Percutaneous Electrolysis Targeting the Muscle-Fascia Chain for Treating Chronic Plantar Fasciitis in Adults

Official title

Effectiveness of Percutaneous Electrolysis Treatment Targeting the Muscle-Fascia Chain in Chronic Plantar Fasciitis: A Randomized Controlled Study

Overview

The aim of this study is to compare, in terms of treatment effectiveness, a control group receiving a combination of a conventional exercise program and percutaneous electrolysis applied to the plantar fascia with an intervention group receiving a combination of a conventional exercise program plus percutaneous electrolysis applied both to the plantar fascia and to myofascial trigger points in the gastrosoleus muscles. Patients participating in the study will be randomized into two groups. Both groups will receive a conventional home exercise program. In the intervention group, percutaneous electrolysis treatment will be applied to both the plantar fascia and the trigger points of the gastrosoleus muscles. In the control group, percutaneous electrolysis treatment will be applied only to the plantar fascia. The percutaneous electrolysis treatment protocol will be administered on the 1st, 8th and 14th days of treatment under ultrasound guidance, using 0.3-millimeter acupuncture needles and an EPTE® percutaneous electrolysis device (Ionclinics \& A. Deionic SL, Valencia, Spain) at an intensity of 350 µA for 80 seconds. The conventional home exercise program will include plantar fascia and Achilles tendon stretching, ball or cylinder rolling, and towel-grasping exercises targeting the intrinsic foot muscles. Patients' subjective pain intensity will be assessed using the Visual Analog Scale (VAS), pressure pain threshold using an algometer, functional level using the Foot Function Index (FFI), tissue parameters using ultrasound, and maximum standing and walking times without heel pain; all outcomes will be measured and recorded before treatment, after treatment, and three months after the start of treatment. The aim of the study is to compare, in terms of treatment effectiveness, the control group receiving a combination of a conventional exercise program and percutaneous electrolysis applied to the plantar fascia with the intervention group receiving a combination of a conventional exercise program plus percutaneous electrolysis applied to both the plantar fascia and the myofascial trigger points in the gastrosoleus muscles.

Interventions

• Other Exercise
  Conventional home-based exercise program consisting of plantar fascia and Achilles tendon stretching, ball or roller rolling under the foot, and towel-grasping exercises targeting the intrinsic foot muscles. Participants are instructed to perform the exercises daily for the duration of the treatment period.
• Device Percutaneous Electrolysis
  Ultrasound-guided percutaneous electrolysis performed with 0.3-mm acupuncture needles connected to an EPTE® percutaneous electrolysis device (Ionclinics \& A. Deionic SL, Valencia, Spain). A direct galvanic current of 350 µA is applied for 80 seconds per point in each session. Three treatment sessions are administered on days 1, 8, and 14. In the active comparator arm the procedure is applied only to the plantar fascia, whereas in the experimental arm it is applied to both the plantar fascia and

Primary outcome measures

• Change in Pain Intensity (VAS) [Time frame: Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.]

Secondary outcome measures (4)

• Change in Pressure Pain Threshold (Algometry) [Time frame: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.]
• Change in Functional Status (Foot Function Index - FFI) [Time frame: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.]
• Change in Ultrasound Tissue Parameters of the Plantar Fascia [Time frame: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.]
• Change in Maximum Pain-Free Standing and Walking Time [Time frame: Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.]

Eligibility criteria

Inclusion criteria

Patients who agree to participate in the study, are between 18 and 70 years of age, have had symptoms for at least 6 weeks, and have a diagnosis of plantar fasciitis confirmed clinically (sharp pain on the plantar surface of the foot upon standing after rest, heel pain that is most severe with the first steps in the morning and decreases with mild activity) and by ultrasonography (plantar fascia thickness recorded as >4 mm on ultrasound), who have not previously received any medical treatment for the condition, who agree not to use anti-inflammatory drugs during the treatment period, who have normal blood laboratory findings, who have no known acute or chronic inflammatory disease, who have a level of education sufficient to understand the treatment and procedures applied, and who are able to complete the treatment evaluation forms will be included in the study.

Exclusion criteria

Patients with malignancy, active infection, a history of systemic inflammatory rheumatic disease, trauma, skin lesions, infection or open wounds on the foot, neuropathy, radiculopathy, peripheral circulatory disorders, coagulopathy, warfarin use, arthropathy, congenital or acquired lower extremity deformity, sequelae of lower extremity fracture, the presence of a prosthesis, internal plate or screw fixation, a cardiac pacemaker, a metal implant in the treatment area, conditions that contraindicate physiotherapy such as pregnancy, or metal allergy will not be included in the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Sivas Devlet Hastanesi — Sivas

Identifiers

NCT: NCT07294196 · EPTE-PF-001-S

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