Diagnostic Ultrasonography in Physiotherapy as a Prevention of the Development of Complications of Post-Traumatic Ankle Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The measurement of swelling
研究概览
简要总结
Ankle injuries are among the most common traumatological injuries of the lower limb accounting for approximately 50% of all sports injuries and 25% of musculoskeletal injuries in general. Correct initial diagnosis and proper management is important to reduce the risk of recurrent ankle instability and other complications, such as reduced range of motion, increased ligament laxity, instability, tendon enthesopathy, possible swelling, formation of calcifications, reduced load on the affected limbs while standing and walking, increased pain intensity and pain duration. To date, few studies showed that the effectiveness of physical therapy increases when it is modified based on diagnostic ultrasonography findings. Sonography is not burdensome for the patient, has high reproducibility, and enables dynamic examination and comparison of the interrelationships of individual structures.
The aim of this study is to investigate if targeted physiotherapy for post-traumatic ankle conditions designed based of diagnostic ultrasonography findings is more effective than standard physiotherapy. The study hypothesis is that in the experimental group there will be a smaller number of complications of post-traumatic ankle conditions than in the control group. If confirmed the study could have clinical implications.
详细描述
A randomized controlled trial
In a randomized controlled trial, patients with post-traumatic soft tissue damage in the ankle area will be randomly divided into two groups. Both groups will undergo the same number of physiotherapy sessions (10 half-hour outpatient sessions over the course of two months) and will be examined with standard clinical tests and diagnostic ultrasonography at the beginning of the program and at week 8 using a standardized protocol published by the European Society of Musculoskeletal Radiology. Both groups will undergo the same physiotherapy techniques. Their choice will be modified in the experimental group based on the current findings of diagnostic sonography, while in the control group they will be applied according to the standard procedure recommended by the physician.
Randomization
Participants meeting the entry criteria will be examined by diagnostic ultrasonography, then randomly assigned to two groups using software (https://www.randomizer.org/) and sent for an entry examination by an independent investigator. Group 1 will undergo standard physiotherapy without continuous monitoring of the course and effect of treatment with diagnostic ultrasonography. The treatment of the second group will be modified based on the current findings of the diagnostic ultrasonography. The therapeutic protocol for each patient will be given to an independent physiotherapist (the therapist will not know the details of the study) in a sealed envelope.
Study participants
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 15 years and ≤ 65 years
- •Post-traumatic conditions in the ankle area, 0 - 6 weeks after the primary injury
- •Ability to undergo continuous outpatient physiotherapy treatment
- •Active cooperation of the patient
排除标准
- •Age < 15 years and > 65 years
- •Serious diseases affecting effective physiotherapy (e.g. tissue damage of metabolic, degenerative, neurological or oncological origin)
- •Previous ankle surgery
- •Gypsum fixation
结局指标
主要结局
The measurement of swelling
时间窗: The change from baseline to 8 weeks
Over the course of the therapy, we will measure the swelling with a standard retractable four-inch plastic tape measure and a marking pen according to a standardized protocol. (decreasing the size of edema over time marks positive change).
Pain level
时间窗: The change from baseline to 8 weeks
Examination using the Wong-Baker scale. The scale is used to subjectively assess pain. Pain rating scale (0-10): 0 - no pain; 2 - hurts a little; 4 - hurts a little more; 6 - hurts even more; 8 - hurts a lot; 10 - hurts the most (0 is the best value, 10 is the worst).
The range of motion of the ankle
时间窗: The change from baseline to 8 weeks
Goniometry will be performed with a stainless steel two-arm goniometer (ref. SH5103). Measurement of the ankle (talocrural joint) dorsiflexion range of motion: Participants will actively adduct the tip of the injured ankle while sitting on a physical therapy table. The expected range of motion with knee extension is approx. 10 degrees, with 20 degrees of knee flexion. For the evaluation, we will use a 3-point evaluation scale: 0-3 (0 - no limitation in dorsiflexion, 1 - small limitation in dorsiflexion, 2 - great limitation in dorsiflexion, 3 - no movement in dorsiflexion) (0 means the best value, 3 is the worst).
Number of complications
时间窗: The change from baseline to 8 weeks
The following complications will be monitored using sonographic examination based on a standardized protocol issued by the European Society of Musculoskeletal Radiology using a 7L4BP 5-10 MHz linear probe. The following complications will be measured according to standardized methodologies and evaluated by comparison with the same measured parameters on the ankle of the uninjured leg: 1. greater thickness of the ligaments (anterior tibiofibular and anterior talofibular ligament); 2. the presence of exudate in the area of anterior talofibular ligament, 3. the presence of calcifications, 4. a reduction in the continuity of the ligament apparatus in the ankle or the continuity of the syndesmosis compared to the non-affected leg. A higher number means a higher number of complications.
次要结局
- Chronic ankle instability rate(The change from baseline to 8 weeks)
- Analysis of standing and walking(The change from baseline to 8 weeks)
- Examination of ankle dorsiflexion muscle strength(The change from baseline to 8 weeks)
研究者
Petr Routner
Principal Investigator
Charles University, Czech Republic