Plantar FascitisNCT05432895

Dynamic Versus Static Night Splinting of Plantar Fasciitis

A study testing Dynamic splint in people with Plantar Fascitis, run by Stanford University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Plantar Fascitis
What is being tested?: Dynamic splint
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 2 sitesUnited States
Study dates: 31 Oct 2023to 30 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Demographic - Over 18 years of age and ambulatory without a gait aid with no history of narcotic use
Diagnosis - Unilateral or bilateral acute (< 6 months of pain) plantar fasciitis (i.e., Heel pain that increases with weightbearing, "First step pain": heel pain that occurs after a period of non-weightbearing, such as in the morning when arising from bed or when arising after prolonged sitting; the pain is improved after a few minutes walking but will worsen again with prolonged weightbearing, tenderness over the medial calcaneal tuberosity at the insertion of the plantar fasciitis)
Permitted - Icing, NSAIDS( ibuprofen), Custom Shoe Inserts, Diagnostic Ultrasound

Who cannot join

Demographic - Under 18 year of age, requires a gait aid for ambulation; if not covered by insurance,
Diagnosis of - Arthritis of the Ankle, Midfoot, or Forefoot; Inflammatory Arthritis; Gout; Turf Toe; Hallux Rigidus; Hallux Limitus; Sesamoiditis; Tendonitis or Tendinopathy; Prior tear or Rupture of the Plantar Fascia; Fibromyalgia, Neuralgia, or Neuropathy; Peripheral Vascular Disease; Prior Trauma to the Heel, Fracture of the Calcaneus; Infection; Corn; Callus; Ingrown Nail.
Patient with history of Symptoms for over 6 months
Refractory to prior splint-based treatments
Prior injection of the plantar fascia
Prior surgery on the plantar fascia
Narcotic use

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Stanford University School of Medicine
Palo Alto, California, 94063
Stanford outpatient center
Redwood City, California, 84063

Other trials in United States

About this study

The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

Read the detailed description

A physical rehabilitation device for the treatment of a medical condition of the foot known as plantar fasciitis includes a splint which is connected to the toe and ankle of a patient. Static splint is the use of inelastic components to apply torque to a joint in order to statically position it as close to end range as possible. A dynamic splint uses a tension spring that is integrated into a brace, usually via a mechanical hinge. The tension spring can be adjusted for more or less tension to achieve range of motion goals with less pain. The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

Conditions: Plantar Fascitis
Being tested: Dynamic splint

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dynamic splintDevice
Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Study groups in NCT05432895
Study group	Role	What they receive
Control( static splinting)	Active comparator	conventional static splint Receives: Device: Dynamic splint
Experiment( dynamic splinting)	Experimental	Device treats plantar fasciitis and replacing boot immobilization Receives: Device: Dynamic splint

What is being measured

The primary outcome is the main question the study is designed to answer.

NO Pain at 1 Month Follow up
Pain measured on a visual analog scale (VAS): score range: 0 (no pain) to 10 (worst pain)
Measured: 1 months
NO Pain at 3 Months Follow up
Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain)
Measured: 3 months
NO Pain at 6 Months Follow up
Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain)
Measured: 6 months

Secondary outcomes (3)

Foot Function Index (FFI) Score
The FFI asks a series of 17 questions related to foot function, each rated on a scale of 1 to 10, which are summed and averaged to create an overall score of 1 to 10 (for both the subscale and overall scores, higher scores correspond to worse symptoms).
Measured: 1 month
Foot Function Index (FFI)
The FFI asks a series of 17 questions related to foot function, each rated on a scale of 1 to 10, which are summed and averaged to create an overall score of 1 to 10 (for both the subscale and overall scores, higher scores correspond to worse symptoms).
Measured: 3 months
Foot Function Index (FFI)
The FFI asks a series of 17 questions related to foot function, each rated on a scale of 1 to 10, which are summed and averaged to create an overall score of 1 to 10 (for both the subscale and overall scores, higher scores correspond to worse symptoms).
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 202330 Jan 2025

First posted27 Jun 2022
Study start31 Oct 2023
Primary completion30 Jan 2025
Study completion30 Jan 2025

Why it stopped: Lack of funding/personnel to accomplish enrollment tasks.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Plantar FascitisStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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: Parallel groups
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05432895
Sponsor's protocol ID: 60879
Status last verified: Aug 2026
First submitted: 4 May 2022
Last updated: 9 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
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
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic

All Plantar Fascitis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dynamic Versus Static Night Splinting of Plantar Fasciitis
ClinicalTrials.gov ID: NCT05432895
Acronym / sponsor ID: 60879
Conditions: Plantar Fascitis
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of funding/personnel to accomplish enrollment tasks.
Enrolment: 21 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 31 Oct 2023 (actual)
Primary completion: 30 Jan 2025 (actual)
Study completion: 30 Jan 2025 (actual)
First posted: 27 Jun 2022 (actual)
Results: Posted 9 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control( static splinting)	Active comparator	Device: Dynamic splintconventional static splint
Experiment( dynamic splinting)	Experimental	Device: Dynamic splintDevice treats plantar fasciitis and replacing boot immobilization

