Meralgia ParestheticaNCT05893732
HILT for Meralgia Paresthetica
A study testing High-Intensity Laser Therapy (HILT) in people with Meralgia Paresthetica and Lateral Femoral Cutaneous Nerve Entrapment, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This randomized controlled trial aims to investigate the efficacy of High-Intensity Laser Therapy (HILT) in the management of Meralgia Paresthetica (MP), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. Read more about this study
- Who is it for?
- Ages 35 to 55 years
- Conditions the study is for
- Meralgia Paresthetica, Lateral Femoral Cutaneous Nerve Entrapment
- What is being tested?
- High-Intensity Laser Therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 8 Sep 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Meralgia Paresthetica, confirmed by a neurologist or a specialist in neuromuscular disorders, based on clinical signs and symptoms, and supported by nerve conduction studies.
- Presence of pain, numbness, or tingling in the anterolateral thigh for at least three months.
- Aged between 35 and 55 years.
- Willing and able to provide informed consent.
- Able to comply with the study protocol and attend all treatment sessions and follow-up assessments.
Who cannot join
- Previous surgical treatment for Meralgia Paresthetica.
- Concomitant lower back or hip pain due to other causes, such as lumbar radiculopathy, hip joint pathology, or trochanteric bursitis.
- Presence of other neuromuscular or nerve compression disorders such as diabetic neuropathy
- Significant trauma or surgery to the affected thigh or lumbar spine within the past six months.
- Pregnancy or planning to become pregnant during the study period.
- Known contraindications to High-Intensity Laser Therapy, such as active skin infection, malignancy, or photosensitivity disorders.
- Current use of anticoagulant medications or immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: Efficacy of High-Intensity Laser Therapy in the Management of Meralgia Paresthetica: a Randomized Controlled Trial
This randomized controlled trial aims to investigate the efficacy of High-Intensity Laser Therapy (HILT) in the management of Meralgia Paresthetica (MP), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. Participants with MP will be randomly allocated to either the HILT or sham HILT (control) group. The study will evaluate the effects of HILT on pain intensity, functional outcomes, and quality of life. Findings from this trial will provide insights into the potential benefits of HILT as a non-invasive and safe treatment option for patients with MP.
- Being tested
- High-Intensity Laser Therapy (HILT), Sham High-Intensity Laser Therapy (Sham HILT)
- Medical subject headings
- Femoral Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser Therapy (HILT)Device
Also called High power laser therapy
Participants will undergo HILT treatment using a diode laser device (wavelength: 1064 nm; power: 12 W; peak power: 50 W; energy density: 600 J/cm²; spot size: 1 cm²; pulse duration: 200 μs; pulse frequency: 10 Hz) applied in continuous mode. The laser probe will make contact with the skin over the LFCN entrapment site at three specific points: (a) the inguinal ligament, (b) the point of maximum tenderness along the nerve pathway, and (c) the mid-point between the ASIS and the lateral border of the patella. Each point will be treated for 1 minute and 40 seconds, totaling a 5-minute session. Participants will undergo 12 sessions in total, with three sessions per week for four weeks.
Sham High-Intensity Laser Therapy (Sham HILT)Device
Participants will undergo sham HILT treatment using an identical laser device with no active laser output, following the same treatment protocol as the HILT group. The laser probe will make contact with the skin over the LFCN entrapment site at the same three specific points as the HILT group. Each point will be treated for 1 minute and 40 seconds, totaling a 5-minute session. Participants will undergo 12 sessions in total, with three sessions per week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy (HILT) Group | Experimental | Participants in this group will receive High-Intensity Laser Therapy (HILT) treatment for Meralgia Paresthetica (MP). Receives: Device: High-Intensity Laser Therapy (HILT) |
| Sham High-Intensity Laser Therapy (Sham HILT) Group | Sham comparator | Participants in this group will receive sham High-Intensity Laser Therapy (sham HILT) treatment for Meralgia Paresthetica (MP). Receives: Device: Sham High-Intensity Laser Therapy (Sham HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain Intensity
The secondary outcome measure is the change in pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a self-reported scale ranging from 0 (no pain) to 10 (worst pain imaginable). A reduction in NPRS scores indicates a decrease in pain intensity.
