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临床试验/NCT05859425
NCT05859425已完成不适用

Investigation of Real-time Diagnostic Ultrasound as a Means of Biofeedback Training in Transversus Abdominus Re-education of Patients With Non-specific Low Back Pain: Prospective Randomized Controlled Pilot Study

University of Patras1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2022年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

As rehabilitative ultrasound imaging (RUSI) for monitoring and re-educating deep trunk muscles is becoming more and more popular in current musculoskeletal rehabilitation and research, the purpose of this pilot study was to explore the effects of applying ultrasound-guided imaging as a means of feedback for the activation/contraction of the deep transervsus abdominis muscle of the trunk during an exercise programme in people with non-specific low back pain (NSLBP). The outcome mesures being explored were pain intensity (primary outcome) through Numeric Pain Rating Scale (NPRS), functional, muscular and psychosocial parameters.

详细描述

Background: It is believed that ultrasound-guided imaging of activation/contraction of the deep abdominal muscles (such as transervsus abdominis) is useful for assisting deep muscle re-education, which is often dysfunctional in non-specific low back pain (NSLBP). Thus, this pilot study aimed to evaluate the use of real-time ultrasound (US) as a feedback device for transverse abdominis (TrA) activation/contraction during an exercise program in chronic NSLBP patients.

Methods: Chronic NSLBP patients are recruited and randomly assigned to an US-guided or control group. The same motor control-based exercise program is applied to both groups. All patients would receive physiotherapy twice per week for 7 weeks. Outcome measures, tested at baseline and post-intervention, include Numeric Pain Rating Scale (NPRS), TrA activation level (measured through a pressure biofeedback unit-based developed protocol), seven established motor control tests, Roland-Morris Disability Questionnaire (RMDQ) and Hospital Anxiety and Depression Scale (HADS). Analysis of variance utilizing a two-way mixed ANOVA model for dependent measures of two factors (treatment group and time point of measurement) of which only one is repeated (time point of measurement) is performed to determine between- and within-group differences before and after treatment. Additionally, independent samples' t-test and paired samples' t-test are used for differences between and within groups, respectively, as well as χ2 tests for differences on the motor control tests and the TrA activation level procedure across the groups.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • adults aged 18-60 years-old
  • suffered from NSLBP lasting longer than 12 weeks, producing moderate or severe disability

排除标准

  • people with previous spinal surgery
  • people suffering from systemic diseases
  • pregnant women

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: Change from baseline Numeric Pain Rating Scale at 2 months

Pain intensity measure, in a 0-10 point scale, where 0 refers to NO PAIN and 10 to the WORST PAIN

次要结局

  • Roland-Morris Disability Questionnaire (RMDQ)(Change from baseline Roland Morris Disability Questionannaire at 2 months)
  • Hospital Anxiety and Depression Scale (HADS)(Change from baseline Hospital Anxiety and Depression Scale at 2 months)
  • Transversus Abdominus (TrA) Activation Level(Change from the baseline Transversus abdominus activation level at 2 months)
  • Motor Control Tests (MCT)(Change from the baseline motor control tests (how many performed CORRECTLY) at 2 months)

研究者

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

Evdokia Billis

Professor in Physiotherapy

University of Patras

研究点 (1)

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