Clinical trial NCT02645123: Gait in Low Back Pain Patients After Spinal Mobilization
Official title: Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: spinal mobilization
manual therapy
gait analysis
low back pain
chronic
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Numerical Pain Rating Scale
timeFrame: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient
measure: Change in the Oswestry Low Back Pain Disability Index
timeFrame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
measure: Change in the Roland-Morris Disability Questionnaire
timeFrame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
measure: Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
timeFrame: before the beginning and after the end of 5 weeks for each patient
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Ioannina
name: GEORGIOS O KREKOUKIAS, PT, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ioannina
name: IOANNIS D GELALIS, MD, PhD
role: STUDY_DIRECTOR
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