NCT03099941

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

March 21, 2017

Last Update Submit

April 4, 2017

Conditions

Keywords

Low Back Pain, Mechanical, Biofeedback, Pain, Chronic

Outcome Measures

Primary Outcomes (1)

  • Revised Oswestry Disability Index

    Disability

    1 month

Study Arms (2)

Biofeedback group

EXPERIMENTAL

The biofeedback application which helps patient to understand neutral position and how to maintain it in exercises that are prescribed by the physical therapist

Other: Biofeedback

Physical therapist feedback group

ACTIVE COMPARATOR

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

Other: Biofeedback

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.

Biofeedback groupPhysical therapist feedback group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Low Back PainPainBronchiolitis Obliterans Syndrome

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

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