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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSivas State Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise

    Other intervention

    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.

  • Percutaneous Electrolysis

    Device

    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 the myofascial trigger points of the gastrosoleus muscles.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Plantar Fascia Percutaneous Electrolysis plus ExerciseActive comparator 2 interventions
Group B: Muscle-Fascia Chain Percutaneous Electrolysis plus ExerciseExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in Pain Intensity (VAS)

Pain intensity related to plantar heel pain will be assessed using a 10-cm Visual Analog Scale (VAS). Higher scores indicate greater pain.

Time frame
Baseline (before treatment), immediately after completion of the 3rd treatment session (approximately 2 weeks), and 3 months after treatment initiation.

Secondary outcomes

1

Change in Pressure Pain Threshold (Algometry)

Pressure will be applied with an algometer at a right angle to the point on the plantar fascia where tenderness is most pronounced, and the patient will be asked to indicate the level at which discomfort is felt. The pressure value at which pain occurs will be determined as the pain threshold, and the pressure-pain threshold will be objectively assessed and recorded. Measurements will be repeated three times, and the best value will be recorded.

Time frame
Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.
2

Change in Functional Status (Foot Function Index - FFI)

Foot-related pain and disability will be evaluated using the Foot Function Index (FFI). Higher scores indicate greater pain and functional limitation.

Time frame
Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.
3

Change in Ultrasound Tissue Parameters of the Plantar Fascia

Tissue characteristics of the plantar fascia (e.g., thickness and echotexture, presence of hypoechogenic areas or neovascularization) will be assessed using musculoskeletal ultrasound.

Time frame
Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.
4

Change in Maximum Pain-Free Standing and Walking Time

The maximum time that participants can stand and walk on a flat surface without plantar heel pain will be recorded using a stopwatch. Longer times indicate better functional capacity.

Time frame
Baseline, post-treatment (approximately 2 weeks), and 3 months after treatment initiation.

Other outcomes

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