Dynamic Versus Static Night Splinting of Plantar Fasciitis

NCT ID: NCT05432895

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2026-06-18

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.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control( static splinting)

conventional static splint

Group Type: ACTIVE_COMPARATOR

Dynamic splint

Intervention Type: DEVICE

Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Experiment( dynamic splinting)

Device treats plantar fasciitis and replacing boot immobilization

Group Type: EXPERIMENTAL

Dynamic splint

Intervention Type: DEVICE

Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Interventions

Dynamic splint

Device treats plantar fasciitis and replacing boot immobilization which is quite benign

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Loretta Chou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University School of Medicine

Palo Alto, California, United States

Site Status: RECRUITING

Stanford outpatient center

Redwood City, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Prerna Arora

Role: CONTACT

arprerna@stanford.edu

6507217631

Facility Contacts

Prerna Arora, M.Tech

Role: primary

arprerna@stanford.edu

650-721-7631

Prerna Arora

Role: primary

6507217631

Other Identifiers

60879

Identifier Type: -

Identifier Source: org_study_id