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

Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)
Overall Status
Completed
CT.gov ID
NCT03020693
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
13.5
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Invasive electrostimulation combined with exercises
  • Procedure: Placebo electrostimulation and exercises
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial
Actual Study Start Date :
Jan 27, 2017
Actual Primary Completion Date :
Mar 13, 2018
Actual Study Completion Date :
Mar 13, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis. [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.

    Secondary Outcome Measures

    1. Change in strength scores at 6 weeks from first session in patients with plantar fasciitis. [6 weeks]

      It will evaluate the strength using dynamometer in the first and tenth session. At 6 weeks, a new measurement will be made.

    2. Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis. [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.

    3. Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis. [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.

    4. Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fundacion Hospital Ramón y Cajal Madrid Spain 28834

    Sponsors and Collaborators

    • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
    ClinicalTrials.gov Identifier:
    NCT03020693
    Other Study ID Numbers:
    • PI-2015-12
    First Posted:
    Jan 13, 2017
    Last Update Posted:
    Feb 15, 2019
    Last Verified:
    Feb 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
    electrostimulation
    exercise program
    Additional relevant MeSH terms:
    Fasciitis
    Fasciitis, Plantar

    Study Results

    No Results Posted as of Feb 15, 2019