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NCT Number: NCT02645123

Gait in Low Back Pain Patients After 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.

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Key information

Conditions

Chronic Low Back Pain Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Low Back Pain Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

21 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

Enraf-Nonius Sonopuls 692

Spinal mobilization

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

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

Acronym: SpinMob

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2016
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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