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临床试验/NCT03099941
NCT03099941已完成不适用

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

Istanbul University0 个研究点目标入组 38 人开始时间: 2015年5月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
主要终点
Revised Oswestry Disability Index

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

干预措施: Biofeedback (Other)

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

干预措施: Biofeedback (Other)

结局指标

主要结局

Revised Oswestry Disability Index

时间窗: 1 month

Disability

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GÜLVİN DİLAN CANAN

Director Investigator

Istanbul University

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