MS Spinal Mobilisation Study

Analysis of a Spinal Mobilisation Intervention in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05090709

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Participant Muscle Stiffness Measure > 0.05
Participant Muscle Stiffness Measure > 0.05
Participant Single Leg Stance Body Sway Path Length < 0.05
Participant Single Leg Stance Body Sway Path Length < 0.05
Participant Sit-to-Stand Velocity > 0.05
Participant Sit-to-Stand Velocity > 0.05
Participant Pain Score - Visual Analogue Scale (VAS) > 0.05
Participant Pain Score - Visual Analogue Scale (VAS) > 0.05
Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale. < 0.05
Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale. > 0.05

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Spinal Mobilisation Intervention

Compared with

  • General Massage

Results by group

Participant Muscle Stiffness Measure

Taken at baseline, pre-treatment.

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention350.83 Newton-metres51.54 (Standard Error)10
Experimental B - General Massage240.07 Newton-metres18.51 (Standard Error)10

Experimental A - Mobilisation Intervention

350.83

Experimental B - General Massage

240.07

Participant Muscle Stiffness Measure

Taken immediately post 1st treatment, same day as baseline measures (week 1).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention306.27 Newton-metres27.41 (Standard Error)10
Experimental B - General Massage234.77 Newton-metres22.08 (Standard Error)10

Experimental A - Mobilisation Intervention

306.27

Experimental B - General Massage

234.77

Participant Muscle Stiffness Measure

Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention306.47 Newton-metres39.87 (Standard Error)10
Experimental B - General Massage232.37 Newton-metres24.08 (Standard Error)10

Experimental A - Mobilisation Intervention

306.47

Experimental B - General Massage

232.37

Participant Muscle Stiffness Measure

Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention340.87 Newton-metres51.27 (Standard Error)10
Experimental B - General Massage235.33 Newton-metres27.54 (Standard Error)10

Experimental A - Mobilisation Intervention

340.87

Experimental B - General Massage

235.33

Participant Muscle Stiffness Measure

Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention324.37 Newton-metres46.21 (Standard Error)10
Experimental B - General Massage220.27 Newton-metres17.4 (Standard Error)10

Experimental A - Mobilisation Intervention

324.37

Experimental B - General Massage

220.27

p = > 0.05

Participant Single Leg Stance Body Sway Path Length

Taken at baseline, pre-treatment.

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention495.22 Millimeters57.12 (Standard Error)10
Experimental B - General Massage619.57 Millimeters77.36 (Standard Error)10

Experimental A - Mobilisation Intervention

495.22

Experimental B - General Massage

619.57

Participant Single Leg Stance Body Sway Path Length

Taken immediately post 1st treatment, same day as baseline measures (week 1).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention458.45 Millimeters51.23 (Standard Error)10
Experimental B - General Massage524.29 Millimeters65.21 (Standard Error)10

Experimental A - Mobilisation Intervention

458.45

Experimental B - General Massage

524.29

Participant Single Leg Stance Body Sway Path Length

Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention387.23 Millimeters52.1 (Standard Error)10
Experimental B - General Massage543.4 Millimeters73.15 (Standard Error)10

Experimental A - Mobilisation Intervention

387.23

Experimental B - General Massage

543.4

Participant Single Leg Stance Body Sway Path Length

Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention386.32 Millimeters40.55 (Standard Error)10
Experimental B - General Massage509.36 Millimeters51.12 (Standard Error)10

Experimental A - Mobilisation Intervention

386.32

Experimental B - General Massage

509.36

Participant Single Leg Stance Body Sway Path Length

Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention389.22 Millimeters55.6 (Standard Error)10
Experimental B - General Massage491.92 Millimeters58.75 (Standard Error)10

Experimental A - Mobilisation Intervention

389.22

Experimental B - General Massage

491.92

p = < 0.05

Participant Sit-to-Stand Velocity

Taken at baseline, pre-treatment.

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention160.66 Millimeters/second11.95 (Standard Error)10
Experimental B - General Massage156.41 Millimeters/second20.78 (Standard Error)10

Experimental A - Mobilisation Intervention

160.66

Experimental B - General Massage

156.41

Participant Sit-to-Stand Velocity

Taken immediately post 1st treatment, same day as baseline measures (week 1).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention176.01 Millimeters/second12.95 (Standard Error)10
Experimental B - General Massage142.65 Millimeters/second14.04 (Standard Error)10

Experimental A - Mobilisation Intervention

176.01

Experimental B - General Massage

142.65

Participant Sit-to-Stand Velocity

Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention189.25 Millimeters/second13.77 (Standard Error)10
Experimental B - General Massage158.36 Millimeters/second14.61 (Standard Error)10

Experimental A - Mobilisation Intervention

189.25

Experimental B - General Massage

158.36

Participant Sit-to-Stand Velocity

Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention166.07 Millimeters/second19 (Standard Error)10
Experimental B - General Massage131 Millimeters/second9.38 (Standard Error)10

Experimental A - Mobilisation Intervention

166.07

Experimental B - General Massage

131

Participant Sit-to-Stand Velocity

Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention164.18 Millimeters/second18.13 (Standard Error)10
Experimental B - General Massage145.06 Millimeters/second13.76 (Standard Error)10

Experimental A - Mobilisation Intervention

164.18

Experimental B - General Massage

145.06

p = > 0.05

Participant Pain Score - Visual Analogue Scale (VAS)

Taken at baseline, pre-treatment.

