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

June 1, 2024 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Range of Motion (ROM) of the Shoulder joint
Time Frame: Baseline
Active and passive ROM will be measured using a standard goniometer.
Baseline
Range of Motion (ROM) of the Elbow joint
Time Frame: Baseline
Active and passive ROM will be measured using a standard goniometer.
Baseline
Range of Motion (ROM) of the Wrist joint
Time Frame: Baseline
Active and passive ROM will be measured using a standard goniometer.
Baseline
Isometric Muscle Strength of shoulder
Time Frame: Baseline
Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer.
Baseline
Isometric Muscle Strength of elbow
Time Frame: Baseline
Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer.
Baseline
Isometric Muscle Strength of wrist
Time Frame: Baseline
Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer.
Baseline
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.
Baseline
Nerve Conduction Studies of ulnar nerve
Time Frame: Baseline
Nerve conduction studies will assess the function/integrity of the ulnar nerve.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahram Canadian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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