Herniated Lumbar DiscNCT06831227
High Power Laser Therapy for Herniated Disc and Lumbosacral Radiculopathy
A study testing High power Laser Therapy and physical therapy exercise program and hot pack in people with Herniated Lumbar Disc, run by Cairo University at 1 site in Egypt.
Trial summary
To determine the effect of high-power laser therapy on the size of herniated disc and functional outcome in patients with lumbosacral radiculopathy. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Herniated Lumbar Disc
- What is being tested?
- High power Laser Therapy and physical therapy exercise program and hot pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Nov 2025
- 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed by orthopedic or neurological consultants depended on MRI assessment as disc herniation (L4-L5/L5-S1levels) with lumbar radiculopathy.
- patients from both genders.
- The patient age will range from 30-45 years old.
- Duration of illness ranged from 3 to 6 months.
- All patients in the study should be ambulant independently.
- Medically and psychologically stable patients.
Who cannot join
- Previous lumbar or hip surgery.
- Cauda equina syndrome
- Fracture of the bones of lower extremity.
- Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
- BMI not more than 30.
- Vascular Impairment.
- Pregnancy and Gynecological problems
- Red flags: spinal tumors, spinal fractures, osteoporosis, infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of High-Power Laser Therapy on the Size of Herniated Disc and Functional Outcome in Patients with Lumbosacral Radiculopathy.
To determine the effect of high-power laser therapy on the size of herniated disc and functional outcome in patients with lumbosacral radiculopathy.
Read the detailed description
A herniated disc is a condition in which annulus fibrosus is damaged enabling the nucleus pulposus (which is normally located within the center of the disc) to herniate. It is a common cause of back pain. Unlike mechanical back pain, herniated disc pain is often burning or stinging, and may radiate into the lower extremity. Furthermore, in more severe cases, there can be associated with weakness or sensation changes. herniated disc injury may compress the nerve or the spinal cord causing pain consistent with nerve compression or spinal cord dysfunction, also known as myelopathy.
Lumbosacral radiculopathy is a disorder that causes pain in the lower back and hip which radiates down the back of the thigh into the leg. This damage is caused by compression of the nerve roots which exit the spine at levels of L1- S4. The compression can result in tingling, radiating pain, numbness, paraesthesia, and occasional shooting pain.
A combination of factors including pressure, inflammation, and an immune response seem to be implicated in the pathogenesis of both acute and chronic radicular pain. Pressure would not be a cause of pain, but rather of nerve dysfunction such as weakness and numbness, while the addition of both inflammation and immune response could explain the severe pain experienced by patients suffering from radicular pain.
High power laser therapy (HPLT) is a new, non-invasive, painless, and powerful method with anti-inflammatory and reparative effects. HPLT has therapeutic benefits through photochemical, photothermal, and photomechanical mechanisms, possibly due to its potential for reducing inflammation, enhancing microcirculation, and stimulating immunological proteins and nerve regeneration and secretion of β-endorphins.
MRI: It is the study of choice to visualize herniated disc. MRI findings will help surgeons and other providers plan procedural care if it is indicated. Disc protrusion and nerve root compression can be identified. As Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.
Imaging for diagnosis disc herniation are X-rays: These are very accessible at most clinics and outpatient offices. This imaging technique can be used to assess for any structural instability. If x-rays show an acute fracture, it needs to be further investigated using a computed tomogram (CT) scan or magnetic resonance imaging (MRI) .
- Conditions
- Herniated Lumbar Disc
- Being tested
- High power Laser Therapy, physical therapy exercise program and hot pack
- Keywords
- High Power Laser, Herniated disc, LUMBOSACRAL RADICULOPATHY
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High power Laser TherapyDevice
A total course protocol: 18 sessions, for 6 weeks ,3 sessions per week. Patients will receive High power Laser treatment. manually set to bio stimulation mode with high peak power (5 - 6 W), energy per impulse 150 mJ/c2, wavelength measuring 1064 nm, and spot beam diameter area of 1 cm2.
