Evaluation of the Efficacy of Adding Low-intensity Percutaneous Musculoskeletal Electrolysis to the Conservative Treatment of Noninsertional Achilles Tendinopathy: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Victorian Institute of Sport Assessment - Achilles - Week 1
研究概览
简要总结
Achilles tendinopathy (AT) is one of the most reported myotendinous pathologies due to overuse in the literature. In the general adult population, its incidence is 2.35 cases per 1,000 patients, with no difference between men and women. The international literature reports that up to 29% of patients fail with conservative treatment.
Within physiotherapy, new alternatives for the treatment of tendinopathies arise, applying electric currents percutaneously, which from a mechanical effect associated to the use of a needle and an electric effect by the use of galvanic currents, generate a local inflammatory response; activation of the central nervous system and analgesia.
The aim of the research is to evaluate the efficacy of adding low intensity percutaneous electrolysis to the treatment with a high load eccentric exercise program based on the protocol of Silbernagel et al. in adults with Achilles tendinopathy to improve its functionality.
A randomized, double-blind, blinded, evaluator-blinded, controlled clinical trial will be conducted in parallel groups (experimental treatment vs. sham treatment), with a follow-up at 26 and 52 weeks after the first intervention. Non-probability and intentional sampling will be performed.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Presence of symptoms in one or both Achilles tendons with a minimum duration of two months. In case the symptoms are bilateral, the intervention or placebo will only be administered and its results evaluated- in the limb with greater symptomatology. If it is not possible to differentiate which one presents greater pain, the right Achilles tendon will be chosen.
- •Spontaneous pain of at least three points measured by a visual analog scale (VAS), reproducible by palpation between 2 and 6 cm above the insertion of the Achilles tendon in the calcaneal bone.
- •Evidence of tendinopathy by MRI.
- •Presence of post-static dyskinesia.
- •Willingness to not perform additional treatments (such as footwear modifications, physical therapy, orthotics, injections, or surgery) for Achilles tendon pain during the conduct of the trial.
- •Willingness to attempt to discontinue self-administration of medications (NSAIDs) for pain relief Achilles tendon(s) pain for at least 14 days prior to baseline assessment and during the course of the trial.
排除标准
- •Presence or suspicion of pregnancy.
- •Previous surgical intervention on the AT in the symptomatic leg(s)
- •Total or partial rupture in the symptomatic AT
- •Chronic ankle instability, in the foot with symptomatic tendon(s).
- •Pathologies that can derive in pain in the region of the AT without being proper of the picture. (e.g.: osteoarthritis, impingement syndromes).
- •Presence of arthritis or any metabolic or endocrine disorder (type 1 or 2 diabetes).
- •Psychological disorders.
- •Oncologic history.
- •Treatment with quinolones or fluoroquinolones during the last two years.
- •Treatment with statins for the control of hypercholesterolemia for more than two months
- •Treatments within or at the periphery of the Achilles tendon, with anesthetics, corticosteroids or any other pharmacological agent during the last three months.
- •Needle phobia
- •Allergy to metal
研究组 & 干预措施
Experimental group
A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.
干预措施: low intensity percutaneous musculoskeletal electrolysis (Device)
Experimental group
A single weekly intervention of low intensity galvanic currents will be applied in an ultrasound-guided manner.
干预措施: Silbernagel protocol (Other)
Simulated group.
The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.
干预措施: Sham application (Device)
Simulated group.
The application of a single weekly intervention of low intensity galvanic currents will be simulated in an echogenic way, with the equipment turned off.
干预措施: Silbernagel protocol (Other)
结局指标
主要结局
Victorian Institute of Sport Assessment - Achilles - Week 1
时间窗: one week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 3
时间窗: three week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 12
时间窗: twelve week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Baseline
时间窗: Baseline
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 2
时间窗: two week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 4
时间窗: four week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 7
时间窗: seven week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 6
时间窗: six week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 9
时间窗: nine week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 52
时间窗: fifty-two week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 5
时间窗: five week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 8
时间窗: eight week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 11
时间窗: eleven week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 10
时间窗: ten week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
Victorian Institute of Sport Assessment - Achilles - Week 26
时间窗: twenty-six week at study entry
patient reported outcomes specifically designed for the assessment of pain and function in the achilles tendinopathy. It has a scale from 0 (worst) to 100 (best).
次要结局
- visual analog scale - Baseline(Baseline)
- visual analog scale - Week 1(one week at study entry)
- visual analog scale - Week 4(four week at study entry)
- visual analog scale - Week 26(twenty-six week at study entry)
- visual analog scale - Week 52(fifty-two week at study entry)
- visual analog scale - Week 6(six week at study entry)
- visual analog scale - Week 9(nine week at study entry)
- The Foot and Ankle Ability Measure - Week 3(three week at study entry)
- The Foot and Ankle Ability Measure - Week 9(nine week at study entry)
- visual analog scale - Week 2(Two week at study entry)
- visual analog scale - Week 5(five week at study entry)
- visual analog scale - Week 7(seven week at study entry)
- visual analog scale - Week 8(eight week at study entry)
- visual analog scale - Week 3(three week at study entry)
- visual analog scale - Week 10(ten week at study entry)
- The Foot and Ankle Ability Measure - Week 11(eleven week at study entry)
- The Foot and Ankle Ability Measure - Week 12(twelve week at study entry)
- The Foot and Ankle Ability Measure - Week 52(fifty-two week at study entry)
- ultrasound Shear Wave elastography - Week 8(eight week at study entry)
- visual analog scale - Week 11(eleven week at study entry)
- visual analog scale - Week 12(twelve week at study entry)
- The Foot and Ankle Ability Measure - Baseline(Baseline)
- The Foot and Ankle Ability Measure - Week 1(one week at study entry)
- The Foot and Ankle Ability Measure - Week 2(two week at study entry)
- The Foot and Ankle Ability Measure - Week 4(four week at study entry)
- The Foot and Ankle Ability Measure - Week 6(six week at study entry)
- The Foot and Ankle Ability Measure - Week 7(seven week at study entry)
- The Foot and Ankle Ability Measure - Week 10(ten week at study entry)
- Vienna Achilles tendon morphological score - MRI - Week 8(eight week at study entry)
- The Foot and Ankle Ability Measure - Week 5(five week at study entry)
- The Foot and Ankle Ability Measure - Week 8(eight week at study entry)
- The Foot and Ankle Ability Measure - Week 26(twenty-six week at study entry)
- ultrasound Shear Wave elastography - Week 4(four week at study entry)
- ultrasound Shear Wave elastography - Week 52(fifty-two week at study entry)
- Vienna Achilles tendon morphological score - MRI - Week 26(twenty-six week at study entry)
- ultrasound Shear Wave elastography - baseline(Baseline)
- ultrasound Shear Wave elastography - Week 12(twelve week at study entry)
- ultrasound Shear Wave elastography - Week 26(twenty-six week at study entry)
- Vienna Achilles tendon morphological score - MRI - Week 4(four week at study entry)
- Vienna Achilles tendon morphological score - MRI - baseline(Baseline)
- Vienna Achilles tendon morphological score - MRI - Week 12(twelve week at study entry)
- Vienna Achilles tendon morphological score - MRI - Week 52(fifty-two week at study entry)
研究者
Santiago Marcelo d'Almeida, PT SCS PhD Candidate
Research Professor
Maimonides University