Clinical trial NCT03020693: Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis
Official title: Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar
Keywords: electrostimulation
exercise program
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.
timeFrame: 6 weeks
measure: Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.
timeFrame: 6 weeks
measure: Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
timeFrame: 6 weeks
measure: Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Hospital Ramón y Cajal
Study officials:
References:
citation: 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.
citation: 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.