The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
Primary Purpose
Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Biofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain, Mechanical, Biofeedback, Pain, Chronic focused on measuring Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Biofeedback group
Physical therapist feedback group
Arm Description
The biofeedback application which helps patient to understand neutral position and how to maintain it in exercises that are prescribed by the physical therapist
In 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
Outcomes
Primary Outcome Measures
Revised Oswestry Disability Index
Disability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03099941
Brief Title
The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 11, 2015 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
June 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
Keywords
Low Back Pain, Mechanical, Biofeedback, Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback group
Arm Type
Experimental
Arm Description
The biofeedback application which helps patient to understand neutral position and how to maintain it in exercises that are prescribed by the physical therapist
Arm Title
Physical therapist feedback group
Arm Type
Active Comparator
Arm Description
In 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
Intervention Type
Other
Intervention Name(s)
Biofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Revised Oswestry Disability Index
Description
Disability
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain
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