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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

Tracking Information
First Submitted Date  ICMJE March 11, 2020
First Posted Date  ICMJE April 2, 2020
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shockwave Therapy for Plantar Fasciitis RCT
Official Title  ICMJE Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Plantar Fascitis
Intervention  ICMJE
  • 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.
  • 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
Study Arms  ICMJE
  • Active Comparator: Control
    Patients in the control group will be treated using the home therapy protocol only.
    Intervention: Other: Home therapy
  • Active Comparator: Radial shockwave therapy
    Patients will receive 4 sessions of radial shockwave therapy.
    Interventions:
    • Procedure: Radial shockwave therapy
    • Device: Shockwave therapy device
    • Other: Home therapy
  • Active Comparator: Focused shockwave therapy
    Patients will receive 4 sessions of focused shockwave therapy.
    Interventions:
    • Procedure: Focused shockwave therapy
    • Device: Shockwave therapy device
    • Other: Home therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
104
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jennifer Cheng, PhD 6467146870 chengj@hss.edu
Contact: Rachel Rothman 2127747386 rothmanr@hss.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04332471
Other Study ID Numbers  ICMJE 2019-1517
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristina Quirolgico, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP