Thoracic Outlet SyndromeNCT05934734
Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity
An observational study of Thoracic Outlet Syndrome, run by Ahram Canadian University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thoracic Outlet Syndrome
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2023to 16 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18-65 years
- Diagnosed with thoracic outlet syndrome
- Willing and able to provide informed consent
Who cannot join
- History of upper extremity surgery unrelated to thoracic outlet syndrome
- Other upper extremity disorders unrelated to thoracic outlet syndrome
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: 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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- No intervention
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (Mild) | Participants with mild self-reported thoracic outlet syndrome symptoms (visual analog scale score 1-3). Receives: 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. Receives: 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 Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion (ROM) of the Shoulder joint
Active and passive ROM will be measured using a standard goniometer.
Measured: Baseline
Range of Motion (ROM) of the Elbow joint
Active and passive ROM will be measured using a standard goniometer.
Measured: Baseline
Range of Motion (ROM) of the Wrist joint
Active and passive ROM will be measured using a standard goniometer.
Measured: Baseline
Isometric Muscle Strength of shoulder
Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer.
Measured: Baseline
Isometric Muscle Strength of elbow
Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer.
Measured: Baseline
Isometric Muscle Strength of wrist
Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer.
Measured: 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.
Measured: Baseline
Nerve Conduction Studies of ulnar nerve
Nerve conduction studies will assess the function/integrity of the ulnar nerve.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 Jun 2023
- Primary completion16 May 2024
- Study completion16 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934734
- Sponsor's protocol ID
- 09876543
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Thoracic Outlet Syndrome Severity on Upper Extremity Function and Neural Integrity: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05934734
- Acronym / sponsor ID
- 09876543
- Conditions
- Thoracic Outlet Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (Mild) | – | Other: No interventionParticipants with mild self-reported thoracic outlet syndrome symptoms (visual analog scale score 1-3). |
| Cohort 2 (Moderate) | – | Other: No interventionParticipants with moderate self-reported thoracic outlet syndrome symptoms (visual analog scale score 4-6). No intervention will be provided. |
| Cohort 3 (Severe) | – | Other: No interventionparticipants with severe self-reported thoracic outlet syndrome symptoms (visual analog scale score 7-9). No intervention will be provided |
| Cohort 4 (Very Severe) | – | Other: No interventionParticipants with very severe self-reported thoracic outlet syndrome symptoms (visual analog scale score 10). No intervention will be provided. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18-65 years
- Diagnosed with thoracic outlet syndrome
- Willing and able to provide informed consent
Key exclusion criteria (2 listed)
- History of upper extremity surgery unrelated to thoracic outlet syndrome
- Other upper extremity disorders unrelated to thoracic outlet syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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. | Other | Cohort 1 (Mild), Cohort 2 (Moderate), Cohort 3 (Severe), Cohort 4 (Very Severe) |
Primary outcome
Range of Motion (ROM) of the Shoulder joint
Time frame: Baseline
Active and passive ROM will be measured using a standard goniometer.
Range of Motion (ROM) of the Elbow joint
Time frame: Baseline
Active and passive ROM will be measured using a standard goniometer.
Range of Motion (ROM) of the Wrist joint
Time frame: Baseline
Active and passive ROM will be measured using a standard goniometer.
Isometric Muscle Strength of shoulder
Time frame: Baseline
Maximum voluntary isometric strength of shoulder muscles will be measured using a handheld dynamometer.
Isometric Muscle Strength of elbow
Time frame: Baseline
Maximum voluntary isometric strength of elbow muscles will be measured using a handheld dynamometer.
Isometric Muscle Strength of wrist
Time frame: Baseline
Maximum voluntary isometric strength of wrist muscles will be measured using a handheld dynamometer.
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.
Nerve Conduction Studies of ulnar nerve
Time frame: Baseline
Nerve conduction studies will assess the function/integrity of the ulnar nerve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Outlet Syndrome, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (ROM) of the Shoulder joint (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.