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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05934734
Recruitment Status : Recruiting
First Posted : July 7, 2023
Last Update Posted : July 7, 2023
Sponsor:
Information provided by (Responsible Party):
Mohamed Magdy ElMeligie, Ahram Canadian University

Study Description
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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.

Condition or disease Intervention/treatment
Thoracic Outlet Syndrome Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity: A Cross-Sectional Study
Estimated Study Start Date : June 30, 2023
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Range of Motion (ROM) of the Shoulder joint [ Time Frame: Baseline ]
    Active and passive ROM will be measured using a standard goniometer.

  2. Range of Motion (ROM) of the Elbow joint [ Time Frame: Baseline ]
    Active and passive ROM will be measured using a standard goniometer.

  3. Range of Motion (ROM) of the Wrist joint [ Time Frame: Baseline ]
    Active and passive ROM will be measured using a standard goniometer.

  4. Isometric Muscle Strength of shoulder [ Time Frame: Baseline ]
    Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer.

  5. Isometric Muscle Strength of elbow [ Time Frame: Baseline ]
    Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer.

  6. Isometric Muscle Strength of wrist [ Time Frame: Baseline ]
    Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer.

  7. Self-reported upper extremity function [ Time Frame: Baseline ]
    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.

  8. Nerve Conduction Studies of ulnar nerve [ Time Frame: Baseline ]
    Nerve conduction studies will assess the function/integrity of the ulnar nerve.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05934734


Contacts
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Contact: Mohamed M ElMeligie, Ph.d +201064442032 mohamed.elmeligie@acu.edu.eg

Locations
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Egypt
Outpatient clinic of faculty of physical therapy, Ahram Canadian University Recruiting
Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
Contact: Mohamed M ElMeligie, Ph.d    01064442032    mohamed.elmeligie@acu.edu.eg   
Sponsors and Collaborators
Ahram Canadian University
Investigators
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Study Director: Amal Fawzy, Ph.d Faculty of Physical Therapy, Ahram Canadian University
More Information
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Responsible Party: Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier: NCT05934734    
Other Study ID Numbers: 09876543
First Posted: July 7, 2023    Key Record Dates
Last Update Posted: July 7, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thoracic Outlet Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
 Cardiovascular Diseases
Nerve Compression Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases