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

S

Sivas State Hospital

Status

Enrolling

Conditions

Plantar Fasciitis

Treatments

Device: Percutaneous Electrolysis
Other: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07294196
EPTE-PF-001-S

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Plantar Fascia Percutaneous Electrolysis plus Exercise
Active Comparator group
Description:
Participants receive a conventional home-based exercise program including plantar fascia and Achilles tendon stretching, ball or roller rolling, and towel-grasping exercises targeting the intrinsic foot muscles, plus three sessions of ultrasound-guided percutaneous electrolysis applied only to the plantar fascia on days 1, 8, and 14, using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device (350 µA, 80 seconds).
Treatment:
Other: Exercise
Device: Percutaneous Electrolysis
Muscle-Fascia Chain Percutaneous Electrolysis plus Exercise
Experimental group
Description:
Participants receive the same conventional home-based exercise program as the active comparator group, plus three sessions of ultrasound-guided percutaneous electrolysis applied to both the plantar fascia and the myofascial trigger points of the gastrosoleus muscles on days 1, 8, and 14, using 0.3-mm acupuncture needles and an EPTE® percutaneous electrolysis device (350 µA, 80 seconds).
Treatment:
Other: Exercise
Device: Percutaneous Electrolysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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