mild)

Participants with mild self-reported thoracic outlet syndrome symptoms (visual analog scale score 1-3).

Other: No intervention

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

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

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

Interventions

No intervention OTHER

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 1 (Mild); Cohort 2 (Moderate); Cohort 3 (Severe); Cohort 4 (Very Severe)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18-65 years
• Diagnosed with thoracic outlet syndrome
• Willing and able to provide informed consent

You may not qualify if:

• History of upper extremity surgery unrelated to thoracic outlet syndrome
• Other upper extremity disorders unrelated to thoracic outlet syndrome

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 7, 2023
• Study Start: June 30, 2023
• Primary Completion: May 16, 2024
• Study Completion: May 16, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)