Clinical trial NCT05826301: Neuromodulation vs. Electrolysis in Plantar Fasciitis
Official title: Percutaneous Neuromodulation in Tibial Nerve vs. Electrolysis in Plantar Fasciitis Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: pain
plantar fasciitis
ultrasound imaging
quality of life
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain intensity
timeFrame: Pre intervention
measure: Pain intensity
timeFrame: immediately post intervention
measure: Pain intensity
timeFrame: at 4 weeks
Secondary outcomes:
measure: quality of life perception
timeFrame: Pre intervention
measure: quality of life perception
timeFrame: immediately post intervention
measure: quality of life perception
timeFrame: at 4 weeks
measure: Ultrasonography of extrinsic foot muscles
timeFrame: Pre intervention
measure: Ultrasonography of extrinsic foot muscles
timeFrame: immediately post intervention
measure: Ultrasonography of extrinsic foot muscles
timeFrame: at 4 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: UEM
city: Madrid
country: Spain
facility: Universidad Europea
Study officials:
References:
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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.
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.
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.
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.
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.