Effect of a Common Exercise Programme With an Individualized Progression Criterion Based on the Measurement of Neuromuscular Capacity Versus Eccentric Training for Lower Limb Tendinopathies (MaLaGa Trial): Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Victorian Institute of Sport Assessment (VISA) questionnaire POST
研究概览
简要总结
This study compares the effect of a therapeutic physical exercise programme based on an individualized control of the exercise dose by monitoring the force-speed curves against the current best practice in the treatment of tendinopathies of the lower limb. Half of the participants will receive the experimental intervention, while the other half will receive the best current practice.
详细描述
The current best practice is based on a progressive strength training sustained in the continuous model of tendinopathy proposed by Cook and Purdam (Cook & Purdam, 2009), showing in the literature this methodology more effective than the wait and see approach or that the use of corticosteroid injections, accentuating the differences in long-term follow-up evaluations (Mellor et al., 2018). However, the current system lacks an objectification methodology for the severity of the pathology and objective criteria for the progression of the load, usually based on subjective feelings of discomfort or pre-established intensities.
Therefore, the investigators hypothesize that the development and introduction of a methodology for the quantification and progression of the loads, with an individual control and management of the exercise dose, as well as the execution of specific exercises for each one of them, could improve the clinica and functional results. Moreover, achieving neuromuscular adaptations based on the characteristics of the neuromuscular system, could improve the times and results of the intervention, as well as the rate of treatment failures, in the tendinopathies of the lower limbs.
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
- Single (Outcomes Assessor)
盲法说明
Assessors are not aware of the allocation group of the participants
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
- •People between 18 and 65 years with a clinical diagnosis of mid-portion Achilles, patellar, or gluteal tendinopathy;
- •Pain duration for at least one month.
排除标准
- •Corticosteroid injection in the studied tendon in the last 12 months;
- •Other injuries in the affected lower limb in the last 12 months;
- •Previous surgery for musculoskeletal causes of the affected lower limb in the last 12 months;
- •Tendinous rupture history in the affected lower limb;
- •Systemic diseases such as rheumatic arthritis or diabetes mellitus.
研究组 & 干预措施
Best current practice exercise programme
Therapeutic physical exercise, best current practice:
Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: two exercises performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).
Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: one exercise performed eccentrically, twice daily, 7 days/week, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).
Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL, from daily to twice weekly, 14 weeks (6 weeks are added to the program to match the volume of weeks of the experimental group).
干预措施: Best current practice exercise programme (Other)
Experimental exercise programme
Therapeutic physical exercise common for the three locations (Achilles, patellar and gluteal tendinopathy), based on an individual dosage and neuromuscular adaptations (five stages):
Strength training four exercises, once daily, three times/week, 14 weeks Aerobic training: Once daily, twice weekly
干预措施: Experimental exercise programme (Other)
结局指标
主要结局
Victorian Institute of Sport Assessment (VISA) questionnaire POST
时间窗: Post, 14 weeks after start of the intervention (when intervention is finished)
Visa-A for Achilles tendon, Visa-P for Patellar tendon, Visa-G for Gluteal tendon: functional mobility, life participation, and pain. Assessed from 0 (worst value) to 100 (best value).
