- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07785427
Effect of Mechanically Loaded Neuro-dynamics in Subjects With Thoracic Outlet Syndrome
Effect of Mechanically Loaded Neuro-dynamics on Physiological Findings and Functional Outcomes in Subjects With Thoracic Outlet Syndrome
the study was done to: To assess the effect of Mechanically Loaded Neuro-dynamics on pain reduction in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on shoulder range of motion in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on clinical provocative tests in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on neurophysiological findings in subjects with thoracic outlet syndrome.
To assess the effect of Mechanically Loaded Neuro-dynamics on quality of life and psychological status in subjects with thoracic outlet syndrome.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed Abdulmohsen Almohamadi, physical therapist
- Phone Number: 01050366830
- Email: ptmohammed1993@gmail.com
Study Locations
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Kafr ash Shaykh, Egypt
- out-patient clinic, faculty of physical therapy - Kafrelsheikh University.
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Contact:
- Mohammed Abdulmohsen Almohamadi, physical therapist
- Phone Number: 01050366830
- Email: ptmohammed1993@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects from both genders diagnosed with Thoracic Outlet Syndrome will be recruited through direct referrals from their neurosurgeon.
- Subjects age between 30.8±7.4 years
- Subjects body mass index = 19.5±2.8
- Control group includes health volunteer subjects with negative root test results under supervision of neurosurgeon.
Exclusion Criteria:
The exclusion criteria are:
- head injury, stroke.
- epilepsy episodes.
- mental disorders.
- cardiovascular disease.
- having a pacemaker or cochlear implant.
- pregnancy, oncological episodes, inflammatory disease, myelopathy, degenerative changes in the cervical spine (after verification on computed tomography or magnetic resonance imaging scans).
- peripheral neuropathies from the level of the arm and COVID-19-related symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Mechanically Loaded Neuro-dynamics
involved 18 participants and received physical therapy management will include 11 visits over 11 weeks, Mechanically Loaded Neuro-dynamics was implemented using green medium-resistance bands (approximately 4.6-6.9
lbs. at 100% elongation).
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Physical therapy management will include 11 visits over 11 weeks, utilizing green medium-resistance bands (4.6-6.9 pounds at 100% elongation).
The protocol involves: weeks 3-4 with low tension isometric holds (5-10 seconds) in partial range; weeks 5-7 with dynamic repetitions (10-15 repetitions, 3 sets) in full range; and weeks 8-11 featuring sport-specific load progression with cycling postures and upper extremity tasks.
Repetitions will be slow and controlled, with cues to minimize guarding or Valsalva.
Progression will depend on symptom response and visual analogue scale scores, with Mechanically Loaded Neuro-dynamics performed 1-2 times weekly in-clinic and daily home exercises.
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Active Comparator: traditional physical therapy program
involved 18 participants and received a traditional physical therapy program for Thoracic Outlet Syndrome (TOS)
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traditional physical therapy program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
assessment of Active and passive Range of motion
Time Frame: At baseline and after 11 weeks
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Cervical spine range of motion (ROM) was assessed using a goniometer.
Participants were positioned comfortably in a standardized sitting position, with the trunk stabilized to minimize compensatory movements.
Cervical flexion, extension, lateral flexion, and rotation were measured in degrees.
The goniometer was aligned according to standard anatomical landmarks for each movement, and the active ROM was recorded at the end of the available pain-free range.
Measurements were performed consistently for all participants under the same testing conditions.
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At baseline and after 11 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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assessment of sensory nerve conduction velocity
Time Frame: At baseline and after 11 weeks
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For the digital sensory nerve conduction study, we will use standard antidromic techniques with a fixed distance of 11 cm between the recording and stimulating electrodes for the ulnar and 13 cm for the median sensory nerves.
Standard techniques and distances between recording and stimulating electrodes will be used for the medial antebrachial cutaneous (12 cm), lateral antebrachial cutaneous (12 cm), and the dorsal ulnar cutaneous (8 cm) nerve conduction study.
Sensory nerve conduction study parameters included sensory nerve action potential, amplitude and peak latency
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At baseline and after 11 weeks
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assessment of motor nerve conduction velocity
Time Frame: At baseline and after 11 weeks
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For motor nerve conduction study, also will be used a fixed distance of 7 cm between the recording and stimulating electrodes for both median and ulnar nerves.
motor nerve conduction study parameters included compound muscle action potential amplitude, area, distal latency, duration of the negative phase, and forearm conduction velocity.
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At baseline and after 11 weeks
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assessment of physical function and symptoms of the upper limb
Time Frame: At baseline and after 11 weeks
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The Disabilities of the Arm, Shoulder and Hand is a 30-item instrument assessing health status in daily activities, symptoms, social functioning, and psychological factors over the past week.
Responses range from 1 (no difficulty) to 5 (unable to perform), yielding scores from 0 to 100, where higher scores indicate greater disability.
The he Disabilities of the Arm, Shoulder and Hand demonstrates strong reliability, with an intraclass correlation coefficient of 0.74-0.95.
The minimum detectable change is 11 points, while the minimum clinically important difference is 10.83 points, indicating significant changes in patient function.
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At baseline and after 11 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mohammed_Msc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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