Multiple SclerosisNCT05090709
MS Spinal Mobilisation Study
A study testing Spinal Mobilisation Intervention and General Massage in people with Multiple Sclerosis, run by Edinburgh Napier University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Spinal Mobilisation Intervention and General Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have Multiple Sclerosis diagnosis.
- Must be able to walk independently.
- Must have an EDSS score of 6 or below.
Who cannot join
- Respond positively to any absolute contraindications for spinal manual therapy including:
- segment instability
- infectious disease
- osteomyelitis
- bone tumours
- severe haemophilia
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Edinburgh Napier University
Edinburgh, County, EH11 4BN
About this study
Official title: Analysis of a Spinal Mobilisation Intervention in People With Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Spinal Mobilisation Intervention, General Massage
- Keywords
- multiple sclerosis, myometer, muscle stiffness, spinal mobilisations, body sway, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Mobilisation InterventionOther
30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.
General MassageOther
30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.
| Study group | Role | What they receive |
|---|---|---|
| Experimental A - Mobilisation Intervention | Experimental | Participants receive 4 separate treatment sessions of the 30 minute spinal mobilisation intervention. Receives: Other: Spinal Mobilisation Intervention |
| Experimental B - General Massage | Active comparator | Participants receive 4 separate treatment sessions of the 30 minute general massage. Receives: Other: General Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Muscle Stiffness Measure
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.
Measured: Taken at baseline, pre-treatment.
Participant Muscle Stiffness Measure
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Muscle Stiffness Measure
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Muscle Stiffness Measure
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Muscle Stiffness Measure
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Path Length
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.
Measured: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Path Length
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Path Length
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Path Length
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Path Length
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Sit-to-Stand Velocity
Force plate recording from sit-to-stand test.
Measured: Taken at baseline, pre-treatment.
Participant Sit-to-Stand Velocity
Force plate recording from sit-to-stand test.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Sit-to-Stand Velocity
Force plate recording from sit-to-stand test.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Sit-to-Stand Velocity
Force plate recording from sit-to-stand test.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Sit-to-Stand Velocity
Force plate recording from sit-to-stand test.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
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.
Measured: 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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
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.
Measured: 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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Secondary outcomes (35)
Participant Muscle Tone Measure
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.
Measured: Taken at baseline, pre-treatment.
Participant Muscle Tone Measure
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Muscle Tone Measure
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Muscle Tone Measure
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Muscle Tone Measure
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Muscle Elasticity Measure
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.
Measured: Taken at baseline, pre-treatment.
Participant Muscle Elasticity Measure
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Muscle Elasticity Measure
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Muscle Elasticity Measure
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Muscle Elasticity Measure
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
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.
Measured: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
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.
Measured: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Velocity
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.
Measured: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Velocity
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Velocity
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Velocity
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Velocity
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Sit-to-Stand Rising Index
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.
Measured: Taken at baseline, pre-treatment.
Participant Sit-to-Stand Rising Index
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Sit-to-Stand Rising Index
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Sit-to-Stand Rising Index
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Sit-to-Stand Rising Index
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Sit-to-Stand Weight Transfer
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.
Measured: Taken at baseline, pre-treatment.
Participant Sit-to-Stand Weight Transfer
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.
Measured: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Sit-to-Stand Weight Transfer
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.
Measured: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Sit-to-Stand Weight Transfer
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.
Measured: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Sit-to-Stand Weight Transfer
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.
Measured: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Mixed factor: between-subject, repeated measures (mobilisation intervention vs general massage).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edinburgh Napier University
- Sponsor type
- University, hospital or other
- Collaborators
- Scottish Hospital Endowments Research Trust, Pacla Medical Limited
- Responsible party
- Principal investigator, Rebecca Hamilton, Edinburgh Napier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090709
- Sponsor's protocol ID
- MS_2
- Status last verified
- Mar 2023
- First submitted
- 5 Sep 2021
- Last updated
- 5 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data sets that underlie the results for publication will be shared on a raw data set. This includes the anthropometric data, MS information data, myometer data, functional balance data, pain and fatigue data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of a Spinal Mobilisation Intervention in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05090709
- Acronym / sponsor ID
- MS_2
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, myometer, muscle stiffness, spinal mobilisations, body sway, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Edinburgh Napier UniversityUniversity, hospital or other
- Collaborators
- Scottish Hospital Endowments Research Trust, Pacla Medical Limited
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Posted 5 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed factor: between-subject, repeated measures (mobilisation intervention vs general massage).
| Arm | Type | Receives |
|---|---|---|
| Experimental A - Mobilisation Intervention | Experimental | Other: Spinal Mobilisation InterventionParticipants receive 4 separate treatment sessions of the 30 minute spinal mobilisation intervention. |
| Experimental B - General Massage | Active comparator | Other: General MassageParticipants receive 4 separate treatment sessions of the 30 minute general massage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must have Multiple Sclerosis diagnosis.
