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

NCT04917406 | Completed

• 1 other identifier: US-Foot 3
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Plantar fascia thickness in mm

  The plantar fascia is assessed by ultrasound.

  Baseline

Secondary Outcomes (1)

• Patient Global Impression of Improvement PGI-I questionnaire

  1 month

Study Arms (2)

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.

Drug: Application of lidocaine together with dexamethasone

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.

Device: Application of ultrasound as physical therapy

Interventions

Application of lidocaine together with dexamethasone DRUG

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.

Use of iontophoresis

Application of ultrasound as physical therapy DEVICE

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.

Use of ultrasound

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Universidad de Sevilla

Seville, 41008, Spain

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Acute Pain

Interventions

Dexamethasone; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Aurora Castro-Méndez

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: May 20, 2021
• Primary Completion: September 15, 2021
• Study Completion: October 1, 2021
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

ES (1)