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临床试验/NCT03961477
NCT03961477已完成不适用

Effect of Interferential Therapy on Pain, Range of Motion and Quality of Life in Patients With Chronic Non-specific Low Back Pain: A Randomized Controlled Trial

Ahlia University2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2017年12月5日最近更新:
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
61
试验地点
2
主要终点
Visual Analogue Scale (VAS)

研究概览

简要总结

Background: Chronic non-specific low back pain is defined as unknown mechanical musculoskeletal pain lasting more than 3 months. Electrotherapy is a non-pharmacologic, non-invasive and simple method back pain treatment that is mainly applied using interferential (IF) therapy. The current study was designed to investigate the effect of IF on pain, range of motion, and quality of life in patients with chronic non-specific low back pain. Materials and methods: 61 patients suffered from chronic non-specific low back pain (CNLBP) were randomly assigned to IF group (n=30) and placebo IF (n=31). The entire patient received suggested exercise 3 times per week for 4 weeks. The outcome measures were visual analogue scale (VAS), lumbar range of motion (ROM) in terms of flexion& extension and the Short Form-36 (SF-36) health questionnaire to evaluate the quality of life (QOL).

详细描述

Participants The study was conducted in outpatient clinics in Cairo University Hospitals. 60 patients (29 males and 31 females) were invited to participate in the current study. Subjects were included in the study if they had LBP of at least three months duration and aged between 25 and 60 years. Patients with spinal pathology (tumor, nerve root, fracture, and compromise), cardiopulmonary conditions, pregnancy, and received physiotherapy in the last eight weeks or any contraindications to the use of electrotherapy were excluded.

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
Double (Participant, Outcomes Assessor)

盲法说明

Each subject in both groups was positioned in prone lying and the area to be treated was exposed. The IF group which included 30 subjects received IF. The IF current was increased gradually according the subject's condition with comfortable tingling sensation.

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •*Subjects were included in the study if they had LBP of at least three months duration * Age between 25 and 60 years.

排除标准

  • •Patients with spinal pathology (tumor, nerve root, fracture, and compromise),
  • •Cardiopulmonary conditions
  • •Pregnancy,
  • •Received physiotherapy in the last eight weeks
  • •Any contraindications to the use of electrotherapy were excluded.

研究组 & 干预措施

IF group

Active Comparator

Interferential therpapy

干预措施: Interferential therapy (Other)

Placebo

No Intervention

No intervention

结局指标

主要结局

Visual Analogue Scale (VAS)

时间窗: 6 months

The severity of pain was evaluated using a visual analogue scale (VAS). The participants were requested to put a line on the scale perpendicularly that matched to their pain intensity. VAS scores represent the pain intensity as none, mild, moderate, or severe. The accompanying cutoff was used for the pain scale: 0- 4 , no pain; 5- 44, mild pain; 45- 74, moderate pain; and 75-100, severe pain

次要结局

未报告次要终点

研究者

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

Dr Sayed Tantawy

Professor

Ahlia University

研究点 (2)

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