Plantar FasciitisPhase 3NCT01431066
ActiPatch Plantar Fasciitis Clinical Trial
A Phase 3 study testing ActiPatch PRFE Device in people with Plantar Fasciitis and Plantar Fasciopathy, run by University of British Columbia at 1 site in Canada.
Trial summary
Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fasciitis, Plantar Fasciopathy
- What is being tested?
- ActiPatch PRFE Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with diagnosis of plantar fasciitis agreeing to participate
- Over 18 years old
- Able to wear unit and keep data up-to-date records of use
- Agree to forgo additional treatments during the study period
Who cannot join
- Patients who have refused, are unable to give or have withdrawn consent
- Patients with heel pain present less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy
Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.
The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.
The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.
- Conditions
- Plantar Fasciitis, Plantar Fasciopathy
- Being tested
- Sham pulsed radio-frequency electromagnetic device, ActiPatch PRFE Device
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham pulsed radio-frequency electromagnetic deviceDevice
Disabled PRFE device
ActiPatch PRFE DeviceDevice
Actipatch PRFE device
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Sham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled. Receives: Device: Sham pulsed radio-frequency electromagnetic device |
| Actipatch | Experimental | Use of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy Receives: Device: ActiPatch PRFE Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for pain
Measured: 4 Weeks Follow-up
Secondary outcomes (3)
Visual analog scale for pain
Measured: 26 weeks
Foot and ankle disability index
Measured: 26 weeks
Tegner activity scale
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- BioElectronics Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431066
- Sponsor's protocol ID
- H11-01828
- Status last verified
- Sep 2011
- First submitted
- 7 Sep 2011
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Low Energy Pulsed Radio Frequency Electromagnetic Field Therapy for the Treatment of Plantar Fasciopathy
- ClinicalTrials.gov ID
- NCT01431066
- Acronym / sponsor ID
- H11-01828
- Conditions
- Plantar Fasciitis, Plantar Fasciopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- BioElectronics Corporation
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 Sep 2011 (estimated)
- 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.
Plantar fasciopathy is a chronic condition affecting both sedentary populations, individuals in the workplace who must stand for prolonged periods of time, and athletes. It can be disabling. There is no single accepted treatment course that is recommended in the literature.
The use of pulsed radio-frequency electromagnetic (PRFE) devices has been proposed as a treatment option in chronic soft-tissue injury due to its ability to reduce pain and inflammation.
The proposed study will investigate the efficacy of the use of a PRFE device for the treatment of chronic heel pain using a double blind randomized placebo controlled design study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: Sham pulsed radio-frequency electromagnetic deviceSham device that resembles the Actipatch PRFE device, including the light that illuminates when active, but the transmitting function has been disabled. |
| Actipatch | Experimental | Device: ActiPatch PRFE DeviceUse of the Actipatch PRFE device that is integrated into a viscoelastic heel pad for the treatment of plantar fasciopathy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with diagnosis of plantar fasciitis agreeing to participate
- Over 18 years old
- Able to wear unit and keep data up-to-date records of use
- Agree to forgo additional treatments during the study period
Key exclusion criteria (2 listed)
- Patients who have refused, are unable to give or have withdrawn consent
- Patients with heel pain present less than 3 months
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 |
|---|---|---|
| Sham pulsed radio-frequency electromagnetic deviceDisabled PRFE device | Device | Control |
| ActiPatch PRFE DeviceActipatch PRFE device | Device | Actipatch |
Primary outcome
Visual Analog Scale (VAS) for pain
Time frame: 4 Weeks Follow-up
3 secondary outcomes
Visual analog scale for pain
Time frame: 26 weeks
Foot and ankle disability index
Time frame: 26 weeks
Tegner activity scale
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ActiPatch PRFE Device in people with Plantar Fasciitis and Plantar Fasciopathy, run by University of British Columbia at 1 site in Canada.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Mar 2014. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (VAS) for pain (time frame: 4 Weeks Follow-up). 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 3 Mar 2014.