Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve

Does Obesity EffectThe Successful Response to the Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve in Meralgia Parestetica? : A Retrospective Cohort Study

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 Overview

• Status: Completed
• Conditions: Meralgia Paresthetica

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Mersin, Turkey
    • Suna Aşkın Turan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; patients treated with PRFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to PRF	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcomes were to identify the clinical and diagnostic features of the MP	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.	6 months

Collaborators and Investigators

• Sponsor: Mersin Training and Research Hospital
• Investigators: Study Chair: Aşkın Turan, MD, Mersin Şehir Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: obesity; neuropathic pain; pulsed radiofrequency; meralgia parestetica; dn4
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Femoral Neuropathy
• Other Study ID Numbers: MersinTRHlfcn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The Data and materials are available from the corresponding author upon reasonable request and are subject to ethical review.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No