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临床试验/NCT05057091
NCT05057091已完成不适用

Immediate Effects of Two Spinal Manipulative Techniques on Clinical Outcomes and Muscle Mechanical Properties in Chronic Low Back Pain: An Assessor Blinded, Randomized Controlled Trial

Alanya Alaaddin Keykubat University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年9月19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
46
试验地点
1
主要终点
Mechanical properties measurements

研究概览

简要总结

The aim of this study is to investigate the instant effects of direct vertabral manipulation and indirect vertebral manipulation techniques on muscles mechanical properties, pressure-pain threshold and joint range of motion in individuals with chronic low back pain. Another purpose of this study was to compare the effects of both treatment methods on the parameters studied.

详细描述

Resolving chronic low back pain is a costly obstacle. There is a wide spectrum of treatment for chronic low back pain, such as exercise training, pain training and spinal manipulation.It is the recommended spinal manipulation in the short and long term in chronic low back pain. Clinical Spinal manipulation is one of the most preferred methods of reducing pain and disability.

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
None

盲法说明

A power analysis was conducted to determine the number of cases to be included in the study. In order for the study to be performed at 80% strength and with a 5% margin of error, at least 23 people from each group should be included in the study to find a difference of 30 N/m after application, in the case where the lumbal extensor November hardness is 320 N/m and the standard deviation is 74 N/m

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

  • 18-65 ages
  • Individuals with non-specific chronic low back pain who have continued pain for at least 3 months
  • According to VAS, individuals with pain of at least 3 severity

排除标准

  • Pregnancy situation or suspicion
  • Spinal Stenosis
  • Vertebral fracture
  • Osteoporosis
  • Individuals with BMI over 30 kg/m2
  • Those with neurological disease that leads to November loss of muscle strength or spasticity-rigidity

结局指标

主要结局

Mechanical properties measurements

时间窗: through study completion, an average of 1 hour

A MyotonPro was used to measure the mechanical properties of selected muscles. the measurements of the medial gastrocnemius and biceps femoris muscles were performed while individuals were in prone position the knees at full extension, and the ankle at neural position. The measurements of medial gastrocnemius were performed on plumped portion of the muscle at a point 70% of the lower leg length in line with the popliteal crease to the lateral malleolus. For biceps femoris muscle, measurements were performed at the middle points between tuberosity of the ischium and the head of the fibula.the mechanical properties of lumbar extensor muscle were performed while the individuals were prone position the hip and knee at full extension. For lumbar extensor muscle, the measurements were performed at the point 3 cm from the midpoint of the L3/L4 intervertebral space. The average of three consecutive measurements was recorded.

次要结局

  • Fear Avoidance Beliefs Questionnare(Through study completion, an average of 1 hour)
  • Oswestry low back pain scale(Through study completion, an average of 1 hour)
  • Roland morris disability scale(Through study completion, an average of 1 hour)
  • Visual analog scale(Through study completion, an average of 1 hour)

研究者

发起方
Alanya Alaaddin Keykubat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Araci

pHd., Clinical Physiotherapist, Principal invetsigator

Alanya Alaaddin Keykubat University

研究点 (1)

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