Effect of Iontophoresis vs. Ultrasound and Iontophoresis in Plantar Fasciitis". Plantar Fasciitis"

University of Seville

Status: Completed

Conditions: Fasciitis, Plantar; Ultrasound Therapy; Complications; Iontophoresis; Pain, Acute

Treatments: Drug: Application of lidocaine together with dexamethasone; Device: Application of ultrasound as physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04917406

US-Foot 3

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Use of iontophoresis

Experimental group

Description:

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.

Treatment:

Drug: Application of lidocaine together with dexamethasone

Use of ultrasound

Active Comparator group

Description:

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.

Treatment:

Device: Application of ultrasound as physical therapy