MS Spinal Mobilisation Study

Study Overview
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Brief Summary
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The objective of the study is to measure the effect of a spinal mobilisation intervention on para-spinal muscle tissue quality, functional balance measures, pain and fatigue in people with multiple sclerosis. The mobilisation intervention group will be compared to a general massage group to analyse the difference between the specificities of the intervention compared to general manual touch. Participants will be randomly allocated to a group condition for a between-subject, repeated measures study. The study hypothesises a decrease in lumbar stiffness, body sway, pain and fatigue post the intervention compared to the general massage group.

Detailed Description
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The long term management of multiple sclerosis (MS) symptoms may often involve manual therapeutics due to observed improvements in muscle stiffness, pain, fatigue and balance. Though these improvements are often anecdotal without objective measurement and without analysis of the manual therapeutic. This is partly due to the vast array of manual therapeutics available as well as the many possible influencing factors contributing to these symptoms. The objective of this study is to measure and analyse the cumulative effect of a spinal mobilisation intervention on muscle tissue quality, functional balance, pain and fatigue in people with MS. The intervention will be analysed at a specific rate, pressure and location and compared to a general manual touch session with no specificities on rate, pressure or location. Both therapy sessions will be 30 minutes long. The force of both therapy sessions will be recorded in real time by monitoring the vertical ground reaction force (GRF) profile using 2 Kistler force plates placed underneath the treatment plinth. A 0 force will be generated once each participant is lying supine and still on the plinth and recordings will be taken in 30 second samples during the treatment sessions. The summation of the vertical GRFs will be graphed and monitored to check consistency of the treatment force. The mobilisation intervention will be given at a rate of 0.37Hz (22 beats per minute) maintained by a metronome on silent within view of the therapist, the pressure will be maintained at a pressure grade of less than 1 (equal to a threshold of 80N), and maintained consistent physical contact on paraspinal region within L1-L5. The general massage will be applied on the mid-lower back, with no specificities or consistencies; physical contact, rate and force magnitude will not be kept constant. This will be tested on 20 participants with MS who are randomly allocated to a group condition for a between-subject, repeated measures study. Participants will be randomly allocated to either an intervention or general massage group for which they will attend 4 separate therapy sessions. During the 1st session, the participants will carry out tests for lumbar muscle response, measured stiffness, tone and elasticity (using MyotonPro), functional balance measures in a single-leg balance and sit-to-stand tests (using Kistler force plates), self-reported pain and self-reported fatigue for pre and post treatment sessions. During the subsequent 3 sessions, the participants will complete tests for the myometer, balance and pain post the treatment sessions, and the final fatigue test will be completed after their last session. Participants will therefore complete 5 set of tests for the myometer, balance and pain and the fatigue test is completed pre and post all therapy sessions due to the set-up of the questionnaire. Participants will complete an online questionnaire before their 1st to screen for eligibility criteria and collect anthropometric details and information on their MS condition. This will be analysed with the results into descriptive statistics and summarised into mean, range and dispersion values. All dependent variables measured for muscle tissue response, functional balance, pain and fatigue will be analysed in between-subject repeated measured ANOVA to determine differences between the 2 treatment groups and between the different treatment time points. Pearson correlations will be carried out on the myometer variables to compare the baseline values to the level of change after their final session due to previously found significant correlations. More participants were intended for recruitment in the study, a post-hoc power calculation revealed a power of 0.9 with an alpha level at 0.05 with a range of large effect sizes in the results.

