Effect of High-Power Laser Therapy on Disc Morphology, Pain, Electrophysiological Outcomes, and Functional Activity in Patients With Cervical Radiculopathy

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, pain reduction, nerve function, and overall functional activity

Study Overview

• Status: Not yet recruiting
• Conditions: Radiculopathy
• Intervention / Treatment: Device: High-Power Laser Therapy (HPLT); Device: Ultrasound, Interferential Current, and Hot Packs

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, nerve function, 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, electrophysiological measures, 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diana Aahed Mahmoud Mushtaha, M.Sc; Phone Number: +201119221077; Email: daiana.mushtaha@gmail.com
• Study Contact Backup: Name: Ibrahim Mohamed Hamoda, Assistant Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: Control Group; Control Group: This group will consist of 30 patients, who will receive Ultrasound, Interferential Current, and Hot Packs for eight weeks.; 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.	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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disc height	Disc height: Measured using sagittal images, comparing the anterior and posterior heights of the cervical disc, height in meters.	8 weeks
Disc hydration	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.	8 weeks
Disc protrusion	- 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	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity:	Measured using the Visual Analog Scale (VAS) at baseline, and post-treatment	8 weeks
Electrophysiological parameters	Nerve conduction velocity (NCV) and sensory nerve action potential (SNAP) are assessed using electromyography (EMG).	8 weeks
Functional outcomes	Neck Disability Index (NDI) is used to assess disability related to neck pain and functional activity at baseline, and post-treatment.	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hussein Ahmed Shaker, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: P.T.REC/012/005800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes