Neuromodulation vs. Electrolysis in Plantar Fasciitis

October 25, 2023 updated by: Universidad Europea de Madrid

Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects

The aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. Authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain
        • UEM
      • Madrid, Spain
        • Universidad Europea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patiens with plantar fasciitis

Exclusion Criteria:

  • Lower limb disturbances
  • Sistemic diseases
  • Not involved in other drug or manual therapy interventions
  • Infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous neuromodulation in tibial nerve

Specifically, the procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve.

2 times per week
Other: Percutaneous neuromodulation in tibial nerve
The procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve.
Active Comparator: Percutaneous electrolysis

The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds.

1 time per week
Other: Percutaneous electrolysis

The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds.

1 time per weeK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Pre intervention
visual analoge scale (VAS)
Pre intervention
Pain intensity
Time Frame: immediately post intervention
visual analogue scale (VAS)
immediately post intervention
Pain intensity
Time Frame: at 4 weeks
visual analogue scale (VAS)
at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life perception
Time Frame: Pre intervention
SF-36 questionnaire
Pre intervention
quality of life perception
Time Frame: immediately post intervention
SF-36 questionnaire
immediately post intervention
quality of life perception
Time Frame: at 4 weeks
SF-36 questionnaire
at 4 weeks
Ultrasonography of extrinsic foot muscles
Time Frame: Pre intervention
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
Pre intervention
Ultrasonography of extrinsic foot muscles
Time Frame: immediately post intervention
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
immediately post intervention
Ultrasonography of extrinsic foot muscles
Time Frame: at 4 weeks
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

February 21, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-11/8/HMC/DADCI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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