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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917406
• Other study ID #: US-Foot 3
• Status: Completed
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: June 2023
• Source: University of Seville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 1, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Fasciitis
• Fasciitis, Plantar
• Pain, Acute
• Ultrasound Therapy; Complications

Intervention

Drug:
• Application of lidocaine together with dexamethasone
Lidocaine 2% is applied on the positive pole while dexamethasone 4 mg/ml is applied on the negative pole. Through the use of current the drugs penetrate the fascia.

Device:
• Application of ultrasound as physical therapy
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 a 1MZ head.

Locations

Country	Name	City	State
Spain	Universidad de Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasciitis pain	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	Baseline
Primary	Health status	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	Baseline
Primary	Plantar fascia thickness in mm	The plantar fascia is assessed by ultrasound.	Baseline
Secondary	Patient Global Impression of Improvement PGI-I questionnaire	Patient (PGI-I). Patient Global Impression of Improvement.	1 month