Effect of Mechanically Loaded Neuro-dynamics in Subjects With Thoracic Outlet Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-37
SponsorKafrelsheikh University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
head injury, stroke.
epilepsy episodes.
mental disorders.
cardiovascular disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Mechanically Loaded Neuro-dynamics
Other interventionPhysical 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.
traditional physical therapy program
Other interventiontraditional physical therapy program
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Mechanically Loaded Neuro-dynamicsExperimental treatment 1 intervention
Group B: traditional physical therapy programActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
assessment of Active and passive Range of motion
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.
Time frame
At baseline and after 11 weeksSecondary outcomes
1
assessment of sensory nerve conduction velocity
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
Time frame
At baseline and after 11 weeks2
assessment of motor nerve conduction velocity
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.
Time frame
At baseline and after 11 weeks3
assessment of physical function and symptoms of the upper limb
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.
Time frame
At baseline and after 11 weeksSponsors and contacts
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Source ClinicalTrials.gov
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