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Shockwave Therapy for Plantar Fasciitis RCT

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ClinicalTrials.gov Identifier: NCT04332471
Recruitment Status : Recruiting
First Posted : April 2, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Plantar Fascitis Procedure: Radial shockwave therapy Procedure: Focused shockwave therapy Device: Shockwave therapy device Other: Home therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : October 1, 2021

Arm Intervention/treatment
Active Comparator: Control
Patients in the control group will be treated using the home therapy protocol only.
Other: Home therapy
Stretching and ice massage

Active Comparator: Radial shockwave therapy
Patients will receive 4 sessions of radial shockwave therapy.
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.

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

Active Comparator: Focused shockwave therapy
Patients will receive 4 sessions of focused shockwave therapy.
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.

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




Primary Outcome Measures :
  1. Visual analog scale pain - morning [ Time Frame: Up to 1 year ]
    Morning pain. This will be assessed on a scale of 0-100, with a higher score representing more pain.

  2. Visual analog scale pain - after prolonged walking or standing [ Time Frame: Up to 1 year ]
    Pain after prolonged walking or standing. This will be assessed on a scale of 0-100, with a higher score representing more pain.


Secondary Outcome Measures :
  1. PROMIS Physical Function computer adaptive test score [ Time Frame: Up to 1 year ]
    This computer adaptive questionnaire assesses physical function. A higher score represents higher function. A score of 50 represents the population average.

  2. Foot and Ankle Outcome Score (FAOS) [ Time Frame: Up to 1 year ]
    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.

  3. Treatment satisfaction [ Time Frame: Up to 1 year ]
    Satisfaction with the assigned treatment will be determined on a 0-10 scale, with 10 being most satisfied and 0 being least satisfied.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332471


Contacts
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Contact: Jennifer Cheng, PhD 6467146870 chengj@hss.edu
Contact: Rachel Rothman 2127747386 rothmanr@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Bridget Hayes    212-774-2056    hayesb@hss.edu   
Principal Investigator: Kristina Quirolgico, MD         
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Kristina Quirolgico, MD Hospital for Special Surgery, New York
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT04332471    
Other Study ID Numbers: 2019-1517
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases