Electrolysis in Patients With Chronic Plantar Fasciitis

NCT06674902 | Not Yet Recruiting

• 2 other identifiers: UCM#2#19/044
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the Study The aim of this study is to investigate the differential effects of high-intensity and low-intensity percutaneous electrolysis (PCE) on pain perception and muscle tissue properties in individuals with chronic plantar fasciitis. Research Questions Pain Perception: Does high-intensity PCE induce greater changes in pressure pain threshold (PPT) in the plantar fascia compared to low-intensity PCE in individuals with chronic plantar fasciitis? Muscle Tissue Properties: Does high-intensity PCE reduce stiffness in the plantar fascia to a greater extent than low-intensity PCE in individuals with chronic plantar fasciitis?

Conditions

Plantar Fasciitis

Keywords

Pain; Electrolysis; shear-wave elastography; pain sensitivity

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Participants will rate their pain intensity on an 11-point numeric rating scale (NPRS; 0 = no pain; 10 = worst possible pain). They will consider the pain intensity of their first step in the morning, the average pain intensity during the day, and the maximum pain experienced in the past week. The average of all these values will be used to calculate a pain intensity score for the primary analysis.

  Baseline, immediately after

Secondary Outcomes (4)

• Foot function

  Baseline, immediately after

• Pain threshold

  Baseline, immediately after

• Tolerance

  Baseline, during intervention, immediately after

• Tissue stiffness

  Baseline, immediately after

Study Arms (3)

Experimental 1: Electrolysis with 4 mA

EXPERIMENTAL

A charge of 24 mC will be delivered at 4 mA for 6 seconds, followed by a 54-second pause.

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Experimental 2: Electrolysis with 400 μA

EXPERIMENTAL

A charge of 24 mC will be delivered at 400 µA for 60 seconds.

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Experimental 3: Electrolysis with 600 μA

EXPERIMENTAL

A charge of 36 mC will be delivered at 600 µA for 60 seconds.

Device: Electrolysis Percutaneous Therapeutic (EPTE)

Interventions

Electrolysis Percutaneous Therapeutic (EPTE) DEVICE

EPTE device (Ionclinics, Valencia, Spain)

Experimental 1: Electrolysis with 4 mA; Experimental 2: Electrolysis with 400 μA; Experimental 3: Electrolysis with 600 μA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 years or older,
• unilateral heel pain lasting longer than 3 months,
• a clinical diagnosis of chronic plantar fasciitis according to the clinical practice guidelines of the Orthopaedic Section of the American Physical Therapy Association (APTA), i.e., sudden onset of pain on the plantar surface of the heel after a period of non-weight bearing, pain that is worse in the morning with the first step, and tenderness to palpation at the proximal attachment site of the plantar fascia.

You may not qualify if:

• previous lower extremity surgery,
• the presence of positive neurological signs consistent with nerve root compression,
• any medical conditions causing heel pain, such as rheumatoid arthritis, diabetes, or peripheral neuropathy,
• receipt of any foot treatment within the past 6 weeks.

Sponsors & Collaborators

• Wroclaw University of Health and Sport Sciences: lead
• Universidad Complutense de Madrid: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Faculty of Nursery, Physiotherapy and Podiatry

Madrid, 28040, Spain

Location

Related Publications (3)

• Alburquerque-Sendin F, Rios-Leon M, Valera-Calero JA, Plaza-Manzano G, Fernandez-de-Las-Penas C, Ortega-Santiago R, Priscila Rodrigues-de-Souza D. Clinical, Psychological, and Neurophysiological Outcomes Associated with Pain and Function in Individuals with Unilateral Plantar Heel Pain. Pain Med. 2022 Aug 31;23(9):1613-1620. doi: 10.1093/pm/pnac018.

  PMID: 35089360 BACKGROUND

• Rios-Leon M, Valera-Calero JA, Ortega-Santiago R, Varol U, Fernandez-de-Las-Penas C, Plaza-Manzano G. Analyzing the Interaction between Clinical, Neurophysiological and Psychological Outcomes Underlying Chronic Plantar Heel Pain: A Network Analysis Study. Int J Environ Res Public Health. 2022 Aug 18;19(16):10301. doi: 10.3390/ijerph191610301.

  PMID: 36011936 BACKGROUND

• Valera-Calero JA, Sanchez-Mayoral-Martin A, Varol U. Short-term effectiveness of high- and low-intensity percutaneous electrolysis in patients with patellofemoral pain syndrome: A pilot study. World J Orthop. 2021 Oct 18;12(10):781-790. doi: 10.5312/wjo.v12.i10.781. eCollection 2021 Oct 18.

  PMID: 34754834 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar; Pain

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Antonio Valera-Calero

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Central Study Contacts

Sebastian Klich

CONTACT

+48713473176; sebastian.klich@awf.wroc.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A triple-blinded, pilot randomized controlled trial

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: November 11, 2024
• Primary Completion: November 22, 2024
• Study Completion: November 30, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)