N/A
Completed N=75
Gait in Low Back Pain Patients After Spinal Mobilization
Source: ClinicalTrials.gov NCT02645123 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Change in the Numerical Pain Rating Scale — 5.96; 6.12; 6; 1.22 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Numerical Pain Rating Scale |
5.96; 6.12; 6; 1.22; 5.88; 4.96 | — |
| PRIMARY Change in the Oswestry Low Back Pain Disability Index |
33.28; 32; 31.04; 9.84; 31.76; 27.28 | — |
| PRIMARY Change in the Roland-Morris Disability Questionnaire |
8.56; 10; 9.96; 2.44; 10.04; 8.76 | — |
| PRIMARY Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms) |
-1.147; 0.852; -0.4; -1.307; 0.172; -0.429 | — |
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
Data sourced from ClinicalTrials.gov (NCT02645123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.