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临床试验/NCT07245498
NCT07245498已完成不适用

Efficacy of Extracorporeal Shock Wave Therapy in Chronic Non-radicular Low Back Pain

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
visual analog scale(VAS)

研究概览

简要总结

The goal of this interventional study is to compare the effects of ESWT in women and men between the age 18-65 with non radicular non specific low back pain . The main question it aims to answer is:

Is intervention ESWT more effective than conventional physical therapy agents. Patients were divided into 2 groups; Group 1 ESWT+conventional physical therapy and group 2: sham ESWT+conventional physical therapy. Study follow up time before treatment, 0 week after treatment, and 1 month after treatment.

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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients between the ages of 18 and 65 who have had low back pain for at least three months and have been diagnosed with chronic low back pain.
  • Patients who consent to participate in the study according to the informed consent form will be included in the study.

排除标准

  • Diagnosis of spondylolisthesis, spondylolysis, spinal tumors, intervertebral disc infections, severe osteoporosis, or lumbar vertebral fractures and patients with a history of prior spine surgery,
  • Currently using anti-inflammatory drugs or analgesics in last four weeks,
  • Local skin infection or damage at the treatment site,
  • Inflammatory rheumatic diseases,
  • Pregnancy
  • Concomitant mental diseases.

结局指标

主要结局

visual analog scale(VAS)

时间窗: Before treatment, Baseline and 1month after treatment

The VAS is a validated tool for assessing pain intensity. It consists of a 10-cm horizontal line anchored by "no pain" (0) at the left end and "worst imaginable pain" (10) at the right end. Participants indicate their perceived pain level by marking a point on the line, which is then measured in centimeters to provide a continuous pain score from 0 to 10.

次要结局

  • oswestry disability score(ODI),(Before treatment, Baseline, 1st month after treatment)
  • hospital anxiety and depression scale(HADS)(Before treatment, Baseline, 1st month after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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