Low Level Laser TherapyLLLT-NM-LDPNCT07138300
Combined Effect of Low Level Laser Therapy and Neural Mobilization on Lumber Disc Prolapse
A study testing Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy) and neural mobilization in people with Low Level Laser Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
This study attempts to answer the following research question: what is the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse in decreasing pain, improving functional disability, improving neural mobility and improve lumber flexion mobility? Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Low Level Laser Therapy
- What is being tested?
- Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy) and neural mobilization
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 3 Jun 2025
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1-patients referred from orthopedic surgeon with diagnosis of lumbar disc prolapse and radiculopathy (subacute >3 weeks or chronic > 3 months and lasting up to 12 months) .
- 2-Participants had MRI examination, which confirmed the diagnosis of lumber disc prolapse in addition of radiological changes in the intervertebral discs of the spine and affection of peripheral nerve root.
- 3-Aged between 30 and 50 years .
Who cannot join
- 1- Patients who had undergone any surgical intervention in the spine. 2- Any other dysfunctions of the spine rather than lumber disc prolapse (fractures, tumors, spondylolisthesis, rheumatic diseases, and cauda equina syndrome).
- 3- The patient is under any medical treatment. 4- Pregnancy, cardiovascular failure, pacemaker, metal implants, skin lesions in the treatment area.
- 5- Neurological deficits such as myelopathy, lumber canal stenosis and Piriformis syndrome 6- Malignancy, systemic inflammatory disease, or infectious disease. 7- Acute lumber disc prolapse will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study attempts to answer the following research question: what is the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse in decreasing pain, improving functional disability, improving neural mobility and improve lumber flexion mobility?
Read the detailed description
Lumbar disc prolapse is a movement of disc material out of the intervertebral disc space. Protruded nucleus comes in contact with the surrounding nerves, causing their compression that in turn results in severe radicular pain.
The purpose of this study is to assess the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse, this assessment will be done through assessment of pain, functional disability, neural mobility and lumber flexion mobility.
Subjects and Methods : 40 Patients with lumber disc prolapse and radiculopathy based on clinical examination by orthopedic surgeon and (MRI) imaging aged between 30 and 50 years . This study will be a double blinded randomized controlled trial .
After including patients in the study, they will be randomly assigned into 2groups :
Control group (A) (n=20): will receive placebo laser therapy plus neural mobilization.
Experimental group (B) (n=20): patients will receive low level laser therapy plus neural mobilization Both control group and experimental group receive infrared as warming up before treatment for12 sessions, each for 15 min, 3 days per week, for a period of 4 weeks .
All patients will perform all assessment procedures accurately (straight leg raising test, slump test and Schober's test ) and will fill (VAS) and (ODI) accurately.
Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner).Neural mobilization will be applied in form of 3 sets every set 10 repetitions and the end Position was hold for 5 seconds and the rest between sets was 5 minutes. All the patients will receive 12 sessions (3 times/week for 4 weeks).
: patients receive LLLT will lie in side lying on the non-affected side which is opposite to the side of radicular pain, hip and knee in flexion 90.Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain and 8 points over thigh for 3 sessions per weak for 4 Weeks.
The hypotheses for this study are:
- There will be significant improvement in pain after combination of LLLT and neural mobilization.
- There will be significant improvement in functional disability after combination of LLLT and neural mobilization.
- There will be significant improvement in lumber flexion mobility after combination of LLLT and neural mobilization.
- There will be significant improvement in neural mobility after combination of LLLT and neural mobilization.
- Conditions
- Low Level Laser Therapy
- Being tested
- Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy), neural mobilization, placebo laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy)Device
(Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy) .
Patient lies in side lying on the non-affected side which is opposite to the side of radicular pain, hip and knee in flexion 90. Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain, from l2 to s1 vertebra, distance between these points is 2 cm. In the thigh, eight points were marked at equal distances from each other, four in the path of l5 root and four in the path of s1 root from hip to knee. The leaser probe is held in 90 degree over the skin with complete skin contact
neural mobilizationProcedure or surgery
Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner.
•The slider neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk flexion, knee flexion, and ankle plantar flexion, to a position of neck and trunk extension, knee extension and ankle dorsiflexion
The tension neurodynamic mobilization technique:
The patient moves actively and conversely from a position of neck and trunk extension, knee flexion, and ankle plantar flexion, to a position of neck and trunk flexion, knee extension, and ankle dorsiflexion
placebo laser therapyOther
patients receive the same treatment on the same area as experimental group for the same period without turning on the device.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (B) | Experimental | 20 patients will receive low level laser therapy plus neural mobilization.
