Neuromodulation vs. Electrolysis in Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05826301
• Other study ID #: AA-11/8/HMC/DADCI
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 15, 2023

Study information

• Verified date: April 2023
• Source: Universidad Europea de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 15, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patiens with plantar fasciitis

Exclusion Criteria:

• Lower limb disturbances
• Sistemic diseases
• Not involved in other drug or manual therapy interventions
• Infections

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Other:
• Percutaneous neuromodulation in tibial nerve
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 electrolysis
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

Locations

Country	Name	City	State
Spain	UEM	Madrid
Spain	Universidad Europea	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Borrella-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. — View Citation

Calderon-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. — View Citation

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. — View Citation

Ilfeld 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. — View Citation

Ilfeld 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. — View Citation

Ilfeld 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. — View Citation

Munoz-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. Erratum In: Front Biosci (Landmark Ed). 2022 Mar 21;27(3):109. Fernandez, Alberto Carlos Munoz [corrected to Munoz-Fernandez, Alberto Carlos]; Carballar, Carlos Barragan [corrected to Barragan-Carballar, Carlos]; Perez, Sebastian Martin [corrected to Martin-Perez, Sebastian]; Perez, Jose Luis Alonso [corrected to Alon. — View Citation

San-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	visual analoge scale (VAS)	Pre intervention
Primary	Pain intensity	visual analogue scale (VAS)	immediately post intervention
Primary	Pain intensity	visual analogue scale (VAS)	at 4 weeks
Secondary	quality of life perception	SF-36 questionnaire	Pre intervention
Secondary	quality of life perception	SF-36 questionnaire	immediately post intervention
Secondary	quality of life perception	SF-36 questionnaire	at 4 weeks
Secondary	Ultrasonography of extrinsic foot muscles	Ultrasound imaging of the thickness and cross-sectional area of the tibiais	Pre intervention
Secondary	Ultrasonography of extrinsic foot muscles	Ultrasound imaging of the thickness and cross-sectional area of the tibiais	immediately post intervention
Secondary	Ultrasonography of extrinsic foot muscles	Ultrasound imaging of the thickness and cross-sectional area of the tibiais	at 4 weeks