Effectiveness of Transcranial Direct Current Stimulation on Functionality and Pain in Individuals With Patellar Tendinopathy: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Knee functionality
研究概览
简要总结
The aim of the present study is to investigate the effectiveness of transcranial direct current stimulation (tDCS) prior to a therapeutic eccentric exercise program on parameters related to pain and functionality in individuals with patellar tendinopathy. For this purpose, participants will be randomly divided into two groups: i) experimental group, receiving tDCS prior to a therapeutic exercise program; and ii) control group, receiving sham tDCS and a therapeutic exercise program. The interventions will last for 8 weeks. Additionally, four assessments will be conducted (baseline, week 4, week 8 and week 12). The variables studied are related to pain, functionality, muscle activity and strength, proprioception, and quality of life.
详细描述
Patellar tendinopathy is a painful condition affecting the anterior portion of the knee, commonly exacerbated by activities putting pressure on the patellofemoral joint. It remains a challenge for the healthcare system, not only due to its high prevalence, but also because of its high persistence and negative consequences. Although therapeutic exercise has been widely studied as a treatment strategy, eccentric exercise protocols, while effective, often require long application periods, which may affect treatment adherence. Additionally, eccentric exercise is pain-provoking and its therapeutic benefits for pain relief and functional improvement are controversial when used during the competitive season. More adaptable and personalized treatment strategies could enhance clinical outcomes and treatment adherence in patients with patellar tendinopathy. In this context, interventions combining exercise with other techniques have been proposed. However, existing evidence does not definitively determine the optimal approach for combining conservative treatment options to maximize benefits.
An emerging therapeutic approach combines Transcranial Direct Current Stimulation (tDCS) with therapeutic exercise protocols. tDCS involves the application of weak direct current to specific cortical areas, aiming to modulate brain excitability. This non-invasive method offers painless, selective, and focal stimulation with minimal side effects. Research increasingly supports the effectiveness of integrating tDCS with exercise for patellar tendinopathy, offering the potential to amplify exercise effects by modulating brain excitability. However, to date, no study has investigated the impact of tDCS combined with eccentric exercise on variables related to function and pain in patellar tendinopathy individuals.
Therefore, the aim of this study is to investigate the effectiveness of tDCS prior to a therapeutic eccentric exercise program on parameters related to pain and functionality in individuals with patellar tendinopathy.
This study is a randomized clinical trial in which two groups will participate, with different interventions: i) Experimental group: tDCS + Therapeutic eccentric exercise; and ii) Control group: Sham tDCS + Therapeutic eccentric exercise. The interventions will last for 8 weeks. Participants will be evaluated in four moments, at baseline, week 4, week 8 and week 12. The variables studied are related to pain, functionality, muscle strength and activity, proprioception, and quality of life.
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 (Participant)
盲法说明
Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 50 years.
- •Diagnosis of patellar tendinopathy (VISA-P score of 80 or lower).
- •Pain lasting more than 3 months.
排除标准
- •Previous knee surgery.
- •Corticosteroid injection in the previous 6 weeks.
- •Systemic inflammatory, autoimmune, or rheumatic diseases.
- •Cognitive or behavioural issues that hinder comprehension and adherence to the intervention.
- •Any neurological disease.
- •Neoplastic disease.
- •Subjects presenting contraindications for tDCS (Thair et al., 2017), including: personal and family history of epilepsy, metallic implants in the head, implanted medication pump, pacemaker, recurrent headaches, skin conditions (psoriasis, eczema), or major head surgeries, pregnancy, heart diseases, and various medications (psychotropic or antihistamines).
- •Subjects must not have undergone pharmacological treatment or knee physical rehabilitation programs for a period of 1 year.
研究组 & 干预措施
Experimental group
Participants will undergo an 8-week intervention of supervised eccentric exercise by a physiotherapist (3 sessions/week). During the first 4 weeks, real tDCS will be administered at a rate of 3 sessions per week (12 in total) as an adjunct to exercise . A direct current of 1.5 mA will be applied for 20 minutes to the primary motor cortex (M1) during each session of eccentric exercises. Additionally, all participants will perform the eccentric exercise program on the remaining weekdays at home unsupervised.
干预措施: tDCS + Therapeutic eccentric exercise (Other)
Sham group
Participants will undergo an 8-week intervention of supervised eccentric exercise by a physiotherapist (3 sessions/week). During the first 4 weeks, sham tDCS will be administered at a rate of 3 sessions per week (12 in total) as an adjunct to exercise. The current will be interrupted after 30 seconds. Additionally, all participants will perform the eccentric exercise program on the remaining weekdays at home unsupervised.
干预措施: Sham tDCS + Therapeutic eccentric exercise (Other)
结局指标
主要结局
Knee functionality
时间窗: 5 minutes
The Victorian Institute of Sport Assessment-Patella (VISA-P) is a questionnaire to assess the severity of patellar tendinopathies. It consists of 8 items with a rating range from 0 to 100. The optimal state would correspond to a score of 100.
次要结局
- Pain intensity(2 minutes)
- Health-related quality of life(2 minutes)
- Muscle strength(10 minutes)
- Electromyographic activity of lower limb muscles(5 minutes)
- Muscle flexibility(5 minutes)
- Muscle tone(5 minutes)
- Proprioception(5 minutes)
- Patient global perception of change(1 minute)
研究者
Marta Inglés de la Torre
Assistant Professor of Physiotherapy
University of Valencia