* Mobilization will be through using slump sitting maneuver (Both techniques
1. The slider neurodynamic mobilization technique:
The patient moves actively and conversely from a position of neck and trunk flexion, knee flexion, and ankle plantar flexion, to a position of neck and trunk extension, knee extension and ankle dorsiflexion.
2. The tension neurodynamic mobilization technique:
The patient moves actively and conversely from a position of neck and trunk extension, knee flexion, and ankle plantar flexion, to a position of neck and trunk flexion, knee extension, and ankle dorsiflexion
* Low level laser therapy : Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain, from l2 to s1 vertebra, distance between these points is 2 cm. In the thigh, eight points were marked at equal distances from each other, four in the path of l5 root and four in the path of Receives: Device: Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy); Procedure: neural mobilization |
| control group (A) | Active comparator | 20 will receive placebo laser therapy plus neural mobilization. Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner.
Placebo laser therapy: patients receive the same treatment on the same area as experimental group for the same period without turning on the device.
all 20 will receive Placebo laser therapy: patients receive the same treatment on the same area as experimental group for the same period without turning on the device. Receives: Procedure: neural mobilization; Other: placebo laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain assessment before and after treatment
by visual analog scale (VAS)
Measured: 4 weeks
Functional disability :evaluate the patient's ability to perform various activities of daily living
by Oswestry Disability Index (ODI)
Measured: 4 weeks
evaluate neural mobility before and after treatment
by Straight leg raising test (SLR) ,The range of motion of the SLR test was measured as the angle of hip flexion in relation to the horizontal
Measured: 4weeks
evaluate lumbar flexion mobility before and after treatment
by Schober's test
Measured: 4weeks
Neurological assessment screening of neuropathic pain
by slump test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Feb 2025
- Primary completion25 May 2025
- Study completion3 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Level Laser TherapyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasr Awad Abdelkader Othman, Cairo University
- Investigators
- Nasr A Abdelkader, PHD, Principal investigator, Assistant professor, Department of physical therapy for musculoskeletal disorders and its surgeries
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138300
- Sponsor's protocol ID
- P.T.REC\012\004894
- Acronym
- LLLT-NM-LDP
- Status last verified
- Jun 2025
- First submitted
- 16 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Low Level Laser Therapy and Neural Mobilization on Lumber Disc Prolapse
- ClinicalTrials.gov ID
- NCT07138300
- Acronym / sponsor ID
- LLLT-NM-LDP / P.T.REC\012\004894
- Conditions
- Low Level Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 3 Jun 2025 (actual)
- First posted
- 22 Aug 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.
This study attempts to answer the following research question: what is the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse in decreasing pain, improving functional disability, improving neural mobility and improve lumber flexion mobility?
Detailed description
Lumbar disc prolapse is a movement of disc material out of the intervertebral disc space. Protruded nucleus comes in contact with the surrounding nerves, causing their compression that in turn results in severe radicular pain.
The purpose of this study is to assess the combined effect of low level laser therapy and neural mobilization on lumber disc prolapse, this assessment will be done through assessment of pain, functional disability, neural mobility and lumber flexion mobility.
Subjects and Methods : 40 Patients with lumber disc prolapse and radiculopathy based on clinical examination by orthopedic surgeon and (MRI) imaging aged between 30 and 50 years . This study will be a double blinded randomized controlled trial .
After including patients in the study, they will be randomly assigned into 2groups :
Control group (A) (n=20): will receive placebo laser therapy plus neural mobilization.
Experimental group (B) (n=20): patients will receive low level laser therapy plus neural mobilization Both control group and experimental group receive infrared as warming up before treatment for12 sessions, each for 15 min, 3 days per week, for a period of 4 weeks .
All patients will perform all assessment procedures accurately (straight leg raising test, slump test and Schober's test ) and will fill (VAS) and (ODI) accurately.
Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner).Neural mobilization will be applied in form of 3 sets every set 10 repetitions and the end Position was hold for 5 seconds and the rest between sets was 5 minutes. All the patients will receive 12 sessions (3 times/week for 4 weeks).
: patients receive LLLT will lie in side lying on the non-affected side which is opposite to the side of radicular pain, hip and knee in flexion 90.Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain and 8 points over thigh for 3 sessions per weak for 4 Weeks.
The hypotheses for this study are:
- There will be significant improvement in pain after combination of LLLT and neural mobilization.
- There will be significant improvement in functional disability after combination of LLLT and neural mobilization.
- There will be significant improvement in lumber flexion mobility after combination of LLLT and neural mobilization.