Official Title
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Analysis of a Spinal Mobilisation Intervention in People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Spinal Mobilisation Intervention
* Other: General Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must have Multiple Sclerosis diagnosis. Must be able to walk independently. Must have an EDSS score of 6 or below. Exclusion Criteria: Respond positively to any absolute contraindications for spinal manual therapy including: segment instability infectious disease osteomyelitis bone tumours severe haemophilia spinal cord damage cervical arterial dysfunction Respond positively to any relative contraindications for spinal manual therapy including: spinal disc prolapse spondylosis inflammatory arthritides osteoporosis hypermobile syndrome pregnancy pregnancy cancer cardiovascular disease respiratory disease healing injury adverse reaction to previous spinal treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Mixed factor: between-subject, repeated measures (mobilisation intervention vs general massage).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental A - Mobilisation Intervention<br>Participants receive 4 separate treatment sessions of the 30 minute spinal mobilisation intervention. | Other: Spinal Mobilisation Intervention<br>* 30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.<br>|
| Active Comparator: Experimental B - General Massage<br>Participants receive 4 separate treatment sessions of the 30 minute general massage. | Other: General Massage<br>* 30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Muscle Stiffness Measure | Myometer measured stiffness taken from Erector Spinae muscle central belly. | Taken at baseline, pre-treatment. | 
| Participant Muscle Stiffness Measure | Myometer measured stiffness taken from Erector Spinae muscle central belly. | Taken immediately post 1st treatment. | 
| Participant Muscle Stiffness Measure | Myometer measured stiffness taken from Erector Spinae muscle central belly. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Muscle Stiffness Measure | Myometer measured stiffness taken from Erector Spinae muscle central belly. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Muscle Stiffness Measure | Myometer measured stiffness taken from Erector Spinae muscle central belly. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Path Length | Force plate recording from single leg stance balance test. | Taken at baseline, pre-treatment. | 
| Participant Single Leg Stance Body Sway Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 1st treatment. | 
| Participant Single Leg Stance Body Sway Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Single Leg Stance Body Sway Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Sit-to-Stand Velocity | Force plate recording from sit-to-stand test. | Taken at baseline, pre-treatment. | 
| Participant Sit-to-Stand Velocity | Force plate recording from sit-to-stand test. | Taken immediately post 1st treatment. | 
| Participant Sit-to-Stand Velocity | Force plate recording from sit-to-stand test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Sit-to-Stand Velocity | Force plate recording from sit-to-stand test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Sit-to-Stand Velocity | Force plate recording from sit-to-stand test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Pain Score - Visual Analogue Scale (VAS) | Self-reported pain score annotated by participant pointing on the VAS sheet. Score is between 0-10 with 0 as lowest pain score and 10 as highest pain score. | Taken at baseline, pre-treatment. | 
| Participant Pain Score - Visual Analogue Scale (VAS) | Self-reported pain score annotated by participant pointing on the VAS sheet. Score is between 0-10 with 0 as lowest pain score and 10 as highest pain score. | Taken immediately post 1st treatment. | 
| Participant Pain Score - Visual Analogue Scale (VAS) | Self-reported pain score annotated by participant pointing on the VAS sheet. Score is between 0-10 with 0 as lowest pain score and 10 as highest pain score. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Pain Score - Visual Analogue Scale (VAS) | Self-reported pain score annotated by participant pointing on the VAS sheet. Score is between 0-10 with 0 as lowest pain score and 10 as highest pain score. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Pain Score - Visual Analogue Scale (VAS) | Self-reported pain score annotated by participant pointing on the VAS sheet. Score is between 0-10 with 0 as lowest pain score and 10 as highest pain score. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale. | Self-reported fatigue score from filling out 5 questions on the fatigue questionnaire with possible answers ranging from 0-4. 0 representing 'never experienced' and 4 representing 'almost always experienced'. Total score ranges between 0-20 with 0 representing never experiencing fatigue and 20 representing almost always experiencing fatigue. | Taken at baseline, pre-treatment. | 
| Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale. | Self-reported fatigue score from filling out 5 questions on the fatigue questionnaire with possible answers ranging from 0-4. 0 representing 'never experienced' and 4 representing 'almost always experienced'. Total score ranges between 0-20 with 0 representing never experiencing fatigue and 20 representing almost always experiencing fatigue. | Taken immediately post 4th treatment, 3 weeks after baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Muscle Tone Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken at baseline, pre-treatment. | 
| Participant Muscle Tone Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 1st treatment. | 
