The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
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
1 other identifier
interventional
38
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 21, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedApril 6, 2017
April 1, 2017
1.1 years
March 21, 2017
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Revised Oswestry Disability Index
Disability
1 month
Study Arms (2)
Biofeedback group
EXPERIMENTALThe biofeedback application which helps patient to understand neutral position and how to maintain it in exercises that are prescribed by the physical therapist
Physical therapist feedback group
ACTIVE COMPARATORIn physical therapist feedback group feedback applied by oral and tactile stimulation of physical therapist to helps patient to understand neutral position and how to maintain it in exercises that are prescribed
Interventions
The aim of this study is to investigate effects of a biofeedback application that is alternative to physical therapist feedback in core stabilization training of patients with CNLBP.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- Director Investigator
Study Record Dates
First Submitted
March 21, 2017
First Posted
April 4, 2017
Study Start
May 11, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
April 6, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share