The Efficacy of High-Power Laser Therapy in Meralgia Paresthetica
ConditionMeralgia Paresthetica
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUşak University
About this trial
The management of MP typically follows a conservative pathway, encompassing patient education, lifestyle modifications (e.g., avoidance of tight garments, weight loss), pharmacotherapy (such as neuropathic pain agents or corticosteroid injections), and physical therapy. However, evidence supporting the efficacy of these interventions is largely anecdotal or derived from low-quality studies, and a substantial proportion of patients experience persistent symptoms refractory to standard care.
Therefore, the primary objective of this randomized, sham-controlled, assessor-blinded study is to investigate the efficacy of HPLT as an adjunct to standard conservative care on pain intensity, sensory symptoms, and functional capacity in patients with chronic Meralgia Paresthetica. The investigators hypothesize that patients receiving active HPLT will demonstrate significantly greater improvements in these outcomes compared to those receiving a sham laser procedure
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-65 years.
Clinical diagnosis of MP (based on history: burning pain, tingling, numbness in the lateral thigh; tenderness over the inguinal ligament near the anterior superior iliac spine (ASIS); and a positive pelvic compression test or Tinel's sign over the lateral femoral cutaneous nerve (LFCN)).
Symptoms persistent for at least 3 months (chronic).
A baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS).
Disqualifiers
Secondary MP (e.g., due to pelvic surgery, trauma, or tumor mass effect confirmed by imaging).
Significant lumbar radiculopathy (L1-L2).
Coagulopathy, use of anticoagulants.
Pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
High-power laser
DeviceOperating Mode: Continuous wave Power Output: 10 Watts Energy Dose: A typical effective dose for deep nerves is "800 J per session"
Sham laser
Other interventionThe device will beep and display as if it is working.
Standard Conservative Care
Other interventionEducation: Advice on avoiding tight belts/trousers, weight loss if applicable, and posture modification. -Home Exercise Program: Stretching exercises for the hip flexors (iliopsoas, rectus femoris) and tensor fasciae latae (TFL) to reduce tension on the inguinal ligament.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Experimental Group: HPLTExperimental treatment 2 interventions
Group B: Control Group: Sham LaserSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
PainDETECT
PainDETECT screening questionnaire: PainDETECT is a simple, easy to use screening questionnaire. The questionnaire consists of 9 items and is completed by the patient (no clinical examination is required). There are 7 weighted sensory descriptor items (never to very strongly) and 2 items relating to spatial and temporal pain characteristics. A total score of 19 or more is indicative of likely neuropathic pain.
Time frame
Baseline, 3rd week, 3rd monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Uşak University
Lead sponsor
Balikesir University
Collaborator
Source ClinicalTrials.gov