Focused Shockwave Therapy for Plantar Fasciopathy

NCT07471035 | Not Yet Recruiting

• 1 other identifier: 23
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Plantar Fascitis; Chronic Plantar Fasciitis; Fasciitis

Keywords

FOCUSED SHOCK WAVE THERAPY; fESWT; PLANTAR FASCIA THICKNESS

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline,4,8 and 12 weeks

• 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.

  Baseline, 4 weeks, 8 weeks, and 12 weeks.

Secondary Outcomes (1)

• Foot Function Index (FFI) Score

  Baseline, 4 weeks, 8 weeks, and 12 weeks.

Study Arms (2)

fESWT

EXPERIMENTAL

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.

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

Wait-list Control: Exercise Only

OTHER

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.

Other: Wait-list Control: Exercise Only

Interventions

fESWT DEVICE

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.

fESWT

Wait-list Control: Exercise Only OTHER

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.

Wait-list Control: Exercise Only; fESWT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sierra Varona SL: lead
• Universidad Europea de Madrid: collaborator

MeSH Terms

Conditions

Fasciitis, Plantar; Fasciitis

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Foot Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor is blinded to the group allocation. This assessor performs all ultrasonographic measurements and clinical data analysis to prevent observation bias and ensure the objective evaluation of plantar fascia structural changes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, wait-list controlled pilot study utilizing a parallel assignment model. Participants are randomized into two groups to compare the clinical and structural effects of focused Extracorporeal Shockwave Therapy (fESWT) against a control group.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: April 15, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share