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临床试验/NCT03543501
NCT03543501已完成不适用

Comparison of the Pressure Biofeedback Unit and Rehabilitative Ultrasound Imaging as Biofeedback Tools to Train the Transversus Abdominis Muscle Activation in Healthy Subjects

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年12月1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
40
试验地点
2
主要终点
Change in thickness of the Transversus abdominis in supine

研究概览

简要总结

Introduction: Non specific low back pain (NSLBP) is a low back pain (LBP) that cannot be attributable to a known pathology. LBP has prevalence as high as 84%, making it a heavy burden for health services and society worldwide. Furthermore, LBP seems to be more prevalent as the population gets older, and is the cause of severe functional limitations. One of the treatment recommended for LBP is physical therapy. It has been shown that the trunk muscles usually maintain trunk stability by making a sequence of postural adjustment in advance of distal movement to prevent any loss of balance. However, in NSLBP, this motor control adjusting is lacking, and, furthermore, stays so even after the resolution of acute LBP, which could contribute to the recurrence of LBP. Physical therapy therefore addresses NSLBP by rehabilitating the timing and activation of trunk muscle, among other things. The importance of trunk musculature has been highlighted by many studies showing the feedforward contraction of the trunk muscles in anticipation of extremity movement. Those trunk muscles comprise the transversus abdominis (TrA) and lumbar multifidus (LM). Since those muscles create no movement, but rather an increase in abdominal pressure, it is thus often a complex contraction to teach. To help with that teaching, physical therapist may use one of the two feedback tools that exist to teach a TrA contraction, namely the pressure biofeedback unit (PBU) and rehabilitative ultrasound imaging (RUSI). Unfortunately, their efficiency to help with the teaching of TrA contraction is yet to be shown in an elderly population, and few studies compared their efficiency. Furthermore, even though the teaching of the TrA contraction must be followed by a translation of that skill in more functional position such as standing, no studies looked at the effect of the feedback in supine to the skill of TrA contraction in standing.

Objective: The principal aim of this study is thus to compare, throughout a healthy population of 60 to 80 years old, the immediate efficiency of adding PBU or RUSI to the TrA contraction teaching in supine. The secondary objectives are as follow: 1) to see if that teaching in supine can be translated by a better contraction of the TrA in standing, and if one of the two tools is superior in doing so and 2) to see if one tool favor a more specific contraction of TrA when compared to the other muscles of the lateral abdominal wall. The hypothesis is that the RUSI will prove superior to the PBU.

Method: This will be a single-blinded controlled laboratory study with randomization. The independent variables will be the group of randomization, either PBU or RUSI. The dependent variable will be the TrA contraction. To answer our objectives, forty (40) healthy people aged between 60 and 80 will be recruited. The subjects will be healthy with no current pain and no history of limiting LBP in the past year. Of those, 20 will be women. The randomization will be made in blocks to allow a good balance of the sex throughout the groups. Every subject's TrA contraction (principal outcome) will be measured before and after the intervention (immediate effect) with the RUSI (change of thickness between resting and contracting state) both in supine and standing. The intervention will consist of a 5-minute education on the trunk muscle and their role, a brief teaching of how to contract them properly and the use of the feedback tool used in their group. Will follow a training program of 15 contractions with the feedback tool (PBU vs RUSI). Descriptive analysis will be used to describe the subjects. The TRA activation ratio (AR) and preferential activation ratio (PAR) will be compared after the intervention with Wilcoxon signed rank tests for each subject first. The group's mean will then be compared, first for each age group, then for each feedback tool as a whole with the Wilcoxon rank sum test.

Impact: Age and LBP both influence the motor control and feedforward contraction of the trunk muscles. Since NSLBP is highly prevalent throughout the ages and cost a lot for the society, the identification of the best tool to help in teaching the TrA contraction is crucial. This project will provide the first steps to justify a bigger controlled study on NSLBP. Moreover, this project will familiarize the Canadian physical therapist society to the use of RUSI, a tool still seldom used in the clinic in Canada but highly promising.

详细描述

  1. Introduction Low back pain is defined as a pain in the lower back bad enough to limit your usual activities or change your daily routine for more than 1 day, that may or may not go down one or both legs and lasting at least a day. The pain must be comprised on the back, within the limits of the lower rib and the lower gluteal fold. Low back pain (LBP) can further be compartmentalized in "specific LBP", by definition a LBP that be attributable to a known cause, or in "non-specific LBP" (NSLBP), defined as a LBP that cannot be associated to a known cause. LBP is one of the leading causes of functional limitations and sick leave, carrying a heavy financial cost for both individuals and society. According the 2010 Global burden Disease study, LBP is classified the 6th in the overall burden when compared to 290 other pathologies. Global prevalence of LBP is between 11% and 84%, and would reach its peak value à 80 years old. Therefore, the impact of LBP would be more important in societies where the life expectancy is higher, such as Canada and the United States. Moreover, aging would be accompanied by an increase in the frequency of severe back pain, as well as an increase in the prevalence of pain and other symptoms and conditions associated with low back pain, occasioning higher social and functional limitations. It also is one of the main causes of physical therapy consultation, which uses therapeutic exercises, such as core muscle training to address it. Yet, it is unknown as today which method is to be privileged to teach how to contract those muscles in the elderly.
  2. Literature review One of the favoured approaches in physical therapy to address LBP is the training of the core muscles, specifically the transversus abdominis (TrA). In a healthy subject, trunk muscles will maintain trunk stability by making a sequence of postural adjustment in advance of distal movement to prevent any loss of balance. This fine tuning adjusting happening before any kinesthetic or sensorial feedback may happen, it is considered as planned by the central nervous system (CNS). Yet, it has been shown that those postural adjustments are lacking in the patients with LBP, and would persist even after the resolution of the LBP episode, which might contribute to the recurrence of LBP. Furthermore, aging is also accompanied by a diminution of motor control of the trunk, constituting a part of the LBP in the elderly. Fortunately, these postural adjustments of the TrA have been shown to be trainable again.

