跳至主要内容
临床试验/NCT06187883
NCT06187883已完成不适用

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

Mersin Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
response to PRF

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

response to PRF

时间窗: 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.

次要结局

  • Secondary outcomes were to identify the clinical and diagnostic features of the MP(6 months)

研究者

发起方
Mersin Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Suna Aşkın Turan

Pain Department Physician

Mersin Training and Research Hospital

研究点 (1)

Loading locations...

相似试验