The Effect of Lumbopelvic Non-Thrust Spinal Manipulation on Muscle Thickness of the Sacral Multifidi, Lumbar Motion, and Self-Reported Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in Sacral Multifidus Muscle Thickness
研究概览
简要总结
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.
详细描述
The proposed study aims to determine if the impact of a newly-described manual procedure, that includes a non-thrust force applied to the low back region, has an impact on patient centered-outcomes. Rehabilitation Ultrasound Imaging (RUSI) will be used to determine MF muscle thickness (MT) at rest and during a maximum voluntary contraction (MVC) immediately following application of the manual procedure.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Changes in Sacral Multifidus Muscle Thickness
时间窗: Change from Pre to immediately Post Manipulation/Sham
Rehabilitation Ultrasound Images of Sacral Multifidus muscle thickness at rest and during a maximal isometric contraction
次要结局
- Changes in Oswestry Disability Questionnaire (0-100 scale, 0=no disability, 100=bed bound, exaggerating symptoms)(Change from Baseline to 24-48 hours post session)
- Changes in Fear-Avoidance Beliefs Questionnaire (0-96, 96=maximum fear-avoidance beliefs)(Change from Baseline to 24-48 hours post session)
- Changes in Lumbar Active Range of Motion(Change from Pre to immediately Post Manipulation/Sham)
- Changes in Low Back Pain(Change from Baseline to immediately Post Manipulation/Sham 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)(Change from Baseline to 24-48 hours post session)
研究者
Christopher H. Wise
Physical Therapy Department Chair, Professor of Physical Therapy
Alvernia University