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NOT YET RECRUITING
NCT07471035
NA

Focused Shockwave Therapy for Plantar Fasciopathy

Sponsor: Sierra Varona SL

View on ClinicalTrials.gov

Summary

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.

Official title: Focused ESWT vs. Wait-list Management for Plantar Fasciopathy: A Randomized Controlled Trial Evaluating Pain, Function, and Ultrasonographic Plantar Fascia Thickness

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-04-15

Completion Date

2027-06-30

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

DEVICE

fESWT

Three 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.

OTHER

Wait-list Control: Exercise Only

Participants 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.