Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Investigation of Muscle Stiffness, Tone and Elasticity After a Spinal Mobilisation Intervention in People With Lower Back Pain

Conditions
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Lower Back Pain

Intervention / Treatment
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* Other: Manual spinal mobilisations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suffering from lower back pain (region between 12th rib and gluteal folds), acute or chronic. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cross-over study design, within-subject repeated measures (intervention versus no intervention).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - Intervention then control<br>Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session. | Other: Manual spinal mobilisations<br> <br> |
| Experimental: B - Control then intervention<br>Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session. | Other: Manual spinal mobilisations<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Erector Spinae Stiffness Change | 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. | Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention. | 
| Control Erector Spinae Stiffness Change. | 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. | Change in muscle stiffness immediately after the 30 minute control session (lying still). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention Erector Spinae Tone Change | Tone 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. | Change in muscle tone immediately after the 30 minute spinal mobilisation intervention. | 
| Control Erector Spinae Tone Change | Tone 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. | Change in muscle tone immediately after the 30 minute control session (lying still). | 
| Intervention Erector Spinae Elasticity Change | Elasticity 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. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis. | Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention. | 
| Control Erector Spinae Elasticity Change | Elasticity 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. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis. | Change in muscle elasticity immediately after the 30 minute control session (lying still). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myometer, lower back pain, muscle stiffness, spinal mobilisations