Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve

NCT06187883 | Completed

• 1 other identifier: MersinTRHlfcn
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Meralgia Paresthetica

Keywords

meralgia parestetica; pulsed radiofrequency; obesity; dn4; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary outcomes were to identify the clinical and diagnostic features of the MP

  6 months

Study Arms (1)

1

patients treated with PRFT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin Training and Research Hospital: lead

Study Sites (1)

Suna Aşkın Turan

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Neuropathy; Obesity; Neuralgia

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Aşkın Turan, MD

  Mersin Şehir Hastanesi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pain Department Physician

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: January 3, 2024
• Study Start: November 21, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 6, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)