- Must be able to walk independently.
- Must have an EDSS score of 6 or below.
Key exclusion criteria (21 listed)
- segment instability
- infectious disease
- osteomyelitis
- bone tumours
- severe haemophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Mobilisation Intervention30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5. | Other | Experimental A - Mobilisation Intervention |
| General Massage30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch. | Other | Experimental B - General Massage |
Primary outcome
Participant Muscle Stiffness Measure
Time frame: Taken at baseline, pre-treatment.
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 Muscle Stiffness Measure
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
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 Muscle Stiffness Measure
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
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 Muscle Stiffness Measure
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
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 Muscle Stiffness Measure
Time frame: 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 Single Leg Stance Body Sway Path Length
Time frame: Taken at baseline, pre-treatment.
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 Single Leg Stance Body Sway Path Length
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
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 Single Leg Stance Body Sway Path Length
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
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 Single Leg Stance Body Sway Path Length
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
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 Single Leg Stance Body Sway Path Length
Time frame: 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 Sit-to-Stand Velocity
Time frame: Taken at baseline, pre-treatment.
Force plate recording from sit-to-stand test.
Participant Sit-to-Stand Velocity
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Force plate recording from sit-to-stand test.
Participant Sit-to-Stand Velocity
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Force plate recording from sit-to-stand test.
Participant Sit-to-Stand Velocity
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Force plate recording from sit-to-stand test.
Participant Sit-to-Stand Velocity
Time frame: 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)
Time frame: Taken at baseline, pre-treatment.
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 Pain Score - Visual Analogue Scale (VAS)
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
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 Pain Score - Visual Analogue Scale (VAS)
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
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 Pain Score - Visual Analogue Scale (VAS)
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
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 Pain Score - Visual Analogue Scale (VAS)
Time frame: 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.
Time frame: Taken at baseline, pre-treatment.
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.
Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.
Time frame: 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.
35 secondary outcomes
Participant Muscle Tone Measure
Time frame: Taken at baseline, pre-treatment.
Participant Muscle Tone Measure
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Muscle Tone Measure
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Muscle Tone Measure
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Muscle Tone Measure
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Muscle Elasticity Measure
Time frame: Taken at baseline, pre-treatment.
Participant Muscle Elasticity Measure
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Muscle Elasticity Measure
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Muscle Elasticity Measure
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Muscle Elasticity Measure
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
Time frame: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
Time frame: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Single Leg Stance Body Sway Velocity
Time frame: Taken at baseline, pre-treatment.
Participant Single Leg Stance Body Sway Velocity
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Single Leg Stance Body Sway Velocity
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Single Leg Stance Body Sway Velocity
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Single Leg Stance Body Sway Velocity
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Sit-to-Stand Rising Index
Time frame: Taken at baseline, pre-treatment.
Participant Sit-to-Stand Rising Index
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Sit-to-Stand Rising Index
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Sit-to-Stand Rising Index
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Sit-to-Stand Rising Index
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Participant Sit-to-Stand Weight Transfer
Time frame: Taken at baseline, pre-treatment.
Participant Sit-to-Stand Weight Transfer
Time frame: Taken immediately post 1st treatment, same day as baseline measures (week 1).
Participant Sit-to-Stand Weight Transfer
Time frame: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).
Participant Sit-to-Stand Weight Transfer
Time frame: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).
Participant Sit-to-Stand Weight Transfer
Time frame: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymised participant data sets that underlie the results for publication will be shared on a raw data set. This includes the anthropometric data, MS information data, myometer data, functional balance data, pain and fatigue data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Mobilisation Intervention and General Massage in people with Multiple Sclerosis, run by Edinburgh Napier University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Muscle Stiffness Measure (time frame: Taken at baseline, pre-treatment.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.