- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04332471
Shockwave Therapy for Plantar Fasciitis RCT
Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Cheng, PhD
- Phone Number: 6467146870
- Email: chengj@hss.edu
Study Contact Backup
- Name: Olivia Rau
- Phone Number: 2127747386
- Email: rauo@hss.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital For Special Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Patients in the control group will be treated using the home therapy protocol only.
|
Stretching and ice massage
|
Active Comparator: Radial shockwave therapy
Patients will receive 4 sessions of radial shockwave therapy.
|
Stretching and ice massage
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.
The shockwave therapy device will be used to administer either radial or focused shockwave therapy.
|
Active Comparator: Focused shockwave therapy
Patients will receive 4 sessions of focused shockwave therapy.
|
Stretching and ice massage
The shockwave therapy device will be used to administer either radial or 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
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.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
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.
|
Up to 1 year
|
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.
|
Up to 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kristina Quirolgico, MD, Hospital for Special Surgery, New York
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1517
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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