Shockwave Therapy for Plantar Fasciitis RCT

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Plantar Fascitis

Intervention / Treatment
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* Procedure: Radial shockwave therapy
* Procedure: Focused shockwave therapy
* Device: Shockwave therapy device
* Other: Home therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Patients in the control group will be treated using the home therapy protocol only. | Other: Home therapy<br>* Stretching and ice massage<br>|
| Active Comparator: Radial shockwave therapy<br>Patients will receive 4 sessions of radial shockwave therapy. | Procedure: Radial shockwave therapy<br>* 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.<br>Device: Shockwave therapy device<br>* The shockwave therapy device will be used to administer either radial or focused shockwave therapy.<br>Other: Home therapy<br>* Stretching and ice massage<br>|
| Active Comparator: Focused shockwave therapy<br>Patients will receive 4 sessions of focused shockwave therapy. | Procedure: Focused shockwave therapy<br>* 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.<br>Device: Shockwave therapy device<br>* The shockwave therapy device will be used to administer either radial or focused shockwave therapy.<br>Other: Home therapy<br>* Stretching and ice massage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |