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The Efficacy Of Instrument-Assisted Soft Tissue Mobilization At Lumbar Region Disc Herniations

2020年7月7日 更新者:Ali Yıldırım、Bezmialem Vakif University

This study was carried out to investigate the effect of instrument-assisted soft tissue mobilization in patients with lomber region disc herniation. 60 patients with lumbar disc herniation between the ages of 30-65 were included in the study. Following the evaluation, the patients were divided into two groups by closed envelope method; control group (n=30) and experimental group (n=30). In both groups, 4 weeks (20 sessions) hot pack (hotpack), conventional transcutaneous electrical nerve stimulation (TENS), therapeutic physical therapy program with therapeutic ultrasound applications were performed. In addition to this program, Instrumental Assisted Soft Tissue Mobilization (IASTM) was applied to the experimental group in 12 sessions of 3 times a week. This technique was performed by using stainless steel tools of different sizes and shapes. IASTM treatment was performed (including SWEEP-FAN-BRUSH-SWEEP technique, 45° angle with the skin, by 8-10 repetitions) for the ilicostalis lumborum, priformis, gluteus medius, erector spines, quadratus lumborum muscles, superficial and deep fascia. Depression levels of the patients were evaluated with Beck Depression Scale, before the treatment and after 4 weeks pain severity, VAS pain scale, functional status with Oswestry Scale, quality of life with Short Form-36 (SF-

36) and normal range of motion with goniometer. The results were analyzed by using SPSS v.20 program. In all analyzes, the significance ratio was accepted as p <0.05. At the end of the four-week treatment program, significant improvements were observed in VAS levels, normal joint movements (flexion, extension, right-left lateral flexion, rotation) in both groups (p <0.05). Oswestry and Beck Depression Scale scores showed significant improvement merely in the experimental group compared to the control group (p <0.05). There was no significant difference in VAS values, normal joint motion and Oswestry scale while there was no notable difference in SF-36 and Beck Depression Scale. As a result of the study, it was concluded that IASTM is a more effective method on normal range of motion and functionality in comparison with traditional physiotherapy program in patients with lumbar disc herniation and it can be used as an alternative method in patients during the physiotherapy and rehabilitation program if needed.

研究概览

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Istanbul、火鸡
        • Bezmialem Vakif University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Bulging and protruding disc presence
  2. Facet joint problem
  3. Mechanical low back pain

Exclusion Criteria:

  1. Extruded and sequestrated disc presence
  2. Previous operational status through the lumbar region
  3. Having inflammatory pain (osteoarthritis)
  4. Pain associated with malignancy (primary or metastatic tumors)
  5. Severe psychological discomfort
  6. Having communication problems

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Control group

All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.

As a traditional treatment, patients received hot packs, conventional transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound and exercise.

Hot packs used as superficial heat were wrapped in a towel and applied to the waist area for 20 minutes.

Conventional TENS used as analgesic current were applied to the waist region for 20 minutes with 4 electrodes with 2 outputs, with a current time of 180 ms at a frequency of 80 Hz.

It was applied with a dose of 1Mhz for 5 minutes with ultrasan (Chattanooga Intelect Mobile Combo model device) used to heat deep tissues.

Waist exercises were asked to be done during the treatment, with 10 repetitions, each exercise twice a day (morning and evening).

All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.
实验性的:Experiment group

In addition to the traditional physiotherapy program, tool-assisted soft tissue mobilization was performed 3 times a week (12 sessions with 1 day interval) in the experimental group.

Instrument Assisted Soft Tissue Mobilization (IASTM) treatment was applied to ilicostalis lumborum, priformism, gluteus medius, erector spinas, quadratus lumborum muscles, superficial and deep fascia. Before applying the application, petroleum jelly was applied to the area and the tool was slipped.

IASTM treatment was applied to the treated muscle fibers for 6 minutes, each technique (SWEEP-FAN-BRUSH-SWEEP techniques) with 8-10 repetitions.

