Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve

Completed

• Conditions: Meralgia Paresthetica

• Registration Number: NCT06187883
• Lead Sponsor: Mersin Training and Research Hospital

Brief Summary

In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP.

Detailed Description

In the current retrospective cohort study, conducted by both pain specialists and neurophysiologists, the primary outcome was to search for the effect of obesity on the efficacy of PRF of LFCN in refractory MP for 6 months. Secondary outcomes were to identify the clinical and diagnostic features of the MP.

Study Timeline

• Study Start: 2023-11-21
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-06
• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-28
• Study First Posted: 2024-01-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• older than 18 years treated with PRF neuromodulation of LFCN for MP
• followed up at least 6 months in the pain clinic of the tertiary hospital between January 2020 and August 2023.

Exclusion Criteria

• inadequate follow-up or missing documentation
• If a new analgesic drug was prescribed during the follow-up period that could affect the evaluation of outcomes, the patients were also excluded.
• Patients who missed appointments, or were unable to communicate with; were not included in the study.
• Patients with secondary entrapment neuropathy (e.g., diabetes, inflammatory arthritis, hypothyroidism), malignancy, pregnancy, skin infection in the inguinal region or dermatitis, lumbar radiculopathy, polyneuropathy, and cardiac pacemakers were excluded.
• In the SSEP analysis, when the latency of LFCN was not evaluated in both sides, these patients were not also included in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response to PRF	6 months	loss of neuropathic pain, lasting at least 6 months was defined as a positive categorical outcome. Neuropathic pain was assessed with Douleur Neuropathique 4 questionnaire (DN4) at baseline, and at 1., 3, 6 months by the pain specialist authors. DN4 consisted of 10 items. The first seven items were associated with the patients' subjective compliants related to pain and sensational variations while the last three items were associated with the clinical findings. Those patients who had a score ≥ 4were considered to have neuropathic pain. Patients with a positive outcome at the 1 or 3 month follow-up,but did not come again were excluded from the study. After the data collection, the patients wer divided into two groups: responders with a positive outcome and nonresponders with a negative outcome.MP for 6 months. Age, sex, body mass index (BMI), employment, tight clothing, belts, carrying things at the back of pants were asked in detail at the initial visit of the Pain Clinic.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were to identify the clinical and diagnostic features of the MP	6 months	Secondary outcomes were to identify the clinical and diagnostic features of the MP. The outcome was assesed by the clinical and electrophysiological data collected from the hospital records. The data was analyzed deeply.

Trial Locations

Locations (1)

Suna Aşkın Turan; 🇹🇷 Mersin, Turkey