NCT05826301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

October 30, 2023

Status Verified

April 1, 2023

Enrollment Period

2.4 years

First QC Date

February 21, 2023

Last Update Submit

October 25, 2023

Conditions

Plantar Fascitis

Keywords

painplantar fasciitisultrasound imagingquality of life

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    visual analoge scale (VAS)

    Pre intervention

  • Pain intensity

    visual analogue scale (VAS)

    immediately post intervention

  • Pain intensity

    visual analogue scale (VAS)

    at 4 weeks

Secondary Outcomes (6)

  • quality of life perception

    Pre intervention

  • quality of life perception

    immediately post intervention

  • quality of life perception

    at 4 weeks

  • Ultrasonography of extrinsic foot muscles

    Pre intervention

  • Ultrasonography of extrinsic foot muscles

    immediately post intervention

  • +1 more secondary outcomes

Study Arms (2)

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

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

Other: Percutaneous electrolysis

Interventions

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 neuromodulation in 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

Percutaneous electrolysis

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patiens with plantar fasciitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UEM

Madrid, Spain

Location

Universidad Europea

Madrid, Spain

Location

Related Publications (8)

  • 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.

    PMID: 34063673BACKGROUND

  • 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.

    PMID: 33313729BACKGROUND

  • 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.

    PMID: 30160335BACKGROUND

  • 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.

    PMID: 28086940BACKGROUND

  • 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.

    PMID: 33876885BACKGROUND

  • 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.

    PMID: 36497812BACKGROUND

  • 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.

    PMID: 36231206BACKGROUND

  • 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.

    PMID: 34856761BACKGROUND

MeSH Terms

Conditions

PainFasciitis, Plantar

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsFasciitisMusculoskeletal DiseasesFoot Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2023

First Posted

April 24, 2023

Study Start

May 1, 2020

Primary Completion

September 30, 2022

Study Completion

August 15, 2023

Last Updated

October 30, 2023

Record last verified: 2023-04

Locations

ES(2)