Can a flexible night splint ease heel pain as well as a rigid one?
NCT ID NCT05432895
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers at Stanford University are comparing two types of night splints for people with plantar fasciitis, a common cause of heel pain. The trial tests whether a dynamic splint, which allows some foot movement, works as well as a static splint that holds the foot in one position. Adults with recent heel pain wear the assigned splint at night, and the team tracks pain and foot function over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a dynamic night splint worn on the foot
- What this could lead to
- If the dynamic splint works as well as the static one, people with plantar fasciitis could have a more comfortable option for overnight treatment.
- What could go wrong
- This is a small study of 21 people, so the results may not apply to everyone. Night splints can be bulky or uncomfortable, and some people may not wear them consistently.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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21 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University School of Medicine
Palo Alto, California, 94063, United States
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Stanford outpatient center
Redwood City, California, 84063, United States
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