Clinical trial NCT05432895: Dynamic Versus Static Night Splinting of Plantar Fasciitis
Official title: Dynamic Versus Static Night Splinting of Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: NO pain at 1 month follow up
timeFrame: 1 months
measure: NO pain at 3 months follow up
timeFrame: 3 months
measure: NO pain at 6 months follow up
timeFrame: 6 months
Secondary outcomes:
measure: Clinically relevant change in Foot Function Index (FFI)
timeFrame: 1 months
measure: Clinically relevant change in Foot Function Index (FFI)
timeFrame: 3 months
measure: Clinically relevant change in Foot Function Index (FFI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Redwood City
country: United States
facility: Stanford outpatient center
state: California
Study officials:
References: