Lumbar RadiculopathyNCT07393750
High-power Laser Versus Pulsed Electromagnetic Therapy in Lumbar Radiculopathy.
A study testing high-power laser, Pulsed electromagnetic field and physiotherapy program in people with Lumbar Radiculopathy and Hoffman's Reflex, run by Cairo University at 1 site in Egypt.
Trial summary
To compare between high-power laser versus pulsed electromagnetic therapy on pain and Hoffman reflex in lumbar radiculopathy. Read more about this study
- Who is it for?
- Ages 35 to 48 years
- Conditions the study is for
- Lumbar Radiculopathy, Hoffman's Reflex, Pulsed Electromagnetic Therapy
- What is being tested?
- high-power laser, Pulsed electromagnetic field and physiotherapy program
- 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
- 15 Feb 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 to 48 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Sixty lumbar radiculopathy patients, of both sexes, will represent the sample.
- The patient's age will range from 35 to 48 years old.
- Patients with lumbar disc lesion at L5-S1 confirmed by MRI and latency in H- reflex.
- Patients with unilateral sciatic radiating pain (from 5 to 8 by visual analogue scale).
- Patient with normal cognitive function (MME more than 25)
- BMI from 20-29.9
Who cannot join
- The patients will be excluded if they have one of the followings:
- Patients with pacemakers and presence of electronic implants.
- Pregnant women.
- History of or existing malignant conditions, active tuberculosis of the lungs.
- Any medical condition that may cause sciatic nerve lesion except lumbar radiculopathy, (e.g., diabetes mellitus or collagen disorders).
- Cardiac, renal or hepatic failures recent or previous history of seizures or epilepsy.
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- Previous surgery at L5-S1.
- Bleeding disorders.
- Serious infections of a viral, bacterial and fungal origin, conditions after organ transplants, upper motor neuron lesions.
- Patients with cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High-Power Laser Versus Pulsed Eectromagnetic Therapy on Pain and Hoffman Reflex in Lumbar Radiculopathy.
To compare between high-power laser versus pulsed electromagnetic therapy on pain and Hoffman reflex in lumbar radiculopathy.
Read the detailed description
Lumbar radiculopathy is one of the most common complaints evaluated by a spine surgeon. Its prevalence has been estimated to be 3%-5% of the population, affecting both men and women. Age is a primary risk factor, as it occurs secondary to the degenerative process within the spinal column. Symptoms typically begin in midlife, with men often affected in the 40s while women are affected in the 50s and 60s. Disc herniation is one of the primary causes of lumbar radiculopathy.
The pressure exerted by the herniated disc on the longitudinal ligament and the local inflammation results in localized back pain. The lumbar radicular pain arises when disc material exerts pressure or contacts the thecal sac or lumbar nerve roots, resulting in nerve root ischemia and inflammation. The annulus fibrosus is thinner on the posterolateral aspect and lacks support from the posterior longitudinal ligament, making it vulnerable to herniations. Due to the proximity of the nerve root, a posterolateral herniation is more likely to result in nerve root compression.
High Intensity Power Laser (HILT) delivers high-intensity light energy to deep tissues in short pulses (120-200 µs). It causes minor and slow light absorption by the chromophores, which increases mitochondrial bioenergetics by causing extra adenosine triphosphate synthesis and oxygen consumption, as well as RNA and DNA production, resulting in tissue stimulation. Various studies have shown that laser light has anti-inflammatory and analgesic effects and that it reduces edema. HILT also has photothermal properties, resulting from the transformation of high-energy light into heat in tissue.
Magnetic therapy is considered as a safe, easy and non-invasive physical therapy modality used to treat pain, inflammation and other types of pathologies and diseases. Pulsed electromagnetic field (PEMF) refers to a basic law of electromagnetism that describes how a magnetic field interacts with an electric circuit to produce an electromotive force known as electromagnetic induction. Exposure to PEMF has been reported to modulate neuronal excitation and neurogenesis related to Na+ channel activity. Neurons excited by the exogenous electromagnetic force can also affect neighboring cells by ephaptic interaction. They also modulate levels of various growth factors that prevent autoimmune disease and inhibit tissue degeneration.
The H-reflex or "Hoffmann reflex" is obtained by electrode stimulation of the posterior tibial nerve in the popliteal space-at a slow rate with long duration-submaximal electrical shock, and recorded with surface electrodes over the gastrocnemius-soleus complex. The impulse travels up the sensory fibers to the spinal cord, synapses with the alpha motor neuron and returns down the motor fibers to the calf muscle. H-reflex latencies are long, in the 40 to 45 msec range. They are mostly carried out in the S1 root distribution and cannot be recorded consistently from other muscles.