The hand piece was positioned in contact with and perpendicular to the treated area with the patient inside lying position with knee to chest. Scanning will perform transversely and longitudinally paravertebral region on the lower lumbar area at the level of the disc concerned. Each session included three phases (fast scan, sensitive trigger points, slow scan) and had a total duration of 20 minutes. During each session, a total energy of 3000 J was applied through three phases of treatment.
physical therapy exercise program and hot packDevice
this group will receive the same selected physical therapy exercise program (45 minutes) and hot pack (10 min) for 18 session. All patients will attend the physical therapy clinic three times weekly for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| HPLT | Active comparator | this group will receive high power laser therapy (HPLT) for 20 minutes in addition to selected physical therapy exercise program 25 minutes and hot pack ten for 18 sessions three times weekly for 6 weeks. Receives: Device: High power Laser Therapy; Device: physical therapy exercise program and hot pack |
| physical therapy exercise program and hot pack | Sham comparator | This group will receive the same selected physical therapy exercise program (45 minutes) and hot pack (10 min) for 18 session. All patients will attend the physical therapy clinic three times weekly for 6 weeks Receives: Device: physical therapy exercise program and hot pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS):
This scale is used to assess the severity of pain. It consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain (10) that the patient could feel
Measured: 3 to 6 months
Back Pain Related Disability (ODI) using Oswestry low back pain disability questionnaire
Modified Oswestry low back disability questionnaire will be used to evaluate patient functional disability. It consists of 10 sections of activities of daily life. Patient asked to answer by checking ONE box in each section for the statement which best applies to her. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5.
Measured: 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herniated Lumbar DiscStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wessam abelfattah mohamed alrefaie, Cairo University
- Investigators
- ashraf ahmed abdelmonem, md, Study director, assistant professor of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831227
- Sponsor's protocol ID
- Pٌٌ.T.REC/012/005509
- Status last verified
- Feb 2025
- First submitted
- 27 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: i will decide later
Publications
Huang Y, Gao D. The effectiveness of high intensity laser therapy in the patients with lumbar disc herniation: A protocol of randomized placebo-controlled trial. Medicine (Baltimore). 2020 Oct 9;99(41):e22520. doi: 10.1097/MD.0000000000022520.
PubMed 33031293
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-Power Laser Therapy on the Size of Herniated Disc and Functional Outcome in Patients with Lumbosacral Radiculopathy.
- ClinicalTrials.gov ID
- NCT06831227
- Acronym / sponsor ID
- Pٌٌ.T.REC/012/005509
- Conditions
- Herniated Lumbar Disc
- Keywords
- High Power Laser, Herniated disc, LUMBOSACRAL RADICULOPATHY
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 18 Feb 2025 (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.
To determine the effect of high-power laser therapy on the size of herniated disc and functional outcome in patients with lumbosacral radiculopathy.
Detailed description
A herniated disc is a condition in which annulus fibrosus is damaged enabling the nucleus pulposus (which is normally located within the center of the disc) to herniate. It is a common cause of back pain. Unlike mechanical back pain, herniated disc pain is often burning or stinging, and may radiate into the lower extremity. Furthermore, in more severe cases, there can be associated with weakness or sensation changes. herniated disc injury may compress the nerve or the spinal cord causing pain consistent with nerve compression or spinal cord dysfunction, also known as myelopathy.
Lumbosacral radiculopathy is a disorder that causes pain in the lower back and hip which radiates down the back of the thigh into the leg. This damage is caused by compression of the nerve roots which exit the spine at levels of L1- S4. The compression can result in tingling, radiating pain, numbness, paraesthesia, and occasional shooting pain.
A combination of factors including pressure, inflammation, and an immune response seem to be implicated in the pathogenesis of both acute and chronic radicular pain. Pressure would not be a cause of pain, but rather of nerve dysfunction such as weakness and numbness, while the addition of both inflammation and immune response could explain the severe pain experienced by patients suffering from radicular pain.
High power laser therapy (HPLT) is a new, non-invasive, painless, and powerful method with anti-inflammatory and reparative effects. HPLT has therapeutic benefits through photochemical, photothermal, and photomechanical mechanisms, possibly due to its potential for reducing inflammation, enhancing microcirculation, and stimulating immunological proteins and nerve regeneration and secretion of β-endorphins.
