Controlled, Randomized, Blind Trial Therapy Exercises and Operant Conditioning for Chronic Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 4
- 主要终点
- Change in Visual Analog Scale (VAS) Pain Score
研究概览
简要总结
This study investigates the effect of two physiotherapy models in the treatment of chronic nonspecific low back pain. Participants will be divided into three groups, two experimental and one control. In both experimental groups, the participants will be included in the intensive program of Therapy Exercises, under the supervision and guidance of the physiotherapist, and the group will differ in implemented behavioral therapy (which he will implement by a physiotherapist). In the control group, subjects will receive the usual treatment. The Back School will be applied in all groups.
详细描述
Low back pain is a global public health problem, one of the main causes of disability of the population, as well as enormous economic costs in the health system. This claim specifically relates to chronic low back pain. The clinical picture of chronic low back pain in addition to pain, muscle spasm, and functional disability dominate psychological problems, which significantly affect the outcome of treatment. The multidisciplinary approach to the treatment of chronic low back pain has proven to be the most effective, bad economically unacceptable, and unavailable in many countries. Therefore, it is necessary to find the most effective and economically most acceptable approach to the treatment of chronic low back pain.
Physiotherapy is an unavoidable method of treating this painful condition, and changes in treatment approaches are most evident in this medical profession. Recently, physiotherapy includes two models in the treatment of chronic low back pain. A biomedical model consisting of well-known physiotherapy methods and a Biopsychosocial model that, in addition to known physiotherapy methods, includes a part of cognitive-behavioral therapy associated with motion and behavior, operative conditioning. Therapy exercise is an effective method indispensable part of both models of physiotherapy.
The reason for changes in physiotherapy is a varied clinical picture of chronic low back pain. Evidence-based effectiveness of therapy exercise has been determined on reduction of the body's symptoms, pain, and functional disabilities. The effect of reducing psychological symptoms has been poorly investigated. Also, the use of therapeutic exercises in the practice creates several concerns related to the intensity of exercise, mode and time-frame of their application, and the type or method of exercise.
Because it's already a known effect of operant conditioning through a multidisciplinary approach to reducing the psychological symptoms of chronic low back pain, it is suggested that this part of cognitive-behavioral therapy be implemented in physiotherapy, namely therapy exercise. Studies aimed to determine the effect of biopsychosocial physiotherapy models are scarce and insufficiently clear.
The aims of this study are:
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
Due to the nature of interventions that will be applied in this study, blinding of therapists who will carry out the intervention regarding Therapy Exercise will not be possible to implement, but physiotherapists (apart from the study designer) will not know the study hypothesis. Fully blinding of the examinees is also impossible to implement, but partially blinding will occur, as the participants in the Graded Activity group will not explain the applied behavioral therapy. Blinding will be applied to researchers who will collect data (measure outcomes) and statisticians.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People with a diagnosis of nonspecific pain in the spinal area with symptoms of pain 3 and > months, confirmed by a doctor specialist family medicine,
- •Age from 18 to 75 years of life,
- •Both sexes.
排除标准
- •Acute and Subacute low back pain,
- •Specific Low Back Pain,
- •Operative interventions on the spine,
- •Other health problems of the patient: pregnancy or gynecological diseases, blood vessels, elevated blood pressure, malignant and benign tumors in the spine, spinal abnormalities, spinal traumas, urological disorders and psychological disorders,
- •Mental health problems that prevent the verbal expression and understanding of the questionnaire, and
- •People who have been included in the therapeutic exercise program for the past 6 months.
结局指标
主要结局
Change in Visual Analog Scale (VAS) Pain Score
时间窗: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Self-reported pain intensity, Each item scored 0-100 mm (0=No pain; 100=Pain as bad as can be).
次要结局
- Change in Short Form Health Survey 12 (SF-12) core(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
- Change in Finger to Floor Test (FTF)(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
- Change in Hospital Anxiety and Depression Scale (HAD) Score(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
- Questionnaire assessment of satisfaction with treatment(6 month post-randomization)
- Change in Prone Double Straight Leg Raise Test (PDSLRT) Score(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
- Change in Roland Morris Disability Questionnaire (RMDQ) Score(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
- Change in Goniometry of spine (ROM) Score(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
- Change in Fear-Avoidance Beliefs Questionnaire (FABQ) Score(Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization)
研究者
Antonija Hrkać
Master of Physiotherapy, Postgraduate Study in Health Sciences
University of Mostar