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OpenTrials
Completed

NCT Number: NCT03099941

The Effectiveness of Two Different Feedbacks in Core Stabilization Education for Chronic Nonspecific Low Back Pain

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biofeedback

Other

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 outcomes

  1. Revised Oswestry Disability Index

    Time frame: 1 month

    Disability

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2017
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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