The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intervention Erector Spinae Stiffness Change
研究概览
简要总结
The objective of the study is to measure and analyse the effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The mobilisation intervention will be compared to a control with participants taking part in both conditions for a factorial, within-subject repeated measures study. The study will analyse lumbar muscle response to the manual intervention and analyse the potential influence of anthropometric measures of participants. The study hypothesises a decrease in lumbar stiffness post the intervention, compared to the control session.
详细描述
Various types of spinal manual therapies have been common practice for many years, particularly for treatment of lower back pain. Spinal mobilisation is a specific technique within spinal physiotherapy, often used as a treatment for lower back pain. This is despite limited objective evidence of the effect on muscle tissue quality.
The objective of this study is to measure and analyse the acute effect of a spinal mobilisation intervention on muscle tissue quality in people with lower back pain. The intervention consists of the mobilisation of the lumbar spine for 30 minutes, at a specific rate and pressure. This will be performed by a chartered physiotherapist. This will be tested with 40 participants with lower back pain. This was the recommended sample size given by G Power for a medium effect size, a power of 0.95 and alpha level of 0.05.
Participants will take part in an intervention and a control condition. Lumbar muscle response will be measured for stiffness, tone and elasticity immediately before and after the intervention and the control. The control session consists of lying still for the 30 minutes. Results for both sessions will then be compared. A myometer (MyotonPRO) will be used to assess the change in lumbar muscle objectively. This is a non-invasive, handheld device with many reliability studies on its functionality. Analysis will consider the degree of muscle response with individual covariates involved. This includes gender, height, weight, waist circumference, BMI and level of back pain (discerned by score on Oswestry Disability Index).
The results will compared in 2-way repeated measures, within participant ANOVA for significant differences between conditions and time. Anthropometric measures will be analysed in separate ANOCOVAs to determine any significant factors contributing to level of change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic.
排除标准
- •Respond positively to any absolute contraindications for spinal therapy, including:
- •segment instability
- •infectious disease
- •osteomyelitis
- •bone tumours
- •neurological deficit
- •upper motor neuron lesion
- •spinal cord damage
- •cervical arterial dysfunction
- •Respond positively to relative contra-indications, excluded based on severity, including:
- •osteoporosis
- •spinal instability
- •rheumatoid arthritis
- •inflammatory disease
- •active history of cancer
- •hypermobile syndrome
- •segment hypermobility
- •cardiovascular disease
- •cervical anomalies
- •nerve root disorder
- •spinal surgery
- •respiratory problems
- •thrombosis
- •open wounds
- •local infection
- •fractures or dislocations
结局指标
主要结局
Intervention Erector Spinae Stiffness Change
时间窗: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Control Erector Spinae Stiffness Change.
时间窗: Change in muscle stiffness immediately after the 30 minute control session (lying still).
Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
次要结局
- Control Erector Spinae Tone Change(Change in muscle tone immediately after the 30 minute control session (lying still).)
- Intervention Erector Spinae Elasticity Change(Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.)
- Intervention Erector Spinae Tone Change(Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.)
- Control Erector Spinae Elasticity Change(Change in muscle elasticity immediately after the 30 minute control session (lying still).)
研究者
Rebecca Hamilton
Principal Investigator, PhD student
Edinburgh Napier University