Kinesio Taping Method for Chronic Mechanical Low Back Pain: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in "Roland Morris Disability Questionnaire"
研究概览
简要总结
The purpose of this study is to determine whether the kinesio taping method is effective in the treatment of chronic (more than six months duration) low back pain.
详细描述
Hypothesis: Kinesio taping treatment in patients with chronic low back pain, in which fascial mobilisation represents a treatment effect modifier, reduces pain and disability and improves quality of live, in comparison with simulated kinesio taping.
Objective:
- Primary objective: To evaluate kinesio taping method effectiveness at short term (1 month) and medium term (6 months) - pain, disability and quality of live - in patients with chronic low back pain.
- Secondary objective: To analyze the influence of fear-avoidance beliefs, catastrophizing ideas and anxiety-depression presence in kinesio taping method effectiveness for chronic low back pain patients.
Method:
Chronic low back pain patients are recruited from the outpatient rehabilitation service of a health area of Valencia which serves a population of 320,000 inhabitants.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Chronic low back pain least 6 months duration.
- •Improvement of pain with mobilization of skin/fascias in physical examination.
- •Signature of informed consent.
排除标准
- •Having had previous treatment experience with kinesio taping method.
- •Presence of components of neuropathic pain (radiculopathy, lumbar canal stenosis).
- •Specific origin pain (vertebral fracture, tumor or nerve column structures, spondyloarthropathy, spondylodiscitis).
- •Prior spine surgery.
- •Mental retardation, severe mental illness, substance abuse or dependency, illiteracy.
研究组 & 干预措施
Kinesio Taping method
The tape is applied depending on the physical examination:
- Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively.
- Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point.
- Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers.
干预措施: Kinesio Taping method (Device)
Kinesio Taping sham
The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.
干预措施: Kinesio Taping sham (Device)
结局指标
主要结局
Change in "Roland Morris Disability Questionnaire"
时间窗: pretreatment, 4 weeks, 6 month
Assess activity limitations due to back pain. Consists of 24 statements. Patients were asked to answer yes or no to each statement. Each positive answer is worth one point with scores ranging from 0 (no disability) to 24 (severely disabled). The Spanish version has been validated.
次要结局
- Change in "Hospital Anxiety and Depression subscale"(pretreatment, 4 weeks, 6 month)
- Change in "Fear Avoidance Beliefs Questionnaire"(pretreatment, 4 weeks, 6 month)
- Change in "Pain Catastrophizing Scale"(pretreatment, 4 weeks, 6 month)
研究者
Julio Domenech
MD-PhD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana