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临床试验/NCT02942147
NCT02942147已完成不适用

Comparison of the Efficacy of Conventional Radiofrequency, Pulse Radiofrequency, and TENS Therapies for Lumbar Facet Joint Pain: A Single-blind Randomized Controlled Trial

Ege University0 个研究点目标入组 60 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
主要终点
Change-Visual Analogue Scale

研究概览

简要总结

Objective: The objective of this study is to compare the efficacy of TENS (transcutaneous electrical nerve stimulation) therapy with those of the conventional radiofrequency and pulse radiofrequency therapies.

Design: A single-blind randomized controlled trial

Setting: An outpatient physical therapy and rehabilitation clinic

Subjects: The study included 60 patients who presented with a complaint of chronic low back pain prevailing at least for 3 months and who were diagnosed with facet joint syndrome.

Interventions: The patients were randomized into 3 groups so that Group 1 (n: 20) patients would receive conventional radiofrequency therapy, Group 2 (n: 20) patients conventional TENS procedure for 15 days and Group 3 (n: 20) patients pulse radiofrequency therapy.

Main measures: The patients were assessed before treatment, and at month 1 and 6 for pain (visual analogue scale), disability (Oswestry Disability Index), lumbar movements (hand-floor distance), functional status (20-meter walking times, 6-min walking distances), quality of life (Short Form 36), and depression (Beck Depression Inventory).

详细描述

Patient selection

The study included patients who presented to the outpatient clinics of these units with the complaint of chronic low back pain prevailing for at least 3 months that had not responded to previous medical treatment. Medical history were obtained from the patients and their low back and lower extremity musculoskeletal systems and neurologic systems were examined. Patients were assessed using their two-way lumbar X-rays taken within the last 1 year and lumbar magnetic resonance imaging outcomes. After all these examinations and assessments, the patients who were excluded from the study consisted of those who had a coagulation disorder, a history of malignity, a mental disorder, a psychiatric disorder, pregnancy, prior low back surgery, a history of TENS or radiofrequency procedure at their low back region within the last 1 year, an advanced (grade 3-4) spondylolisthesis defect in their lumbar vertebrae, an extruded and sequestrated disk hernia or a spinal narrow canal in their magnetic resonance imaging, a cauda equine syndrome or advanced paresis, an examination finding suggesting radiculopathy with pain noticeably extending under the knee, a history of systemic inflammatory disease, an advanced cardiac deficiency and a diagnosis of pulmonary disease. In the light of the medical history, examination findings and other tests, the patients who were thought to have facet joint syndrome and who did not meet any of the exclusion criteria above were informed about the study and treatment procedures.

The patients who agreed to receive the treatment based on the information given to them were administered a diagnostic test dose at the operating room of the Algology Division to confirm whether the present pain was associated with the facet syndrome meeting the inclusion criteria. This diagnostic procedure involved injection of 0.4 cc of bupivacaine under fluoroscopy to the median of dorsal ramus that enable innervation of lumbar facet joints. The patients whose pain receded more than 50% after this administration of a test dose and who met the other two inclusion criteria, visual analogue scale pain level >3 and 18-75 years of age, were included in the study.

The patients included in the study were informed both in writing and verbally about the purpose and length of the study, the way of implementing it, and possible side effects and problems that can arise. Patients signed the "subject informed consent form" and local ethics committee approval was obtained.

Intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • The study included patients who presented to the outpatient clinics of these units with the complaint of chronic low back pain prevailing for at least 3 months that had not responded to previous medical treatment

排除标准

  • The patients who were excluded from the study consisted of those who had:
  • coagulation disorder
  • history of malignity
  • mental disorder
  • psychiatric disorder
  • pregnancy
  • prior low back surgery
  • advanced (grade 3-4) spondylolisthesis defect
  • extruded and sequestrated disk hernia
  • spinal narrow canal
  • cauda equine syndrome
  • history of systemic inflammatory disease
  • advanced cardiac deficiency
  • diagnosis of pulmonary disease

研究组 & 干预措施

conventional radiofrequency therapy

Active Comparator

In the conventional radiofrequency method applied to Group 1 patients, the targeted facet joints were marked while the fluoroscope was in antero-posterior position.

干预措施: Conventional or Pulse Radiofrequency (Procedure)

conventional TENS

Active Comparator

Group 2 patients were administered TENS therapy 30 minutes a day for 15 days at the outpatient physiotherapy unit of the Physiotherapy and Rehabilitation Department. The TENS therapy was applied in the form of conventional TENS subtype with 80-100 Hz frequency by placing four electrodes on the region where the pain was most intense.

干预措施: TENS (Device)

pulse radiofrequency therapy

Active Comparator

In the pulse radiofrequency method applied to Group 3 patients, the targeted facet joints were marked while the fluoroscope was in antero-posterior position.

干预措施: Conventional or Pulse Radiofrequency (Procedure)

结局指标

主要结局

Change-Visual Analogue Scale

时间窗: Pre-treatment, 1 month, 6 month

次要结局

  • Change-Short Form 36(0 month, 1 month, 6 month)
  • Change-Oswestry Disability Index(0 month, 1 month, 6 month)
  • Change-Beck Depression Inventory(0 month, 1 month, 6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Eyigor

Prof

Ege University

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