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临床试验/NCT07692347
NCT07692347已完成不适用

Global Myofascial Treatment With Focused Shockwave for Non-Specific Low Back Pain: a Randomized Control Trial.

University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年8月1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
发起方
入组人数
44
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

This study aims to examine the effects of shockwave therapy on myofascial tissue (muscles, fascia, and connective tissue), focusing on pain reduction and improvement of mobility. The results will be compared with those of conventional manual physiotherapy.

Myofascial tissue can be a source of back pain, as it may contain painful spots known as myofascial trigger points (MTrPs). Shockwave therapy can stimulate these trigger points, potentially leading to muscle and fascia relaxation and, as a result, a decrease in pain.

The study investigates how focused shockwave trigger point therapy influences back function and pain perception compared to traditional physiotherapeutic treatment.

Participation is voluntary. The examinations will only be carried out if you provide written informed consent. You may refuse participation or withdraw your consent at any time without any disadvantages.

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 (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic low back pain (LBP) of the lumbar spine lasting more than 12 weeks
  • age between 18 and 70 years
  • pain stage 1 or 2 according to Gerbershagen
  • female, male or diverse
  • capable of giving informed consent

排除标准

  • Severe neurological
  • neoplastic or bony disorders, as well as cognitive impairments
  • according to the judgment and assessment of the examiner
  • flexisting radicular symptoms (e.g., foot drop).

研究组 & 干预措施

shockwave therapy

Experimental

干预措施: Shockwave therapy (Device)

conventional manual physiotherapy

Placebo Comparator

干预措施: Conventional physiotherapy (Procedure)

结局指标

主要结局

Visual Analog Scale

时间窗: 3 months

Pain measurement

Oswestry Disability Index

时间窗: 3 months

Disability related to low back pain measured using the Oswestry Disability Index (ODI). Scores range from 0 to 100, where higher scores indicate greater disability and worse functional outcome.

Visual Analog Scale for Pain

时间窗: 3 months

Pain intensity measured using the Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain.

次要结局

  • Quebec Back Pain Disability Scale(3 Months)
  • SF-12 Health Survey(3 months)
  • Roland-Morris Disability Questionnaire (RMDQ)(3 months)

研究者

发起方
University Hospital Muenster
申办方类型
Other
责任方
Sponsor

研究点 (1)

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