Effect of Iontophoresis vs. Ultrasound in Plantar Fasciitis". Plantar Fasciitis"
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04917406|
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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
- 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
- Plantar fascia thickness in mm [ Time Frame: Baseline ]The plantar fascia is assessed by ultrasound.
- Patient Global Impression of Improvement PGI-I questionnaire [ Time Frame: 1 month ]Patient (PGI-I). Patient Global Impression of Improvement.
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
|Universidad de Sevilla||Recruiting|
|Sevilla, Spain, 41008|
|Contact: Aurora Castro, Dra.677 677608957 email@example.com|