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.

Study Overview

• Status: Recruiting
• Conditions: Plantar Fascitis
• Intervention / Treatment: Device: Dynamic splint

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prerna Arora; Phone Number: 6507217631; Email: arprerna@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94063
      • Recruiting
      • Stanford University School of Medicine
      • Contact: Prerna Arora, M.Tech; Phone Number: 650-721-7631; Email: arprerna@stanford.edu
    • Redwood City, California, United States, 84063
      • Recruiting
      • Stanford outpatient center
      • Contact: Prerna Arora; Phone Number: 6507217631

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): June 18, 2026

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: 60879

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes