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

Not Applicable

Completed

• Conditions: Fasciitis, Plantar
• Interventions: Procedure: Invasive electrostimulation combined with exercises; Procedure: Placebo electrostimulation and exercises

• Registration Number: NCT03020693
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

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 Timeline

• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Study Start: 2017-01-27
• Status Verified: 2018-02
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Invasive electrostimulation combined with exercises.	Invasive electrostimulation combined with exercises	Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.
Placebo electrostimulation and exercises.	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Fundacion Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain