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

Primary Purpose

Fasciitis, Plantar

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Invasive electrostimulation combined with exercises
Placebo electrostimulation and exercises
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasciitis, Plantar focused on measuring electrostimulation, exercise program

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundacion Hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Invasive electrostimulation combined with exercises.

Placebo electrostimulation and exercises.

Arm Description

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

Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
December 28, 2016
Last Updated
February 11, 2019
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT03020693
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
March 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis, Plantar
Keywords
electrostimulation, exercise program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Invasive electrostimulation combined with exercises.
Arm Type
Experimental
Arm Description
Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program.
Arm Title
Placebo electrostimulation and exercises.
Arm Type
Active Comparator
Arm Description
Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program.
Intervention Type
Procedure
Intervention Name(s)
Invasive electrostimulation combined with exercises
Other Intervention Name(s)
dry needling with TENS
Intervention Description
Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.
Intervention Type
Procedure
Intervention Name(s)
Placebo electrostimulation and exercises
Other Intervention Name(s)
Non-invasive electrostimulation combined with exercises
Intervention Description
First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.
Primary Outcome Measure Information:
Title
Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.
Description
It will evaluate the strength using dynamometer in the first and tenth session. At 6 weeks, a new measurement will be made.
Time Frame
6 weeks
Title
Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.
Description
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.
Time Frame
6 weeks
Title
Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
Description
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.
Time Frame
6 weeks
Title
Change in the functionality and quality of life of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fundacion Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28834
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27526703
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.
Results Reference
background
PubMed Identifier
27683642
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.
Results Reference
result

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

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