- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Mohammed Abdulmohsen Almohamadi, physical therapist
- Telefonnummer: 01050366830
- E-Mail: ptmohammed1993@gmail.com
Studienorte
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Kafr ash Shaykh, Ägypten
- out-patient clinic, faculty of physical therapy - Kafrelsheikh University.
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Kontakt:
- Mohammed Abdulmohsen Almohamadi, physical therapist
- Telefonnummer: 01050366830
- E-Mail: ptmohammed1993@gmail.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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assessment of Active and passive Range of motion
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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assessment of sensory nerve conduction velocity
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Mohammed_Msc
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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