Teaching to contract the TrA often gets to be quite a challenge, since its contraction creates no visible movement. It requires an understanding and/or a good feeling of the desired contraction from the patient. To help in the teaching of the TrA, physical therapists (PT) may use one of the few feedback tools that have been shown to be efficient in that regard. Biofeedback is a technique where the biological information otherwise unknown to the patient is transmitted in real time to him. That information goes over what is usually accessible for those patients. In physical therapy, biofeedback comes from the biomechanical measure of physiological measure of the human body. Adding biofeedback to a usual physical therapy intervention enables the patient to control physical adjustments that were thought to be controlled by the CNS, such as the postural adjustments. It also allows for a better tuning in the tasks and engages the patient in a more proactive therapy. In the literature, two non-invasive biofeedback tools used in clinics are documented for their efficiency to assist in the teaching of the TrA contraction and for their validity to measure its activation, the rehabilitative ultrasound imaging (RUSI) and the pressure biofeedback unit (PBU).

The use of RUSI by physiotherapists is growing. RUSI is a non-invasive technique to provide immediate visual feedback on changes in the thickness of the abdominal wall muscles, reflecting the contraction of these muscles, more specifically the TrA. This is done by transmitting, on a screen, an ultrasound image produced by a probe placed on the abdomen of the participant. The probe emits ultrasound waves which passes through the tissues and then return to the probe in the form of echoes. RUSI would detect recruitment of TrA at a contraction as low as 12% of the maximum voluntary contraction (MVC), and recruitment of the internal oblique (OI) when contracted to 22% a MVC. This visual feedback, coupled with the usual explanations for TrA recruitment, reduces the number of trials required for an effective recruitment of TrA in patients with and without low back pain immediately after training and in the short-term follow-up.

The PBU is a simple and inexpensive device that measures the change in pressure in a three-compartment bag filled with air placed under the patient's lumbar spine whilst lying on his back (supine position). The movement of the lumbar spine on the three-compartment bag produced by a false contraction of the TrA changes the intensity of the pressure and this change can be seen on an adjustable gauge, and therefore avoided. However, Lima et al. (2012) have shown a low association between the pressure measured with the PBU and the surface electromyography (EMG) (r = 0.2, p <0.2), with a sensitivity and a specificity of 60%. A systematic review by the same author concludes that inter- and intra-evaluative reliability ranges from medium to good (intra-class correlation (ICC) of 0.42 to 0.82 and 0.5 to 0.81, respectively) and a construct validity ranging from medium to excellent (ICC from 0.48 to 0.90). Nevertheless, it is a widely used apparatus for learning TRA in physiotherapy because of its low cost and ease of use.

Only three studies compared the efficacy of RUSI and PBU on the recruitment of TrA in both young and asymptomatic individuals and low back pain. Bajaj et al. (2010) report that low back pain patients trained with RUSI acquire more rapidly the ability to recruit TrA (significant reduction in the number of trials required to activate the TrA and the number of days needed to consolidate learning) than those performed with the PBU. Lee et al. (2016) randomized a sample of young and asymptomatic individuals into three groups according to the type of feedback used during training: tactile, RUSI or PBU. The primary measurement was the thickness of the TrA measured with an ultrasound. An increase in TrA thickness (reflecting a better TrA activation) was observed in all three groups. When compared to the tactile feedback group, the RUSI group had significantly higher TrA thickness. Finally, Wooldridge et al. (2014) compared the immediate effect of training with different types of feedback (PBU, RUSI and PBU + RUSI) in a population similar to that of Lee et al. (mean age = 22.2 years). The authors report no significant difference in the activation of TrA, measured with different parameters extracted from ultrasound images, pre and post-training and between 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)

盲法说明

A single-blind study where the assessor will be taking measurement before and after the intervention, albeit without knowing which intervention was given.

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Good health
  • without back pain for more than 12 month
  • free from pain for 1 week
  • live in community,

排除标准

  • No chronic health condition restricting activities or requiring punctual care
  • a capacity to specifically contract the TrA
  • surgery to the thorax, abdomen or spine in the last 3 years
  • pacemaker
  • previous training of TrA
  • structural scoliosis
  • lower than 24 on the MMSE

结局指标

主要结局

Change in thickness of the Transversus abdominis in supine

时间窗: Baseline (pre-intervention); 5 minutes post intervention

The dependent variable is the change in thickness of the TrA muscle between the rest state and the recruitment state measured from an ultrasound image (LOGIQ E, GE Healthcare, 13 MHz linear probe, at B-mode). Before and after the intervention, three images will be taken in the supine, knee-flexed (main objective) position at rest and during a TrA recruitment maneuver.

次要结局

  • Change in thickness of the Transversus abdominis in standing(Baseline (pre-intervention); 5 minutes post intervention)
  • Activation ratio of the Transversus abdominis(Baseline (pre-intervention); 5 minutes post intervention)

研究者

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

Nathaly Gaudreault

Principal investigator, professor

Université de Sherbrooke

研究点 (2)

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