Low Back Pain, Mechanical, Biofeedback, Pain, Chronic Clinical Trial
Official title:
The Comparison of the Effects of Two Different Feedback in the Core Stabilization Training for Patients With Chronic Nonspecific Low Back Pain (CNLBP): Randomized Parallel Group Trial
| Verified date | April 2017 |
| Source | Istanbul University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Abstract. Insufficient motor control mechanism of transversus abdominus and multifidus
muscles is the most important cause of the chronic nonspecific low back pain (CNLBP).
Recently, applications sre developed that generates audio and vibrant stimuli in response to
anteroposterior and mediolateral rotations and can be adapted according to subject-specific
movement sensitivity.
Objective. The objective of this study was to compare effects of a biofeedback application
that is alternative to physiotherapist feedback in core stabilization training of patients
with chronic nonspecific low back pain.
Design. This study was a parallel group randomized controlled trial with outcome assessment.
Patients. The participants were 38 patients with chronic (≥12 weeks) nonspecific low back
pain.
Interventions. Patients were randomly assigned to receive either physiotherapist feedback or
Perfect Practice (Level Belt Pro Inc.) biofeedback. Patients in both groups received 12
sessions, 30 minutes of three weekly graded functional core education trial.
Measurements. Primary outcome measures were muscle strength (transversus abdominus and
multifidus) pain intensity (Visual Analog Scale) and functional level (Revised Oswestry
Disability Index); secondary outcomes were flexibility (modified Schober test), range of
motion (universal goniometer), proprioception (Active Reposition Test), patient beliefs
(Fear Avoidance Beliefs Questionnaire), psychological status (Beck Depression Index), and
quality of life(36 Item Short-Form Health Survey questionnaire [SF-36]).
Limitations. Outcome measures for muscle strength did not include objective assesment.
Keywords. Chronic low back, core stabilization training, biofeedback, pain, function
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | June 1, 2016 |
| Est. primary completion date | June 1, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 25 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - Age between 25 and 65 years - Continuous or recurrent episodes of pain in the lower back lasting for more than 12 weeks (chronic) - No specific cause for pain complaints - No other pathologic complaints or immobility - Sufficient auditory and visual communication skills and - Sufficient knowledge of the Turkish language Exclusion Criteria: - Any chronic disorder that may prevent exercise, - Personal history of neurologic or rheumatologic disease, - Pregnant or lactating women, - Patients with malignancy or a lumbar comorbidity - Terminal or progressive disease and any other musculoskeletal condition - Surgery in the last 6 months and - Any type of treatment for low back pain within past 6 months |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Istanbul University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Revised Oswestry Disability Index | Disability | 1 month |