Shockwave Therapy for Plantar Fasciitis RCT

Plantar Fascitis Clinical Trial

Official title:

Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04332471
• Other study ID #: 2019-1517
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 114
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Procedure:
• 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.
• 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.

Device:
• Shockwave therapy device
The shockwave therapy device will be used to administer either radial or focused shockwave therapy.

Other:
• Home therapy
Stretching and ice massage

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale pain - morning	Morning pain. This will be assessed on a scale of 0-100, with a higher score representing more pain.	Up to 1 year
Primary	Visual analog scale pain - after prolonged walking or standing	Pain after prolonged walking or standing. This will be assessed on a scale of 0-100, with a higher score representing more pain.	Up to 1 year
Secondary	PROMIS Physical Function computer adaptive test score	This computer adaptive questionnaire assesses physical function. A higher score represents higher function. A score of 50 represents the population average.	Up to 1 year
Secondary	Foot and Ankle Outcome Score (FAOS)	The FAOS assess pain, symptoms, activities of daily living, sports, and quality of life related to foot and ankle pain. This will be assessed on a scale of 0-100, where 100 indicates no problems and 0 indicates extreme problems.	Up to 1 year
Secondary	Treatment satisfaction	Satisfaction with the assigned treatment will be determined on a 0-10 scale, with 10 being most satisfied and 0 being least satisfied.	Up to 1 year