RadiculopathyNCT07661290
Effect of High-Power Laser Therapy on Disc Morphology and Functional Outcome in Patients With Cervical Radiculopathy
A study testing High-Power Laser Therapy (HPLT) and Ultrasound, Interferential Current, and Hot Packs in people with Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Radiculopathy
- What is being tested?
- High-Power Laser Therapy (HPLT) and Ultrasound, Interferential Current, and Hot Packs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ibrahim Mohamed Hamoda, Assistant Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Al Kasr Al Aini French Teaching Hospital
Cairo
Diana Aahed Mahmoud Mushtaha, M.Sc. in Physical Therapy, +201119221077
Daiana.mushtaha@gmail.com
About this study
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
Read the 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.
- Conditions
- Radiculopathy
- Being tested
- High-Power Laser Therapy (HPLT), Ultrasound, Interferential Current, and Hot Packs
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Ultrasound, Interferential Current, and Hot PacksDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Ultrasound, Interferential Current, and Hot Packs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disc height
Disc height: Measured using sagittal images, comparing the anterior and posterior heights of the cervical disc, height in meters.
Measured: 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.
Measured: 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
Measured: 8 weeks
Secondary outcomes (1)
Functional outcome
Neck Disability Index (NDI) is used to assess disability related to neck pain and functional activity at baseline, and post-treatment.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start10 Jul 2026 (estimated)
- Primary completion20 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Aahed Mahmoud Mushtaha, Cairo University
- Investigators
- Hussein Ahmed Shaker, Study chair, Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661290
- Sponsor's protocol ID
- P.T.REC/012/005800
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Power Laser Therapy on Disc Morphology and Functional Outcome in Patients With Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT07661290
- Acronym / sponsor ID
- P.T.REC/012/005800
- Conditions
- Radiculopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: High-Power Laser Therapy (HPLT)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. |
| Control Group | Active comparator | Device: Ultrasound, Interferential Current, and Hot PacksControl 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | study group |
| 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. | Device | Control Group |
Primary outcome
Disc height
Time frame: 8 weeks
Disc height: Measured using sagittal images, comparing the anterior and posterior heights of the cervical disc, height in meters.
Disc hydration
Time frame: 8 weeks
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.
Disc protrusion
Time frame: 8 weeks
- 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
1 secondary outcome
Functional outcome
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ibrahim Mohamed Hamoda, Assistant Professor contact
Hussein Ahmed Shaker study chair
Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Power Laser Therapy (HPLT) and Ultrasound, Interferential Current, and Hot Packs in people with Radiculopathy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Aahed Mahmoud Mushtaha, M.Sc (+201119221077, daiana.mushtaha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disc height (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.