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

NCT07661290 | Recruiting

• 1 other identifier: P.T.REC/012/005800
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Radiculopathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Functional outcome

  8 weeks

Study Arms (2)

study group

EXPERIMENTAL

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)

Control Group

ACTIVE COMPARATOR

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

Interventions

High-Power Laser Therapy (HPLT) DEVICE

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.

study group

Ultrasound, Interferential Current, and Hot Packs DEVICE

\- 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.

Control Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al Kasr Al Aini French Teaching Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hussein Ahmed Shaker

  Professor, Cairo university

  STUDY CHAIR

Central Study Contacts

Diana Aahed Mahmoud Mushtaha, M.Sc

CONTACT

+201119221077; daiana.mushtaha@gmail.com

Ibrahim Mohamed Hamoda, Assistant Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: June 22, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

EG (1)