- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07643701
Neurodynamic Mobilization for Cervical Radiculopathy (NDM-CR)
Effectiveness of Adding Neurodynamic Mobilization to Conventional Physiotherapy in Patients With Cervical Radiculopathy: A Randomized Controlled Trial
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Cervical radiculopathy is a condition where a nerve in the neck becomes irritated or compressed. This can cause neck pain, pain that spreads into the arm, numbness, tingling, and difficulty performing daily activities. It can significantly affect a person's quality of life.
This study investigated whether adding a specific physiotherapy technique called neurodynamic mobilization to standard physiotherapy could improve recovery in patients with cervical radiculopathy.
A total of 50 participants took part in the study. They were randomly divided into two groups. One group received standard physiotherapy treatment only, while the other group received standard physiotherapy combined with neurodynamic mobilization techniques.
Both treatment programs were carried out over five weeks, with a total of 10 treatment sessions.
Participants were evaluated before and after treatment to measure pain levels and how much their neck condition affected daily activities. Pain was measured using a simple rating scale, and disability was measured using a questionnaire.
The results showed that both groups improved over time. However, the group that received the additional neurodynamic mobilization experienced greater reductions in pain and better improvement in daily function compared to the group that received standard physiotherapy alone.
The study suggests that adding neurodynamic mobilization may enhance the effectiveness of physiotherapy for people with cervical radiculopathy.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Beirut
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Jounieh, Beirut, Libanon, 0000
- Lebanese German University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Adults aged 18-65 years.
- Diagnosis of cervical radiculopathy.
- pain radiating to the upper limb.
- Presence of at least one neurological sign, including: Sensory deficit, or Muscle weakness, or Diminished reflexes.
Exclusion Criteria:
- Previous cervical spine surgery.
- Cervical myelopathy.
- Cervical fractures.
- Tumors affecting the cervical spine.
- Inflammatory disorders.
- Any contraindication to physiotherapy interventions.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Conventional Physiotherapy
Participants received conventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities aimed at reducing pain and improving function.
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Conventional physiotherapy consisted of a standardized rehabilitation program including therapeutic exercises, manual therapy techniques, and physical modalities.
Therapeutic exercises focused on cervical range of motion, strengthening, and postural correction.
Manual therapy included soft tissue techniques and joint mobilization of the cervical spine.
Physical modalities were applied to reduce pain and improve function.
The intervention was delivered over 5 weeks, with a total of 10 sessions.
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Experimentální: Conventional Physiotherapy + Neurodynamic Mobilization
Participants received conventional physiotherapy including therapeutic exercises, manual therapy, and physical modalities aimed at reducing pain and improving function.
In addition, neurodynamic mobilization techniques targeting cervical nerve roots were applied to improve neural mobility and reduce mechanosensitivity.
The intervention was delivered over 5 weeks, with a total of 10 sessions.
Techniques included neurodynamic sliding mobilization performed within pain-free or low-pain ranges, individually adapted to patient symptoms.
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Conventional physiotherapy consisted of a standardized rehabilitation program including therapeutic exercises, manual therapy techniques, and physical modalities.
Therapeutic exercises focused on cervical range of motion, strengthening, and postural correction.
Manual therapy included soft tissue techniques and joint mobilization of the cervical spine.
Physical modalities were applied to reduce pain and improve function.
The intervention was delivered over 5 weeks, with a total of 10 sessions.
Neurodynamic mobilization consisted of specific neural tissue mobilization techniques targeting the affected cervical nerve roots.
The techniques were applied in addition to conventional physiotherapy and aimed to restore normal neural mobility and reduce mechanosensitivity.
Treatment was delivered over 5 weeks (10 sessions).
Each session included standardized neurodynamic sliding techniques performed within pain-free or low-pain ranges, combined with conventional physiotherapy interventions including therapeutic exercises, manual therapy, and physical modalities.
The intervention was individually tailored based on patient symptoms and clinical presentation.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Intensity
Časové okno: Baseline and after 5 weeks of intervention.
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Pain intensity will be assessed using the Visual Analogue Scale (VAS), a validated self-reported measure of pain severity.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline and after 5 weeks of intervention.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Functional Disability
Časové okno: Baseline and after 5 weeks of intervention.
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Functional disability will be assessed using the Neck Disability Index (NDI), a validated questionnaire designed to evaluate the impact of neck pain on daily activities.
The NDI consists of 10 items, with total scores ranging from 0 to 50.
Higher scores indicate greater neck-related disability.
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Baseline and after 5 weeks of intervention.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Samir Matar, Professor, Lebanese German University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- LGU-DPT-RCT-2024-01
- pk4fs (Identifikátor registru: Open Science Framework OSF)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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