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

May 3, 2017 updated by: Georgios Krekoukias, University of Ioannina

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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.
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)
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.
before the beginning and after the end of 5 weeks for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 721α/11-10-2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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