Focused Shockwave Therapy for Plantar Fasciopathy

Sierra Varona SL

Status: Not yet enrolling

Conditions: Plantar Fascitis; Fasciitis; Chronic Plantar Fasciitis

Treatments: Other: Wait-list Control: Exercise Only; Device: fESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT07471035

23

Details and patient eligibility

About

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.

Full description

This is a prospective, randomized, wait-list controlled pilot study designed to evaluate the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) on chronic plantar fasciopathy.Study Design and Participants:Twenty participants with chronic plantar heel pain lasting more than six months were enrolled. Inclusion criteria required a diagnosis of plantar fasciopathy confirmed by a thickness of > 4.0 mm on ultrasound. Participants were randomized 1:1 into an Experimental Group (fESWT + High-Load Strength Training) or a Wait-list Control Group (High-Load Strength Training only).Intervention Protocol:fESWT Administration: The experimental group received three sessions of fESWT once per week. Each session consisted of 2,000 pulses at a frequency of 5-8 Hz.Energy Settings: The Energy Flux Density (EFD) was titrated based on patient tolerance, ranging from 0.10 to 0.30 mJ/mm^2, using a "point-and-shoot" technique at the site of maximal tenderness.Standard of Care: All participants followed a progressive High-Load Strength Training (HLST) protocol, performing heel raises every other day.Assessments and Follow-up:The primary outcome measures include pain intensity via the Visual Analogue Scale (VAS) and functional disability via the Foot Function Index (FFI). Secondary outcomes focus on structural remodeling of the plantar fascia measured by high-resolution ultrasound. Evaluations are conducted at baseline and at 4, 8, and 12 weeks post-intervention to track both immediate rescue effects and long-term tissue normalization.Wait-list Management:To maintain ethical standards, the wait-list control group received the fESWT intervention after the initial 4-week comparative period.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged between 18 and 70 years. Diagnosis of chronic plantar fasciopathy with symptoms persisting for more than 6 months.

Presence of plantar fascia (PF) thickness > 4.0 mm, confirmed by high-resolution ultrasound.

Clinical history of localized pain at the medial calcaneal tubercle, specifically upon first steps in the morning or after prolonged rest.

Failure of previous conservative treatments (e.g., stretching, orthotics, or medication).

Ability to follow the High-Load Strength Training (HLST) exercise protocol.

Exclusion criteria

• Previous treatment with shockwave therapy or corticosteroid injections in the affected foot within the last 6 months.

Previous surgery for plantar heel pain.

Presence of systemic inflammatory diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).

Pregnancy.

Coagulopathies or use of anticoagulant medication.

Local infection or presence of skin lesions at the application site.

Known or suspected malignancy in the treatment area.

Presence of neurological conditions or peripheral neuropathy (e.g., tarsal tunnel syndrome).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

fESWT

Experimental group

Description:

Participants in this arm receive three weekly sessions of focused Extracorporeal Shockwave Therapy (fESWT). The treatment consists of 2,000 pulses per session with an Energy Flux Density (EFD) titrated to patient tolerance (ranging from 0.10 to 0.30 mJ/mm2) at a frequency of 5-8 Hz.

Treatment:

Device: fESWT

Other: Wait-list Control: Exercise Only

Wait-list Control: Exercise Only

Other group

Description:

Participants in this wait-list control arm perform only the standardized High-Load Strength Training (HLST) program (progressive heel-rises every other day) during the initial 4-week comparative phase. This arm serves as the control group to evaluate the specific clinical and structural added value of fESWT. For ethical reasons, after the primary 4-week assessment is completed, these participants are offered the same fESWT protocol administered to the experimental group.

Treatment:

Other: Wait-list Control: Exercise Only