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临床试验/NCT04917406
NCT04917406已完成不适用

Randomized Clinical Trial: Comparison in the Treatment of Plantar Fasciitis by Iontophoresis Versus Ultrasound.

University of Seville1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
1
主要终点
Fasciitis pain

研究概览

简要总结

Plantar fasciitis is inflammation of plantar fascia.The main symptom of plantar fasciitis manifests itself as localized pain in the inner area of the foot and increases in intensity after long periods of standing or resting. Its etiology is multifactorial and risk factors include overweight, female gender, physical exercise (impact sports), biomechanical imbalances of the foot and possible dysfunction of the functional twin-ankle-plantar system.Generally speaking, conservative measures are recommended as initial treatment for plantar fasciitis, and in situations where these are ineffective, corticosteroids are sometimes administered. At the local level, the route of administration can be by infiltration or iontophoresis.Iontophoresis consists of administering a drug through the skin by applying an electric current locally. This technique can be considered as a safe and effective method within the SLTF (Transcutaneous Drug Delivery Systems). It consists of introducing ions through the skin by means of electricity using a direct current, with an electrode carrying a positive charge (anode) and a negative charge (cathode). Its administration is produced thanks to the repulsive force to carry the compound through the skin by means of galvanic current.

This study aims to assess whether treatment with iontophoresis in subjects with plantar fasciitis can show a more positive evolution in pain after a 6-week treatment period (treatment frequency: 1 time per week) versus ultrasound (3 times per week) for 6 weeks.

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)

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

入选标准

  • plantar fasciitis
  • fascia thickness (greater or equal to 4mm).

排除标准

  • skin lesion
  • sensory neuropathy
  • current use of plantar supports
  • taking pharmacological treatment (15 days) or previous infiltrations (6 months)
  • previous surgery or fractures of the lower limb
  • pregnancy
  • allergy to the applied drugs.

研究组 & 干预措施

Use of iontophoresis

Experimental

Lidocaine (local anesthetic) associated with dexamethasone (corticosteroid) will be administered by iontophoresis technique. Dose per session and iontophoresis: 10 minutes with an intensity of 4 mA.

干预措施: Application of lidocaine together with dexamethasone (Drug)

Use of ultrasound

Active Comparator

The treatment for the control group will be applied with a frequency of 3 times a week as usually performed in the ACP of the University of Seville. The application dose will be 0.65 Watt for 7 minutes in the area of most painful affectation by means of a circular movement and 1MZ head.

干预措施: Application of ultrasound as physical therapy (Device)

结局指标

主要结局

Fasciitis pain

时间窗: Baseline

Visual analog scale VAS to evaluate Heel pain intensity was referred to as 0-10, in which 0= no pain at all and 10= the worst pain possible

Plantar fascia thickness in mm

时间窗: Baseline

The plantar fascia is assessed by ultrasound.

Health status

时间窗: Baseline

EQ-5D assesses health status in terms of five dimensions of health and is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition. EQ-5D can also be referred to as a patient-reported outcome (PRO) measure, because patients can complete the questionnaire themselves to provide information about their current health status and how this changes over time. 'EQ-5D' is not an abbreviation and is the correct term to use when referring to the instrument in general

次要结局

  • Patient Global Impression of Improvement PGI-I questionnaire(1 month)

研究者

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

Aurora Castro Mendez

Aurora Castro-Méndez

University of Seville

研究点 (1)

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