MRI: It is the study of choice to visualize herniated disc. MRI findings will help surgeons and other providers plan procedural care if it is indicated. Disc protrusion and nerve root compression can be identified. As Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in the body.
Imaging for diagnosis disc herniation are X-rays: These are very accessible at most clinics and outpatient offices. This imaging technique can be used to assess for any structural instability. If x-rays show an acute fracture, it needs to be further investigated using a computed tomogram (CT) scan or magnetic resonance imaging (MRI) .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPLT | Active comparator | Device: High power Laser Therapy, Device: physical therapy exercise program and hot packthis group will receive high power laser therapy (HPLT) for 20 minutes in addition to selected physical therapy exercise program 25 minutes and hot pack ten for 18 sessions three times weekly for 6 weeks. |
| physical therapy exercise program and hot pack | Sham comparator | Device: physical therapy exercise program and hot packThis group will receive the same selected physical therapy exercise program (45 minutes) and hot pack (10 min) for 18 session. All patients will attend the physical therapy clinic three times weekly for 6 weeks |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed by orthopedic or neurological consultants depended on MRI assessment as disc herniation (L4-L5/L5-S1levels) with lumbar radiculopathy.
- patients from both genders.
- The patient age will range from 30-45 years old.
- Duration of illness ranged from 3 to 6 months.
- All patients in the study should be ambulant independently.
Key exclusion criteria (8 listed)
- Previous lumbar or hip surgery.
- Cauda equina syndrome
- Fracture of the bones of lower extremity.
- Major neurological condition (e.g., stroke, multiple sclerosis, Epilepsy, Meningitis, and Brain tumor).
- BMI not more than 30.
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 TherapyA total course protocol: 18 sessions, for 6 weeks ,3 sessions per week. Patients will receive High power Laser treatment. manually set to bio stimulation mode with high peak power (5 - 6 W), energy per impulse 150 mJ/c2, wavelength measuring 1064 nm, and spot beam diameter area of 1 cm2. The hand piece was positioned in contact with and perpendicular to the treated area with the patient inside lying position with knee to chest. Scanning will perform transversely and longitudinally paravertebral region on the lower lumbar area at the level of the disc concerned. Each session included three phases (fast scan, sensitive trigger points, slow scan) and had a total duration of 20 minutes. During each session, a total energy of 3000 J was applied through three phases of treatment. | Device | HPLT |
| physical therapy exercise program and hot packthis group will receive the same selected physical therapy exercise program (45 minutes) and hot pack (10 min) for 18 session. All patients will attend the physical therapy clinic three times weekly for 6 weeks | Device | HPLT, physical therapy exercise program and hot pack |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 3 to 6 months
Visual Analogue Scale (VAS): This scale is used to assess the severity of pain. It consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) to the worst pain (10) that the patient could feel
Back Pain Related Disability (ODI) using Oswestry low back pain disability questionnaire
Time frame: 3-6 months
Modified Oswestry low back disability questionnaire will be used to evaluate patient functional disability. It consists of 10 sections of activities of daily life. Patient asked to answer by checking ONE box in each section for the statement which best applies to her. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5.
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 18 Feb 2025.
- Background: PubMed 33031293Huang Y, Gao D. The effectiveness of high intensity laser therapy in the patients with lumbar disc herniation: A protocol of randomized placebo-controlled trial. Medicine (Baltimore). 2020 Oct 9;99(41):e22520. doi: 10.1097/MD.0000000000022520.
- Individual participant dataSharing planned: Undecided. i will decide later
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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.
ashraf ahmed abdelmonem, md study director
assistant professor of physical therapy
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 and physical therapy exercise program and hot pack in people with Herniated Lumbar Disc, 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 8 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: opening soon, as of the sponsor's last update on 18 Feb 2025. 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. Some participants in this study may receive a placebo. 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 wessam mohamed alrefaie, master degree (+201063045651, wessamrefaay1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: 3 to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06831227, which also lists 1 linked publication.
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 18 Feb 2025.