Trial Outcomes & Findings for MS Spinal Mobilisation Study (NCT NCT05090709)
NCT ID: NCT05090709
Last Updated: 2024-01-05
Results Overview
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.
COMPLETED
NA
20 participants
Taken at baseline, pre-treatment.
2024-01-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 12.69 • n=10 Participants
|
39.4 years
STANDARD_DEVIATION 8.33 • n=10 Participants
|
42.1 years
STANDARD_DEVIATION 10.81 • n=20 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=10 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height (m)
|
1.71 meters
STANDARD_DEVIATION 0.09 • n=10 Participants
|
1.72 meters
STANDARD_DEVIATION 0.1 • n=10 Participants
|
1.72 meters
STANDARD_DEVIATION 0.09 • n=20 Participants
|
|
Mass (kg)
|
80.01 Kilograms
STANDARD_DEVIATION 29.89 • n=10 Participants
|
81.15 Kilograms
STANDARD_DEVIATION 26.57 • n=10 Participants
|
80.58 Kilograms
STANDARD_DEVIATION 27.53 • n=20 Participants
|
|
Body Mass Index
|
26.95 Kilograms/meters^2
STANDARD_DEVIATION 8.48 • n=10 Participants
|
26.95 Kilograms/meters^2
STANDARD_DEVIATION 7.29 • n=10 Participants
|
26.95 Kilograms/meters^2
STANDARD_DEVIATION 7.61 • n=20 Participants
|
|
Expanded Disability Status Scale
|
2.45 Units on a scale
STANDARD_DEVIATION 0.86 • n=10 Participants
|
2.15 Units on a scale
STANDARD_DEVIATION 0.75 • n=10 Participants
|
2.3 Units on a scale
STANDARD_DEVIATION 0.8 • n=20 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Stiffness Measure
|
350.83 Newton-metres
Standard Error 51.54
|
240.07 Newton-metres
Standard Error 18.51
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Stiffness Measure
|
306.27 Newton-metres
Standard Error 27.41
|
234.77 Newton-metres
Standard Error 22.08
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Stiffness Measure
|
306.47 Newton-metres
Standard Error 39.87
|
232.37 Newton-metres
Standard Error 24.08
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Stiffness Measure
|
340.87 Newton-metres
Standard Error 51.27
|
235.33 Newton-metres
Standard Error 27.54
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Stiffness Measure
|
324.37 Newton-metres
Standard Error 46.21
|
220.27 Newton-metres
Standard Error 17.4
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Path Length
|
495.22 Millimeters
Standard Error 57.12
|
619.57 Millimeters
Standard Error 77.36
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Path Length
|
458.45 Millimeters
Standard Error 51.23
|
524.29 Millimeters
Standard Error 65.21
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Path Length
|
387.23 Millimeters
Standard Error 52.1
|
543.4 Millimeters
Standard Error 73.15
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Path Length
|
386.32 Millimeters
Standard Error 40.55
|
509.36 Millimeters
Standard Error 51.12
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Path Length
|
389.22 Millimeters
Standard Error 55.6
|
491.92 Millimeters
Standard Error 58.75
|
PRIMARY outcome
Timeframe: Taken at baseline, pre-treatment.Force plate recording from sit-to-stand test.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Velocity
|
160.66 Millimeters/second
Standard Error 11.95
|
156.41 Millimeters/second
Standard Error 20.78
|
PRIMARY outcome
Timeframe: Taken immediately post 1st treatment, same day as baseline measures (week 1).Force plate recording from sit-to-stand test.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Velocity
|
176.01 Millimeters/second
Standard Error 12.95
|
142.65 Millimeters/second
Standard Error 14.04
|
PRIMARY outcome
Timeframe: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).Force plate recording from sit-to-stand test.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Velocity
|
189.25 Millimeters/second
Standard Error 13.77
|
158.36 Millimeters/second
Standard Error 14.61
|
PRIMARY outcome
Timeframe: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).Force plate recording from sit-to-stand test.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Velocity
|
166.07 Millimeters/second
Standard Error 19
|
131 Millimeters/second
Standard Error 9.38
|
PRIMARY outcome
Timeframe: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).Force plate recording from sit-to-stand test.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Velocity
|
164.18 Millimeters/second
Standard Error 18.13
|
145.06 Millimeters/second
Standard Error 13.76
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Pain Score - Visual Analogue Scale (VAS)
|
1.2 Units on a scale
Standard Error 0.57
|
0.8 Units on a scale
Standard Error 0.59
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Pain Score - Visual Analogue Scale (VAS)
|
0.5 Units on a scale
Standard Error 0.31
|
0.7 Units on a scale
Standard Error 0.6
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Pain Score - Visual Analogue Scale (VAS)
|
0.6 Units on a scale
Standard Error 0.34
|
0.4 Units on a scale
Standard Error 0.22
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Pain Score - Visual Analogue Scale (VAS)
|
0.6 Units on a scale
Standard Error 0.34
|
0.67 Units on a scale
Standard Error 0.21
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Pain Score - Visual Analogue Scale (VAS)
|
0.5 Units on a scale
Standard Error 0.31
|
0.3 Units on a scale
Standard Error 0.21
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.
