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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal mobilization | Experimental | 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 |
|
| Sham Treatment | Sham Comparator | The investigator touched the skin overlying the low back statically for 10 minutes |
|
| Classic Physiotherapy | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS | Device | Enraf-Nonius Sonopuls 692 |
| |
| spinal mobilization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient |
| 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 | before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient |
| 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. | before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GEORGIOS O KREKOUKIAS, PT, MSc, PhD | University of Ioannina | Principal Investigator |
| IOANNIS D GELALIS, MD, PhD | University of Ioannina | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10863253 | Background | Goodsell M, Lee M, Latimer J. Short-term effects of lumbar posteroanterior mobilization in individuals with low-back pain. J Manipulative Physiol Ther. 2000 Jun;23(5):332-42. | |
| 24960844 | Background | Managing chronic low back pain. How to avoid the problem, lower risk, and manage the discomfort when it occurs. Duke Med Health News. 2014 May;20(5):1-2. No abstract available. |
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individual participant's grade of disc degeneration has been shared as an appendix in an already published article: http://dx.doi.org/10.1080/10669817.2016.1184435. Please note that no more IPD will be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Georgios Krekoukias | University of Ioannina School of Medicine | 00306934609400 | gkrekos@gmail.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Procedure |
passive physiological intervertebral movements and passive accessory posteroanterior mobilization |
|
| swedish type massage | Procedure | petrissage, effleurage, tapotement |
|
| static hamstring stretch | Procedure | static hamstring stretching |
|
| sham treatment | Procedure | touching of the skin overlying the lumbar area |
|
| before the beginning and after the end of 5 weeks for each patient |
| 9413588 | Background | Goel A, Loudon J, Nazare A, Rondinelli R, Hassanein K. Joint moments in minor limb length discrepancy: a pilot study. Am J Orthop (Belle Mead NJ). 1997 Dec;26(12):852-6. |
| 9531400 | Background | Liu XC, Fabry G, Molenaers G, Lammens J, Moens P. Kinematic and kinetic asymmetry in patients with leg-length discrepancy. J Pediatr Orthop. 1998 Mar-Apr;18(2):187-9. |
| 1913023 | Background | McCaw ST, Bates BT. Biomechanical implications of mild leg length inequality. Br J Sports Med. 1991 Mar;25(1):10-3. doi: 10.1136/bjsm.25.1.10. |
| 7855687 | Background | Kawaguchi Y, Matsui H, Tsuji H. Back muscle injury after posterior lumbar spine surgery. Part 2: Histologic and histochemical analyses in humans. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2598-602. doi: 10.1097/00007632-199411001-00018. |
| 12486343 | Background | Taylor H, McGregor AH, Medhi-Zadeh S, Richards S, Kahn N, Zadeh JA, Hughes SP. The impact of self-retaining retractors on the paraspinal muscles during posterior spinal surgery. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2758-62. doi: 10.1097/00007632-200212150-00004. |
| 14569260 | Background | Wang D, Bergstrom E, Clarke M, Henderson N, Gardner B. Mobility of the spine after spinal surgery in acute spinal cord injury. Spinal Cord. 2003 Nov;41(11):593-9. doi: 10.1038/sj.sc.3101528. |
| 9431633 | Background | O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020. |
| 21550245 | Background | Egerton T, Danoudis M, Huxham F, Iansek R. Central gait control mechanisms and the stride length - cadence relationship. Gait Posture. 2011 Jun;34(2):178-82. doi: 10.1016/j.gaitpost.2011.04.006. Epub 2011 May 7. |
| 17548125 | Background | Mello RG, Oliveira LF, Nadal J. Digital Butterworth filter for subtracting noise from low magnitude surface electromyogram. Comput Methods Programs Biomed. 2007 Jul;87(1):28-35. doi: 10.1016/j.cmpb.2007.04.004. Epub 2007 Jun 4. |
| 2522493 | Background | Love A, Leboeuf C, Crisp TC. Chiropractic chronic low back pain sufferers and self-report assessment methods. Part I. A reliability study of the Visual Analogue Scale, the Pain Drawing and the McGill Pain Questionnaire. J Manipulative Physiol Ther. 1989 Feb;12(1):21-5. |
| 18828921 | Background | Moutzouri M, Billis E, Strimpakos N, Kottika P, Oldham JA. The effects of the Mulligan Sustained Natural Apophyseal Glide (SNAG) mobilisation in the lumbar flexion range of asymptomatic subjects as measured by the Zebris CMS20 3-D motion analysis system. BMC Musculoskelet Disord. 2008 Oct 1;9:131. doi: 10.1186/1471-2474-9-131. |
| 18839484 | Background | Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420. |
| 15125918 | Background | Henriksen M, Lund H, Moe-Nilssen R, Bliddal H, Danneskiod-Samsoe B. Test-retest reliability of trunk accelerometric gait analysis. Gait Posture. 2004 Jun;19(3):288-97. doi: 10.1016/S0966-6362(03)00069-9. |
| 15705040 | Background | Weir JP. Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005 Feb;19(1):231-40. doi: 10.1519/15184.1. |
| 24579210 | Result | Pivec R, Stokes M, Chitnis AS, Paulino CB, Harwin SF, Mont MA. Clinical and economic impact of TENS in patients with chronic low back pain: analysis of a nationwide database. Orthopedics. 2013 Dec;36(12):922-8. doi: 10.3928/01477447-20131120-04. |
| 23178541 | Result | Shum GL, Tsung BY, Lee RY. The immediate effect of posteroanterior mobilization on reducing back pain and the stiffness of the lumbar spine. Arch Phys Med Rehabil. 2013 Apr;94(4):673-9. doi: 10.1016/j.apmr.2012.11.020. Epub 2012 Nov 23. |
| 18164469 | Result | Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S. Evidence-informed management of chronic low back pain with spinal manipulation and mobilization. Spine J. 2008 Jan-Feb;8(1):213-25. doi: 10.1016/j.spinee.2007.10.023. |
| 8742274 | Result | Kaufman KR, Miller LS, Sutherland DH. Gait asymmetry in patients with limb-length inequality. J Pediatr Orthop. 1996 Mar-Apr;16(2):144-50. doi: 10.1097/00004694-199603000-00002. |
| 9507623 | Result | Thomas E, Silman AJ, Papageorgiou AC, Macfarlane GJ, Croft PR. Association between measures of spinal mobility and low back pain. An analysis of new attenders in primary care. Spine (Phila Pa 1976). 1998 Feb 1;23(3):343-7. doi: 10.1097/00007632-199802010-00011. |
| 10619108 | Result | Callaghan JP, Patla AE, McGill SM. Low back three-dimensional joint forces, kinematics, and kinetics during walking. Clin Biomech (Bristol). 1999 Mar;14(3):203-16. doi: 10.1016/s0268-0033(98)00069-2. |
| 6863337 | Result | Chao EY, Laughman RK, Schneider E, Stauffer RN. Normative data of knee joint motion and ground reaction forces in adult level walking. J Biomech. 1983;16(3):219-33. doi: 10.1016/0021-9290(83)90129-x. |
| 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
| OG002 | 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. |
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient |
|
|
|
| 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. | all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale | Posted | Mean | Standard Deviation | quotient: degrees/degrees=no unit | before the beginning and after the end of 5 weeks for each patient |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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 | 0 | 25 | 0 | 25 |
| EG002 | 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 | 0 | 25 | 0 | 25 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |
|
| 6 months after |
|
|
| 6 months after |
|
|
| pelvis position frontal plane quotient at T2 |
|
| torso position coronal plane quotient at T2 |
|
| pelvis position frontal plane quotient at T3 |
|