Focused Shockwave Therapy for Plantar Fasciopathy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSierra Varona SL
About this trial
This study investigates whether focused Extracorporeal Shockwave Therapy (fESWT) helps people with chronic heel pain, commonly known as plantar fasciitis. Many patients suffer from this condition for more than six months without relief.
The study compares two groups: one receiving fESWT treatment plus a specific exercise program, and a "wait-list" group that only performs the exercises at first. The shockwave treatment uses precise sound waves targeted at the painful area to stimulate the body's natural healing process.
Researchers will measure if the treatment reduces pain and improves the patient's ability to walk and perform daily activities. Additionally, ultrasound will be used to see if the thickness of the plantar fascia (the tissue under the foot) decreases and returns to a healthier state. The goal is to confirm if fESWT provides a faster and more effective recovery than exercise alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female aged between 18 and 70 years. Diagnosis of chronic plantar fasciopathy with symptoms persisting for more than 6 months.
Disqualifiers
Previous treatment with shockwave therapy or corticosteroid injections in the affected foot within the last 6 months.
Trial design
Design model
Parallel
Treatments tested in this trial
fESWT
DeviceThree weekly sessions of focused shockwave therapy. Each session consists of 2,000 pulses at a frequency of 5-8 Hz. The Energy Flux Density (EFD) is titrated between 0.10 and 0.30 mJ/mm2 based on patient tolerance. The "point-and-shoot" technique is applied to the site of maximal tenderness.
Wait-list Control: Exercise Only
Other interventionParticipants assigned to this arm will undergo a wait-list period of 4 weeks during which they only perform the standardized High-Load Strength Training (HLST) program. The HLST consists of progressive unilateral heel-rise exercises performed every other day. This group serves as a comparative control to assess the clinical and structural changes (plantar fascia thickness) without the addition of shockwave therapy during the initial phase. After the primary 4-week assessment is completed, participants in this arm are offered the same focused Extracorporeal Shockwave Therapy (fESWT) protocol as the experimental group for ethical reasons.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: fESWTExperimental treatment 2 interventions
Group B: Wait-list Control: Exercise OnlyOther 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analogue Scale (VAS)
Pain intensity will be measured using a 100-cm Visual Analogue Scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable." A higher score indicates greater pain intensity.
Time frame
baseline,4,8 and 12 weeks2
Plantar Fascia (PF) Thickness
The thickness of the plantar fascia will be measured in millimeters (mm) using high-resolution B-mode ultrasound. Measurements are taken approximately 1 cm distal to the calcaneal insertion. A decrease in thickness is associated with tissue remodeling and clinical recovery.
Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks.Secondary outcomes
1
Foot Function Index (FFI) Score
The Foot Function Index (FFI) is a self-administered questionnaire used to measure foot pain and disability. The score is expressed as a percentage (0-100%), where higher percentages indicate greater disability and worse foot health.
Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sierra Varona SL
Lead sponsor
Universidad Europea de Madrid
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: