Plantar FascitisNCT05826301
Neuromodulation vs. Electrolysis in Plantar Fasciitis
A study testing Percutaneous neuromodulation in tibial nerve and Percutaneous electrolysis in people with Plantar Fascitis, run by Universidad Europea de Madrid at 2 sites in Spain.
Trial summary
The aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. Authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Percutaneous neuromodulation in tibial nerve and Percutaneous electrolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesSpain
- Study dates
- 1 May 2020to 15 Aug 2023
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patiens with plantar fasciitis
Who cannot join
- Lower limb disturbances
- Sistemic diseases
- Not involved in other drug or manual therapy interventions
- Infections
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects
The aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. Authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure.
- Conditions
- Plantar Fascitis
- Being tested
- Percutaneous neuromodulation in tibial nerve, Percutaneous electrolysis
- Keywords
- pain, plantar fasciitis, ultrasound imaging, quality of life
- Medical subject headings
- Pain, Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous neuromodulation in tibial nerveOther
The procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve.
Percutaneous electrolysisOther
The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds.
1 time per weeK
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous neuromodulation in tibial nerve | Experimental | Specifically, the procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve.
2 times per week Receives: Other: Percutaneous neuromodulation in tibial nerve |
| Percutaneous electrolysis | Active comparator | The procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds.
1 time per week Receives: Other: Percutaneous electrolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
visual analoge scale (VAS)
Measured: Pre intervention
Pain intensity
visual analogue scale (VAS)
Measured: immediately post intervention
Pain intensity
visual analogue scale (VAS)
Measured: at 4 weeks
Secondary outcomes (6)
quality of life perception
SF-36 questionnaire
Measured: Pre intervention
quality of life perception
SF-36 questionnaire
Measured: immediately post intervention
quality of life perception
SF-36 questionnaire
Measured: at 4 weeks
Ultrasonography of extrinsic foot muscles
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
Measured: Pre intervention
Ultrasonography of extrinsic foot muscles
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
Measured: immediately post intervention
Ultrasonography of extrinsic foot muscles
Ultrasound imaging of the thickness and cross-sectional area of the tibiais
Measured: at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2020
- Primary completion30 Sep 2022
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies 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
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826301
- Sponsor's protocol ID
- AA-11/8/HMC/DADCI
- Status last verified
- Apr 2023
- First submitted
- 21 Feb 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.
PubMed 34063673Ilfeld BM, Gelfand H, Dhanjal S, Hackworth R, Plunkett A, Turan A, Vijjeswarapu AM, Cohen SP, Eisenach JC, Griffith S, Hanling S, Mascha EJ, Sessler DI. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S53-S61. doi: 10.1093/pm/pnaa332.
PubMed 33313729Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.
PubMed 30160335Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7.
PubMed 28086940San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.
PubMed 33876885Borrella-Andres S, Malo-Urries M, Perez-Bellmunt A, Arias-Buria JL, Rodriguez-Sanz J, Albarova-Corral MI, Gonzalez-Rueda V, Gallego-Sendarrubias GM, Fernandez-de-Las-Penas C, Lopez-de-Celis C. Application of Percutaneous Needle Electrolysis Does Not Elicit Temperature Changes: An In Vitro Cadaveric Study. Int J Environ Res Public Health. 2022 Nov 26;19(23):15738. doi: 10.3390/ijerph192315738.
PubMed 36497812Calderon-Diez L, Sanchez-Sanchez JL, Robles-Garcia M, Belon-Perez P, Fernandez-de-Las-Penas C. Cadaveric and Ultrasound Validation of Percutaneous Electrolysis Approach at the Achilles Tendon as a Potential Treatment for Achilles Tendinopathy: A Pilot Study. Int J Environ Res Public Health. 2022 Sep 21;19(19):11906. doi: 10.3390/ijerph191911906.
PubMed 36231206Munoz-Fernandez AC, Barragan-Carballar C, Villafane JH, Martin-Perez S, Alonso-Perez JL, Diaz-Meco R, Garcia-Jimenez D, Sanchez-Romero EA. A new ultrasound-guided percutaneous electrolysis and exercise treatment in patellar tendinopathy: three case reports. Front Biosci (Landmark Ed). 2021 Nov 30;26(11):1166-1175. doi: 10.52586/5017.
PubMed 34856761
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects
- ClinicalTrials.gov ID
- NCT05826301
- Acronym / sponsor ID
- AA-11/8/HMC/DADCI
- Conditions
- Plantar Fascitis
- Keywords
- pain, plantar fasciitis, ultrasound imaging, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 24 Apr 2023 (actual)
- 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.
The aim of the present study will be the implementation of two protocols in plantar fasciitis individuals: a) percutaneous neuromodulation, b) percutaneous electrolysis in plantar fascia. Authors hypothesized that percutaneous neuromodulation may have benefits in: pain, quality of life, muscular structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous neuromodulation in tibial nerve | Experimental | Other: Percutaneous neuromodulation in tibial nerveSpecifically, the procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve. 2 times per week |
| Percutaneous electrolysis | Active comparator | Other: Percutaneous electrolysisThe procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds. 1 time per week |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patiens with plantar fasciitis
Key exclusion criteria (4 listed)
- Lower limb disturbances
- Sistemic diseases
- Not involved in other drug or manual therapy interventions
- Infections
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 |
|---|---|---|
| Percutaneous neuromodulation in tibial nerveThe procedure consisted in the application of a square wave biphasic electrical current, with 2-4 Hz frequency, 450 μs pulse during 25 minutes with a needle (0.30mm x 40 mm) inserted proximal to the surface on the tibial nerve. | Other | Percutaneous neuromodulation in tibial nerve |
| Percutaneous electrolysisThe procedure consist on placed a needle (0.30mm x 40 mm) on the most hyperalgesic plantar fascia location with a galvanic current of 3mA, 3 times during 3 seconds. 1 time per weeK | Other | Percutaneous electrolysis |
Primary outcome
Pain intensity
Time frame: Pre intervention
visual analoge scale (VAS)
Pain intensity
Time frame: immediately post intervention
visual analogue scale (VAS)
Pain intensity
Time frame: at 4 weeks
visual analogue scale (VAS)
6 secondary outcomes
quality of life perception
Time frame: Pre intervention
quality of life perception
Time frame: immediately post intervention
quality of life perception
Time frame: at 4 weeks
Ultrasonography of extrinsic foot muscles
Time frame: Pre intervention
Ultrasonography of extrinsic foot muscles
Time frame: immediately post intervention
Ultrasonography of extrinsic foot muscles
Time frame: at 4 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 30 Oct 2023.
- Background: PubMed 34063673De-la-Cruz-Torres B, Abuin-Porras V, Navarro-Flores E, Calvo-Lobo C, Romero-Morales C. Ultrasound-Guided Percutaneous Neuromodulation in Patients with Chronic Lateral Epicondylalgia: A Pilot Randomized Clinical Trial. Int J Environ Res Public Health. 2021 May 3;18(9):4877. doi: 10.3390/ijerph18094877.
- Background: PubMed 33313729Ilfeld BM, Gelfand H, Dhanjal S, Hackworth R, Plunkett A, Turan A, Vijjeswarapu AM, Cohen SP, Eisenach JC, Griffith S, Hanling S, Mascha EJ, Sessler DI. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Pragmatic Effectiveness Trial of a Nonpharmacologic Alternative for the Treatment of Postoperative Pain. Pain Med. 2020 Dec 12;21(Suppl 2):S53-S61. doi: 10.1093/pm/pnaa332.
- Background: PubMed 30160335Ilfeld BM, Said ET, Finneran JJ 4th, Sztain JF, Abramson WB, Gabriel RA, Khatibi B, Swisher MW, Jaeger P, Covey DC, Robertson CM. Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: Neuromodulation of the Femoral Nerve for Postoperative Analgesia Following Ambulatory Anterior Cruciate Ligament Reconstruction: A Proof of Concept Study. Neuromodulation. 2019 Jul;22(5):621-629. doi: 10.1111/ner.12851. Epub 2018 Aug 30.
- Background: PubMed 28086940Ilfeld BM, Gilmore CA, Grant SA, Bolognesi MP, Del Gaizo DJ, Wongsarnpigoon A, Boggs JW. Ultrasound-guided percutaneous peripheral nerve stimulation for analgesia following total knee arthroplasty: a prospective feasibility study. J Orthop Surg Res. 2017 Jan 13;12(1):4. doi: 10.1186/s13018-016-0506-7.
- Background: PubMed 33876885San-Emeterio-Iglesias R, Minaya-Munoz F, Romero-Morales C, De-la-Cruz-Torres B. Correct Sciatic Nerve Management to Apply Ultrasound-Guided Percutaneous Neuromodulation in Patients With Chronic Low Back Pain: A Pilot Study. Neuromodulation. 2021 Aug;24(6):1067-1074. doi: 10.1111/ner.13396. Epub 2021 Apr 20.
- Background: PubMed 36497812Borrella-Andres S, Malo-Urries M, Perez-Bellmunt A, Arias-Buria JL, Rodriguez-Sanz J, Albarova-Corral MI, Gonzalez-Rueda V, Gallego-Sendarrubias GM, Fernandez-de-Las-Penas C, Lopez-de-Celis C. Application of Percutaneous Needle Electrolysis Does Not Elicit Temperature Changes: An In Vitro Cadaveric Study. Int J Environ Res Public Health. 2022 Nov 26;19(23):15738. doi: 10.3390/ijerph192315738.
- Background: PubMed 36231206Calderon-Diez L, Sanchez-Sanchez JL, Robles-Garcia M, Belon-Perez P, Fernandez-de-Las-Penas C. Cadaveric and Ultrasound Validation of Percutaneous Electrolysis Approach at the Achilles Tendon as a Potential Treatment for Achilles Tendinopathy: A Pilot Study. Int J Environ Res Public Health. 2022 Sep 21;19(19):11906. doi: 10.3390/ijerph191911906.
- Background: PubMed 34856761Munoz-Fernandez AC, Barragan-Carballar C, Villafane JH, Martin-Perez S, Alonso-Perez JL, Diaz-Meco R, Garcia-Jimenez D, Sanchez-Romero EA. A new ultrasound-guided percutaneous electrolysis and exercise treatment in patellar tendinopathy: three case reports. Front Biosci (Landmark Ed). 2021 Nov 30;26(11):1166-1175. doi: 10.52586/5017.
Related trials for Plantar Fascitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Recruiting
F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
Plantar Fascitis, Chronic Heel Pain
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Recruiting
Effects of Deep Transverse Friction Massage and Instrument Assisted Soft Tissue Mobilization in Plantar Fasciitis.
Plantar Fascitis
Active, not recruiting
HP Arize 3D Orthotics for Planar Fasciitis
Plantar Fascitis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous neuromodulation in tibial nerve and Percutaneous electrolysis in people with Plantar Fascitis, run by Universidad Europea de Madrid at 2 sites 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 1 inclusion and 4 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Pain intensity (time frame: Pre intervention). The study lists 3 primary outcomes in all. 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 NCT05826301, which also lists 8 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 30 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.