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临床试验/NCT05262972
NCT05262972招募中不适用

APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN

University of Seville1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Distribution of plantar pressures

研究概览

简要总结

Percutaneous electrolysis is a minimally invasive method that involves the application of a galvanic current through an acupuncture needle. The needle is placed directly into the soft tissue structures, essential with ultrasound guidance. This technique involves the combination of mechanical stimulation produced by the needle and electrical/biochemical stimulation provided by the electrical current.

Endogenous pain modulation shows clinical relevance of this technique and plays an important role in the experience of pain.

Plantar plate injury is a pathology that frequently occurs in the forefoot, especially in middle-aged women, causing metatarsalgia that is sometimes very intense. In most cases it is secondary to a mechanical imbalance of the forefoot, related to an insufficiency of the first radius. For this reason, the researchers hypothesize that the application of ultrasound-guided percutaneous electrolysis on the plantar plate, combined with the conservative treatment consisting of the development of a personalized plantar orthosis, can cause positive effects in the patient's clinic as well as improve their 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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adult female patients (40-65 years old)
  • Having pain in the 2nd MTP joint of the foot due to pathology of the plantar plate, diagnosed by a specialized professional.

排除标准

  • to have suffered an injury to their musculoskeletal system in the last 6 months.
  • to have the present neuritic pathology,
  • to have complete rupture of the plantar plate, 2nd finger supraadductus, flexor digitorum longus tenosynovitis,
  • to have problems in the lumbar spine,
  • to have undergone surgery in the lumbar spine or lower limbs.
  • to use a plantar orthosis.
  • to have the presence of associated pathologies in the foot,
  • to be under the influence of any medication at the time of the study, fear of needles
  • to be pregnant
  • to be epileptic.

结局指标

主要结局

Distribution of plantar pressures

时间窗: 1 month

Podiatric platform (pressure percentage 0-100%)

level of pain at palpation

时间窗: 1 month

Intensity of pain on palpation in the injured structure (0, no pain; 10, worse pain)

Quality of life

时间窗: 1 month

Foot Health Status Questionnaire

Subjetive level of pain

时间窗: 1 month

Intensity of subjective pain in the injured structure (0, no pain; 10, worse pain)

次要结局

未报告次要终点

研究者

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

Blanca de la Cruz Torres

Director

University of Seville

研究点 (1)

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Percutaneous Needle Electrolysis on Metatarsalgia | 临床试验