Gait in Low Back Pain Patients After Spinal Mobilization

NCT ID: NCT02645123

Last Updated: 2017-06-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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).

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

spinal mobilization

Intervention Type PROCEDURE

passive physiological intervertebral movements and passive accessory posteroanterior mobilization

Sham Treatment

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

Group Type SHAM_COMPARATOR

sham treatment

Intervention Type PROCEDURE

touching of the skin overlying the lumbar area

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)

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

Enraf-Nonius Sonopuls 692

swedish type massage

Intervention Type PROCEDURE

petrissage, effleurage, tapotement

static hamstring stretch

Intervention Type PROCEDURE

static hamstring stretching

Interventions

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TENS

Enraf-Nonius Sonopuls 692

Intervention Type DEVICE

spinal mobilization

passive physiological intervertebral movements and passive accessory posteroanterior mobilization

Intervention Type PROCEDURE

swedish type massage

petrissage, effleurage, tapotement

Intervention Type PROCEDURE

static hamstring stretch

static hamstring stretching

Intervention Type PROCEDURE

sham treatment

touching of the skin overlying the lumbar area

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ioannina

OTHER

Sponsor Role lead

Responsible Party

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Georgios Krekoukias

Physiotherapist MSc PhD MMACP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GEORGIOS O KREKOUKIAS, PT, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ioannina

IOANNIS D GELALIS, MD, PhD

Role: STUDY_DIRECTOR

University of Ioannina

References

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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. No abstract available.

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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.

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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.

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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. doi: 10.3928/01477447-20131120-04.

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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. doi: 10.1097/00007632-199802010-00011.

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Other Identifiers

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721α/11-10-2011

Identifier Type: -

Identifier Source: org_study_id

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