Trial Outcomes & Findings for Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain (NCT NCT02660801)
NCT ID: NCT02660801
Last Updated: 2019-06-26
Results Overview
Global stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N
TERMINATED
NA
26 participants
two-minutes before spinal manipulation delivery up to two-minutes after
2019-06-26
Participant Flow
the participants were recruited among the local community
Participant milestones
| Measure |
Spinal Manipulation Then Spinal Mobilization
Participants first received spinal manipulation\*. After a washout period of 48h, they then received a spinal mobilization\* at the same spinal level.
\*Spinal manipulation is characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s) and spinal mobilization use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
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Spinal Mobilization Then Spinal Manipulation
Participants first received spinal mobilization\*. After a washout period of 48h, they then received a spinal manipulation\* at the same spinal level.
\*Spinal manipulation is characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s) and spinal mobilization use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
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|---|---|---|
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Overall Study
STARTED
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11
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15
|
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Overall Study
COMPLETED
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11
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15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Manipulation and Spinal Mobilization Effects in Participants With and Without Back Pain
Baseline characteristics by cohort
| Measure |
All Participants
n=26 Participants
Experimental group 1: spinal manipulation, spinal mobilization Participants first received spinal manipulation. After a washout period of 48h, they then received a spinal mobilization at the same spinal level.
Experimental group 2: spinal mobilization, spinal manipulation Participants first received spinal mobilization. After a washout period of 48h, they then received a spinal manipulation at the same spinal level.
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|---|---|
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Age, Continuous
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29.9 years
STANDARD_DEVIATION 9.14 • n=99 Participants
|
|
Sex: Female, Male
Female
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15 Participants
n=99 Participants
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Sex: Female, Male
Male
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11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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26 Participants
n=99 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
|
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Region of Enrollment
Canada
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26 Participants
n=99 Participants
|
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Global spinal stiffness
Spinal Manipulation
|
7.7 N/mm
STANDARD_DEVIATION 1.4 • n=99 Participants
|
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Global spinal stiffness
Spinal mobilization
|
7.6 N/mm
STANDARD_DEVIATION 1.8 • n=99 Participants
|
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Terminal spinal stiffness
Spinal manipulation
|
7.9 N/mm
STANDARD_DEVIATION 1.5 • n=99 Participants
|
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Terminal spinal stiffness
Spinal mobilization
|
7.8 N/mm
STANDARD_DEVIATION 1.9 • n=99 Participants
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Pressure provoked pain
Spinal manipulation
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47.9 units on a scale
STANDARD_DEVIATION 22.8 • n=99 Participants
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Pressure provoked pain
Spinal mobilization
|
47.2 units on a scale
STANDARD_DEVIATION 23.2 • n=99 Participants
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PRIMARY outcome
Timeframe: two-minutes before spinal manipulation delivery up to two-minutes afterGlobal stiffness was defined as the slope of the straight-line best fitting the force-displacement data between 10 and 45 N
Outcome measures
| Measure |
Spinal Manipulation
n=26 Participants
SMa characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s)
|
Spinal Mobilization
n=26 Participants
SMo use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
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|---|---|---|
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Global Spinal Stiffness
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7.6 N/mm
Standard Deviation 1.8
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7.8 N/mm
Standard Deviation 1.7
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PRIMARY outcome
Timeframe: two-minutes before spinal mobilization delivery up to two-minutes afterTerminal stiffness was defined as the ratio of the variation of force and displacement between 10 and 45 N
Outcome measures
| Measure |
Spinal Manipulation
n=26 Participants
SMa characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s)
|
Spinal Mobilization
n=26 Participants
SMo use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
|
|---|---|---|
|
Terminal Spinal Stiffness
|
7.9 N/mm
Standard Deviation 1.5
|
7.8 N/mm
Standard Deviation 1.9
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PRIMARY outcome
Timeframe: immediately after the therapeutic modality applicationPressure provoked pain intensity was assessed immediately after each spinal stiffness assessment using a 0 to 100 visual analog pain scale minimum value=0, maximum value=100. 0 is no pain while 100 is the worse outcome
Outcome measures
| Measure |
Spinal Manipulation
n=26 Participants
SMa characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s)
|
Spinal Mobilization
n=26 Participants
SMo use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
|
|---|---|---|
|
Pressure Provoked Pain
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36.6 score on a scale
Standard Deviation 23.7
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45.4 score on a scale
Standard Deviation 24.3
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PRIMARY outcome
Timeframe: During the spinal manipulation and mobilizationTo assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.
Outcome measures
| Measure |
Spinal Manipulation
n=26 Participants
SMa characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s)
|
Spinal Mobilization
n=26 Participants
SMo use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
|
|---|---|---|
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Muscular Response, Superior Level Ratio
|
0.78 ratio
Standard Deviation 0.56
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0.16 ratio
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: During the spinal manipulation and mobilizationTo assess the muscular response during therapeutic modalities, the resulting bipolar sEMG signals were first digitally band-pass filtered using a frequency bandwidth of 20-450 Hz (2nd order Butterworth filter). For SMa, the peak root mean square (RMS) value was computed for each electrode using a 250 ms window (125 ms before and 125 ms after the peak force). The RMS values obtained for each electrode were then normalized (nRMS) to the respective RMS value calculated during the sEMG normalization trial.
Outcome measures
| Measure |
Spinal Manipulation
n=26 Participants
SMa characterized by a preload force of 70 N for 500 ms leading to a peak force of 260 N in 125 ms (rate of force application: 1520 N/s)
|
Spinal Mobilization
n=26 Participants
SMo use 3 oscillatory cycles of 85 N in 800 ms (rate of force application: 106 N/s)
|
|---|---|---|
|
Muscular Response, Inferior Level Ratio, Normalized RMS
|
0.79 ratio
Standard Deviation 0.60
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0.16 ratio
Standard Deviation 0.10
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Adverse Events
Spinal Manipulation Then Spinal Mobilization
Spinal Mobilization Then Spinal Manipulation
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