Clinical trial NCT04332471: Shockwave Therapy for Plantar Fasciitis RCT
Official title: Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2020-04-02
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Visual analog scale pain - morning
timeFrame: Up to 1 year
measure: Visual analog scale pain - after prolonged walking or standing
timeFrame: Up to 1 year
Secondary outcomes:
measure: PROMIS Physical Function computer adaptive test score
timeFrame: Up to 1 year
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Up to 1 year
measure: Treatment satisfaction
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Kristina Quirolgico, MD
role: PRINCIPAL_INVESTIGATOR
References: