Chronic Low Back Pain
Conditions
Keywords
spinal mobilization, manual therapy, gait analysis, low back pain, chronic
Brief summary
Introduction: patients with chronic back pain as a result of degenerated disc disease, besides pain also present with impaired gait. The purpose of this study is to evaluate both the clinical data using clinical rating scales, such as Oswestry Disability Index Greek version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic characteristics during gait analysis in patients with chronic low back pain as a result of the degenerated disc disease (Disc Degenerative Disease), before and after application of manual therapy techniques. Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain were randomly divided into 3 groups of 25 each. Each group received five sessions with the first group receiving manual therapy treatment (spinal mobilisation), the second a sham treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To evaluate the effectiveness of each treatment, the visual analog pain scale, two questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording and analysis of gait (kinetic and kinematic data) were utilized.
Detailed description
This was a randomized controlled trial comparing the efficacy of spinal mobilization with other physiotherapy interventions (stretching, TENS application and Swedish type massage) and sham treatment in a group of chronic low back pain patients. The outcome measures included three dimensional gait analysis (kinetic and kinematic data) as well as clinical indicators (numerical pain rating scale, Oswestry disability index, Roland-Moris Disability questionnaire).
Interventions
DEVICETENS
Enraf-Nonius Sonopuls 692
PROCEDUREspinal mobilization
passive physiological intervertebral movements and passive accessory posteroanterior mobilization
PROCEDUREswedish type massage
petrissage, effleurage, tapotement
PROCEDUREstatic hamstring stretch
static hamstring stretching
PROCEDUREsham treatment
touching of the skin overlying the lumbar area
Sponsors
University of Ioannina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
* low back pain for over 3 months * recent lumbar MRI (up to 12 months) * able to walk without the need of walking aids
Exclusion criteria
* leg length discrepancy of over 2 cm * history of spinal surgery * history of autoimmune disease * history of spondylolysis and spondylolisthesis * spinal fractures * pregnancy * respiratory and/or cardiac disease * history of stroke * hip, knee or ankle osteoarthritis * cauda equina syndrome * spinal inflammation * spinal tumor * steroid drug use in the last month * osteoporosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Numerical Pain Rating Scale | before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient | 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. |
| Change in the Oswestry Low Back Pain Disability Index | before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient | this 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 |
| Change in the Roland-Morris Disability Questionnaire | before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient | The 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. |
| Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms) | before the beginning and after the end of 5 weeks for each patient | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Mobilization 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. | 25 |
| Sham Treatment 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. | 25 |
| Classic Physiotherapy 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. | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Sham Treatment | Classic Physiotherapy | Spinal Mobilization | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 6 Participants | 5 Participants | 14 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 19 Participants | 20 Participants | 61 Participants |
| Age, Continuous | 50.08 years STANDARD_DEVIATION 12.61 | 45.48 years STANDARD_DEVIATION 14.58 | 46.96 years STANDARD_DEVIATION 16.07 | 47.5 years STANDARD_DEVIATION 14.58 |
| Region of Enrollment Greece | 25 participants | 25 participants | 25 participants | 75 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 13 Participants | 33 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 12 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
Primary
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
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.
Time frame: before the beginning and after the end of 5 weeks for each patient
Population: all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Mobilization | 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 |
| Spinal Mobilization | 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 |
| Spinal Mobilization | 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 |
| Spinal Mobilization | 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 |
| Spinal Mobilization | 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 |
| Sham Treatment | 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 | 1.295 quotient: degrees/degrees=no unit | Standard Deviation 0.355 |
| Sham Treatment | 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 | 0.852 quotient: degrees/degrees=no unit | Standard Deviation 0.25 |
| Sham Treatment | 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 | 0.172 quotient: degrees/degrees=no unit | Standard Deviation 0.025 |
| Sham Treatment | 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 | 1.645 quotient: degrees/degrees=no unit | Standard Deviation 0.454 |
| Sham Treatment | 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 | -0.16 quotient: degrees/degrees=no unit | Standard Deviation 0.128 |
| Classic Physiotherapy | 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 | -0.679 quotient: degrees/degrees=no unit | Standard Deviation 0.254 |
| Classic Physiotherapy | 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 | -1.819 quotient: degrees/degrees=no unit | Standard Deviation 0.485 |
| Classic Physiotherapy | 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 | -0.4 quotient: degrees/degrees=no unit | Standard Deviation 0.18 |
| Classic Physiotherapy | 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 | 1.044 quotient: degrees/degrees=no unit | Standard Deviation 0.422 |
| Classic Physiotherapy | 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 | -0.429 quotient: degrees/degrees=no unit | Standard Deviation 0.33 |
Primary
Change in the Numerical Pain Rating Scale
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.
Time frame: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Mobilization | Change in the Numerical Pain Rating Scale | Baseline values | 5.96 units on a scale | Standard Deviation 1.37 |
| Spinal Mobilization | Change in the Numerical Pain Rating Scale | 6 months after | 1.32 units on a scale | Standard Deviation 0.75 |
| Spinal Mobilization | Change in the Numerical Pain Rating Scale | 5 sessions after | 1.22 units on a scale | Standard Deviation 1.1 |
| Sham Treatment | Change in the Numerical Pain Rating Scale | 5 sessions after | 5.88 units on a scale | Standard Deviation 0.92 |
| Sham Treatment | Change in the Numerical Pain Rating Scale | 6 months after | 6.02 units on a scale | Standard Deviation 0.93 |
| Sham Treatment | Change in the Numerical Pain Rating Scale | Baseline values | 6.12 units on a scale | Standard Deviation 1.05 |
| Classic Physiotherapy | Change in the Numerical Pain Rating Scale | 5 sessions after | 4.96 units on a scale | Standard Deviation 0.89 |
| Classic Physiotherapy | Change in the Numerical Pain Rating Scale | 6 months after | 5.08 units on a scale | Standard Deviation 0.95 |
| Classic Physiotherapy | Change in the Numerical Pain Rating Scale | Baseline values | 6 units on a scale | Standard Deviation 1 |
Primary
Change in the Oswestry Low Back Pain Disability Index
this 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
Time frame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Mobilization | Change in the Oswestry Low Back Pain Disability Index | 5 sessions after | 9.84 units on a scale | Standard Deviation 3.87 |
| Spinal Mobilization | Change in the Oswestry Low Back Pain Disability Index | Baseline values | 33.28 units on a scale | Standard Deviation 15.02 |
| Spinal Mobilization | Change in the Oswestry Low Back Pain Disability Index | 6 months after | 8.96 units on a scale | Standard Deviation 3.75 |
| Sham Treatment | Change in the Oswestry Low Back Pain Disability Index | 5 sessions after | 31.76 units on a scale | Standard Deviation 8.51 |
| Sham Treatment | Change in the Oswestry Low Back Pain Disability Index | Baseline values | 32 units on a scale | Standard Deviation 8.32 |
| Sham Treatment | Change in the Oswestry Low Back Pain Disability Index | 6 months after | 32.8 units on a scale | Standard Deviation 8.64 |
| Classic Physiotherapy | Change in the Oswestry Low Back Pain Disability Index | Baseline values | 31.04 units on a scale | Standard Deviation 11.07 |
| Classic Physiotherapy | Change in the Oswestry Low Back Pain Disability Index | 6 months after | 28.56 units on a scale | Standard Deviation 9.62 |
| Classic Physiotherapy | Change in the Oswestry Low Back Pain Disability Index | 5 sessions after | 27.28 units on a scale | Standard Deviation 9.53 |
Primary
Change in the Roland-Morris Disability Questionnaire
The 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.
Time frame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Mobilization | Change in the Roland-Morris Disability Questionnaire | 5 sessions after | 2.44 units on a scale | Standard Deviation 1.76 |
| Spinal Mobilization | Change in the Roland-Morris Disability Questionnaire | Baseline values | 8.56 units on a scale | Standard Deviation 3.56 |
| Spinal Mobilization | Change in the Roland-Morris Disability Questionnaire | 6 months after | 2.48 units on a scale | Standard Deviation 1.29 |
| Sham Treatment | Change in the Roland-Morris Disability Questionnaire | 5 sessions after | 10.04 units on a scale | Standard Deviation 2.05 |
| Sham Treatment | Change in the Roland-Morris Disability Questionnaire | Baseline values | 10 units on a scale | Standard Deviation 1.96 |
| Sham Treatment | Change in the Roland-Morris Disability Questionnaire | 6 months after | 10.23 units on a scale | Standard Deviation 1.89 |
| Classic Physiotherapy | Change in the Roland-Morris Disability Questionnaire | Baseline values | 9.96 units on a scale | Standard Deviation 3.19 |
| Classic Physiotherapy | Change in the Roland-Morris Disability Questionnaire | 6 months after | 8.68 units on a scale | Standard Deviation 2.87 |
| Classic Physiotherapy | Change in the Roland-Morris Disability Questionnaire | 5 sessions after | 8.76 units on a scale | Standard Deviation 2.96 |