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NCT Number: NCT05432895

Dynamic Versus Static Night Splinting of Plantar Fasciitis

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

Recruiting

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic Splint

Device

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

Primary outcomes

  1. NO pain at 1 month follow up

    Time frame: 1 months

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

  2. NO pain at 3 months follow up

    Time frame: 3 months

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

  3. NO pain at 6 months follow up

    Time frame: 6 months

    We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

Secondary outcomes

  1. Clinically relevant change in Foot Function Index (FFI)

    Time frame: 1 months

    Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID

  2. Clinically relevant change in Foot Function Index (FFI)

    Time frame: 3 months

    Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID

  3. Clinically relevant change in Foot Function Index (FFI)

    Time frame: 6 months

    Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID

Study contacts

Contact information is provided by the study sponsor or research team.

Prerna Arora

CONTACT

[email protected]

6507217631

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2022
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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