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

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ClinicalTrials.gov Identifier: NCT04917406
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Aurora Castro Mendez, 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.


Condition or disease Intervention/treatment Phase
Iontophoresis Ultrasound Therapy; Complications Fasciitis, Plantar Pain, Acute Drug: Application of lidocaine together with dexamethasone Device: Application of ultrasound as physical therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial: Comparison in the Treatment of Plantar Fasciitis by Iontophoresis Versus Ultrasound.
Actual Study Start Date : May 20, 2021
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Use of iontophoresis
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
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.

Active Comparator: Use of ultrasound
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
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 Measures :
  1. Fasciitis pain [ Time Frame: 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

  2. Health status [ Time Frame: 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

  3. Plantar fascia thickness in mm [ Time Frame: Baseline ]
    The plantar fascia is assessed by ultrasound.


Secondary Outcome Measures :
  1. Patient Global Impression of Improvement PGI-I questionnaire [ Time Frame: 1 month ]
    Patient (PGI-I). Patient Global Impression of Improvement.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04917406


Locations
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Spain
Universidad de Sevilla Recruiting
Sevilla, Spain, 41008
Contact: Aurora Castro, Dra.677    677608957    auroracastro@us.es   
Sponsors and Collaborators
University of Seville
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Responsible Party: Aurora Castro Mendez, Aurora Castro-Méndez, University of Seville
ClinicalTrials.gov Identifier: NCT04917406    
Other Study ID Numbers: US-Foot 3
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Acute Pain
Musculoskeletal Diseases
Foot Diseases
Pain
Neurologic Manifestations
Dexamethasone
Lidocaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action