Gait in Low Back Pain Patients After Spinal Mobilization

Chronic Low Back Pain Clinical Trial

— SpinMob  

Official title:

Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645123
• Other study ID #: 721a/11-10-2011
• Status: Completed
• Phase: N/A
• First received: December 23, 2015
• Last updated: December 31, 2015
• Start date: December 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Device:
• Transcutaneous electrical nerve stimulation
Enraf-Nonius Sonopuls 692

Procedure:
• spinal mobilization
passive physiological intervertebral movements and passive accessory posteroanterior mobilization
• swedish type massage
petrissage, effleurage, tapotement
• muscle stretching
static hamstring stretching
• sham treatment
touching of the skin overlying the lumbar area

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient	No
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	before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient	No
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.	before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient	No
Primary	change in the 3 dimensional gait characteristics (Motion Analysis gait analysis system along with Kistler force platforms)	optoelectronic gait analysis system along with 2 force plates to record kinetic and kinematic data. This data was recorded by a computer using relevant software.	before the beginning and after the end of 5 weeks for each patient	No