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Neuromodulation vs. Electrolysis in Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Percutaneous neuromodulation in tibial nerve
Percutaneous electrolysis
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring pain, plantar fasciitis, ultrasound imaging, quality of life

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patiens with plantar fasciitis Exclusion Criteria: Lower limb disturbances Sistemic diseases Not involved in other drug or manual therapy interventions Infections

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Percutaneous neuromodulation in tibial nerve

    Percutaneous electrolysis

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Pain intensity
    visual analoge scale (VAS)
    Pain intensity
    visual analogue scale (VAS)
    Pain intensity
    visual analogue scale (VAS)

    Secondary Outcome Measures

    quality of life perception
    SF-36 questionnaire
    quality of life perception
    SF-36 questionnaire
    quality of life perception
    SF-36 questionnaire
    Ultrasonography of extrinsic foot muscles
    Ultrasound imaging of the thickness and cross-sectional area of the tibiais
    Ultrasonography of extrinsic foot muscles
    Ultrasound imaging of the thickness and cross-sectional area of the tibiais
    Ultrasonography of extrinsic foot muscles
    Ultrasound imaging of the thickness and cross-sectional area of the tibiais

    Full Information

    First Posted
    February 21, 2023
    Last Updated
    April 20, 2023
    Sponsor
    Universidad Europea de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05826301
    Brief Title
    Neuromodulation vs. Electrolysis in Plantar Fasciitis
    Official Title
    Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2023 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Europea de Madrid

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plantar Fascitis
    Keywords
    pain, plantar fasciitis, ultrasound imaging, quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Percutaneous neuromodulation in tibial nerve
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Percutaneous electrolysis
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Percutaneous neuromodulation in tibial nerve
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Percutaneous electrolysis
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    visual analoge scale (VAS)
    Time Frame
    Pre intervention
    Title
    Pain intensity
    Description
    visual analogue scale (VAS)
    Time Frame
    immediately post intervention
    Title
    Pain intensity
    Description
    visual analogue scale (VAS)
    Time Frame
    at 4 weeks
    Secondary Outcome Measure Information:
    Title
    quality of life perception
    Description
    SF-36 questionnaire
    Time Frame
    Pre intervention
    Title
    quality of life perception
    Description
    SF-36 questionnaire
    Time Frame
    immediately post intervention
    Title
    quality of life perception
    Description
    SF-36 questionnaire
    Time Frame
    at 4 weeks
    Title
    Ultrasonography of extrinsic foot muscles
    Description
    Ultrasound imaging of the thickness and cross-sectional area of the tibiais
    Time Frame
    Pre intervention
    Title
    Ultrasonography of extrinsic foot muscles
    Description
    Ultrasound imaging of the thickness and cross-sectional area of the tibiais
    Time Frame
    immediately post intervention
    Title
    Ultrasonography of extrinsic foot muscles
    Description
    Ultrasound imaging of the thickness and cross-sectional area of the tibiais
    Time Frame
    at 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patiens with plantar fasciitis Exclusion Criteria: Lower limb disturbances Sistemic diseases Not involved in other drug or manual therapy interventions Infections
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lola Pujol
    Phone
    +34696878594
    Email
    mariadolores.pujol@universidadeuropea.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lola Pujol
    Email
    mariadolores.pujol@universidadeuropea.es

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34063673
    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.
    Results Reference
    background
    PubMed Identifier
    33313729
    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.
    Results Reference
    background
    PubMed Identifier
    30160335
    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.
    Results Reference
    background
    PubMed Identifier
    28086940
    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.
    Results Reference
    background
    PubMed Identifier
    33876885
    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.
    Results Reference
    background
    PubMed Identifier
    36497812
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36231206
    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.
    Results Reference
    background
    PubMed Identifier
    34856761
    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.
    Results Reference
    background

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    Neuromodulation vs. Electrolysis in Plantar Fasciitis

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