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Completed

NCT Number: NCT06187883

Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve

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.

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Key information

Conditions

Meralgia Paresthetica Body Weight Femoral Neuropathy Mononeuropathies Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Suna Aşkın Turan

Mersin, Turkey (Türkiye)

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. response to PRF

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mersin Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 3, 2024
Registry last updated
Apr 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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