Gait in Low Back Pain Patients After Spinal Mobilization

NCT02645123 | Completed Results

• 1 other identifier: 721α/11-10-2011
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)

  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

Study Arms (3)

Spinal mobilization

EXPERIMENTAL

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

Sham Treatment

SHAM COMPARATOR

The investigator touched the skin overlying the low back statically for 10 minutes

Procedure: sham treatment

Classic Physiotherapy

ACTIVE COMPARATOR

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; Procedure: swedish type massage; Procedure: static hamstring stretch

Interventions

TENS DEVICE

Enraf-Nonius Sonopuls 692

Classic Physiotherapy

spinal mobilization PROCEDURE

passive physiological intervertebral movements and passive accessory posteroanterior mobilization

Spinal mobilization

swedish type massage PROCEDURE

petrissage, effleurage, tapotement

Classic Physiotherapy

static hamstring stretch PROCEDURE

static hamstring stretching

Classic Physiotherapy

sham treatment PROCEDURE

touching of the skin overlying the lumbar area

Sham Treatment

Eligibility Criteria

• Age: 21 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• low back pain for over 3 months
• recent lumbar MRI (up to 12 months)
• able to walk without the need of walking aids

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ioannina: lead

Related Publications (23)

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  PMID: 24579210 RESULT

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  PMID: 23178541 RESULT

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  PMID: 18164469 RESULT

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  PMID: 8742274 RESULT

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• 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. doi: 10.1016/0021-9290(83)90129-x.

  PMID: 6863337 RESULT

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Dr. Georgios Krekoukias
• Organization: University of Ioannina School of Medicine

gkrekos@gmail.com

00306934609400

Study Officials

• GEORGIOS O KREKOUKIAS, PT, MSc, PhD

  University of Ioannina

  PRINCIPAL INVESTIGATOR

• IOANNIS D GELALIS, MD, PhD

  University of Ioannina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist MSc PhD MMACP

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: January 1, 2016
• Study Start: December 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 8, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share