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Recruiting NCT07661290

Effect of High-Power Laser Therapy on Disc Morphology and Functional Outcome in Patients With Cervical Radiculopathy

No phase Interventional Radiculopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Power Laser Therapy (HPLT), Ultrasound, Interferential Current, and Hot Packs.
Who it may be relevant to
Registry conditions: Radiculopathy. Basic parameters: 40 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The study aims to evaluate the effectiveness of high-power laser therapy (HPLT) in patients with cervical radiculopathy, focusing on its impact on disc morphology, and overall functional activity

Detailed description

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.

Interventions

  • Device High-Power Laser Therapy (HPLT)
    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.
  • Device Ultrasound, Interferential Current, and Hot Packs
    \- 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 re

Primary outcome measures

  • Disc height [Time frame: 8 weeks]
  • Disc hydration [Time frame: 8 weeks]
  • Disc protrusion [Time frame: 8 weeks]
Secondary outcome measures (1)
  • Functional outcome [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Al Kasr Al Aini French Teaching Hospital — Cairo

Identifiers

NCT: NCT07661290 · P.T.REC/012/005800

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