The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Individuals With Low Back Pain
The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain
The purpose of this experiment is to determine the effects of a non-thrust manipulation procedure on muscle function, spinal mobility, and pain level on those experiencing low back pain (LBP) in a sample of individuals who identify English as their primary language. The rationale for this language criterion is provided in Section 9:F of this application. Muscle function will be measured via the muscle thickness of a deep spinal stabilizing muscle (multifidus, MF) while in both a resting state and during a maximum voluntary contraction (MVC). Spinal mobility will be measured as the active range of motion of both forward and backward trunk bending. Pain level will be a self-report measure recorded during rest and active range of motion.
Hypothesis 1: A non-thrust manipulation procedure will increase the thickness of the sacral multifidus both at rest and during a maximum voluntary contraction
Hypothesis 2: A non-thrust manipulation procedure will result in greater low back active range of motion.
Hypothesis 3: A non-thrust manipulation procedure will result in a reduction in the participant's self-reported pain levels both at rest and during active range of motion movements.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Pennsylvania
-
Reading、Pennsylvania、美国、19606
- Alvernia University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Participants are individuals with current complaint of low back pain, defined as pain that is present in the region from just below the rib cage to just below the buttocks.
- Participants will be 18 years of age or older
- Participants must be experiencing an episode of low back pain at the present time that is at any level on a Numerical Pain Rating Scale & Pain Diagram (NPRS) from 1-10
- Participants must demonstrate the ability to maintain standing and prone postures for several minutes at a time and perform lumbar active range of motion in a standing position
- Participants must report the presence of their low back pain during performance of active forward and/or backward bending in standing
- Participants must demonstrate the ability to communicate in conversational English, that includes speaking, reading, and writing.
Exclusion Criteria:
- Participants who are currently involved in litigation that is directly related to the participant's current episode of low back pain
- Participants with known or suspected pregnancy
Participants with confirmed diagnosis of any of the following conditions:
- Central nervous system disorder
- Rheumatoid Arthritis
- Spinal Fracture
- Spondyloarthropathy (i.e., Ankylosing Spondylitis)
- Tumor or infection of the spine
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lumbar Manipulation Group
Group that receives experimental lumbar non-thrust manipulation
|
Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.
|
|
假比较器：Sham Manipulation Group
Group that receives sham lumbar non-thrust manipulation
|
Lumbar non-thrust manipulation without force applied
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Sacral Multifidus Muscle Thickness
大体时间：Change from Pre to immediately Post Manipulation/Sham
|
Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
|
Change from Pre to immediately Post Manipulation/Sham
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Lumbar Active Range of Motion
大体时间：Change from Pre to immediately Post Manipulation/Sham
|
Inclinometry of Lumbar Active Range of Motion in Standing
|
Change from Pre to immediately Post Manipulation/Sham
|
|
Changes in Low Back Pain
大体时间：Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
|
Visual Analogue Scale of Low Back Pain (0-10 scale with 0=least pain, 10=worst pain)
|
Change from Baseline to immediately Post Manipulation/Sham to 24-48 hours post session
|
|
Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)
大体时间：Change from Baseline to 24-48 hours post session
|
Self-assessment disability paper survey
|
Change from Baseline to 24-48 hours post session
|
|
Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)
大体时间：Change from Baseline to 24-48 hours post session
|
Self-assessment disability paper survey
|
Change from Baseline to 24-48 hours post session
|
|
Changes in Global Rating of Change (-7 to +7 scale, -7=a very great deal worse, +7=a very great deal better)
大体时间：Change from Baseline to 24-48 hours post session
|
Self-assessment disability paper survey
|
Change from Baseline to 24-48 hours post session
|
合作者和调查者
调查人员
- 学习椅：Joshua Cleland, PhD、Nova Southeastern University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.