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临床试验/NCT05539586
NCT05539586尚未招募不适用

Effectiveness of Tecar Therapy in Patients With Chronic Achilles Tendinopathy. Randomized Controlled Clinical Trial

Universitat Internacional de Catalunya0 个研究点目标入组 50 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Change in numerical pain rating scale (0-10)

研究概览

简要总结

Achilles tendinopathy is characterized by pain, decreased performance and swelling in and around the tendon. Up to 29% of patients with Achilles tendinopathy may require surgical intervention. It can be complicated by partial tears or complete rupture, placing a long-term burden on the healthcare system and making treatment more difficult.

The most common location of Achilles tendinopathy is in the insertional area of the calcaneus, 1.5 to 2 cm cranial to the bone. The most common location of pathologic inflammation was at the fascial intersection of the medial gastrocnemius and soleus when fused with the proximal Achilles tendon (66% of patients and the distal part of the Achilles tendon near the calcaneus. The four cornerstones of tendon histopathology are: cellular activation and increased cell number, increased ground substance, collagen disorganization and neovascularization. In addition, blood supply is one of the most influential factors in tendon tissue repair. A recent clinical trial compared the outcome after low frequency microwave hyperthermia with traditional ultrasound. The hyperthermia group recorded significantly better results after treatment and one month later. The use of deep heating modalities, due to their beneficial effects of increased circulation and cellular metabolism resulting in increased waste and nutrient exchange in a specific area, has long been accepted as part of the treatment of overuse tendinopathies . The application of heat has been reported to improve blood flow and oxygen saturation in the Achilles tendon.Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. he effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, elimination of excess fluid and increased cell proliferation. Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current. There are currently numerous treatment proposals for this pathology, however, the only one that has shown significant improvements are eccentric exercise protocols. The only drawback of this type of exercise is that the results are obtained in the long term.

There is currently no study that has compared the effectiveness of adding a tecartherapy protocol to the eccentric exercise protocol in chronic Achilles tendinopathy in athletes in the short and medium term in both functional and structural variables.

详细描述

Achilles tendinopathy is characterized by pain, decreased performance and swelling in and around the tendon. Up to 29% of patients with Achilles tendinopathy may require surgical intervention. It can be complicated by partial tears or complete rupture, placing a long-term burden on the healthcare system and making treatment more difficult.

The most common location of Achilles tendinopathy is in the insertional area of the calcaneus, 1.5 to 2 cm cranial to the bone. The most common location of pathologic inflammation was at the fascial intersection of the medial gastrocnemius and soleus when fused with the proximal Achilles tendon (66% of patients and the distal part of the Achilles tendon near the calcaneus. The four cornerstones of tendon histopathology are: cellular activation and increased cell number, increased ground substance, collagen disorganization and neovascularization. In addition, blood supply is one of the most influential factors in tendon tissue repair. There is an animal study in which when the blood supply to the Achilles tendon of a rabbit was decreased, the following changes were observed: the normally attached fascicles of the rabbit tendon separated and the tenocytes became disorganized from the interfascicular spaces. Collagen filaments became acellular and fragmented. Furthermore, it was shown that the changes observed in chronic degenerative tendon disorders in humans are the same as those that occur when the blood supply to the rabbit Achilles tendon is disturbed. This demonstrates that vascular supply is one of the important factors in treating tendon tissue.

A recent clinical trial compared the outcome after low frequency microwave hyperthermia with traditional ultrasound. The hyperthermia group recorded significantly better results after treatment and one month later. The use of deep heating modalities, due to their beneficial effects of increased circulation and cellular metabolism resulting in increased waste and nutrient exchange in a specific area, has long been accepted as part of the treatment of overuse tendinopathies . The application of heat has been reported to improve blood flow and oxygen saturation in the Achilles tendon. Thus, thermal agents may be an effective method to treat this type of tendon disorders.

Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. While the heat conducted by surface thermotherapy cannot reach the muscle due to the electrical resistance of the tissues, the capacitive-resistive electric currents in CRet therapy can generate heating of deep muscle tissues, which in turn improves hemoglobin saturation. In Europe, CRet is widely used in various medical rehabilitation processes. The physiological effects of this type of physiotherapy are generated by the application to the human body of an electromagnetic field with a frequency of approximately 0.5 MHz. The effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, elimination of excess fluid and increased cell proliferation.

Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Study participants must have signed the informed consent form in order to evaluate their participation in the study.
  • Actively practice some sporting activity.
  • Have a medical diagnosis of chronic Achilles tendinopathy of more than 3 months of evolution.
  • Not having previously received any tecartherapy treatment.
  • Be over 18 years of age.

排除标准

  • Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity.
  • Subjects with bilateral tendinopathies.
  • Subjects who report allergies to the conductive cream.
  • Not understanding the information provided by the therapist.
  • Participating in other research studies.
  • Subjects undergoing pharmacological medical treatment that may interfere with the measurements, such as treatment with anticonvulsants, antidepressants.

结局指标

主要结局

Change in numerical pain rating scale (0-10)

时间窗: Baseline; 3 weeks follow-up; 7 weeks follow-up

EVA pain scale will be used, where the patient will tell us the pain in numerical form.

Change in visual analogue scale (0-100 mm)

时间窗: Baseline; 3 weeks follow-up; 7 weeks follow-up

EVA pain scale will be used, where the patient will point on a fingertip on a straight line without numbers which has been his perception of pain.

次要结局

  • VISA-A questionnaire(Baseline; 3 weeks follow-up; 7 weeks follow-up)
  • Strength (kilograms)(Baseline; 3 weeks follow-up; 7 weeks follow-up)
  • Ankle range of motion in loading (degrees)(Baseline; 3 weeks follow-up; 7 weeks follow-up)
  • GROC scale(Baseline; 3 weeks follow-up; 7 weeks follow-up)
  • Cross-sectional area (mm2)(Baseline; 3 weeks follow-up; 7 weeks follow-up)
  • Stinfess (N m -1 )(Baseline; 3 weeks follow-up; 7 weeks follow-up)
  • Longitudinal section (mm)(Baseline; 3 weeks follow-up; 7 weeks follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maxim Canet Vintró

Principal Investigator

Universitat Internacional de Catalunya

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