|
10.1 Units on a scale
Standard Error 1.22
|
8.7 Units on a scale
Standard Error 1.56
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Fatigue Score - 5 Item Modified Fatigue Impact Scale.
|
6.6 Units on a scale
Standard Error 0.92
|
7.4 Units on a scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: Taken at baseline, pre-treatment.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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Tone Measure
|
15.87 Hertz
Standard Error 1.48
|
13.2 Hertz
Standard Error 0.59
|
SECONDARY outcome
Timeframe: Taken immediately post 1st treatment, same day as baseline measures (week 1).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Tone Measure
|
14.93 Hertz
Standard Error 0.84
|
13 Hertz
Standard Error 0.84
|
SECONDARY outcome
Timeframe: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Tone Measure
|
14.7 Hertz
Standard Error 1.05
|
12.83 Hertz
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Tone Measure
|
15.46 Hertz
Standard Error 1.17
|
12.78 Hertz
Standard Error 0.83
|
SECONDARY outcome
Timeframe: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Tone Measure
|
14.86 Hertz
Standard Error 1.1
|
12.32 Hertz
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Taken at baseline, pre-treatment.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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Elasticity Measure
|
1.36 Natural log of acceleration peak ratio
Standard Error 0.13
|
1.35 Natural log of acceleration peak ratio
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Taken immediately post 1st treatment, same day as baseline measures (week 1).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Elasticity Measure
|
1.51 Natural log of acceleration peak ratio
Standard Error 0.12
|
1.37 Natural log of acceleration peak ratio
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Elasticity Measure
|
1.39 Natural log of acceleration peak ratio
Standard Error 0.12
|
1.36 Natural log of acceleration peak ratio
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Elasticity Measure
|
1.34 Natural log of acceleration peak ratio
Standard Error 0.12
|
1.36 Natural log of acceleration peak ratio
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Muscle Elasticity Measure
|
1.43 Natural log of acceleration peak ratio
Standard Error 0.12
|
1.36 Natural log of acceleration peak ratio
Standard Error 0.13
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Anterior-Posterior position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
|
343 Millimeters
Standard Error 43.38
|
439.46 Millimeters
Standard Error 56.91
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Anterior-Posterior position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
|
295.49 Millimeters
Standard Error 23.98
|
381.02 Millimeters
Standard Error 57.68
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Anterior-Posterior position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
|
260.85 Millimeters
Standard Error 28.08
|
376.86 Millimeters
Standard Error 55.14
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Anterior-Posterior position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
|
272.43 Millimeters
Standard Error 25.31
|
357.17 Millimeters
Standard Error 36.47
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Anterior-Posterior position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Anterior-Posterior Path Length
|
279.76 Millimeters
Standard Error 42.15
|
323.6 Millimeters
Standard Error 37.3
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Medial-Lateral position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
|
275.19 Millimeters
Standard Error 41.87
|
351.67 Millimeters
Standard Error 56.61
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Medial-Lateral position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
|
282.06 Millimeters
Standard Error 54.48
|
286.16 Millimeters
Standard Error 41.95
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Medial-Lateral position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
|
223.9 Millimeters
Standard Error 43.11
|
291.16 Millimeters
Standard Error 51.78
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Medial-Lateral position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
|
211.89 Millimeters
Standard Error 35.94
|
275.46 Millimeters
Standard Error 45.11
|
SECONDARY outcome
Timeframe: 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 body sway travelled in the Medial-Lateral position. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Medial-Lateral Path Length
|
205.69 Millimeters
Standard Error 37.69
|
296.17 Millimeters
Standard Error 47.77
|
SECONDARY outcome
Timeframe: 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 velocity travelled. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Velocity
|
49.02 Millimeters/second
Standard Error 5.67
|
61.5 Millimeters/second
Standard Error 7.66
|
SECONDARY outcome
Timeframe: 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 velocity travelled. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Velocity
|
45.36 Millimeters/second
Standard Error 5.07
|
51.96 Millimeters/second
Standard Error 6.48
|
SECONDARY outcome
Timeframe: 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 velocity travelled. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Velocity
|
38.42 Millimeters/second
Standard Error 5.17
|
53.83 Millimeters/second
Standard Error 7.25
|
SECONDARY outcome
Timeframe: 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 velocity travelled. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Velocity
|
37 Millimeters/second
Standard Error 3.66
|
50.54 Millimeters/second
Standard Error 5.07
|
SECONDARY outcome
Timeframe: 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 velocity travelled. Further details are outlined in the attached Protocol Document.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Single Leg Stance Body Sway Velocity
|
38.57 Millimeters/second
Standard Error 5.52
|
48.77 Millimeters/second
Standard Error 5.81
|
SECONDARY outcome
Timeframe: Taken at baseline, pre-treatment.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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Rising Index
|
53.57 Percentage of Body Weight
Standard Error 4.89
|
56.98 Percentage of Body Weight
Standard Error 2.82
|
SECONDARY outcome
Timeframe: Taken immediately post 1st treatment, same day as baseline measures (week 1).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Rising Index
|
59.31 Percentage of Body Weight
Standard Error 4.99
|
60.92 Percentage of Body Weight
Standard Error 3.28
|
SECONDARY outcome
Timeframe: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Rising Index
|
57.23 Percentage of Body Weight
Standard Error 4.04
|
58.99 Percentage of Body Weight
Standard Error 2.78
|
SECONDARY outcome
Timeframe: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Rising Index
|
57.22 Percentage of Body Weight
Standard Error 3.12
|
59.33 Percentage of Body Weight
Standard Error 3.46
|
SECONDARY outcome
Timeframe: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Rising Index
|
59.06 Percentage of Body Weight
Standard Error 2.28
|
61.53 Percentage of Body Weight
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Taken at baseline, pre-treatment.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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Weight Transfer
|
3.83 Seconds
Standard Error 0.77
|
2.37 Seconds
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Taken immediately post 1st treatment, same day as baseline measures (week 1).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Weight Transfer
|
2.4 Seconds
Standard Error 0.33
|
2.08 Seconds
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Taken immediately post 2nd treatment, 1 week after baseline measurements (week 2).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Weight Transfer
|
2.83 Seconds
Standard Error 0.36
|
2.11 Seconds
Standard Error 0.23
|
SECONDARY outcome
Timeframe: Taken immediately post 3rd treatment, 2 weeks after baseline measurements (week 3).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Weight Transfer
|
2.69 Seconds
Standard Error 0.32
|
2.62 Seconds
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Taken immediately post 4th treatment, 3 weeks after baseline measurements (week 4).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.
Outcome measures
| Measure |
Experimental A - Mobilisation Intervention
n=10 Participants
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
n=10 Participants
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.
|
|---|---|---|
|
Participant Sit-to-Stand Weight Transfer
|
2.44 Seconds
Standard Error 0.21
|
2 Seconds
Standard Error 0.15
|
Adverse Events
Experimental A - Mobilisation Intervention
Experimental B - General Massage
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place