MS Spinal Mobilisation Study

NCT05090709 | Completed Results

• 1 other identifier: MS_2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; myometer; muscle stiffness; spinal mobilisations; body sway; fatigue

Outcome Measures

Primary Outcomes (22)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Taken at baseline, pre-treatment.

• Participant Sit-to-Stand Velocity

  Force plate recording from sit-to-stand test.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (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).

Study Arms (2)

Experimental A - Mobilisation Intervention

EXPERIMENTAL

Participants receive 4 separate treatment sessions of the 30 minute spinal mobilisation intervention.

Other: Spinal Mobilisation Intervention

Experimental B - General Massage

ACTIVE COMPARATOR

Participants receive 4 separate treatment sessions of the 30 minute general massage.

Other: General Massage

Interventions

Spinal Mobilisation Intervention OTHER

30 minutes spinal mobilisations, rate = 0.37Hz, 22 beats per minute, force = less than grade 1, threshold of 80N, location = L1-L5.

Experimental A - Mobilisation Intervention

General Massage OTHER

30 minutes manual touch with no specifications or recordings on rate, pressure or location of touch.

Experimental B - General Massage

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have Multiple Sclerosis diagnosis.
• Must be able to walk independently.
• Must have an EDSS score of 6 or below.

You may not qualify if:

• 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

Sponsors & Collaborators

• Edinburgh Napier University: lead
• Scottish Hospital Endowments Research Trust: collaborator
• Pacla Medical Limited: collaborator

Study Sites (1)

Edinburgh Napier University

Edinburgh, County, EH11 4BN, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was not able to recruit full number of participants required in the sample size calculation and large degree of variability exists within the population. A longer term study with more treatment sessions may show more cumulative effect within the data results. The study used an alternative treatment for group comparison rather than placebo for ethical and feasibility reasons.

Results Point of Contact

• Title: Dr Rebecca Hamilton
• Organization: Edinburgh Napier University

rebeccaisabel.hamilton@napier.ac.uk

0131455

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mixed factor: between-subject, repeated measures (mobilisation intervention vs general massage).

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: October 25, 2021
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be entered when the study is completed and remain until 1 year post publication of summary data.
• Access Criteria: the anonymised participant data underlying the summary data published will be shared on the Edinburgh Napier University University Repository with submission of PhD thesis.

Locations

GB (1)