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

NCT ID: NCT03099941

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-11
• Study Completion Date: 2016-06-01

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

Conditions

Low Back Pain, Mechanical, Biofeedback, Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Biofeedback group

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

Group Type: EXPERIMENTAL

Biofeedback

Intervention Type: 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.

Physical therapist feedback group

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

Group Type: ACTIVE_COMPARATOR

Biofeedback

Intervention Type: 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.

Interventions

Biofeedback

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

GÜLVİN DİLAN CANAN

Director Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IstanbulFizyoterapi

Identifier Type: -

Identifier Source: org_study_id