Plantar Fascitis
Conditions
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.
Interventions
DEVICEDynamic splint
Device treats plantar fasciitis and replacing boot immobilization which is quite benign
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NO Pain at 1 Month Follow up | 1 months | Pain measured on a visual analog scale (VAS): score range: 0 (no pain) to 10 (worst pain) |
| NO Pain at 3 Months Follow up | 3 months | Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain) |
| NO Pain at 6 Months Follow up | 6 months | Pain measured on a VAS: score range: 0 (no pain) to 10 (worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot Function Index (FFI) Score | 1 month | The FFI asks a series of 17 questions related to foot function, each rated on a scale of 1 to 10, which are summed and averaged to create an overall score of 1 to 10 (for both the subscale and overall scores, higher scores correspond to worse symptoms). |
| Foot Function Index (FFI) | 3 months | The FFI asks a series of 17 questions related to foot function, each rated on a scale of 1 to 10, which are summed and averaged to create an overall score of 1 to 10 (for both the subscale and overall scores, higher scores correspond to worse symptoms). |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.00 years STANDARD_DEVIATION 18.1 |
| Foot Function Index (FFI) | 3.4 score on a scale STANDARD_DEVIATION 0.6 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 6 Participants |
| Race/Ethnicity, Customized White | 7 Participants |
| Region of Enrollment United States | 13 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 13 |
| other Total, other adverse events | 0 / 8 | 0 / 13 |
| serious Total, serious adverse events | 0 / 8 | 0 / 13 |
Outcome results
None listed