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临床试验/NCT03434990
NCT03434990已完成不适用

Effects of the Spinal Manipulative Therapy and Myofascial Release on Pain Threshold, Muscle Function and Balance of Individuals With Non-specific Chronic Low Back Pain: Randomized Controlled Trial

University of Brasilia2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年2月8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
90
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

The aim will be to compare a experimental group submitted to a protocol of spinal manipulation and myofascial release; and a control group composed by spinal manipulation only, in individuals with chronic non-specific low back pain. This is a randomized controlled trial, characterized by the application of manual therapy, in two modalities: spinal manipulation plus myofascial release and spinal manipulation alone. Participants will be enrolled and randomly allocated into two groups: 1) spinal manipulation plus myofascial release, totaling 6 sessions, 2x/week, for 3 weeks; 2) spinal manipulation: 6 sessions, 2x/week, for 3 weeks. Participants will be evaluated in two different moments: 1) Baseline (pre-intervention); 2) at the end of intervention period (3 weeks); and 3) after 3 months follow-up. The primary outcomes will be pain intensity (measured in centimeters with the visual analogue scale - VAS) and disability (measured by the Quebec questionnaire - QDS). The secondary outcomes will be muscle fatigue (measured by the Biering-Sorensen test), postural balance (measured by the Y Balance test), pain threshold (algometry, in kgf) and perception of recovery (Likert scale of 6-points) and health status (measured by the Eq5d3L questionnaire). Data analysis will be performed with the SPSS (Statistical Package for the Social Sciences) software version 24.0. Data normality assumptions will be confirmed by the Shapiro Wilk test. If the assumptions were met, a mixed ANOVA with repeated measures will be adopted, based on the outcomes and the independent variables (groups), for the comparison between pre-intervention and post-intervention. Spinal manipulation plus myofascial release is expected to have better effects than spinal manipulation alone, associated with the outcomes of interest.

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)

盲法说明

The outcome assessor won't have any knowledge about the study purposes and will be unaware of the group allocation. The statistical analysis will also be performed blinded for group allocation.

入排标准

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

入选标准

  • presence of non-specific chronic low back pain for more than 12 consecutive weeks;
  • have not performed Physical Therapy, Osteopathic and/or chiropractic sessions for at least 3 months prior to the research.

排除标准

  • history of trauma or fractures in the trunk and lumbar spine;
  • presence of neural root symptoms;
  • infection and inflammation on spine and upper and lower limbs for at least 3 months prior to research;
  • have undergone surgery on spine, chest and abdomen;
  • rheumatologic and myopathic diseases;
  • renal, digestion and neurological diseases;
  • use of anti-inflammatories drugs and analgesic drugs for at least 2 weeks prior the research.

研究组 & 干预措施

Spinal manipulation/myofascial release

Experimental

2x/week, for 3 weeks, performed by a chiropractor. Sessions will last 20 minutes, with 1 individual per session. Myofascial release will be done on paravertebral muscle (Erector spinae, quadratus lumborum) and on gluteus maximus and piriform muscles, the pressure will depend of pain tolerance of each subject. After this procedure, the spinal manipulation will be performed on the sacroiliac join and on the lumbar vertebrae with less mobility.

干预措施: Spinal manipulation/myofascial release (Other)

Spinal manipulation

Active Comparator

2x/week, for 3 weeks, performed by a chiropractor. Sessions will last 20 minutes, with 1 individual per session. The spinal manipulation will be performed on the sacroiliac join and on the lumbar vertebrae with less mobility.

干预措施: Spinal manipulation (Other)

结局指标

主要结局

Pain intensity

时间窗: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Pain intensity measured by a Visual Analog Scale (in centimeters)

Disability

时间窗: Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months)

Quebec Back Pain Disability Scale (scores ranging from 0 to 100)

次要结局

  • Health Status(Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months))
  • Balance(Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months))
  • Perception of Recovery(Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months))
  • Pain threshold(Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months))
  • Muscle fatigue(Change from Pre-Intervention (baseline) compared to Post-Intervention (3 weeks) and Follow up (3 months))

研究者

发起方
University of Brasilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Rodrigo Luiz Carregaro

Prof. Dr.

University of Brasilia

研究点 (2)

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