MS Spinal Mobilisation Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

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.
    

Intervention name(s): Spinal Mobilisation Intervention; General Massage
Intervention type(s): Other; Other
Intervention description(s): 30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.; 30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Mixed factor: between-subject, repeated measures (mobilisation intervention vs general massage).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; myometer; muscle stiffness; spinal mobilisations; body sway; fatigue