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NCT Number: NCT03020693

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

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.

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Key information

Conditions

Fasciitis, Plantar Fasciitis Foot Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Hospital Ramón y Cajal

Madrid, 28834, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Invasive electrostimulation combined with exercises

Procedure

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

Other names: dry needling with TENS

Placebo electrostimulation and exercises

Procedure

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

Other names: Non-invasive electrostimulation combined with exercises

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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