Measured: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Secondary outcomes (3)
Changes in Lateral Femoral Cutaneous Nerve Distal Latency
the change in distal latency of the lateral femoral cutaneous nerve (LFCN), assessed using nerve conduction studies. The distal latency represents the time it takes for an electrical impulse to travel along the nerve to the recording electrode. Reduced distal latency indicates improved nerve conduction and function.
Measured: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Changes in Functional Outcomes
The secondary outcome measure is the change in functional outcomes, assessed using the Roland-Morris Disability Questionnaire (RMDQ), a self-reported questionnaire measuring the level of disability due to lower back and leg pain. Lower RMDQ scores indicate better functional outcomes and less disability.
Measured: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Changes in Quality of Life
The secondary outcome measure is the change in quality of life, assessed using the Short Form-36 Health Survey (SF-36), a self-reported questionnaire evaluating overall health and well-being across eight domains. Higher SF-36 scores indicate better quality of life.
Measured: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023
- Primary completion8 Sep 2024
- Study completion8 Sep 2024
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 Meralgia ParestheticaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Mohamed M ElMeligie, Ph.d, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893732
- Sponsor's protocol ID
- 012/004277
- Status last verified
- Oct 2024
- First submitted
- 30 May 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The researchers of this study are committed to promoting open science and collaboration among researchers. As part of this commitment, we will share de-identified individual participant data (IPD) with other qualified researchers, upon request and in accordance with applicable regulations and ethical guidelines. The dataset will not contain any personally identifiable information or sensitive data that could compromise the privacy and confidentiality of study participants.
Publications
Mogahed HG, ElMeligie MM, Radwan RE, Elmahdy MA, Abdel-Aal NM, Mohamed MH. Efficacy of High-Intensity Laser Therapy for Meralgia Paresthetica: A Randomized, Double-Blind, Sham-Controlled Trial. Am J Phys Med Rehabil. 2026 Sep 1;105(9):777-784. doi: 10.1097/PHM.0000000000002918. Epub 2026 Jun 4.
PubMed 42307460
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Intensity Laser Therapy in the Management of Meralgia Paresthetica: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05893732
- Acronym / sponsor ID
- 012/004277
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 8 Sep 2024 (actual)
- Study completion
- 8 Sep 2024 (actual)
- First posted
- 8 Jun 2023 (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 randomized controlled trial aims to investigate the efficacy of High-Intensity Laser Therapy (HILT) in the management of Meralgia Paresthetica (MP), a peripheral neuropathy causing pain, numbness, and tingling in the thigh region. Participants with MP will be randomly allocated to either the HILT or sham HILT (control) group. The study will evaluate the effects of HILT on pain intensity, functional outcomes, and quality of life. Findings from this trial will provide insights into the potential benefits of HILT as a non-invasive and safe treatment option for patients with MP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) Group | Experimental | Device: High-Intensity Laser Therapy (HILT)Participants in this group will receive High-Intensity Laser Therapy (HILT) treatment for Meralgia Paresthetica (MP). |
| Sham High-Intensity Laser Therapy (Sham HILT) Group | Sham comparator | Device: Sham High-Intensity Laser Therapy (Sham HILT)Participants in this group will receive sham High-Intensity Laser Therapy (sham HILT) treatment for Meralgia Paresthetica (MP). |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of Meralgia Paresthetica, confirmed by a neurologist or a specialist in neuromuscular disorders, based on clinical signs and symptoms, and supported by nerve conduction studies.
- Presence of pain, numbness, or tingling in the anterolateral thigh for at least three months.
- Aged between 35 and 55 years.
- Willing and able to provide informed consent.