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Demographic - Over 18 years of age and ambulatory without a gait aid with no history of narcotic use
Diagnosis - Unilateral or bilateral acute (< 6 months of pain) plantar fasciitis (i.e., Heel pain that increases with weightbearing, "First step pain": heel pain that occurs after a period of non-weightbearing, such as in the morning when arising from bed or when arising after prolonged sitting; the pain is improved after a few minutes walking but will worsen again with prolonged weightbearing, tenderness over the medial calcaneal tuberosity at the insertion of the plantar fasciitis)
Permitted - Icing, NSAIDS( ibuprofen), Custom Shoe Inserts, Diagnostic Ultrasound

Key exclusion criteria (7 listed)

Demographic - Under 18 year of age, requires a gait aid for ambulation; if not covered by insurance,
Diagnosis of - Arthritis of the Ankle, Midfoot, or Forefoot; Inflammatory Arthritis; Gout; Turf Toe; Hallux Rigidus; Hallux Limitus; Sesamoiditis; Tendonitis or Tendinopathy; Prior tear or Rupture of the Plantar Fascia; Fibromyalgia, Neuralgia, or Neuropathy; Peripheral Vascular Disease; Prior Trauma to the Heel, Fracture of the Calcaneus; Infection; Corn; Callus; Ingrown Nail.
Patient with history of Symptoms for over 6 months
Refractory to prior splint-based treatments
Prior injection of the plantar fascia

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
Dynamic splintDevice treats plantar fasciitis and replacing boot immobilization which is quite benign	Device	Control( static splinting), Experiment( dynamic splinting)

Primary outcome

NO Pain at 1 Month Follow up
Time frame: 1 months
Pain measured on a visual analog scale (VAS): score range: 0 (no pain) to 10 (worst pain)
NO Pain at 3 Months Follow up
Time frame: 3 months
Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain)
NO Pain at 6 Months Follow up
Time frame: 6 months
Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain)

3 secondary outcomes

Foot Function Index (FFI) Score
Time frame: 1 month
Foot Function Index (FFI)
Time frame: 3 months
Foot Function Index (FFI)
Time frame: 6 months

Results and safety

Results posted to the registry on 9 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control (Static Splinting)	8	3
Experiment (Dynamic Splinting)	13	3

Primary outcome: NO Pain at 1 Month Follow up

Time frame: 1 months. Count of participants. Unit: Participants

Measure	Control (Static Splinting) n = 0	Experiment (Dynamic Splinting) n = 2
Value	–	0

Population analysed: Participants with data at 1 month. The research member delegated responsibility to record data at study visits did not enter any data for the static splinting arm and only entered some data for the dynamic splinting arm into the electronic data capture system, so no data was collected for the static splinting arm and only partial data was collected for the dynamic splinting arm. Attempts to locate missing data have been exhausted, and the missing data cannot be reported now or in the future.

Primary outcome: NO Pain at 3 Months Follow up

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Control (Static Splinting) n = 0	Experiment (Dynamic Splinting) n = 2
Value	–	0

Population analysed: Participants with data at 3 months. The research member delegated responsibility to record data at study visits did not enter any data for the static splinting arm and only entered some data for the dynamic splinting arm into the electronic data capture system, so no data was collected for the static splinting arm and only partial data was collected for the dynamic splinting arm. Attempts to locate missing data have been exhausted, and the missing data cannot be reported now or in the future.

Primary outcome: NO Pain at 6 Months Follow up

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Control (Static Splinting) n = 0	Experiment (Dynamic Splinting) n = 3
Value	–	0

Population analysed: Participants with data at 6 months. The research member delegated responsibility to record data at study visits did not enter any data for the static splinting arm and only entered some data for the dynamic splinting arm into the electronic data capture system, so no data was collected for the static splinting arm and only partial data was collected for the dynamic splinting arm. Attempts to locate missing data have been exhausted, and the missing data cannot be reported now or in the future.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control (Static Splinting)	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Experiment (Dynamic Splinting)	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): Early termination led to a small number of participants analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Plantar Fascitis

Not yet recruiting
Efficacy of TECAR Therapy in Plantar Fasciitis
Plantar Fasciitis
Active, not recruiting
Active Release Technique vs. Dynamic Soft Tissue Mobilization for Plantar Pain
Plantar Fascitis
Not yet recruiting
Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
Chronic Planter Fascitis
Recruiting
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
Plantar Fascitis, Chronic Heel Pain
Not yet recruiting
Radial vs Focused Shockwave Therapy for Plantar Fasciitis
Plantar Fasciitis, Chronic

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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic splint in people with Plantar Fascitis, run by Stanford University at 2 sites 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 7 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: stopped early, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

NO Pain at 1 Month Follow up (time frame: 1 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432895.

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 9 Sep 2026.