Back to resultsDynamic Versus Static Night Splinting of Plantar Fasciitis
Primary Purpose
Plantar Fascitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dynamic splint
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fascitis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control( static splinting)
Experiment( dynamic splinting)
Arm Description
conventional static splint
Device treats plantar fasciitis and replacing boot immobilization
Outcomes
Primary Outcome Measures
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)
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)
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)
Secondary Outcome Measures
Clinically relevant change in Foot Function Index (FFI)
Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID
Clinically relevant change in Foot Function Index (FFI)
Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID
Clinically relevant change in Foot Function Index (FFI)
Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05432895
Brief Title
Dynamic Versus Static Night Splinting of Plantar Fasciitis
Official Title
Dynamic Versus Static Night Splinting of Plantar Fasciitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 18, 2022 (Anticipated)
Primary Completion Date
June 18, 2024 (Anticipated)
Study Completion Date
June 18, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control( static splinting)
Arm Type
Active Comparator
Arm Description
conventional static splint
Arm Title
Experiment( dynamic splinting)
Arm Type
Experimental
Arm Description
Device treats plantar fasciitis and replacing boot immobilization
Intervention Type
Device
Intervention Name(s)
Dynamic splint
Intervention Description
Device treats plantar fasciitis and replacing boot immobilization which is quite benign
Primary Outcome Measure Information:
Title
NO pain at 1 month follow up
Description
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
Time Frame
1 months
Title
NO pain at 3 months follow up
Description
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
Time Frame
3 months
Title
NO pain at 6 months follow up
Description
We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Clinically relevant change in Foot Function Index (FFI)
Description
Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID
Time Frame
1 months
Title
Clinically relevant change in Foot Function Index (FFI)
Description
Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID
Time Frame
3 months
Title
Clinically relevant change in Foot Function Index (FFI)
Description
Clinically relevant change in Foot Function Index (FFI) of >6.5 points (MCID
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Dynamic Versus Static Night Splinting of Plantar Fasciitis
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