Is Kinesio Taping Effective to the Radial Nerve in Patients With Lateral Epicondylitis? A Randomized-single Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change from baseline of pain on 2nd and 6th weeks
研究概览
简要总结
Lateral epicondylitis (LE) is the most frequent painful musculoskeletal condition, which is characterized by a pain in the lateral epicondyle of the humerus and the common extensor tendon. The incidence of LE is approximately one to three percent of general population. LE is mostly the result of the overuse and repetitive movements of wrists and hands because of occupational or recreational activities. Diagnosis depends on clinical symptoms, history and physical examination including manual provocation tests. Magnetic resonance imaging, ultrasound (US), x-ray and electrophysiological assessment may be used in patient who do not response to conservative treatments. It is known that the radial nerve cross sectional-areas (CSAs) are increased in cases of refractory LE, although nerve conduction studies are normal. There is insufficient evidence to prove the superiority of any of conservative treatments to the others in patients with LE. The literature indicates that Kinesio taping decreases pain intensity, recovers grip strength, and improves functional status in patients with LE. The investigators design a randomized, single-blind, controlled trail to evaluate the effects of Kinesio taping both clinical and using ultrasonography.
详细描述
After obtaining written informed consent, patients of clinically diagnosed with LE are randomized into intervention and control group. To all patients, activity modification is suggested and 750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group, kinesio tape was applied 3 times a week for 2 weeks with a total of 6 sessions. The primary outcome is visual analog scale (VAS) and secondary outcomes include the Patient-Rated Forearm Evaluation Questionnare (PRTEQ), CET thickness and radial nerve CSAs. The evaluation was performed pretreatment as well as on the 2nd week, and 6th week after the treatment.
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 (Investigator, 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
- •the presence of pain in the lateral elbow region at least for three months
- •tenderness around the lateral humeral epicondyle following at least one of these provocation tests: resisted wrist extension, resisted middle finger extension or passive stretch of wrist extensors.
排除标准
- •bilateral LE
- •presence of trigger point in the extensor muscles of the forearm
- •history of proximal upper extremity or neck symptoms
- •cervical pathology
- •central or peripheral neurologic disease
- •nerve entrapment syndromes
- •surgical treatments for LE
- •presence of condition that may prevent the patient using NSAIDs (i.e. gastrointestinal disorders, using anticoagulant)
- •trauma history of upper extremity
- •previous steroid injection around the lateral epicondyle
- •physical therapy targeted for LE in the past 6 months
- •presence of structures like fibrous bands, arc or recurrent radial artery around the radial nerve that may cause the entrapment of nerve
- •pregnancy and having any systemic disease that may cause swelling at nerves such as diabetes mellitus, renal insufficiency, thyroid disease or rheumatic disease.
研究组 & 干预措施
Kinesio tape plus NSAID
Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen.
干预措施: Kinesio Tape (Other)
Kinesio tape plus NSAID
Kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions in addition to 750 mg/day oral naproxen.
干预措施: oral naproxen (Drug)
NSAID
750 mg/day oral naproxen is administered for 10 days.
干预措施: oral naproxen (Drug)
结局指标
主要结局
Change from baseline of pain on 2nd and 6th weeks
时间窗: Pre-treatment, 2nd and 6th weeks after treatment
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. The VAS is a straight horizontal line of fixed length, 10cm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst, 0) to the right (best, 10).
次要结局
- Change from baseline of functional status on 2nd and 6th weeks(Pre-treatment, 2nd and 6th weeks after treatment)
- Change from baseline of radial nerve cross-sectional area (CSA) on 2nd and 6th weeks(Pre-treatment, 2nd and 6th weeks after treatment.)
- Change from baseline of common extensor tendon (CET) thickness on 2nd and 6th weeks(Pre-treatment, 2nd and 6th weeks after treatment.)
研究者
Basak Mansiz-Kaplan
Principal Investigator of Department of Physical Medicine and Rehabilitation
Ankara Education and Research Hospital
