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临床试验/NCT03758807
NCT03758807已完成不适用

A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain: a Randomized Control Trial

St. Ambrose University2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年6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
入组人数
102
试验地点
2
主要终点
Straight Leg Raise

研究概览

简要总结

To determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

详细描述

Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

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)

盲法说明

Patients were randomly assigned to one of two treatment groups

入排标准

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

入选标准

  • adults over the age of 18
  • patients presenting at PT with a primary complaint of LBP
  • LBP being present for 6 months or more
  • fluent in English
  • willing to participate in the study.

排除标准

  • under age 18
  • not able to read/understand the English language
  • prisoners
  • no medical issues precluding physical therapy treatment (red flags)
  • no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
  • prior spine surgery
  • unable to lay prone for the treatment

研究组 & 干预措施

Passive treatment

Sham Comparator

Passive treatment will consist of Manual Therapy with biomechanical explanation of the technique.

干预措施: Manual Therapy with Traditional Biomechanical Explanation (Other)

Active Treatment

Experimental

Active treatment will consist of Manual Therapy with a neuroplasticity explanation of the technique.

干预措施: Manual Therapy with Neuroplastiicity Explanation (Other)

结局指标

主要结局

Straight Leg Raise

时间窗: Change from initial treatment to 2-4 days

Neurodynamic Measurement of Leg Raise (lower limb tension test)

Lumbar flexion

时间窗: Change from initial treatment to 2-4 days

Active trunk forward flexion in cm (distance finger tips to floor)

Low Back Pain Rating

时间窗: Change from initial treatment to 2-4 days

Numeric Pain Rating Scale for Back Pain (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

次要结局

未报告次要终点

研究者

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

Kevin Farrell

Professor, Chair of Clinical Residency Program in Orthopaedic Physical Therapy

St. Ambrose University

研究点 (2)

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