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

NCT ID: NCT03020693

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-27

Study Completion Date

2018-03-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fasciitis, Plantar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Invasive electrostimulation combined with exercises.

Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.

Group Type EXPERIMENTAL

Invasive electrostimulation combined with exercises

Intervention Type PROCEDURE

Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.

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.

Group Type ACTIVE_COMPARATOR

Placebo electrostimulation and exercises

Intervention Type PROCEDURE

First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.

Interventions

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Invasive electrostimulation combined with exercises

Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.

Intervention Type PROCEDURE

Placebo electrostimulation and exercises

First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.

Intervention Type PROCEDURE

Other Intervention Names

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dry needling with TENS Non-invasive electrostimulation combined with exercises

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fundacion Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Countries

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Spain

References

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Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.

Reference Type BACKGROUND
PMID: 27526703 (View on PubMed)

Eftekharsadat B, Babaei-Ghazani A, Zeinolabedinzadeh V. Dry needling in patients with chronic heel pain due to plantar fasciitis: A single-blinded randomized clinical trial. Med J Islam Repub Iran. 2016 Jul 23;30:401. eCollection 2016.

Reference Type RESULT
PMID: 27683642 (View on PubMed)

Other Identifiers

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PI-2015-12

Identifier Type: -

Identifier Source: org_study_id

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