Trial Outcomes & Findings for Gait in Low Back Pain Patients After Spinal Mobilization (NCT NCT02645123)
NCT ID: NCT02645123
Last Updated: 2017-06-08
Results Overview
this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient
Results posted on
2017-06-08
Participant Flow
Participant milestones
| Measure |
Spinal Mobilization
The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration
spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization
|
Sham Treatment
The investigator touched the skin overlying the low back statically for 10 minutes
sham treatment: touching of the skin overlying the lumbar area
|
Classic Physiotherapy
This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)
Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692
swedish type massage: petrissage, effleurage, tapotement
muscle stretching: static hamstring stretching
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gait in Low Back Pain Patients After Spinal Mobilization
Baseline characteristics by cohort
| Measure |
Spinal Mobilization
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Sham Treatment
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Classic Physiotherapy
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Continuous
|
46.96 years
STANDARD_DEVIATION 16.07 • n=5 Participants
|
50.08 years
STANDARD_DEVIATION 12.61 • n=7 Participants
|
45.48 years
STANDARD_DEVIATION 14.58 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 14.58 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
75 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patientthis scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.
Outcome measures
| Measure |
Spinal Mobilization
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Sham Treatment
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Classic Physiotherapy
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
|---|---|---|---|
|
Change in the Numerical Pain Rating Scale
Baseline values
|
5.96 units on a scale
Standard Deviation 1.37
|
6.12 units on a scale
Standard Deviation 1.05
|
6 units on a scale
Standard Deviation 1
|
|
Change in the Numerical Pain Rating Scale
5 sessions after
|
1.22 units on a scale
Standard Deviation 1.1
|
5.88 units on a scale
Standard Deviation 0.92
|
4.96 units on a scale
Standard Deviation 0.89
|
|
Change in the Numerical Pain Rating Scale
6 months after
|
1.32 units on a scale
Standard Deviation 0.75
|
6.02 units on a scale
Standard Deviation 0.93
|
5.08 units on a scale
Standard Deviation 0.95
|
PRIMARY outcome
Timeframe: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patientthis is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points
Outcome measures
| Measure |
Spinal Mobilization
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Sham Treatment
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Classic Physiotherapy
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
|---|---|---|---|
|
Change in the Oswestry Low Back Pain Disability Index
Baseline values
|
33.28 units on a scale
Standard Deviation 15.02
|
32 units on a scale
Standard Deviation 8.32
|
31.04 units on a scale
Standard Deviation 11.07
|
|
Change in the Oswestry Low Back Pain Disability Index
5 sessions after
|
9.84 units on a scale
Standard Deviation 3.87
|
31.76 units on a scale
Standard Deviation 8.51
|
27.28 units on a scale
Standard Deviation 9.53
|
|
Change in the Oswestry Low Back Pain Disability Index
6 months after
|
8.96 units on a scale
Standard Deviation 3.75
|
32.8 units on a scale
Standard Deviation 8.64
|
28.56 units on a scale
Standard Deviation 9.62
|
PRIMARY outcome
Timeframe: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patientThe Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability.
Outcome measures
| Measure |
Spinal Mobilization
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Sham Treatment
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Classic Physiotherapy
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
|---|---|---|---|
|
Change in the Roland-Morris Disability Questionnaire
Baseline values
|
8.56 units on a scale
Standard Deviation 3.56
|
10 units on a scale
Standard Deviation 1.96
|
9.96 units on a scale
Standard Deviation 3.19
|
|
Change in the Roland-Morris Disability Questionnaire
5 sessions after
|
2.44 units on a scale
Standard Deviation 1.76
|
10.04 units on a scale
Standard Deviation 2.05
|
8.76 units on a scale
Standard Deviation 2.96
|
|
Change in the Roland-Morris Disability Questionnaire
6 months after
|
2.48 units on a scale
Standard Deviation 1.29
|
10.23 units on a scale
Standard Deviation 1.89
|
8.68 units on a scale
Standard Deviation 2.87
|
PRIMARY outcome
Timeframe: before the beginning and after the end of 5 weeks for each patientPopulation: all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale
The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F\&frmType=image\&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.
Outcome measures
| Measure |
Spinal Mobilization
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Sham Treatment
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
Classic Physiotherapy
n=25 Participants
The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
|
|---|---|---|---|
|
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
torso position frontal plane quotient at T1
|
-1.147 quotient: degrees/degrees=no unit
Standard Deviation 0.035
|
0.852 quotient: degrees/degrees=no unit
Standard Deviation 0.25
|
-0.4 quotient: degrees/degrees=no unit
Standard Deviation 0.18
|
|
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
torso position frontal plane quotient at T2
|
-1.307 quotient: degrees/degrees=no unit
Standard Deviation 0.127
|
0.172 quotient: degrees/degrees=no unit
Standard Deviation 0.025
|
-0.429 quotient: degrees/degrees=no unit
Standard Deviation 0.33
|
|
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
pelvis position frontal plane quotient at T2
|
0.844 quotient: degrees/degrees=no unit
Standard Deviation 0.102
|
1.295 quotient: degrees/degrees=no unit
Standard Deviation 0.355
|
1.044 quotient: degrees/degrees=no unit
Standard Deviation 0.422
|
|
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
torso position coronal plane quotient at T2
|
0.272 quotient: degrees/degrees=no unit
Standard Deviation 0.058
|
1.645 quotient: degrees/degrees=no unit
Standard Deviation 0.454
|
-1.819 quotient: degrees/degrees=no unit
Standard Deviation 0.485
|
|
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
pelvis position frontal plane quotient at T3
|
-1.236 quotient: degrees/degrees=no unit
Standard Deviation 0.232
|
-0.16 quotient: degrees/degrees=no unit
Standard Deviation 0.128
|
-0.679 quotient: degrees/degrees=no unit
Standard Deviation 0.254
|
Adverse Events
Spinal Mobilization
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Classic Physiotherapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Georgios Krekoukias
University of Ioannina School of Medicine
Phone: 00306934609400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place