Meralgia ParestheticaNCT07335822
The Effectiveness of Low-Level Laser Therapy in the Treatment of Meralgia Paresthetica
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Low-Level Laser Therapy in people with Meralgia Paresthetica and Lateral Femoral Cutaneous Nerve Entrapment, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Patients diagnosed with meralgia paresthetica via electromyography (EMG), who present with neuropathic complaints on the lateral thigh to the Physical Medicine and Rehabilitation outpatient clinics of our hospital, will be included in the study after reviewing exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meralgia Paresthetica, Lateral Femoral Cutaneous Nerve Entrapment
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and Low-Level Laser Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Mar 2026to 7 Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with polyneuropathy
- Patients with radicular pain
- Patients receiving treatment for neuropathic pain
- Patients who have received an injection to the lateral femoral cutaneous nerve within the last three months
- Patients who have undergone physical therapy modalities for a diagnosis of meralgia paresthetica within the last three months
- Patients with a history of pelvic surgery
Show all 11Show fewer
- Patients diagnosed with rheumatologic diseases
- Pregnant women
- Patients with active skin infections
- Malignancy
- Fibromyalgia
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul Training and Research Hospital
Istanbul, Fatih, 34093
Istanbul training and research hospital
Istanbul, Fatih, 34098
About this study
Patients diagnosed with meralgia paresthetica via electromyography (EMG), who present with neuropathic complaints on the lateral thigh to the Physical Medicine and Rehabilitation outpatient clinics of our hospital, will be included in the study after reviewing exclusion criteria. Patients will be randomized into two equal groups using a sealed-envelope system. The treatment group will receive low-level laser therapy (LLLT) combined with simultaneous transcutaneous electrical nerve stimulation (TENS), while the control group will receive placebo laser therapy combined with simultaneous TENS.
An LED gallium-aluminum-arsenide (Ga-Al-As) diode laser device with a power of 1.6 W and a wavelength of 808 nm will be used in the study. The treatment will consist of 10 sessions, applied over two weeks, five days per week.
Read more
Demographic data (age, gender, body mass index, and occupation) of all patients included in the study will be recorded. Pain and functional impairment will be evaluated using the VAS, SF-36, PSQI, and S-LANSS scales for all patients. VAS, SF-36, PSQI, and S-LANSS scores will be assessed at the end of the treatment and on the 30th day after treatment completion (6th-week after baseline). The effectiveness of low-level laser therapy will be investigated using statistical data analysis methods.
Low-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms. In the control group, sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas.
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), Low-Level Laser Therapy
- Keywords
- Meralgia Paresthetica, Lateral Femoral Cutaneous Nerve, Entrapment neuropathy, Low-Level Laser Therapy, thigh pain
- Medical subject headings
- Femoral Neuropathy, Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Other
TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms.
Low-Level Laser TherapyOther
Low-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: LOW LEVER LASER THERAPY AND TENS | Active comparator | Low-level laser therapy will be applied perpendicularly at four different points, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS); Other: Low-Level Laser Therapy |
| Group 2: SHAM LASER AND TENS THERAPY | Sham comparator | Sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas. TENS electrodes will be placed on the painful anterolateral thigh region Receives: Other: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain will be assessed with Visual Analog Scale.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
Measured: It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up.
Secondary outcomes (3)
Neuropathic pain will be assessed using the S-LANSS scale.
In the S-LANSS pain score, the patient evaluates the worst pain they experienced during the past week. The questions are answered with either 'yes' or 'no.' The total score ranges from 0 to 24. If the total score is twelve or higher, the pain is considered primarily neuropathic in nature.
Measured: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
General health status will be assessed with Short Form 36.
Short Form 36 (SF-36) is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Measured: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Consisting of 19 items, the PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction.
Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start2 Mar 2026
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Participants will be randomly divided into two groups; the first group will receive low-level laser therapy and TENS, while the second group will receive sham laser and TENS therapy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Sade Dağdeviren, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335822
- Sponsor's protocol ID
- 21/02/2025;2011-KAEK-50;37
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2025
- Last updated
- 8 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low-Level Laser Therapy in the Treatment of Meralgia Paresthetica
- ClinicalTrials.gov ID
- NCT07335822
- Acronym / sponsor ID
- 21/02/2025;2011-KAEK-50;37
- Keywords
- Meralgia Paresthetica, Lateral Femoral Cutaneous Nerve, Entrapment neuropathy, Low-Level Laser Therapy, thigh pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 13 Jan 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.
Patients diagnosed with meralgia paresthetica via electromyography (EMG), who present with neuropathic complaints on the lateral thigh to the Physical Medicine and Rehabilitation outpatient clinics of our hospital, will be included in the study after reviewing exclusion criteria. Patients will be randomized into two equal groups using a sealed-envelope system. The treatment group will receive low-level laser therapy (LLLT) combined with simultaneous transcutaneous electrical nerve stimulation (TENS), while the control group will receive placebo laser therapy combined with simultaneous TENS.
An LED gallium-aluminum-arsenide (Ga-Al-As) diode laser device with a power of 1.6 W and a wavelength of 808 nm will be used in the study. The treatment will consist of 10 sessions, applied over two weeks, five days per week.
Demographic data (age, gender, body mass index, and occupation) of all patients included in the study will be recorded. Pain and functional impairment will be evaluated using the VAS, SF-36, PSQI, and S-LANSS scales for all patients. VAS, SF-36, PSQI, and S-LANSS scores will be assessed at the end of the treatment and on the 30th day after treatment completion (6th-week after baseline). The effectiveness of low-level laser therapy will be investigated using statistical data analysis methods.
Low-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms. In the control group, sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups; the first group will receive low-level laser therapy and TENS, while the second group will receive sham laser and TENS therapy.
| Arm | Type | Receives |
|---|---|---|
| Group 1: LOW LEVER LASER THERAPY AND TENS | Active comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS), Other: Low-Level Laser TherapyLow-level laser therapy will be applied perpendicularly at four different points, delivering a total of 4 J of energy over 12 minutes. TENS electrodes will be placed on the painful anterolateral thigh region |
| Group 2: SHAM LASER AND TENS THERAPY | Sham comparator | Other: Transcutaneous Electrical Nerve Stimulation (TENS)Sham laser will be applied using the same device and in the same manner; however, no laser beam will be emitted to the designated areas. TENS electrodes will be placed on the painful anterolateral thigh region |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Patients with polyneuropathy
- Patients with radicular pain
- Patients receiving treatment for neuropathic pain
- Patients who have received an injection to the lateral femoral cutaneous nerve within the last three months
- Patients who have undergone physical therapy modalities for a diagnosis of meralgia paresthetica within the last three 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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)TENS electrodes will be placed on the painful anterolateral thigh region in both groups. The stimulation pulse frequency will be set to 100 Hz, and the pulse width will be set to 100 ms. | Other | Group 1: LOW LEVER LASER THERAPY AND TENS, Group 2: SHAM LASER AND TENS THERAPY |
| Low-Level Laser TherapyLow-level laser therapy will be applied perpendicularly, consistent with the lateral femoral cutaneous nerve projection, delivering a total of 4 J of energy over 12 minutes. | Other | Group 1: LOW LEVER LASER THERAPY AND TENS |
Primary outcome
Pain will be assessed with Visual Analog Scale.
Time frame: It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up.
Visual Analog Scale (VAS) score ranges from 0 to 10. High scores describe more pain, and low scores describe less pain.
3 secondary outcomes
Neuropathic pain will be assessed using the S-LANSS scale.
Time frame: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
General health status will be assessed with Short Form 36.
Time frame: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI).
Time frame: It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment.
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 8 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and Low-Level Laser Therapy in people with Meralgia Paresthetica and Lateral Femoral Cutaneous Nerve Entrapment, run by Istanbul Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 0 inclusion and 11 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 8 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 2 sites in Turkey (Türkiye). 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?
Pain will be assessed with Visual Analog Scale. (time frame: It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up.). 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 8 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.