Statement of the problem Is there any difference between high-power laser versus pulsed electromagnetic therapy on pain and hoffman reflex in lumbar radiculopathy?
Purposes of the study:
To compare between high-power laser versus pulsed electromagnetic therapy on pain and Hoffman reflex in lumbar radiculopathy.
- Conditions
- Lumbar Radiculopathy, Hoffman's Reflex, Pulsed Electromagnetic Therapy, Laser Therapy, Herniated Lumbar Disc
- Being tested
- high-power laser, Pulsed electromagnetic field, physiotherapy program
- Medical subject headings
- Radiculopathy, Reflex, Abnormal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-power laserDevice
The study group (G1a) receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group.
Pulsed electromagnetic fieldDevice
group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group.
physiotherapy programOther
Selected Physical therapy program in the form of:
- Nerve gliding exercise for sciatic nerve.
- Hot pack for 15 minutes, for 12 sessions.
- Core stability exercise (static abdominal exercise, bridging, knee to chest).
| Study group | Role | What they receive |
|---|---|---|
| study group 1 (G1a) | Experimental | study group (G1a) will receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group. Receives: Device: high-power laser; Other: physiotherapy program |
| study group 2 (G1b) | Experimental | The study group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group. Receives: Device: Pulsed electromagnetic field; Other: physiotherapy program |
| control group (G2) | Experimental | The control group patients will receive selected physiotherapy program. Receives: Other: physiotherapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) is a tool for measuring pain intensity, using a continuous 10-centimeter line with "no pain" at one end (0) and "worst imaginable pain" at the other (10), where patients mark their current pain level, with a ruler used to measure the score from the zero mark for a score out of 10, commonly used in research and clinical settings to track pain changes.
Measured: baseline
Hoffman reflex or H reflex
H-reflex will be measured in the soleus muscle by stimulating the tibial nerve with a one-millisecond pulse at 0.2pps of H-max. The peak-to-peak amplitude of the highest recorded H-reflex and the latencies of four spaced traces for both lower extremities will be averaged for each participant. The soleus H-reflex will be evoked by tibial nerve stimulation in the popliteal fossa.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Feb 2026
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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
- Model description
- Randomized Control Study The selected patients will be randomly assigned into "three" equal groups: study group 1 (G1a), study group 2 (G1b) and control group (G2). The control group patients will receive selected physiotherapy program. The study group (G1a) will receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group. The study group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Tallah Sherif Hassan, Cairo University
- Investigators
- PROF. DR. MOSHERA HASSAN DARWISH, Professor of Physical Therapy, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393750
- Sponsor's protocol ID
- P.T.REC/012/006166
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Power Laser Versus Pulsed Eectromagnetic Therapy on Pain and Hoffman Reflex in Lumbar Radiculopathy.
- ClinicalTrials.gov ID
- NCT07393750
- Acronym / sponsor ID
- P.T.REC/012/006166
- Conditions
- Lumbar Radiculopathy, Hoffman's Reflex, Pulsed Electromagnetic Therapy, Laser Therapy, Herniated Lumbar Disc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 6 Feb 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.
To compare between high-power laser versus pulsed electromagnetic therapy on pain and Hoffman reflex in lumbar radiculopathy.
Detailed description
Lumbar radiculopathy is one of the most common complaints evaluated by a spine surgeon. Its prevalence has been estimated to be 3%-5% of the population, affecting both men and women. Age is a primary risk factor, as it occurs secondary to the degenerative process within the spinal column. Symptoms typically begin in midlife, with men often affected in the 40s while women are affected in the 50s and 60s. Disc herniation is one of the primary causes of lumbar radiculopathy.
The pressure exerted by the herniated disc on the longitudinal ligament and the local inflammation results in localized back pain. The lumbar radicular pain arises when disc material exerts pressure or contacts the thecal sac or lumbar nerve roots, resulting in nerve root ischemia and inflammation. The annulus fibrosus is thinner on the posterolateral aspect and lacks support from the posterior longitudinal ligament, making it vulnerable to herniations. Due to the proximity of the nerve root, a posterolateral herniation is more likely to result in nerve root compression.
