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

Primary Purpose

Iontophoresis, Ultrasound Therapy; Complications, Fasciitis, Plantar

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Application of lidocaine together with dexamethasone
Application of ultrasound as physical therapy
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iontophoresis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidad de Sevilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Use of iontophoresis

Use of ultrasound

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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
Plantar fascia thickness in mm
The plantar fascia is assessed by ultrasound.

Secondary Outcome Measures

Patient Global Impression of Improvement PGI-I questionnaire
Patient (PGI-I). Patient Global Impression of Improvement.

Full Information

First Posted
June 1, 2021
Last Updated
June 28, 2023
Sponsor
University of Seville
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1. Study Identification

Unique Protocol Identification Number
NCT04917406
Brief Title
Effect of Iontophoresis vs. Ultrasound and Iontophoresis in Plantar Fasciitis". Plantar Fasciitis"
Official Title
Randomized Clinical Trial: Comparison in the Treatment of Plantar Fasciitis by Iontophoresis Versus Ultrasound.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iontophoresis, Ultrasound Therapy; Complications, Fasciitis, Plantar, Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Use of iontophoresis
Arm Type
Experimental
Arm 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.
Arm Title
Use of ultrasound
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Application of lidocaine together with dexamethasone
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Application of ultrasound as physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasciitis pain
Description
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
Time Frame
Baseline
Title
Health status
Description
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
Time Frame
Baseline
Title
Plantar fascia thickness in mm
Description
The plantar fascia is assessed by ultrasound.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Patient Global Impression of Improvement PGI-I questionnaire
Description
Patient (PGI-I). Patient Global Impression of Improvement.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad de Sevilla
City
Sevilla
ZIP/Postal Code
41008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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