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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | It will be evaluated at the baseline, at the end of treatment, and at the sixth-week follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment. |
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Inclusion Criteria: Patients aged 18 to 70 with neuropathic complaints in the anterolateral thigh, whose diagnosis has been confirmed by sensory conduction studies of the lateral femoral cutaneous nerve.
Exclusion Criteria: - Patients with diabetes mellitus
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Training and Research Hospital | Istanbul | Fatih | 34093 | Turkey (Türkiye) | ||
| Istanbul training and research hospital |
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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.
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Patients in the first group will receive low-level laser therapy, while patients in the second group will receive sham low-level laser therapy. Participants will not be informed about which group they are in. In addition, the outcome assessors will also conduct their assessments blinded to the groups to which the patients belong.
| Low-Level Laser Therapy | Other | 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. |
|
| 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. | 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. | It will be evaluated at the baseline, two weeks after the treatment started, and in the sixth week after the start of the treatment. |
| Istanbul |
| Fatih |
| 34098 |
| Turkey (Türkiye) |
| ID | Term |
|---|---|
| D020428 | Femoral Neuropathy |
| D002607 | Charcot-Marie-Tooth Disease |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D015417 | Hereditary Sensory and Motor Neuropathy |
| D009421 | Nervous System Malformations |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D053685 | Laser Therapy |
| D010789 | Phototherapy |
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