Gait in Low Back Pain Patients After Spinal Mobilization (SpinMob)

• ClinicalTrials.gov Identifier: NCT02645123
• Recruitment Status: Completed
• First Posted: January 1, 2016
• Results First Posted: June 8, 2017
• Last Update Posted: June 8, 2017
• Sponsor: University of Ioannina
• Information provided by (Responsible Party): Georgios Krekoukias, University of Ioannina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Device: TENS; Procedure: spinal mobilization; Procedure: swedish type massage; Procedure: static hamstring stretch; Procedure: sham treatment	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization
• Study Start Date: December 2011
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: November 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Procedure: spinal mobilization; passive physiological intervertebral movements and passive accessory posteroanterior mobilization
Sham Comparator: Sham Treatment; The investigator touched the skin overlying the low back statically for 10 minutes	Procedure: sham treatment; touching of the skin overlying the lumbar area
Active Comparator: 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)	Device: TENS; Enraf-Nonius Sonopuls 692; Procedure: swedish type massage; petrissage, effleurage, tapotement; Procedure: static hamstring stretch; static hamstring stretching

Outcome Measures

Primary Outcome Measures :

1. Change in the Numerical Pain Rating Scale [ Time Frame: 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.
2. Change in the Oswestry Low Back Pain Disability Index [ 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 ]
   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
3. Change in the Roland-Morris Disability Questionnaire [ 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 ]

   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.

4. Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 78 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Ioannina

Investigators

• Principal Investigator: GEORGIOS O KREKOUKIAS, PT, MSc, PhD; University of Ioannina
• Study Director: IOANNIS D GELALIS, MD, PhD; University of Ioannina

More Information

Publications of Results:

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.

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.

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. Review.

Kaufman KR, Miller LS, Sutherland DH. Gait asymmetry in patients with limb-length inequality. J Pediatr Orthop. 1996 Mar-Apr;16(2):144-50.

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.

Callaghan JP, Patla AE, McGill SM. Low back three-dimensional joint forces, kinematics, and kinetics during walking. Clin Biomech (Bristol, Avon). 1999 Mar;14(3):203-16.

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.

Other Publications:

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.

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.

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.

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.

McCaw ST, Bates BT. Biomechanical implications of mild leg length inequality. Br J Sports Med. 1991 Mar;25(1):10-3. Review. Erratum in: Br J Sports Med 1991 Dec;25(4):190.

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.

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.

Wang D, Bergström 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.

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.

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.

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. Epub 2007 Jun 4.

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.

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.

Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. Review.

Henriksen M, Lund H, Moe-Nilssen R, Bliddal H, Danneskiod-Samsøe B. Test-retest reliability of trunk accelerometric gait analysis. Gait Posture. 2004 Jun;19(3):288-97.

Weir JP. Quantifying test-retest reliability using the intraclass correlation coefficient and the SEM. J Strength Cond Res. 2005 Feb;19(1):231-40. Review.

• Responsible Party: Georgios Krekoukias, Physiotherapist MSc PhD MMACP, University of Ioannina
• ClinicalTrials.gov Identifier: NCT02645123
• Other Study ID Numbers: 721α/11-10-2011
• First Posted: January 1, 2016
• Results First Posted: June 8, 2017
• Last Update Posted: June 8, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.

Keywords provided by Georgios Krekoukias, University of Ioannina:

spinal mobilization; manual therapy; gait analysis; low back pain; chronic

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations