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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
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 21, 2017
    Last Updated
    April 4, 2017
    Sponsor
    Istanbul University
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    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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