| Participant Muscle Tone Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Muscle Tone Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Muscle Tone Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Muscle Elasticity Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken at baseline, pre-treatment. | 
| Participant Muscle Elasticity Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 1st treatment. | 
| Participant Muscle Elasticity Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Muscle Elasticity Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Muscle Elasticity Measure | Myometer measured tone taken from Erector Spinae muscle central belly. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Height | Measure taken in meters using a stadiometer. | Taken at baseline, pre-treatment. | 
| Participant Mass | Measure taken in kilograms using digital electronic scales by the participant stepping on the scales. | Taken at baseline, pre-treatment. | 
| Participant BMI | Calculated using height and mass. | Taken at baseline, pre-treatment. | 
| Participant Age | Self-reported by participant using pre-screening online survey. | Taken at baseline, pre-treatment. | 
| Participant Expanded Disability Status Scale (EDSS) | Self-reported by participant using pre-screening online survey based on disabilities associated with multiple sclerosis. Scale ranges from 0-10 in 0.5 increments each representing a higher level of disability. 0 represents no disability, 1-4.5 represents people who are able to walk without an aid, 5-9.5 represents more severly disabled and impairment to walking and 10 represents death due to multiple sclerosis complications. | Taken at baseline, pre-treatment. | 
| Participant Self-Reported MS Diagnosed Type | Self-reported by participant using pre-screening online survey. | Taken at baseline, pre-treatment. | 
| Participant Self-Reported Most Symptomatic Functional System | Self-reported by participant using pre-screening online survey. | Taken at baseline, pre-treatment. | 
| Participant Self-Reported Most Symptomatic Side of the Body | Self-reported by participant using pre-screening online survey. | Taken at baseline, pre-treatment. | 
| Participant Self-Reported Dominant Side of the Body | Self-reported by participant using pre-screening online survey. | Taken at baseline, pre-treatment. | 
| Participant Single Leg Stance Body Sway Anterior-Posterior Path Length | Force plate recording from single leg stance balance test. | Taken at baseline, pre-treatment. | 
| Participant Single Leg Stance Body Sway Anterior-Posterior Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 1st treatment. | 
| Participant Single Leg Stance Body Sway Anterior-Posterior Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Single Leg Stance Body Sway Anterior-Posterior Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Anterior-Posterior Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Medial-Lateral Path Length | Force plate recording from single leg stance balance test. | Taken at baseline, pre-treatment. | 
| Participant Single Leg Stance Body Sway Medial-Lateral Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 1st treatment. | 
| Participant Single Leg Stance Body Sway Medial-Lateral Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Single Leg Stance Body Sway Medial-Lateral Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Medial-Lateral Path Length | Force plate recording from single leg stance balance test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Velocity | Force plate recording from single leg stance balance test. | Taken at baseline, pre-treatment. | 
| Participant Single Leg Stance Body Sway Velocity | Force plate recording from single leg stance balance test. | Taken immediately post 1st treatment. | 
| Participant Single Leg Stance Body Sway Velocity | Force plate recording from single leg stance balance test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Single Leg Stance Body Sway Velocity | Force plate recording from single leg stance balance test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Single Leg Stance Body Sway Velocity | Force plate recording from single leg stance balance test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Sit-to-Stand Rising Index | Force plate recording from sit-to-stand test. | Taken at baseline, pre-treatment. | 
| Participant Sit-to-Stand Rising Index | Force plate recording from sit-to-stand test. | Taken immediately post 1st treatment. | 
| Participant Sit-to-Stand Rising Index | Force plate recording from sit-to-stand test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Sit-to-Stand Rising Index | Force plate recording from sit-to-stand test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Sit-to-Stand Rising Index | Force plate recording from sit-to-stand test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 
| Participant Sit-to-Stand Weight Transfer | Force plate recording from sit-to-stand test. | Taken at baseline, pre-treatment. | 
| Participant Sit-to-Stand Weight Transfer | Force plate recording from sit-to-stand test. | Taken immediately post 1st treatment. | 
| Participant Sit-to-Stand Weight Transfer | Force plate recording from sit-to-stand test. | Taken immediately post 2nd treatment, 1 week after baseline. | 
| Participant Sit-to-Stand Weight Transfer | Force plate recording from sit-to-stand test. | Taken immediately post 3rd treatment, 2 weeks after baseline. | 
| Participant Sit-to-Stand Weight Transfer | Force plate recording from sit-to-stand test. | Taken immediately post 4th treatment, 3 weeks after baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple sclerosis, myometer, muscle stiffness, spinal mobilisations, body sway, fatigue