- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07661290
Effect of High-Power Laser Therapy on Disc Morphology and Functional Outcome in Patients With Cervical Radiculopathy
Przegląd badań
Status
Warunki
Szczegółowy opis
cervical radiculopathy is one of the most common and debilitating conditions. It occurs due to the compression or irritation of nerve roots, often caused by intervertebral disc herniation or degenerative disc disease. Patients with this condition typically experience neck pain radiating to the arms, accompanied by sensory disturbances, weakness, or diminished reflexes, which significantly impair functional ability and quality of life (Smith et al., 2020; Jones & Miller, 2019).
Conventional treatment approaches for cervical radiculopathy include conservative methods such as physiotherapy, pharmacological interventions, and in severe cases, surgical decompression. While these options may provide symptomatic relief, they often fail to address underlying structural and physiological changes, such as disc degeneration or nerve dysfunction. Additionally, surgical interventions carry inherent risks, including infection and nerve damage, and are not suitable for all patients. This has driven the search for alternative, non-invasive treatment modalities that can address both symptoms and the root causes of the condition.High-power laser therapy (HPLT) has emerged as a promising solution in this context. HPLT uses focused laser light to deliver high energy to tissues, stimulating cellular repair processes, reducing inflammation, and promoting analgesia through photo biomodulation. Unlike low-level laser therapy, HPLT delivers higher energy levels, allowing deeper tissue penetration and potentially greater therapeutic effects (Clark et al., 2021). These mechanisms make HPLT particularly suited for treating conditions like cervical radiculopathy, where inflammation, nerve irritation, and tissue degeneration coexist.
Despite its growing popularity, the evidence supporting the efficacy of HPLT in cervical radiculopathy is still limited. Current research mainly highlights its potential for pain reduction, but there is a lack of rigorous, controlled trials evaluating its impact on disc morphology and overall functional recovery. For instance, a recent study by Williams et al. (2022) demonstrated significant pain relief in patients treated with HPLT, yet did not assess structural or electrophysiological outcomes. This highlights the need for further investigation to establish HPLT as a comprehensive treatment modality.
This study aims to bridge this knowledge gap by systematically evaluating the effects of high-power laser therapy on key outcomes, including disc morphology, and functional activity in patients with cervical radiculopathy. By addressing these dimensions, the research seeks to provide a comprehensive understanding of HPLT's role in managing cervical radiculopathy. It also aims to contribute to the development of evidence-based guidelines for its clinical application, offering a safer and more effective alternative to traditional interventions.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Diana Aahed Mahmoud Mushtaha, M.Sc
- Numer telefonu: +201119221077
- E-mail: daiana.mushtaha@gmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Ibrahim Mohamed Hamoda, Assistant Professor
Lokalizacje studiów
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Cairo, Egipt
- Rekrutacyjny
- Al Kasr Al Aini French Teaching Hospital
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Kontakt:
- Diana Aahed Mahmoud Mushtaha, M.Sc. in Physical Therapy
- Numer telefonu: +201119221077
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Kontakt:
- E-mail: Daiana.mushtaha@gmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged between 40 to 60 years.
• A Body Mass Index (BMI) range of 18.5-35 (normal to overweight) will be required.
• Diagnosed with cervical radiculopathy, confirmed by clinical examination and diagnostic imaging (e.g., MRI).
• Pain intensity level of at least 4 on the Visual Analog Scale (VAS).
• No previous history of surgery on the cervical spine.
• Able to provide informed consent and participate in the study protocol.
Exclusion Criteria:
- Pregnant women or those planning to become pregnant. • Individuals with severe comorbidities that could interfere with the study, such as uncontrolled diabetes, cancer, or systemic inflammatory diseases.
Individuals with severe cervical stenosis or spinal cord compression.
• Individuals any form of malignancy, active infection, or dermatological issues on the neck.
• Patients using opioid analgesics or other strong pain medications that could alter the results.
• Previous treatment with high-power laser therapy within the last six months.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: study group
This group will consist of 30 patients, who will receive high-power laser therapy (HPLT) for 8 weeks.
High-Power Laser Therapy (HPLT) Description: High-Power Laser Therapy (HPLT): parameters Wavelength: 1064 nm Power output: 8-10 W Frequency: Pulsed wave (CW) Treatment Duration: 10-20 minutes per session Treatment Frequency: 3 sessions per week for 8 weeks (total of 24 sessions).
Application: The laser is applied to the area of pain and nerve root compression, focusing on disc hydration, pain relief, and reduction of inflammation.
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High-Power Laser Therapy (HPLT): parameters Wavelength: 1064 nm Power output: 8-10 W Frequency: Pulsed wave (CW) Treatment Duration: 10-20 minutes per session Treatment Frequency: 3 sessions per week for 8 weeks (total of 24 sessions).
Application: The laser is applied to the area of pain and nerve root compression, focusing on disc hydration, pain relief, and reduction of inflammation.
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Aktywny komparator: Control Group
Control Group: This group will consist of 30 patients, who will receive Ultrasound, Interferential Current, and Hot Packs for eight weeks.
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- Ultrasound therapy: Frequency: 1 MHz (deep tissue penetration) Intensity: 1.5-2 W/cm² Duration: 8-10 minutes per session Application: Applied to the affected cervical region to enhance tissue healing and reduce pain and inflammation. - Interferential current therapy: Frequency: 4,000 Hz (with a beat frequency of 80-150 Hz) Intensity: Adjusted to produce a comfortable muscle contraction without causing pain Duration: 10-15 minutes per session Application: Applied to the cervical region to reduce pain and improve circulation. - Hot Packs: Temperature: 40°C - 45°C Duration: 15-20 minutes per session Application: Applied to the cervical region to promote muscle relaxation and alleviate discomfort. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Disc height
Ramy czasowe: 8 weeks
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Disc height: Measured using sagittal images, comparing the anterior and posterior heights of the cervical disc, height in meters.
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8 weeks
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Disc hydration
Ramy czasowe: 8 weeks
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Disc hydration: Assessing changes in the signal intensity of the intervertebral disc, which indicates water content.
This is typically measured on T2-weighted MRI sequences.
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8 weeks
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Disc protrusion
Ramy czasowe: 8 weeks
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- Disc protrusion: Examined using both sagittal and axial views to detect any changes in the disc's morphology, including the presence of herniation or bulging
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8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Functional outcome
Ramy czasowe: 8 weeks
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Neck Disability Index (NDI) is used to assess disability related to neck pain and functional activity at baseline, and post-treatment.
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8 weeks
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Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Hussein Ahmed Shaker, Professor, Cairo University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/005800
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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