"Effects of Rigid Tape in Patients With Chronic Achilles Tendinopathy"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Change on pain intensity
研究概览
简要总结
The aim of this study will be to determine the clinical effects of rigid tape in patients with chronic MAT. The secondary outcomes will be to evaluate the immediate and short term pain, the height and pain during the vertical jump, the satisfaction of the use of the tape and the global rating of change (GROC) of the intervention. This study will be a double-blinded randomized clinical trial comprising a total sample size of 36 participants with MAT of both genders and aged between 18 and 50 years. Subjects will undergo a screening process by a sports medicine doctor by different diagnostic tests to identify those presenting a diagnosis of painful MAT and then, they will be randomized into either a group performing experimental rigid tape (G1), or a group performing placebo tape (G2). The study will assess the subjects immediate and short-term tendon pain following the tape application during running and vertical jump. Also the tape satisfaction and GROC will be assessed. The rigid tape will be applied in the central portion of the Achilles tendon. Primary and secondary outcomes will be measured at baseline, immediate after the application of the tape and 72 hours after. The GROC will only be assessed at the end of the treatment. All the evaluations will be performed by a blinded physiotherapist. The patient will also be blinded.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of unilateral or bilateral MAT
- •Achilles pain > 3 months
- •Age ranging between 18 to 50 years, both genders
- •Read and speak Spanish well enough to provide informed consent and follow study instructions.
- •Pain during running and jumping.
排除标准
- •Any ankle or foot surgery
- •History of Achilles rupture
- •Heel pain in the last 3 months
- •Systemic disorders/diseases
- •Body mass index > 30kg/m2
- •Self-report of pregnancy
- •Pain < 2/100 of average pain on VAS
- •VISA A score > 90 points
结局指标
主要结局
Change on pain intensity
时间窗: At baseline, immediately and 72 hours after the intervention
The Visual Analog Scale (VAS) will be used to assess pain intensity during running and jumping. This scale consists of a sequence of numbers from 0 (no pain) to 100 mm (most severe pain).
次要结局
- Change on single leg vertical jump(At baseline, immediately and 72 hours after the intervention)
- Change on feeling of comfort of the tape(Immediately and 72 hours after the intervention)
- Change in perception of improvement of the treatment(72 hours after the intervention)
研究者
Gonzalo Elias
Principal Investigator
University of Gran Rosario