次要结局
- Victorian Institute of Sport Assessment (VISA) questionnaire SHOR TERM(Short term, 7 weeks after start of the intervention)
- Central Sensitization Inventory (CSI) PRE(Baseline, 1 week before start of the intervention)
- Fear Avoidance Components Scale (FACS) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Fear Avoidance Components Scale (FACS) FOLLOW-UP(52 weeks after start of the intervention)
- Central Sensitization Inventory (CSI) FOLLOW-UP(52 weeks after start of the intervention)
- Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) SHORT TERM(Short term, 7 weeks after start of the intervention)
- Lower limb Strength PRE(Short term, 7 weeks after start of the intervention)
- Muscular Thickness PRE(Baseline, 1 week before start of the intervention)
- Muscular Thickness POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Muscular Thickness FOLLOW-UP(52 weeks after start of the intervention)
- Victorian Institute of Sport Assessment (VISA) questionnaire PRE(Baseline, 1 week before start of the intervention)
- Central Sensitization Inventory (CSI) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Victorian Institute of Sport Assessment (VISA) questionnaire Follow-up(52 weeks after the start of the intervention)
- Central Sensitization Inventory (CSI) SHORT TERM(Short term, 7 weeks after start of the intervention)
- Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) PRE(Baseline, 1 week before start of the intervention)
- Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Örebro Musculoskeletal Pain Questionnaire (ÖMPQ) FOLLOW-UP(52 weeks after start of the intervention)
- Lower limb Strength SHORT TERM(Short term, 7 weeks after start of the intervention)
- Lower limb Strength FOLLOW-UP(52 weeks after start of the intervention)
- European Quality of Life-5 Dimensions (EQ-5D) PRE(Baseline, 1 week before start of the intervention)
- Lower Limb Functional Index (LLFI) PRE(Baseline, 1 week before start of the intervention)
- Lower Limb Functional Index (LLFI) FOLLOW-UP(52 weeks after start of the intervention)
- Lower limb Strength POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Fear Avoidance Components Scale (FACS) PRE(Baseline, 1 week before start of the intervention)
- Fear Avoidance Components Scale (FACS) SHORT TERM(Short term, 7 weeks after start of the intervention)
- European Quality of Life-5 Dimensions (EQ-5D) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- European Quality of Life-5 Dimensions (EQ-5D) FOLLOW-UP(52 weeks after start of the intervention)
- European Quality of Life-5 Dimensions (EQ-5D) SHORT TERM(Short term, 7 weeks after start of the intervention)
- Lower Limb Functional Index (LLFI) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Lower Limb Functional Index (LLFI) SHORT TERM(Short term, 7 weeks after start of the intervention)
- Pressure Pain Threshold POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Muscular Thickness SHORT TERM(Short term, 7 weeks after start of the intervention)
- Pressure Pain Threshold PRE(Baseline, 1 week before start of the intervention)
- Pressure Pain Threshold SHORT TERM(Short term, 7 weeks after start of the intervention)
- Pain at rest measured with Visual Analogue Scale (VAS) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Pain at rest measured with Visual Analogue Scale (VAS) FOLLOW UP(52 weeks after start of the intervention)
- Pain during activity (running) measured with Visual Analogue Scale (VAS) SHORT-TERM(Short term, 7 weeks after start of the intervention)
- Lower limb Strength measured with hand-held dinamometer PRE(Baseline, 1 week before start of the intervention)
- Pressure Pain Threshold FOLLOW-UP(52 weeks after start of the intervention)
- Pain at rest measured with Visual Analogue Scale (VAS) PRE(Baseline, 1 week before start of the intervention)
- Pain at rest measured with Visual Analogue Scale (VAS) SHORT TERM(Short term, 7 weeks after start of the intervention)
- Pain during activity (running) measured with Visual Analogue Scale (VAS) FOLLOW UP(52 weeks after start of the intervention)
- Treatment satisfaction PRE(Baseline, 1 week before start of the intervention)
- Treatment satisfaction POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) PRE(Baseline, 1 week before start of the intervention)
- Pain during activity (running) measured with Visual Analogue Scale (VAS) PRE(Baseline, 1 week before start of the intervention)
- Pain during activity (running) measured with Visual Analogue Scale (VAS) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Treatment satisfaction SHORT-TERM(Short term, 7 weeks after start of the intervention)
- Lower limb Strength measured with hand-held dinamometer POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Lower limb Strength measured with hand-held dinamometer SHORT TERM(Short term, 7 weeks after start of the intervention)
- Lower limb Strength measured with hand-held dinamometer FOLLOW UP(52 weeks after start of the intervention)
- HDEMG profile with Non Invasive Surface High-Density Electromyography (HDEMG) POST(Post, 14 weeks after start of the intervention (when intervention is finished))
- Treatment satisfaction FOLLOW UP(52 weeks after start of the intervention)
- Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)(52 weeks after start of the intervention)
- Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)(Baseline, 1 week before start of the intervention)
- Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)(Short term, 7 weeks after start of the intervention)
- Amount of physical activity with International Physical Activity Questionnaire Short Form (IPAQ-SF)(Post, 14 weeks after start of the intervention (when intervention is finished))
研究者
Dr. Antonio I Cuesta-Vargas
Director, Clinical Research
University of Malaga