Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2018-10-01
2019-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Experimental A - Mobilisation Intervention
Participants receive 4 separate treatment sessions of the 30 minute spinal mobilisation intervention.
Spinal Mobilisation Intervention
30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.
Experimental B - General Massage
Participants receive 4 separate treatment sessions of the 30 minute general massage.
General Massage
30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.
Interventions
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Spinal Mobilisation Intervention
30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.
General Massage
30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.
Eligibility Criteria
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Inclusion Criteria
* Must be able to walk independently.
* Must have an EDSS score of 6 or below.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Scottish Hospital Endowments Research Trust
OTHER
Pacla Medical Ltd
INDUSTRY
Edinburgh Napier University
OTHER
Responsible Party
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Rebecca Hamilton
Principal Investigator
Locations
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Edinburgh Napier University
Edinburgh, County, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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MS_2
Identifier Type: -
Identifier Source: org_study_id
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