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临床试验/NCT03493438
NCT03493438已完成不适用

The Effect of Different Physiotherapy Interventions on Patients With Chronic Low Back Pain

Baskent University2 个研究点 分布在 2 个国家目标入组 31 人开始时间: 2018年3月26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
31
试验地点
2
主要终点
Pain Intensity

研究概览

简要总结

Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. ) The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.

详细描述

Low back pain is an extremely common health problem that most people suffers at any point in their life. Low back pain is the leading cause of activity limitation and work absence throughout much of the world and it causes some economic problems for just not only individuals but also governments. Low back pain is a symptom rather than a disease. Non-specific low back pain term is used when the pathoanatomical cause of the pain cannot be determined. Most patients had pain that caused interference with daily function. Low back pain can be triggered by physical factors (eg, lifting awkwardly) or psychosocial factors (eg, being fatigued or tired), or by a combination of the two (eg, being distracted while lifting). There are several nonpharmacologic treatment options that include analgesics, muscle relaxants, physical therapy modalities, spinal manipulative therapy, psychological therapies and others for back pain. Unfortunately, none of the therapies has been established as superior to others. Controversly some of the investigators suggest individuals with chronic LBP can more benefit from exercise therapy interventions but still evidence on the effectiveness of nonpharmacologic therapies was very limited. The purpose of the study was to investigate the effects of different physical therapy techniques on pain, function and core stability in patients with low back pain.

Female patients with chronic, nonspecific LBP who were either undergoing or initiating physical therapy treatment at the Baskent University Ankara Hospital Physical Therapy and Rehabilitation outpatient clinic participated in the study.

Before the study began patients were randomized into four groups: Relaxation, Proprioceptive Neuromuscular Facilitation (PNF), core stability and control groups.

Descriptive characteristic of patients was evaluated at the beginning of the study. Pain, functionality, kinesiophobia and core stability was evaluated before and after the treatments. Pain and functionality were the primer outcome measures of this study, kinesiophobia, core stability and satisfaction were seconder. Patient satisfaction was assessed after the treatments.

A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four 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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • inclusion criteria;
  • Patients had to have LBP for at least 3 months,
  • Patients who reported osteoarthritis or disk lesions (without neurologic compromise) with or without leg pain,
  • Patients between 18 and 65 years of age,

排除标准

  • Patients were excluded if they demonstrated any of the following;
  • They had neurologic signs, specific spinal pathology (eg, malignancy, inflammatory joint disease, bone disease),
  • They had undergone back and lower extremity surgery.

结局指标

主要结局

Pain Intensity

时间窗: 6 weeks

Pain intensity was measured with visual analog scale (VAS). For VAS, it is desirable that patients express their pain with a (X) mark on a scale of 100 mm. According to this, "0" means that the patients have no pain and "100" means that they have worst pain. The distance between the marking point and the start of the line is measured in millimeters and the numerical value found determines the pain intensity of patients. The total pain intensity is measured with the scale of Likert type of 6 points. In this scale "0" indicates no pain and "5" indicates worst pain.

Functionality

时间窗: 6 weeks

The Oswestry Low Back Pain Questionnaire was used to assess the functioning of daily living activities in low back pain. There are 10 questions in the questionnaire, 6 options in each question, ranging from 0 to 5 points. The patient is asked to choose the expression that best describes the situation. The highest score was 50, with mild functional impairment between 1-10 points, moderate functional impairment between 11-30 points, and severe functional impairment between 31-50 points. The Turkish version of the questionnaire was validated and reliable.

Kinesiophobia

时间窗: 6 weeks

Individuals' kinesiophobia were assessed by using the Tampa Kinesiophobia Scale. The questionnaire is a 17-item measure designed to measure fear of movement / re-injury. The scale includes injury / re-injury and fear-avoidance parameters in work-related activities. A 4-point Likert Scale (1 = strongly disagree, 4 = fully agree) is used on the scale. A total score is calculated after the reversal of 4, 8, 12, and 16 questions. The patient has a total score between 17-68. The high score on the scale indicates that the kinesophobia is also high. The Turkish version of the questionnaire was validated and reliable

core stability

时间窗: 6 weeks

Core stability was assessed with the pressure device (Stabilizer Pressure Biofeedback, USA, Chattanooga Group, Hixson, TN). For transversus abdominus (TrA) and multifidus (MF) muscle strength the patients performed the drawing-in maneuver in a supine position, with their knees flexed at 90°. To perform abdominal drawing-in maneuver, all the subjects were instructed to slowly draw in their lower abdomen as if they were holding their urine and then draw up their pelvic floor muscle so that it could contract, together with their lower abdomen, while continuing normal breathing. The end part of the pressure device was placed on the posterior superior iliac spine. The pressure gauge was set to indicate 40 mmHg before the drawing-in maneuver began. The subjects were told to increase the pressure by 10 mmHg using the drawing-in maneuver on the verbal instruction, "start", and to maintain the state for 5 seconds. Pressure changes were recorded as mmHg.

次要结局

  • patient satisfaction(6 weeks)

研究者

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

aydan aytar

ASSOC. PROF.

Baskent University

研究点 (2)

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