Fasciitis, PlantarNCT03020693
Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar Fasciitis
A study testing Invasive electrostimulation combined with exercises in people with Fasciitis, Plantar, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- Invasive electrostimulation combined with exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jan 2017to 13 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- Have been treated for plantar fasciitis in the las 4 weeks.
- Previous surgery in the foot
- Pregnancy.
- Communication Disorders.
- Holders of pacemakers or electrostimulators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial
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.
Read the 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.
- Conditions
- Fasciitis, Plantar
- Being tested
- Invasive electrostimulation combined with exercises, Placebo electrostimulation and exercises
- Keywords
- electrostimulation, exercise program
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive electrostimulation combined with exercisesProcedure or surgery
Also called dry needling with TENS
Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.
Placebo electrostimulation and exercisesProcedure or surgery
Also called Non-invasive electrostimulation combined with exercises
First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.
| Study group | Role | What they receive |
|---|---|---|
| Invasive electrostimulation combined with exercises. | Experimental | Dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program. Receives: Procedure: Invasive electrostimulation combined with exercises |
| Placebo electrostimulation and exercises. | Active comparator | Sham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program. Receives: Procedure: Placebo electrostimulation and exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start27 Jan 2017
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020693
- Sponsor's protocol ID
- PI-2015-12
- Status last verified
- Feb 2018
- First submitted
- 28 Dec 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27526703Eftekharsadat 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.
PubMed 27683642
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Invasive Electrostimulation Combined With an Exercise Program in Plantar. A Clinical Trial
- ClinicalTrials.gov ID
- NCT03020693
- Acronym / sponsor ID
- PI-2015-12
- Conditions
- Fasciitis, Plantar
- Keywords
- electrostimulation, exercise program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 27 Jan 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive electrostimulation combined with exercises. | Experimental | Procedure: Invasive electrostimulation combined with exercisesDry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to therapeutic intensity) combined with exercises program. |
| Placebo electrostimulation and exercises. | Active comparator | Procedure: Placebo electrostimulation and exercisesSham dry needling + TENS ( 4 Hz 200 microseconds during 30 minutes to non-therapeutic intensity) with surface electrodes combined with exercises program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive electrostimulation combined with exercisesAlso: dry needling with TENSProcedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program. | Procedure or surgery | Invasive electrostimulation combined with exercises. |
| Placebo electrostimulation and exercisesAlso: Non-invasive electrostimulation combined with exercisesFirst: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program. | Procedure or surgery | Placebo electrostimulation and exercises. |
Primary outcome
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.
4 secondary outcomes
Change in strength scores at 6 weeks from first session in patients with plantar fasciitis.
Time frame: 6 weeks
Change in the pain in the Trigger points at 6 weeks from first session in patients with plantar fasciitis.
Time frame: 6 weeks
Change in the functionality of foot and ankle at 6 weeks from first session in patients with plantar fasciitis.
Time frame: 6 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 27526703Thiagarajah 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 publication: PubMed 27683642Eftekharsadat 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.
Related trials for Fasciitis, Plantar
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Recruiting
Extracorporeal Shock Wave Therapy With or Without Kinesiotaping for Plantar Fasciitis
Plantar Fasciitis
Recruiting
Comparison of Transverse Friction Massage and Instrument- Assisted Soft-Tissue Mobilization in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
Planter Fasciitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive electrostimulation combined with exercises in people with Fasciitis, Plantar, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain scores on the visual analogue scale at 6 weeks in patients with plantar fasciitis. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03020693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.