The Effect of Kinesio Taping on Pain and Functionality in the Rehabilitation Process After Lumbar Disc Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in pain on the 10-point Visual Analog Scale at Day 30.
研究概览
简要总结
In this study, it will be determined whether Kinesio-tape is an effective and reliable application in reducing pain and maintaining functionality after lumbar disc surgery, and its effect on the rehabilitation process will be evaluated.
详细描述
According to the 2019 Global Burden of Disease Survey published by the World Health Organization, the problems that contribute most to disability at the global level are musculoskeletal problems. Approximately 1.71 billion people in the world have musculoskeletal diseases (MSD), and low back pain is among the leading causes of disability in 160 countries. According to Turkey's 2019 Global Burden of Disease results, low back pain ranks first among the top ten causes of life years lost due to disability.
Low back pain is also the most common symptom of lumbar disc herniation. Pharmacological, non-pharmacological, and surgical treatment methods can be applied according to the nature of the damage in lumbar disc herniation. Mild to moderate back and leg pain, disability, limitation of function, and decrease in work performance are among the most common problems encountered by patients after surgical intervention for lumbar disc herniation. It is important to reduce low back pain and increase functionality after surgery. Numerous treatments have been researched for low back pain. Kinesio-tape application is gaining popularity around the world and has recently been seen as a preferred option for low back pain.
Kinesio-tape is a rehabilitation technique, designed to facilitate the natural healing process after trauma/inflammation by providing stability and support to muscles and joints. In recent years, its use has been increasing in musculoskeletal problems, neurological, rheumatic, vascular, and lymphatic problems. The Kinesio-tape is easy to apply, it can stay on the skin for a week; It is thought that it can be easily used by patients because it does not require constant effort and time, as in other physical therapy methods such as exercise. Although it has been suggested that Kinesio taping can be used together with traditional analgesic methods to reduce low back pain, no research has been found on the use of Kinesio tape after lumbar disc surgery. This study, it was aimed to determine whether Kinesio-taping is an effective and safe application in reducing post-operative lumbar pain and preserving functionality and to evaluate its effect on the rehabilitation process.
The study, planned as a randomized controlled experimental study, will be conducted with 80 patients (40 Kinesio and 40 placebo groups) who underwent lumbar disc surgery between 25 july 2022-30 december, 2022. Data will be collected with Introductory Information Form, Visual Comparison Scale, Oswestry Disability Index, Functional Low Back Pain Scale, Medication Tracking Form, Tape Tracking Form, Gait Tracking Form, "Healing Process After Lumbar Hernia Surgery".
The taping process will be done by the researcher Gülşah Bilgin, who has attended the course after receiving training on this subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In a randomized, placebo-controlled experimental trial, the participants and data analyzer will be blinded, and the researcher will be blinded to group assignments. Randomizer org site will be used for random assignment of groups as Kinesio or placebo (httpp://www.random.org/lists/). Index cards prepared by simple randomization by the researcher who did not participate in the clinical part of the study will be placed in closed opaque envelopes and sequence numbers will be written on the envelopes. Envelopes will be retained by the clinical secretary who did not participate in the study. The research data will be entered into the computer database by the researcher as coded as A and B, statistical analyzes will be carried out by the researcher who did not participate in the data collection phase according to this code, and the research report will be written in coded form.
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
- •be between the ages of 18-65,
- •Having had standard discectomy surgery in the last 24 hours, and
- •To sign the Informed Voluntary Consent Form.
排除标准
- •Having had surgery other than standard laminectomy or discectomy surgery in the last 24 hours,
- •Complications developed in the early postoperative period (such as severe bleeding, nausea, vomiting, hemiplegia),
- •Having undergone spinal surgery before,
- •To have applied Kinesio tape treatment,
- •To have received corticosteroid treatment in the two weeks before the surgery, Having clinical signs of central or peripheral nervous system disease (such as sensitivity to touch, lack of coordination, pain even in normal activities, memory loss),
- •Being pregnant, Being under the age of 18 and over the age of 65,
- •Having a neurological or orthopedic problem that may adversely affect the evaluation of exercise capacity, Having been diagnosed with respiratory or heart failure, and Having insulin-dependent diabetes and
- •Not signing the Informed Consent Form.
结局指标
主要结局
Change from baseline in pain on the 10-point Visual Analog Scale at Day 30.
时间窗: Baseline and Day 1, 5, 10, 15, 30.
The visual analogue scale is a 10cm ruler that shows "painlessness" at one end and "the most severe pain possible" at the other end. Change= (day 30- Baseline score)
pain - Medication tracking form
时间窗: from the postoperative period to the 30th day
All drugs used by the patient will be recorded on the drug form by the researcher at the hospital and by the patient or their relatives after they go home.The average score for painkillers will be evaluated as 2 points for narcotics and 1 point for non-narcotic drugs. The score will be calculated according to the dose taken by the patient, and if the patient has taken narcotic analgesics 2 times a day, the score will be 4 points.An increase in the score will be interpreted as an increase in the level of pain.
次要结局
- functionality-Oswestry Disability Index at Day 30.(Baseline and Day 5, 10, 15, 30.)
- functionality-Functional Low Back Pain Scale(Day 1, 5, 10, 15, 30.)
- functionality-Pedometer(Day 5, 10, 15, 30.)
- Evaluation of healing at the surgical site-Kinesio follow-up form(Day 1, 5, 10, 15, 30.)