Dynamic Versus Static Night Splinting of Plantar Fasciitis

Overview

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.

Interventions

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

Primary outcome measures

• NO pain at 1 month follow up [Time frame: 1 months]
• NO pain at 3 months follow up [Time frame: 3 months]
• NO pain at 6 months follow up [Time frame: 6 months]

Secondary outcome measures (3)

• Clinically relevant change in Foot Function Index (FFI) [Time frame: 1 months]
• Clinically relevant change in Foot Function Index (FFI) [Time frame: 3 months]
• Clinically relevant change in Foot Function Index (FFI) [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Stanford University School of Medicine — Palo Alto
• Stanford outpatient center — Redwood City

Identifiers

NCT: NCT05432895 · 60879

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