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention1.2 Units on a scale0.57 (Standard Error)10
Experimental B - General Massage0.8 Units on a scale0.59 (Standard Error)10

Experimental A - Mobilisation Intervention

1.2

Experimental B - General Massage

0.8

Participant Pain Score - Visual Analogue Scale (VAS)

Taken immediately post 1st treatment, same day as baseline measures (week 1).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention0.5 Units on a scale0.31 (Standard Error)10
Experimental B - General Massage0.7 Units on a scale0.6 (Standard Error)10

Experimental A - Mobilisation Intervention

0.5

Experimental B - General Massage

0.7

Participant Pain Score - Visual Analogue Scale (VAS)

Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention0.6 Units on a scale0.34 (Standard Error)10
Experimental B - General Massage0.4 Units on a scale0.22 (Standard Error)10

Experimental A - Mobilisation Intervention

0.6

Experimental B - General Massage

0.4

Participant Pain Score - Visual Analogue Scale (VAS)

Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention0.6 Units on a scale0.34 (Standard Error)10
Experimental B - General Massage0.67 Units on a scale0.21 (Standard Error)10

Experimental A - Mobilisation Intervention

0.6

Experimental B - General Massage

0.67

Participant Pain Score - Visual Analogue Scale (VAS)

Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention0.5 Units on a scale0.31 (Standard Error)10
Experimental B - General Massage0.3 Units on a scale0.21 (Standard Error)10

Experimental A - Mobilisation Intervention

0.5

Experimental B - General Massage

0.3

p = > 0.05

Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.

Taken at baseline, pre-treatment.

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention10.1 Units on a scale1.22 (Standard Error)10
Experimental B - General Massage8.7 Units on a scale1.56 (Standard Error)10

Experimental A - Mobilisation Intervention

10.1

Experimental B - General Massage

8.7

Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.

Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

GroupValueIntervalNumber analysed
Experimental A - Mobilisation Intervention6.6 Units on a scale0.92 (Standard Error)10
Experimental B - General Massage7.4 Units on a scale1.83 (Standard Error)10

Experimental A - Mobilisation Intervention

6.6

Experimental B - General Massage

7.4

p = < 0.05

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Experimental A - Mobilisation Intervention100 (0.0%)0
Experimental B - General Massage100 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Participant Muscle Stiffness Measure

    Taken at baseline, pre-treatment.

  • Participant Muscle Stiffness Measure

    Taken immediately post 1st treatment, same day as baseline measures (week 1).

  • Participant Muscle Stiffness Measure

    Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

  • Participant Muscle Stiffness Measure

    Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

  • Participant Muscle Stiffness Measure

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

  • Participant Single Leg Stance Body Sway Path Length

    Taken at baseline, pre-treatment.

    Walking and mobility

  • Participant Single Leg Stance Body Sway Path Length

    Taken immediately post 1st treatment, same day as baseline measures (week 1).

    Walking and mobility

  • Participant Single Leg Stance Body Sway Path Length

    Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

    Walking and mobility

  • Participant Single Leg Stance Body Sway Path Length

    Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

    Walking and mobility

  • Participant Single Leg Stance Body Sway Path Length

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

    Walking and mobility

  • Participant Sit-to-Stand Velocity

    Taken at baseline, pre-treatment.

  • Participant Sit-to-Stand Velocity

    Taken immediately post 1st treatment, same day as baseline measures (week 1).

  • Participant Sit-to-Stand Velocity

    Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

  • Participant Sit-to-Stand Velocity

    Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

  • Participant Sit-to-Stand Velocity

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

  • Participant Pain Score - Visual Analogue Scale (VAS)

    Taken at baseline, pre-treatment.

    Pain

  • Participant Pain Score - Visual Analogue Scale (VAS)

    Taken immediately post 1st treatment, same day as baseline measures (week 1).

    Pain

  • Participant Pain Score - Visual Analogue Scale (VAS)

    Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

    Pain

  • Participant Pain Score - Visual Analogue Scale (VAS)

    Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

    Pain

  • Participant Pain Score - Visual Analogue Scale (VAS)

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

    Pain

  • Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.

    Taken at baseline, pre-treatment.

    Fatigue

  • Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

    Fatigue

Other measures (35)

  • Participant Muscle Tone Measure

    Taken at baseline, pre-treatment.

  • Participant Muscle Tone Measure

    Taken immediately post 1st treatment, same day as baseline measures (week 1).

  • Participant Muscle Tone Measure

    Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

  • Participant Muscle Tone Measure

    Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

  • Participant Muscle Tone Measure

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

  • Participant Muscle Elasticity Measure

    Taken at baseline, pre-treatment.

  • Participant Muscle Elasticity Measure

    Taken immediately post 1st treatment, same day as baseline measures (week 1).

  • Participant Muscle Elasticity Measure

    Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).

  • Participant Muscle Elasticity Measure

    Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).

  • Participant Muscle Elasticity Measure

    Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).

Who could take part

MS (type not specified) · 18 to 80

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Oct 2018

    2. Main results due

      Apr 2019

    3. Finished

      Apr 2019

    4. Results posted

      Jan 2024

    Assembled by software from public sources.