Clinical trial NCT05090709: MS Spinal Mobilisation Study
Official title: Analysis of a Spinal Mobilisation Intervention in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
myometer
muscle stiffness
spinal mobilisations
body sway
fatigue
Lead sponsor: Edinburgh Napier University
Sponsor class: OTHER
Collaborators: name: Scottish Hospital Endowments Research Trust
name: Pacla Medical Ltd
First posted: 2021-10-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Mixed factor: between-subject, repeated measures (mobilisation intervention vs general massage).
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participant Muscle Stiffness Measure
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Muscle Stiffness Measure
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Muscle Stiffness Measure
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Muscle Stiffness Measure
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Muscle Stiffness Measure
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Single Leg Stance Body Sway Path Length
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Single Leg Stance Body Sway Path Length
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Single Leg Stance Body Sway Path Length
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Single Leg Stance Body Sway Path Length
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Single Leg Stance Body Sway Path Length
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Sit-to-Stand Velocity
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Sit-to-Stand Velocity
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Sit-to-Stand Velocity
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Sit-to-Stand Velocity
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Sit-to-Stand Velocity
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Pain Score - Visual Analogue Scale (VAS)
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Pain Score - Visual Analogue Scale (VAS)
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Pain Score - Visual Analogue Scale (VAS)
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Pain Score - Visual Analogue Scale (VAS)
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Pain Score - Visual Analogue Scale (VAS)
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Secondary outcomes:
measure: Participant Muscle Tone Measure
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Muscle Tone Measure
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Muscle Tone Measure
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Muscle Tone Measure
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Muscle Tone Measure
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Muscle Elasticity Measure
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Muscle Elasticity Measure
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Muscle Elasticity Measure
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Muscle Elasticity Measure
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Muscle Elasticity Measure
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Single Leg Stance Body Sway Medial-Lateral Path Length
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Single Leg Stance Body Sway Medial-Lateral Path Length
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Single Leg Stance Body Sway Medial-Lateral Path Length
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Single Leg Stance Body Sway Medial-Lateral Path Length
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Single Leg Stance Body Sway Medial-Lateral Path Length
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Single Leg Stance Body Sway Velocity
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Single Leg Stance Body Sway Velocity
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Single Leg Stance Body Sway Velocity
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Single Leg Stance Body Sway Velocity
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Single Leg Stance Body Sway Velocity
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Sit-to-Stand Rising Index
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Sit-to-Stand Rising Index
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Sit-to-Stand Rising Index
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Sit-to-Stand Rising Index
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Sit-to-Stand Rising Index
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
measure: Participant Sit-to-Stand Weight Transfer
timeFrame: Taken at baseline, pre-treatment.
measure: Participant Sit-to-Stand Weight Transfer
timeFrame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
measure: Participant Sit-to-Stand Weight Transfer
timeFrame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
measure: Participant Sit-to-Stand Weight Transfer
timeFrame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
measure: Participant Sit-to-Stand Weight Transfer
timeFrame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Napier University
state: County
Study officials:
References: