Gait in Low Back Pain Patients After Spinal Mobilization

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Procedure: spinal mobilization; Procedure: sham treatment; Device: TENS; Procedure: swedish type massage; Procedure: static hamstring stretch

• Registration Number: NCT02645123
• Lead Sponsor: University of Ioannina

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).

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-31
• Study First Posted: 2016-01-01
• Results First Submitted: 2016-05-12
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Results First Posted: 2017-06-08
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Classic Physiotherapy	swedish type massage	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)
Spinal mobilization	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
Sham Treatment	sham treatment	The investigator touched the skin overlying the low back statically for 10 minutes
Classic Physiotherapy	TENS	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)
Classic Physiotherapy	static hamstring stretch	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)

Primary Outcome Measures

Name	Time	Method
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.