Trial Outcomes & Findings for Investigating the Effects of a Spinal Mobilisation Intervention in People With Lower Back Pain (NCT NCT04012970)
NCT ID: NCT04012970
Last Updated: 2019-11-29
Results Overview
Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
COMPLETED
NA
40 participants
Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.
2019-11-29
Participant Flow
Participant milestones
| Measure |
A - Intervention Then Control
Intervention (30 minutes spinal mobilisations) received in first session, control (30 minutes lying still) received in second session.
|
B - Control Then Intervention
Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
|
|---|---|---|
|
Intervention Session, 30 Minutes
STARTED
|
26
|
14
|
|
Intervention Session, 30 Minutes
COMPLETED
|
26
|
14
|
|
Intervention Session, 30 Minutes
NOT COMPLETED
|
0
|
0
|
|
Control Session, 30 Minutes
STARTED
|
26
|
14
|
|
Control Session, 30 Minutes
COMPLETED
|
26
|
14
|
|
Control Session, 30 Minutes
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 |
A - Intervention Then Control
n=26 Participants
Intervention (30 minutes spinal mobilisations) received in first session, then control (30 minutes lying still) received in second session.
|
B - Control Then Intervention
n=14 Participants
Control (30 minutes lying still) received in first session, then intervention (30 minutes spinal mobilisations) received in second session.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.73 years
STANDARD_DEVIATION 12.99 • n=26 Participants
|
28 years
STANDARD_DEVIATION 6.92 • n=14 Participants
|
31.075 years
STANDARD_DEVIATION 11.373 • n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=26 Participants
|
9 Participants
n=14 Participants
|
22 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=26 Participants
|
5 Participants
n=14 Participants
|
18 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Change in muscle stiffness immediately after the 30 minute spinal mobilisation intervention.Stiffness values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Outcome measures
| Measure |
Intervention
n=40 Participants
Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
|
|---|---|
|
Intervention Erector Spinae Stiffness Change
|
-10.959 Newton metres (Nm)
Standard Error 4.132
|
PRIMARY outcome
Timeframe: Change in muscle stiffness immediately after the 30 minute control session (lying still).Stiffness values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Outcome measures
| Measure |
Intervention
n=40 Participants
Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
|
|---|---|
|
Control Erector Spinae Stiffness Change.
|
12.192 Newton metres (Nm)
Standard Error 4.023
|
SECONDARY outcome
Timeframe: Change in muscle tone immediately after the 30 minute spinal mobilisation intervention.Tone values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Outcome measures
| Measure |
Intervention
n=40 Participants
Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
|
|---|---|
|
Intervention Erector Spinae Tone Change
|
-0.317 Hertz (Hz)
Standard Error 0.088
|
SECONDARY outcome
Timeframe: Change in muscle tone immediately after the 30 minute control session (lying still).Tone values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. Recorded 3 times and mean value used for analysis.
Outcome measures
| Measure |
Intervention
n=40 Participants
Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
|
|---|---|
|
Control Erector Spinae Tone Change
|
0.29 Hertz (Hz)
Standard Error 0.1
|
SECONDARY outcome
Timeframe: Change in muscle elasticity immediately after the 30 minute spinal mobilisation intervention.Elasticity values measured before and after 30 minute spinal mobilisation intervention. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis.
Outcome measures
| Measure |
Intervention
n=40 Participants
Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
|
|---|---|
|
Intervention Erector Spinae Elasticity Change
|
0.068 Logarithmic decrement
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Change in muscle elasticity immediately after the 30 minute control session (lying still).Elasticity values measured before and after 30 minute control lying still. Location of muscle assessed by palpation by asking participant to contract lower back muscles and marking the central belly of the muscle. Myometer measurements recorded using handheld device MyotonPRO held over marked area. The device records the logarithmic decrement of the tissue by recording the dissipation of the mechanical energy of the tissue when it recovers shape after deformation. Elasticity is then inversely proportional to the decrement, so a higher decrement value equates to a higher dissipation of mechanical energy and a lower elasticity value. Recorded 3 times and mean value used for analysis.
Outcome measures
| Measure |
Intervention
n=40 Participants
Group A and Group B results for stiffness change due to the spinal mobilisation intervention.
|
|---|---|
|
Control Erector Spinae Elasticity Change
|
0.05 Logarithmic decrement
Standard Error 0.012
|
Adverse Events
Group A - Intervention
Group A - Control
Group B - Intervention
Group B - Control
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