Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis

February 11, 2019 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial

This study evaluates the effectiveness of an electrostimulation treatment with TENS using a needle and a surface electrode combined with an exercise program to fasciitis plantar. Half participants will receive invasive electrostimulation (TENS using a needle) and exercises while the other half will receive electrostimulation placebo and exercises.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are a lot of treatments to fasciitis plantar. Exercises are the treatments more recommended to fasciitis plantar but not all patients improve only with exercises. Dry needling is recommended to relieve the pain in the heel. TENS is used to decrease the pain in the fasciitis plantar. Investigators will apply to half participants a treatment that combines TENS + Dry needling (invasive electrostimulation ) with exercises while the other half receive electrostimulation placebo (TENS using surface electrodes with non-therapeutic intensity) + exercises.

Study Type

Interventional

Enrollment (Actual)

60

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 Locations

  • Spain
      • Madrid, Spain, 28834
        • Fundacion Hospital Ramón y Cajal

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical diagnosis of plantar fasciitis
  • Age equal or superior to 18 years old.
  • VAS minimum of 2 points int the first steps after a prolonged decreasing period.
  • Having an evolution of a month or more of pain.
  • Not having received acupuncture or dry needling as treatment.

Exclusion Criteria:

  • Peripheral Neuropathies.
  • Tarsus tunnel syndrome.
  • Rheumatic diseases.
  • Contraindication to dry needling: nickel allergy, fear of needles, sky with erosions.
  • Clotting disorders such as thrombosis or thrombophlebitis.
  • Fractures, infections and/ or tumor processes.
  • Have been treated for plantar fasciitis in the las 4 weeks.
  • Previous surgery in the foot
  • Pregnancy.
  • Communication Disorders.
  • Holders of pacemakers or electrostimulators.

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: Invasive electrostimulation combined with exercises.
Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.
Procedure: Invasive electrostimulation combined with exercises
Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.
Other Names:
  • dry needling with TENS
Active Comparator: Placebo electrostimulation and exercises.
Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.
Procedure: Placebo electrostimulation and exercises
First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.
Other Names:
  • Non-invasive electrostimulation combined with exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.
Time Frame: 6 weeks
It will evaluate the pain with Visual Analogue Scale in the first step in the first and tenth session. At 6 weeks, a new measurement will be made.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.
Time Frame: 6 weeks
It will evaluate the strength using dynamometer in the first and tenth session. At 6 weeks, a new measurement will be made.
6 weeks
Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.
Time Frame: 6 weeks
It will evaluate the pain with algometer in the first and tenth session in the plantar muscle. It will measure the change of pain in the Trigger points in the plantar muscle. At 6 weeks, a new measurement will be made .Three measurements will be made and the average data will be recorded.
6 weeks
Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
Time Frame: 6 weeks
It will evaluate the functionality using Foot and Ankle Ability Measure questionnaire (FAAM) in the first and tenth session. At 6 weeks, a new measurement will be made.
6 weeks
Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
Time Frame: 6 weeks
It will evaluate the functionality and quality of life using Foot Health Status Questionnaire (FHSQ) in the first and tenth session. At 6 weeks, a new measurement will be made.
6 weeks

Collaborators and Investigators

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

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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)

January 27, 2017

Primary Completion (Actual)

March 13, 2018

Study Completion (Actual)

March 13, 2018

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 11, 2019

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI-2015-12

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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