Shockwave Therapy for Plantar Fasciitis RCT

NCT ID: NCT04332471

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2026-03-01

Brief Summary

Inflammation of the plantar fascia is known as plantar fasciitis and is commonly seen in active or overweight individuals. It can be treated via conservative or surgical therapies. Extracorporeal shockwave therapy has shown promise in the treatment of plantar fasciitis. Several studies have compared the effects of different types of extracorporeal shockwave therapy (radial and focused) with other forms of conservative treatment in patients with chronic plantar fasciitis. No study has yet compared the effect of radial vs. focused shockwave therapy on pain in this population.

Detailed Description

Plantar fasciitis is a common foot problem that affects 3.8 per 1,000 persons in the United States. It is characterized by inflammation of the plantar fascia, a fibrous tissue which connects the calcaneus to the metatarsal heads, and is often seen in individuals who are overweight and/or participate frequently in weight-bearing endurance activities such as running. Pain is typically at its highest during the first steps in the morning, although it can also occur with prolonged weightbearing. Plantar fasciitis can be treated via conservative or surgical measures, although surgery is considered as the last resort. In recent years, extracorporeal shockwave therapy has emerged as an alternative conservative method for treating plantar fasciitis. There are two types -- radial and focused shockwave therapy. Focused therapy creates deeper-penetrating, higher-energy shockwaves, whereas radial therapy produces more superficial shockwaves that can treat a wider area of pathology.

Randomized controlled trials have compared focused and radial shockwave therapy to placebo and other conservative measures in the treatment of chronic plantar fasciitis and overall demonstrated benefit. Only one study has directly compared radial and focused shockwave therapy in this population, although pain was not an outcome of focus in the study. The current study aims to collect patient-reported outcomes on both pain and function following radial vs. focused shockwave therapy vs. control therapy.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Patients in the control group will be treated using the home therapy protocol only.

Group Type: ACTIVE_COMPARATOR

Home therapy

Intervention Type: OTHER

Stretching and ice massage

Radial shockwave therapy

Patients will receive 4 sessions of radial shockwave therapy.

Group Type: ACTIVE_COMPARATOR

Radial shockwave therapy

Intervention Type: PROCEDURE

Target intensity will be within a range of 3.5-5.0 bar at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.

Shockwave therapy device

Intervention Type: DEVICE

The shockwave therapy device will be used to administer either radial or focused shockwave therapy.

Home therapy

Intervention Type: OTHER

Stretching and ice massage

Focused shockwave therapy

Patients will receive 4 sessions of focused shockwave therapy.

Group Type: ACTIVE_COMPARATOR

Focused shockwave therapy

Intervention Type: PROCEDURE

Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.

Shockwave therapy device

Intervention Type: DEVICE

The shockwave therapy device will be used to administer either radial or focused shockwave therapy.

Home therapy

Intervention Type: OTHER

Stretching and ice massage

Interventions

Radial shockwave therapy

Target intensity will be within a range of 3.5-5.0 bar at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.

Intervention Type: PROCEDURE

Focused shockwave therapy

Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.

Intervention Type: PROCEDURE

Shockwave therapy device

The shockwave therapy device will be used to administer either radial or focused shockwave therapy.

Intervention Type: DEVICE

Home therapy

Stretching and ice massage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients presenting with a clinical diagnosis of chronic plantar fasciitis (>3 months) that has been recalcitrant to other treatments
• Minimum VAS pain of 40/100 (4/10; morning pain when taking first steps, pain after prolonged walking/standing)
• English-speaking

Exclusion Criteria

• Cortisone injection within the past 3 months
• Platelet-rich plasma injection within the past 6 months
• History of previous foot surgery
• Bilateral heel pain
• Coagulopathies or use of anti-coagulants
• Local and systemic neurologic or vascular insufficiencies
• Rheumatologic disorders
• Systemic inflammatory disorders
• Active or chronic infection in the area
• Lower extremity bone disorders (e.g., Paget's disease, osteomyelitis)
• Calcaneal fractures
• Nerve entrapment
• Ruptures in tendon
• Non-English speaking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristina Quirolgico, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Other Identifiers

2019-1517

Identifier Type: -

Identifier Source: org_study_id