Electrolysis in Patients With Chronic Plantar Fasciitis

NCT ID: NCT06674902

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-11
• Study Completion Date: 2024-11-30

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?

Detailed Description

A randomized, controlled, triple-blind clinical trial will be conducted to compare the effects of a single session of percutaneous intertissued electrolysis in three different modes (two intervention groups with the same dose but different intensity and time parameters, and one intervention group with a different dose) in patients with chronic plantar fasciitis (PF).

This study will be conducted under the Consolidated Standards of Reporting Trials (CONSORT) guidelines for pragmatic clinical trials and the EQUATOR guidelines to improve health research quality and transparency. Since the study involves patients with plantar pain, participants' rights will be respected under the Declaration of Helsinki. The Ethics Committee of University Hospital 12 de Octubre must approve the study protocol before data collection begins. The study protocol will also be prospectively registered on ClinicalTrials.org before data collection begins.

Sociodemographic variables (age, sex, weight, height, and body mass index), clinical variables (pain intensity, disability related to PF, pain thresholds to pressure), mechanical variables (plantar fascia stiffness), and tolerance to the treatment (visual analog scale to assess the intensity of pain felt during the intervention) will be assessed. Sociodemographic variables will be collected before the intervention, clinical and mechanical variables before and after the intervention, and tolerance to treatment only after the intervention. The assessment of participants will be carried out by an assessor who will not know which intervention group the participant belongs to. Participants will not know what dose they received, and the physiotherapists performing the procedures will also not know what settings the electrotherapy device has.

Participants will be randomly assigned to one of three intervention groups using a random number generator (Research Randomizer, version 4.0). Individual cards with numbers assigned sequentially according to the randomization will be used, which will then be folded and placed in opaque, sealed envelopes to ensure the concealment of allocation. An external researcher will select the envelope and make the assignment, which will only be revealed to the external therapist setting the equipment parameters after the initial data collection is completed. The assessor, therapist, and participants will not know to which group they have been assigned.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental 1: Electrolysis with 4 mA

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

Group Type: EXPERIMENTAL

Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type: DEVICE

EPTE device (Ionclinics, Valencia, Spain)

Experimental 2: Electrolysis with 400 μA

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

Group Type: EXPERIMENTAL

Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type: DEVICE

EPTE device (Ionclinics, Valencia, Spain)

Experimental 3: Electrolysis with 600 μA

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

Group Type: EXPERIMENTAL

Electrolysis Percutaneous Therapeutic (EPTE)

Intervention Type: DEVICE

EPTE device (Ionclinics, Valencia, Spain)

Interventions

Electrolysis Percutaneous Therapeutic (EPTE)

EPTE device (Ionclinics, Valencia, Spain)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: collaborator

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Wroclaw University of Health and Sport Sciences

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Klich

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Antonio Valera-Calero

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

Faculty of Nursery, Physiotherapy and Podiatry

Madrid, , Spain

Countries

Spain

Central Contacts

Sebastian Klich

Role: CONTACT

sebastian.klich@awf.wroc.pl

+48713473176

References

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.

Reference Type: BACKGROUND

PMID: 35089360 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36011936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34754834 (View on PubMed)

Other Identifiers

#19/044

Identifier Type: OTHER

Identifier Source: secondary_id

UCM#2

Identifier Type: -

Identifier Source: org_study_id