Dynamic Versus Static Night Splinting of Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Dynamic Versus Static Night Splinting of Plantar Fasciitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432895
• Other study ID #: 60879
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 18, 2022
• Est. completion date: June 18, 2024

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 18, 2024
• Est. primary completion date: June 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Device:
• Dynamic splint
Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NO pain at 1 month follow up	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)	1 months
Primary	NO pain at 3 months follow up	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)	3 months
Primary	NO pain at 6 months follow up	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)	6 months
Secondary	Clinically relevant change in Foot Function Index (FFI)	Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID	1 months
Secondary	Clinically relevant change in Foot Function Index (FFI)	Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID	3 months
Secondary	Clinically relevant change in Foot Function Index (FFI)	Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID	6 months