Sweep: Applied in all directions at 30 or 60 degree angle. Fan: It was applied by moving one side fixed arm at 30 degree angle. Brush: It was applied in straight steps at 30 degrees angle. Each stage of IASTM treatment was done by the physiotherapist.

All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.

All patients in the experimental group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.

In addition to the traditional physiotherapy program, the patients in the experimental group were subjected to tool-assisted soft tissue mobilization 3 times a week (12 sessions with 1 day interval).

All evaluations were repeated to all patients in the experimental and control groups after four weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Demographic information
大体时间:4 week
Personal information (name, surname, address, telephone, marital status, educational status, occupational and health security), demographic and clinical information (age (year), gender, height (cm), weight (kg), BMI of all patients participating in the study (calculated by the formula of the ratio of body weight to neck squared (kg / m²)), information about the disease, drugs used for lumbar disc hernia, other drugs used, presence of chronic disease, surgical history, smoking and alcohol use] by questioning '' Demographic Information Forms '' recorded.
4 week
Assessment of pain (VAS)
大体时间:4 week

The pain intensities of the patients at rest, during the activity and at night were determined using the Visual Analogue Scale (VAS). VAS is an easy-to-apply scale, as values that cannot be measured numerically can be digitized and quickly understood.

The patients were asked to mark their severity (rest, activity, night) on a 10 cm line. The starting point of the truth was '' 0 '' '' I have no pain '', the end point was '' 10 '' '' I have pain of unbearable severity ''. The point that the patient marked on the right was measured with a ruler and recorded in "cm". Localization of the pain, its frequency and the causes that increase and decrease pain were questioned and recorded. The Turkish validity and reliability study of the scale was performed.

4 week
Evaluation of normal joint motion (NEH)
大体时间:4 week
The limitation of flexion, extension, lateral flexion and rotation movements of the lumbosacral joint was measured using a universal goniometer. All normal joint movements were repeated 3 times and the average of the obtained values was recorded in degrees.
4 week
Evaluation of the quality of life
大体时间:4 week
Quality of life was assessed with the survey "SF-36 (Short form-36) quality of life". SF-36 is a generic scale that evaluates the overall health status. It consists of 36 questions that evaluate 2 main (physical and mental component) and 8 sub parameters (physical function, emotional function, physical role, social function, mental health, pain, general health and vitality). The score of each subgroup is evaluated between 0-100. A high score indicates that the quality of life is good. The Turkish validity and reliability study of the SF-36 questionnaire was conducted.
4 week
Evaluation of depression
大体时间:4 week

Depression level of the patients was evaluated by Beck Depression questionnaire. The scale developed by Beck consists of 21 questions. 4-point Likert scoring is used in the scale. Each item gets points between 0-3. The total score ranges from 0-63.

Points obtained from the survey;

0-10 points → no depression

11-17 points → mild depression

18-23 points → moderate depression

24 points above → interpreted as severe depression.

The Turkish validity and reliability study of the scale was conducted.

4 week
Functional evaluation for low back pain
大体时间:4 week

Oswestry Disability Index was used to evaluate the disability caused by low back pain. The scale evaluates how much back pain affects daily life activities. Pain severity consists of 10 questions evaluating personal care, weight lifting, walking, sitting, standing, sleep quality, social life, ability to travel and the degree of pain. Six-point likert scoring is used. A high total score indicates an increase in disability. The Turkish validity and reliability study of this scale was conducted.

Points obtained from the survey;

0% - 20% → minimal disability

20% to 40% → mild disability

40% to 60% → severe disability

60% - 80% → complete limitation

80% - 100% → bed-dependent (or symptoms are exaggerated)

4 week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年4月16日

初级完成 (实际的)

2020年5月16日

研究完成 (实际的)

2020年6月20日

研究注册日期

首次提交

2020年4月2日

首先提交符合 QC 标准的

2020年4月2日

首次发布 (实际的)

2020年4月6日

研究记录更新

最后更新发布 (实际的)

2020年7月8日

上次提交的符合 QC 标准的更新

2020年7月7日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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