- There will be significant improvement in neural mobility after combination of LLLT and neural mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (B) | Experimental | Device: Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy), Procedure: neural mobilization20 patients will receive low level laser therapy plus neural mobilization. * Mobilization will be through using slump sitting maneuver (Both techniques 1. The slider neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk flexion, knee flexion, and ankle plantar flexion, to a position of neck and trunk extension, knee extension and ankle dorsiflexion. 2. The tension neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk extension, knee flexion, and ankle plantar flexion, to a position of neck and trunk flexion, knee extension, and ankle dorsiflexion * Low level laser therapy : Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain, from l2 to s1 vertebra, distance between these points is 2 cm. In the thigh, eight points were marked at equal distances from each other, four in the path of l5 root and four in the path of |
| control group (A) | Active comparator | Procedure: neural mobilization, Other: placebo laser therapy20 will receive placebo laser therapy plus neural mobilization. Mobilization will be through using slump sitting maneuver (Both techniques slider and tensioner. Placebo laser therapy: patients receive the same treatment on the same area as experimental group for the same period without turning on the device. all 20 will receive Placebo laser therapy: patients receive the same treatment on the same area as experimental group for the same period without turning on the device. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1-patients referred from orthopedic surgeon with diagnosis of lumbar disc prolapse and radiculopathy (subacute >3 weeks or chronic > 3 months and lasting up to 12 months) .
- 2-Participants had MRI examination, which confirmed the diagnosis of lumber disc prolapse in addition of radiological changes in the intervertebral discs of the spine and affection of peripheral nerve root.
- 3-Aged between 30 and 50 years .
Key exclusion criteria (3 listed)
- 1- Patients who had undergone any surgical intervention in the spine. 2- Any other dysfunctions of the spine rather than lumber disc prolapse (fractures, tumors, spondylolisthesis, rheumatic diseases, and cauda equina syndrome).
- 3- The patient is under any medical treatment. 4- Pregnancy, cardiovascular failure, pacemaker, metal implants, skin lesions in the treatment area.
- 5- Neurological deficits such as myelopathy, lumber canal stenosis and Piriformis syndrome 6- Malignancy, systemic inflammatory disease, or infectious disease. 7- Acute lumber disc prolapse will be excluded.
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 |
|---|---|---|
| Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy)(Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy) . Patient lies in side lying on the non-affected side which is opposite to the side of radicular pain, hip and knee in flexion 90. Twenty points were established for treatment, 12 over the lumbar spine, at the same Side of the radicular pain, from l2 to s1 vertebra, distance between these points is 2 cm. In the thigh, eight points were marked at equal distances from each other, four in the path of l5 root and four in the path of s1 root from hip to knee. The leaser probe is held in 90 degree over the skin with complete skin contact | Device | Experimental group (B) |
| neural mobilizationMobilization will be through using slump sitting maneuver (Both techniques slider and tensioner. •The slider neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk flexion, knee flexion, and ankle plantar flexion, to a position of neck and trunk extension, knee extension and ankle dorsiflexion The tension neurodynamic mobilization technique: The patient moves actively and conversely from a position of neck and trunk extension, knee flexion, and ankle plantar flexion, to a position of neck and trunk flexion, knee extension, and ankle dorsiflexion | Procedure or surgery | Experimental group (B), control group (A) |
| placebo laser therapypatients receive the same treatment on the same area as experimental group for the same period without turning on the device. | Other | control group (A) |
Primary outcome
pain assessment before and after treatment
Time frame: 4 weeks
by visual analog scale (VAS)
Functional disability :evaluate the patient's ability to perform various activities of daily living
Time frame: 4 weeks
by Oswestry Disability Index (ODI)
evaluate neural mobility before and after treatment
Time frame: 4weeks
by Straight leg raising test (SLR) ,The range of motion of the SLR test was measured as the angle of hip flexion in relation to the horizontal
evaluate lumbar flexion mobility before and after treatment
Time frame: 4weeks
by Schober's test
Neurological assessment screening of neuropathic pain
Time frame: 4 weeks
by slump test
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 22 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Nasr A Abdelkader, PHD principal investigator
Assistant professor, Department of physical therapy for musculoskeletal disorders and its surgeries
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser Therapy by (Eme Physio, Lasermed 2200), GaAs laser, 1 cm2 beam area,7,000 Hz, 17 mW, 1 J/cm2, Pesaro, Italy) and neural mobilization in people with Low Level Laser Therapy, 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 3 inclusion and 3 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 22 Aug 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. 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?
pain assessment before and after treatment (time frame: 4 weeks). The study lists 5 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 22 Aug 2025.