- Able to comply with the study protocol and attend all treatment sessions and follow-up assessments.
Key exclusion criteria (7 listed)
- Previous surgical treatment for Meralgia Paresthetica.
- Concomitant lower back or hip pain due to other causes, such as lumbar radiculopathy, hip joint pathology, or trochanteric bursitis.
- Presence of other neuromuscular or nerve compression disorders such as diabetic neuropathy
- Significant trauma or surgery to the affected thigh or lumbar spine within the past six months.
- Pregnancy or planning to become pregnant during the study period.
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-Intensity Laser Therapy (HILT)Also: High power laser therapyParticipants will undergo HILT treatment using a diode laser device (wavelength: 1064 nm; power: 12 W; peak power: 50 W; energy density: 600 J/cm²; spot size: 1 cm²; pulse duration: 200 μs; pulse frequency: 10 Hz) applied in continuous mode. The laser probe will make contact with the skin over the LFCN entrapment site at three specific points: (a) the inguinal ligament, (b) the point of maximum tenderness along the nerve pathway, and (c) the mid-point between the ASIS and the lateral border of the patella. Each point will be treated for 1 minute and 40 seconds, totaling a 5-minute session. Participants will undergo 12 sessions in total, with three sessions per week for four weeks. | Device | High-Intensity Laser Therapy (HILT) Group |
| Sham High-Intensity Laser Therapy (Sham HILT)Participants will undergo sham HILT treatment using an identical laser device with no active laser output, following the same treatment protocol as the HILT group. The laser probe will make contact with the skin over the LFCN entrapment site at the same three specific points as the HILT group. Each point will be treated for 1 minute and 40 seconds, totaling a 5-minute session. Participants will undergo 12 sessions in total, with three sessions per week for four weeks. | Device | Sham High-Intensity Laser Therapy (Sham HILT) Group |
Primary outcome
Changes in Pain Intensity
Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
The secondary outcome measure is the change in pain intensity, assessed using the Numeric Pain Rating Scale (NPRS), a self-reported scale ranging from 0 (no pain) to 10 (worst pain imaginable). A reduction in NPRS scores indicates a decrease in pain intensity.
3 secondary outcomes
Changes in Lateral Femoral Cutaneous Nerve Distal Latency
Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Changes in Functional Outcomes
Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
Changes in Quality of Life
Time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups
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 15 Oct 2024.
- Derived from this study: PubMed 42307460Mogahed HG, ElMeligie MM, Radwan RE, Elmahdy MA, Abdel-Aal NM, Mohamed MH. Efficacy of High-Intensity Laser Therapy for Meralgia Paresthetica: A Randomized, Double-Blind, Sham-Controlled Trial. Am J Phys Med Rehabil. 2026 Sep 1;105(9):777-784. doi: 10.1097/PHM.0000000000002918. Epub 2026 Jun 4.
- Individual participant dataSharing planned: Yes. The researchers of this study are committed to promoting open science and collaboration among researchers. As part of this commitment, we will share de-identified individual participant data (IPD) with other qualified researchers, upon request and in accordance with applicable regulations and ethical guidelines. The dataset will not contain any personally identifiable information or sensitive data that could compromise the privacy and confidentiality of study participants.
Related trials for Meralgia Paresthetica
Enrolling by invitation
Percussive vs. Gentle Massage for Recovery After Hip Replacement
Paresthesia, Total Hip Arthroplasty (THA)
Recruiting
The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica
Meralgia Paresthetica
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.
Mohamed M ElMeligie, Ph.d principal investigator
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-Intensity Laser Therapy (HILT) in people with Meralgia Paresthetica and Lateral Femoral Cutaneous Nerve Entrapment, run by Ahram Canadian 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 5 inclusion and 7 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 15 Oct 2024. 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?
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?
Changes in Pain Intensity (time frame: Changes measured at Baseline, immediately post-treatment (4 weeks), and at 1- and 3-month follow-ups). 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 NCT05893732, 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 15 Oct 2024.