About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Electrolysis Percutaneous Therapeutic (EPTE)
DeviceEPTE device (Ionclinics, Valencia, Spain)
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Foot function
Foot function will be assessed using the Foot Function Index (FFI), the most commonly used self-assessment tool for the foot. The FFI has been shown to be reliable, valid, and sensitive to change in individuals with chronic plantar heel pain. The Foot Function Index (FFI) consists of 23 self-reported questions divided into three subscales: pain (nine items), disability (nine items), and activity limitation (five items). Each item is rated on a 0-10 scale (0 = no pain or difficulty, 10 = worst possible pain or difficulty requiring help). Each subscale is scored as a percentage from 0% to 100%, with higher scores indicating lower function and poorer foot-related health-related quality of life. In this study, the total FFI score, calculated as the average of the three subscales, will be used for the primary analysis.
Pain threshold
Participants will avoid pain meds/muscle relaxants for 24 hours. PPT will be measured using an electronic algometer at 30 kPa/s, with 3 measurements per site and a 30-second interval. PPT will be assessed bilaterally at the calcaneus, adjacent muscles, tibialis anterior, and a pain-free site. Inter-rater reliability: 0.74-0.97.
Tolerance
Participants will rate the intensity of pain experienced during the intervention on an 11-point numeric rating scale (NPRS; 0 = no pain; 10 = worst possible pain).
Tissue stiffness
All images will be acquired using a General Electric Logiq P9 ultrasound system equipped with a linear 4-15 MHz probe, located in the Rehabilitation Department of the 12 de Octubre Hospital. Experienced researchers, with over 10 years of experience in musculoskeletal ultrasound and blinded to participant group assignment, will perform the imaging. Device parameters will be identical for all measurements (gain 55 dB, dynamic range 85, brightness 17, depth 4 cm, frequency 8 MHz). The plantar fascia image will be acquired in a longitudinal plane. Subsequently, shear wave elastography mode will be activated, and a region of interest 1 cm wide (corresponding to the width of the algometer head) and an appropriate height to analyze the entire thickness of the fascia will be marked. The ultrasound system will automatically calculate tissue stiffness parameters within the marked region (shear wave velocity and Young's modulus).
Sponsors and contacts
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Wroclaw University of Health and Sport Sciences
Lead sponsor
Universidad Complutense de Madrid
Collaborator
Universidad Rey Juan Carlos
Collaborator
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