Dynamic Versus Static Night Splinting of Plantar Fasciitis

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

Detailed Description
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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.

Official Title
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Dynamic Versus Static Night Splinting of Plantar Fasciitis

Conditions
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Plantar Fascitis

Intervention / Treatment
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* Device: Dynamic splint


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control( static splinting)<br>conventional static splint | Device: Dynamic splint<br>* Device treats plantar fasciitis and replacing boot immobilization which is quite benign<br>|
| Experimental: Experiment( dynamic splinting)<br>Device treats plantar fasciitis and replacing boot immobilization | Device: Dynamic splint<br>* Device treats plantar fasciitis and replacing boot immobilization which is quite benign<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically relevant change in Foot Function Index (FFI) | Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID | 1 months | 
| Clinically relevant change in Foot Function Index (FFI) | Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID | 3 months | 
| Clinically relevant change in Foot Function Index (FFI) | Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID | 6 months |