Dynamic Versus Static Night Splinting of Plantar Fasciitis

Not Applicable

• Conditions: Plantar Fascitis
• Interventions: Device: Dynamic splint

• Registration Number: NCT05432895
• Lead Sponsor: Stanford University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2022-05-04
• Status Verified: 2022-06
• Study Start: 2022-06-18
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Primary Completion: 2024-06-18
• Study Completion: 2024-06-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control( static splinting)	Dynamic splint	conventional static splint
Experiment( dynamic splinting)	Dynamic splint	Device treats plantar fasciitis and replacing boot immobilization

Primary Outcome Measures

Name	Time	Method
NO pain at 1 month follow up	1 months	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
NO pain at 6 months follow up	6 months	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
NO pain at 3 months follow up	3 months	We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)

Secondary Outcome Measures

Name	Time	Method
Clinically relevant change in Foot Function Index (FFI)	6 months	Clinically relevant change in Foot Function Index (FFI) of \>6.5 points (MCID