MS Spinal Mobilisation Study

Not Applicable

Completed

Conditions: Multiple Sclerosis

Interventions: Other: General Massage
Other: Spinal Mobilisation Intervention

Registration Number: NCT05090709

Lead Sponsor: Edinburgh Napier University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Experimental B - General Massage	General Massage	Participants receive 4 separate treatment sessions of the 30 minute general massage.
Experimental A - Mobilisation Intervention	Spinal Mobilisation Intervention	Participants receive 4 separate treatment sessions of the 30 minute spinal mobilisation intervention.

Primary Outcome Measures

Name	Time	Method
Participant Single Leg Stance Body Sway Path Length	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from single leg stance balance test automatically outputted by software using centre of pressure recording to track position total body sway travelled. Further details are outlined in the attached Protocol Document.
Participant Muscle Stiffness Measure	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Myometer measured stiffness taken from Erector Spinae muscle central belly via accelerometer probe registering response from a series of low force mechanical impulses applied perpendicular to the muscle. The muscle central belly was palpated while asking the participant to lift their head and feet at the same time while lying in prone position contracting this muscle. Measurements taken from a myometer device given in Newton-metre units. Further method details are given in the Protocol Document in attachments.
Participant Sit-to-Stand Velocity	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from sit-to-stand test.
Participant Pain Score - Visual Analogue Scale (VAS)	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	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.
Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	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.

Secondary Outcome Measures

Name	Time	Method
Participant Muscle Tone Measure	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Myometer measured muscle tone taken from Erector Spinae muscle central belly via accelerometer probe registering response from a series of low force mechanical impulses applied perpendicular to the muscle. The muscle central belly was palpated while asking the participant to lift their head and feet at the same time while lying in prone position contracting this muscle. Measurements taken from a myometer device given as a frequency measure in Hertz. Further method details are given in the Protocol Document in attachments.
Participant Muscle Elasticity Measure	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Myometer measured muscle elasticity taken from Erector Spinae muscle central belly via accelerometer probe registering response from a series of low force mechanical impulses applied perpendicular to the muscle. The muscle central belly was palpated while asking the participant to lift their head and feet at the same time while lying in prone position contracting this muscle. Measurements taken from a myometer device given as the logarithmic decrement of tissue's natural dampening frequency oscillation characterising its elasticity (dissipation of mechanical energy). Further method details are given in the Protocol Document in attachments.
Participant Single Leg Stance Body Sway Medial-Lateral Path Length	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from single leg stance balance test automatically outputted by software using centre of pressure recording to track position body sway travelled in the Medial-Lateral position. Further details are outlined in the attached Protocol Document.
Participant Sit-to-Stand Rising Index	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from sit-to-stand test automatically outputted by software using percentage of body weight applied to the force plate during the stance phase of movement. Further details are outlined in the attached Protocol Document.
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from single leg stance balance test automatically outputted by software using centre of pressure recording to track position body sway travelled in the Anterior-Posterior position. Further details are outlined in the attached Protocol Document.
Participant Single Leg Stance Body Sway Velocity	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from single leg stance balance test automatically outputted by software using centre of pressure recording to track position total body sway velocity travelled. Further details are outlined in the attached Protocol Document.
Participant Sit-to-Stand Weight Transfer	Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).	Force plate recording from sit-to-stand test automatically outputted by software using the time taken to reach full standing recorded by the force plate. Further details are outlined in the attached Protocol Document.