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

Not Applicable

Completed

• Conditions: Fasciitis, Plantar; Pain, Acute; Iontophoresis; Ultrasound Therapy; Complications
• Interventions: Device: Application of ultrasound as physical therapy; Drug: Application of lidocaine together with dexamethasone

• Registration Number: NCT04917406
• Lead Sponsor: University of Seville

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-20
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-08
• Primary Completion: 2021-09-15
• Study Completion: 2021-10-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of ultrasound	Application of ultrasound as physical therapy	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.
Use of iontophoresis	Application of lidocaine together with dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Fasciitis pain	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	Baseline	The plantar fascia is assessed by ultrasound.
Health status	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

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement PGI-I questionnaire	1 month	Patient (PGI-I). Patient Global Impression of Improvement.

Trial Locations

Locations (1)

Universidad de Sevilla; 🇪🇸 Sevilla, Spain