Plantar FasciitisNCT05216679
Novel Stretching Device Versus Night Splints
A study testing Night splints and Triceps Surae Stretching and Flexibility Assessment Device (TESS) in people with Plantar Fasciitis, run by SAE Orthopedics at 1 site in United States.
Trial summary
A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Night splints and Triceps Surae Stretching and Flexibility Assessment Device (TESS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to 1 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years and older
- diagnosis of plantar fasciitis
- ability to understand the purpose of the study
- ability to safely use the device they are assigned after education and return demonstration.
Who cannot join
- patients with ankle fusion
- significant balance impairment which would prohibit safe use of the AcuFlex device
- corticosteroid injection within last 60 days
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
SAE Orthopedics
Carterville, Illinois, 62918
Mike Davis, MD, 6185253505, mdavis1060@gmail.com
Corey Hopkins, BS, 6183352804, corey.hopkins@saeorthopedics.com
About this study
Official title: Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.
Read the detailed description
The attached recruitment flyers will be distributed to physician's offices, and possibly placed as an ad in the newspaper. Potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in Carterville, IL. During their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. The research participants will then stand on the AcuFlex™ device for 5 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. Measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period.
We will then use a random number generator program from www.random.org to generate a number between 1 and 100. Participants with an odd number will be assigned home use of a United Ortho fitted night splint. Those with an even number will be provided with an AcuFlex™ unit to be used at home a minimum of 5 minutes 2-3 times per day. If at any point the number generator fills maximum participants (50) for either AcuFlex™ or night splints, the remaining participants will automatically be assigned the remaining method of home therapy.
The participants will use their device for 6 weeks. They will receive a check-in phone call at the 3 week mark of their participation.
Contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. Each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device.
Participant's random number will be used to link data in the study to the participant. We will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.
- Conditions
- Plantar Fasciitis
- Being tested
- Night splints, Triceps Surae Stretching and Flexibility Assessment Device (TESS)
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night splintsDevice
A night splint is a brace the patient wears on their foot to keep it in a dorsiflexed position while they sleep. It is the first line treatment for plantar fasciitis.
Triceps Surae Stretching and Flexibility Assessment Device (TESS)Device
The AcuFlex device is a slant board with a bar added for balance that the participant will stand on in 5 minute intervals throughout the day to stretch their calves, and potentially treat their plantar fasciitis symptoms. Measurements will be taken and recorded by sensors beneath the participants heels.
| Study group | Role | What they receive |
|---|---|---|
| Main study | Experimental | This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the AcuFlex device to treat their plantar fasciitis symptoms. Receives: Device: Night splints; Device: Triceps Surae Stretching and Flexibility Assessment Device (TESS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.
The participant will return their device and fill out a questionnaire (the same as the original questionnaire from the first visit) that will ask them to describe their symptoms and pain levels using a standard 0-10 pain scale chart. The investigators will then use a Mixed ANCOVA statistical test to compare the effectiveness of the AcuFlex device to night splints in symptom relief.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start15 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SAE Orthopedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Davis, MD, Principal investigator, SAE Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216679
- Sponsor's protocol ID
- AcuFlex
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All data that underlie a publication will be shared.
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
- Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT05216679
- Acronym / sponsor ID
- AcuFlex
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- SAE OrthopedicsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 31 Jan 2022 (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.
A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.
Detailed description
The attached recruitment flyers will be distributed to physician's offices, and possibly placed as an ad in the newspaper. Potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in Carterville, IL. During their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. The research participants will then stand on the AcuFlex™ device for 5 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. Measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period.
We will then use a random number generator program from www.random.org to generate a number between 1 and 100. Participants with an odd number will be assigned home use of a United Ortho fitted night splint. Those with an even number will be provided with an AcuFlex™ unit to be used at home a minimum of 5 minutes 2-3 times per day. If at any point the number generator fills maximum participants (50) for either AcuFlex™ or night splints, the remaining participants will automatically be assigned the remaining method of home therapy.
The participants will use their device for 6 weeks. They will receive a check-in phone call at the 3 week mark of their participation.
Contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. Each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device.
Participant's random number will be used to link data in the study to the participant. We will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study | Experimental | Device: Night splints, Device: Triceps Surae Stretching and Flexibility Assessment Device (TESS)This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the AcuFlex device to treat their plantar fasciitis symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years and older
- diagnosis of plantar fasciitis
- ability to understand the purpose of the study
- ability to safely use the device they are assigned after education and return demonstration.
Key exclusion criteria (4 listed)
- patients with ankle fusion
- significant balance impairment which would prohibit safe use of the AcuFlex device
- corticosteroid injection within last 60 days
- pregnancy
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 |
|---|---|---|
| Night splintsA night splint is a brace the patient wears on their foot to keep it in a dorsiflexed position while they sleep. It is the first line treatment for plantar fasciitis. | Device | Main study |
| Triceps Surae Stretching and Flexibility Assessment Device (TESS)The AcuFlex device is a slant board with a bar added for balance that the participant will stand on in 5 minute intervals throughout the day to stretch their calves, and potentially treat their plantar fasciitis symptoms. Measurements will be taken and recorded by sensors beneath the participants heels. | Device | Main study |
Primary outcome
Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart.
Time frame: 6 weeks
The participant will return their device and fill out a questionnaire (the same as the original questionnaire from the first visit) that will ask them to describe their symptoms and pain levels using a standard 0-10 pain scale chart. The investigators will then use a Mixed ANCOVA statistical test to compare the effectiveness of the AcuFlex device to night splints in symptom relief.
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.
- Individual participant dataSharing planned: Yes. All data that underlie a publication will be shared.
Related trials for Plantar Fasciitis
RecruitingObservational study
Tibial Nerve Size and Clinical Features in Chronic Plantar Fasciitis
Plantar Fasciitis, Chronic, Tibial Nerve
Recruiting
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Plantar Fasciitis of Both Feet, Plantar Fascitis
Recruiting
Extracorporeal Shock Wave Therapy With or Without Kinesiotaping for Plantar Fasciitis
Plantar Fasciitis
Recruiting
Comparison of Transverse Friction Massage and Instrument- Assisted Soft-Tissue Mobilization in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Comparison of Platelet-Rich Plasma and Prolotherapy for Plantar Fasciitis
Planter Fasciitis
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.
Mike Davis, MD principal investigator
SAE Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night splints and Triceps Surae Stretching and Flexibility Assessment Device (TESS) in people with Plantar Fasciitis, run by SAE Orthopedics 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 4 inclusion and 4 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: looking for participants now, 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?
Contact Mike Davis, MD (618-525-3505, mdavis1060@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart. (time frame: 6 weeks). 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.