Plantar FascitisNCT04332471
Shockwave Therapy for Plantar Fasciitis RCT
A study testing Radial shockwave therapy, Focused shockwave therapy and Shockwave therapy device in people with Plantar Fascitis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Radial shockwave therapy, Focused shockwave therapy and Shockwave therapy device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Plantar Fascitis
- Being tested
- Radial shockwave therapy, Focused shockwave therapy, Shockwave therapy device, Home therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial shockwave therapyProcedure or surgery
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.
Focused shockwave therapyProcedure or surgery
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.
Shockwave therapy deviceDevice
The shockwave therapy device will be used to administer either radial or focused shockwave therapy.
Home therapyOther
Stretching and ice massage
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in the control group will be treated using the home therapy protocol only. Receives: Other: Home therapy |
| Radial shockwave therapy | Active comparator | Patients will receive 4 sessions of radial shockwave therapy. Receives: Procedure: Radial shockwave therapy; Device: Shockwave therapy device; Other: Home therapy |
| Focused shockwave therapy | Active comparator | Patients will receive 4 sessions of focused shockwave therapy. Receives: Procedure: Focused shockwave therapy; Device: Shockwave therapy device; Other: Home therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale pain - morning
Morning pain. This will be assessed on a scale of 0-100, with a higher score representing more pain.
Measured: Up to 1 year
Visual analog scale pain - after prolonged walking or standing
Pain after prolonged walking or standing. This will be assessed on a scale of 0-100, with a higher score representing more pain.
Measured: Up to 1 year
Secondary outcomes (3)
PROMIS Physical Function computer adaptive test score
This computer adaptive questionnaire assesses physical function. A higher score represents higher function. A score of 50 represents the population average.
Measured: Up to 1 year
Foot and Ankle Outcome Score (FAOS)
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.
Measured: Up to 1 year
Treatment satisfaction
Satisfaction with the assigned treatment will be determined on a 0-10 scale, with 10 being most satisfied and 0 being least satisfied.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Jun 2020
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Quirolgico, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332471
- Sponsor's protocol ID
- 2019-1517
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Plantar Fasciitis With Radial Shockwave Therapy vs. Focused Shockwave Therapy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04332471
- Acronym / sponsor ID
- 2019-1517
- Conditions
- Plantar Fascitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Home therapyPatients in the control group will be treated using the home therapy protocol only. |
| Radial shockwave therapy | Active comparator | Procedure: Radial shockwave therapy, Device: Shockwave therapy device, Other: Home therapyPatients will receive 4 sessions of radial shockwave therapy. |
| Focused shockwave therapy | Active comparator | Procedure: Focused shockwave therapy, Device: Shockwave therapy device, Other: Home therapyPatients will receive 4 sessions of focused shockwave therapy. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial shockwave therapyTarget 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 or surgery | Radial shockwave therapy |
| Focused shockwave therapyTarget 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. | Procedure or surgery | Focused shockwave therapy |
| Shockwave therapy deviceThe shockwave therapy device will be used to administer either radial or focused shockwave therapy. | Device | Focused shockwave therapy, Radial shockwave therapy |
| Home therapyStretching and ice massage | Other | Control, Focused shockwave therapy, Radial shockwave therapy |
Primary outcome
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.
3 secondary outcomes
PROMIS Physical Function computer adaptive test score
Time frame: Up to 1 year
Foot and Ankle Outcome Score (FAOS)
Time frame: Up to 1 year
Treatment satisfaction
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Related trials for Plantar Fascitis
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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Radial vs Focused Shockwave Therapy for Plantar Fasciitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Quirolgico, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial shockwave therapy, Focused shockwave therapy and Shockwave therapy device in people with Plantar Fascitis, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale pain - morning (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.