Structured Exercise Program on Pain intensity, sensitivity, and quality in Young Athletes with Acute Lateral Ankle Sprain: A Randomized Controlled Trial (SEPALAS Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain intensity (measure using the NPRS), pain sensitivity (measure using the algometer), and pain quality (assess using the McGill Pain Questionnaire).
研究概览
简要总结
The SEPALAS Trial will be a randomized controlled study designed to evaluate the effectiveness of a Structured Exercise Program (SEP) compared to Usual Care (UC) in young athletes (aged 18–30) with Grade I or II acute lateral ankle sprains confirmed by ultrasound. Eighty participants will be randomly assigned to either the SEP group, which will receive a progressive, physiotherapist-supervised exercise program over 18 sessions following an initial 72-hour PRICE protocol, or the UC group, which will follow standard self-care guidance with optional analgesics. The SEP will progress through three stages: pain and ROM restoration, muscle strengthening with proprioception, and sport-specific functional training. Primary outcomes will include pain intensity (NPRS), pain sensitivity (algometer), and pain quality (McGill Pain Questionnaire). Secondary outcomes will assess muscle strength (dynamometer), physical function (FAAM), and agility (Agility T-test). All outcomes will be measured at baseline, 3 weeks, 6 weeks, and 18 weeks to determine the program’s clinical effectiveness in promoting recovery and functional return.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants will be included if – (1) male or female athletes aged between 18 and 30 years; (2) diagnosis of Grade I or II lateral ankle sprain confirmed by ultrasound imaging; (3) sustained the injury within 0 to 72 hours prior to recruitment; (4) provide written informed consent and agree to participate in the full assessment and intervention protocol.
排除标准
- •Participants will be excluded if – (1) Fracture or dislocation of the foot or ankle, or other soft tissue injuries beyond lateral ankle sprain; (2) History of ankle surgery, or ankle trauma within the past 3 months.
- •(3) Chronic ankle instability or lower limb peripheral nerve injuries; (4) Recent trauma, and pregnancy history; (5) Any medical, legal, or physical condition that hinders safe participation in the exercise program.
结局指标
主要结局
Pain intensity (measure using the NPRS), pain sensitivity (measure using the algometer), and pain quality (assess using the McGill Pain Questionnaire).
时间窗: At baseline, 3 weeks, 6 weeks and 18 weeks
次要结局
- Muscle strength (measure using the dynamometer), Physical function (measure using the Foot and Ankle Ability Measure – FAAM), and Agility (measure using the Agility T-test).(At baseline, 3 weeks, 6 weeks and 18 weeks)
研究者
Kazi Md Azman Hossain
Jashore University of Science and Technology (JUST), Jashore