Comparative effectiveness of a structured exercise program and radial extracorporeal shockwave therapy with McKenzie method on pain intensity, sensitivity and quality in athletes with chronic low back pain: a four-arm randomized controlled trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Pain intensity (Numeric pain rating scale), Pain sensitivity (Pressure pain threshold), Pain quality (Short version of McGill pain questionnaire)
研究概览
简要总结
This study will investigate the comparative effectiveness of four groups for chronic low back pain (LBP) in athletes. Overall, include three types of interventions: a structured exercise program (SEP), rESWT, and the McKenzie method. The study will be a 6-week, four-arm randomized controlled trial targeting athletes aged 15-40 years, experiencing non-specific LBP for more than three months. Primary outcomes include pain intensity, pain sensitivity, and pain quality, measured by the Numeric Pain Rating Scale, Pressure Pain Threshold, and McGill Pain Questionnaire. Secondary outcomes include disability, quality of life, fear avoidance beliefs, and psychological distress. The study aims to evaluate the efficacy of these interventions in improving pain and functional outcomes, providing insights into optimal treatment strategies for athletes with chronic LBP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Athletes with non-specific LBP with pain and symptoms persisting for more than 3 months and (2) visual analog scale of more than 3; (3) Athletes had to participate in level-I (jumping, pivoting, hard cutting like basketball, handball, soccer) or level-II sports (less jumping or hard cutting than level I, like volleyball, racket sports, martial arts, gymnastics) and training or playing five times per week.
- •Athletes must participate in official competitions (state, national or international competitions).
- •(4) athletes aged between 15 and 40 years; (5) pain radiating no further than the buttock (6) X-ray / MRI – normal findings.
排除标准
- •(1) History of lumbar disc herniation or trauma; (2) Any neurological symptoms and disease; (3) previous back surgery, spinal tumors or infections; (4) Pregnant; (5) Athletes who are using analgesics, dietary supplementation and/or anabolic steroids will also be excluded.
结局指标
主要结局
Pain intensity (Numeric pain rating scale), Pain sensitivity (Pressure pain threshold), Pain quality (Short version of McGill pain questionnaire)
时间窗: At baseline, after week-3, week-6, week-12
次要结局
- Disability (Oswestry disability index), Quality of life (SF-36), Fear and avoidance (Fear avoidance beliefs questionnaire), Psychological distress (Depression anxiety stress scale-21)(At baseline, after week-3, week-6, week-12)
研究者
Kazi Md Azman Hossain
Jashore University of Science and Technology (JUST), Jashore