Pulsed Radiofrequency of Lateral Femoral Cutaneous Nerve

Meralgia Paresthetica Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06187883
• Other study ID #: MersinTRHlfcn
• Status: Completed
• Start date: November 21, 2023
• Est. completion date: December 6, 2023

Study information

• Verified date: April 2024
• Source: Mersin Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 6, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Neuropathy
• Meralgia Paresthetica

Locations

Country	Name	City	State
Turkey	Suna Askin Turan	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Mersin Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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