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临床试验/NCT02128607
NCT02128607已完成不适用

Immediate and Short-term Effects of Mulligan "Sustained Natural Apophyseal Glides" for a Subgroup of Low Back Pain Patients: A Randomized Placebo Controlled Trial

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)

研究概览

简要总结

Objectives:

Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional disability and kinesiophobia.

Design:

A randomized double blinded placebo controlled trial with double arms in accordance with the CONSORT statement.

Subjects:

Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a subgroup of them will be included according to specific inclusion criteria tailored for indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).

Method:

Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be treated during a single session, and real/sham SNAG will be applied from a sitting position with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a validated kinematic spine model will be used and recorded with an opto-electronic device (BTS-Elite). Pain at rest and during flexion, as well as functional disability and kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly evaluated before and after treatment to compare both groups with " Two-Way-ANOVA " statistic with for factors; time and groups.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy

排除标准

  • specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied

结局指标

主要结局

Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)

时间窗: Change from baseline until discharge of treatment (same day, single session)

Use of quantitative variables for ROM and SPEED kinematic (Logit scores index)

次要结局

  • Tampa scale for kinesiophobia(change from baseline until two weeks after treatment)
  • Oswestry Disability questionnaire(change from baseline until 2 weeks after treatment)
  • present pain with visual analog scale (VAS)(change from baseline and after treatment the same day (single session))

研究者

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

Benjamin Hidalgo

PhD-s, assistant-teacher

Université Catholique de Louvain

研究点 (2)

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