High Intensity Power Laser (HILT) delivers high-intensity light energy to deep tissues in short pulses (120-200 µs). It causes minor and slow light absorption by the chromophores, which increases mitochondrial bioenergetics by causing extra adenosine triphosphate synthesis and oxygen consumption, as well as RNA and DNA production, resulting in tissue stimulation. Various studies have shown that laser light has anti-inflammatory and analgesic effects and that it reduces edema. HILT also has photothermal properties, resulting from the transformation of high-energy light into heat in tissue.
Magnetic therapy is considered as a safe, easy and non-invasive physical therapy modality used to treat pain, inflammation and other types of pathologies and diseases. Pulsed electromagnetic field (PEMF) refers to a basic law of electromagnetism that describes how a magnetic field interacts with an electric circuit to produce an electromotive force known as electromagnetic induction. Exposure to PEMF has been reported to modulate neuronal excitation and neurogenesis related to Na+ channel activity. Neurons excited by the exogenous electromagnetic force can also affect neighboring cells by ephaptic interaction. They also modulate levels of various growth factors that prevent autoimmune disease and inhibit tissue degeneration.
The H-reflex or "Hoffmann reflex" is obtained by electrode stimulation of the posterior tibial nerve in the popliteal space-at a slow rate with long duration-submaximal electrical shock, and recorded with surface electrodes over the gastrocnemius-soleus complex. The impulse travels up the sensory fibers to the spinal cord, synapses with the alpha motor neuron and returns down the motor fibers to the calf muscle. H-reflex latencies are long, in the 40 to 45 msec range. They are mostly carried out in the S1 root distribution and cannot be recorded consistently from other muscles.
Statement of the problem Is there any difference between high-power laser versus pulsed electromagnetic therapy on pain and hoffman reflex in lumbar radiculopathy?
Purposes of the study:
To compare between high-power laser versus pulsed electromagnetic therapy on pain and Hoffman reflex in lumbar radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Control Study The selected patients will be randomly assigned into "three" equal groups: study group 1 (G1a), study group 2 (G1b) and control group (G2). The control group patients will receive selected physiotherapy program. The study group (G1a) will receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group. The study group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group.
| Arm | Type | Receives |
|---|---|---|
| study group 1 (G1a) | Experimental | Device: high-power laser, Other: physiotherapy programstudy group (G1a) will receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group. |
| study group 2 (G1b) | Experimental | Device: Pulsed electromagnetic field, Other: physiotherapy programThe study group 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group. |
| control group (G2) | Experimental | Other: physiotherapy programThe control group patients will receive selected physiotherapy program. |
Who may qualify
- Ages
- 35 to 48 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Sixty lumbar radiculopathy patients, of both sexes, will represent the sample.
Key exclusion criteria (10 listed)
- The patients will be excluded if they have one of the followings:
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 laserThe study group (G1a) receive 20 minutes of high-power laser therapy followed by 25 the same physical therapy program as control group. | Device | study group 1 (G1a) |
| Pulsed electromagnetic fieldgroup 2 patients will receive 20 minutes of Pulsed electromagnetic field followed by 25 the same selected physiotherapy program as control group. | Device | study group 2 (G1b) |
| physiotherapy programSelected Physical therapy program in the form of: 1. Nerve gliding exercise for sciatic nerve. 2. Hot pack for 15 minutes, for 12 sessions. 3. Core stability exercise (static abdominal exercise, bridging, knee to chest). | Other | control group (G2), study group 1 (G1a), study group 2 (G1b) |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: baseline
The Visual Analogue Scale (VAS) is a tool for measuring pain intensity, using a continuous 10-centimeter line with "no pain" at one end (0) and "worst imaginable pain" at the other (10), where patients mark their current pain level, with a ruler used to measure the score from the zero mark for a score out of 10, commonly used in research and clinical settings to track pain changes.
Hoffman reflex or H reflex
Time frame: baseline
H-reflex will be measured in the soleus muscle by stimulating the tibial nerve with a one-millisecond pulse at 0.2pps of H-max. The peak-to-peak amplitude of the highest recorded H-reflex and the latencies of four spaced traces for both lower extremities will be averaged for each participant. The soleus H-reflex will be evoked by tibial nerve stimulation in the popliteal fossa.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
PROF. DR. MOSHERA HASSAN DARWISH, Professor of Physical Therapy study chair
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, Pulsed electromagnetic field and physiotherapy program in people with Lumbar Radiculopathy and Hoffman's Reflex, 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 10 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: finished, as of the sponsor's last update on 13 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale (VAS) (time frame: baseline). 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?
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 13 Aug 2026.