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Shockwave Therapy for Plantar Fasciitis RCT

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status

Active, not recruiting

Conditions

Plantar Fascitis

Treatments

Procedure: Radial shockwave therapy
Procedure: Focused shockwave therapy
Device: Shockwave therapy device
Other: Home therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04332471
2019-1517

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

114 participants in 3 patient groups

Control
Active Comparator group
Description:
Patients in the control group will be treated using the home therapy protocol only.
Treatment:
Other: Home therapy
Radial shockwave therapy
Active Comparator group
Description:
Patients will receive 4 sessions of radial shockwave therapy.
Treatment:
Other: Home therapy
Device: Shockwave therapy device
Procedure: Radial shockwave therapy
Focused shockwave therapy
Active Comparator group
Description:
Patients will receive 4 sessions of focused shockwave therapy.
Treatment:
Other: Home therapy
Device: Shockwave therapy device
Procedure: Focused shockwave therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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