Novel Stretching Device Versus Night Splints
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Night splints, Triceps Surae Stretching and Flexibility Assessment Device (TESS).
- Who it may be relevant to
- Registry conditions: Plantar Fasciitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Novel Stretching Device Versus Night Splints a Prospective, Randomized Study in the Effectiveness of Treating Plantar Fasciitis
Overview
A set of 100 patients previously diagnosed with plantar fasciitis will be given initial questionnaires about their symptoms and randomly assigned either night splints or the novel calf stretching device. The participants will use each device for 6 weeks. At the end of those 6 weeks, they will return for a follow up questionnaire. The answers in the questionnaire will be analyzed to compare the effectiveness of night splints to calf stretching.
Detailed description
The attached recruitment flyers will be distributed to physician's offices, and possibly placed as an ad in the newspaper. Potential participants will call the enclosed number and an appointment will be arranged to be evaluated at our research facility in Carterville, IL. During their initial evaluation which will take 30 minutes to 1 hour, each participant will complete medical history pertinent to plantar fasciitis and questionnaires regarding symptoms and physical activity. The research participants will then stand on the AcuFlex™ device for 5 minutes during which time their triceps surae flexibility will be assessed by measuring the distance from their heel to the platform at the 30-degree setting. Measurements for each foot will be taken with a distance sensor every 5 seconds for a 5 minute period.
We will then use a random number generator program from www.random.org to generate a number between 1 and 100. Participants with an odd number will be assigned home use of a United Ortho fitted night splint. Those with an even number will be provided with an AcuFlex™ unit to be used at home a minimum of 5 minutes 2-3 times per day. If at any point the number generator fills maximum participants (50) for either AcuFlex™ or night splints, the remaining participants will automatically be assigned the remaining method of home therapy.
The participants will use their device for 6 weeks. They will receive a check-in phone call at the 3 week mark of their participation.
Contact numbers will be given to each participant should they have any questions or concerns during the six-week interval. Each participant will be asked to maintain a daily log of their pain level on a visual analog scale and of their estimated time using each device.
Participant's random number will be used to link data in the study to the participant. We will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record.
Interventions
- Device Night splints
A night splint is a brace the patient wears on their foot to keep it in a dorsiflexed position while they sleep. It is the first line treatment for plantar fasciitis. - Device Triceps Surae Stretching and Flexibility Assessment Device (TESS)
The AcuFlex device is a slant board with a bar added for balance that the participant will stand on in 5 minute intervals throughout the day to stretch their calves, and potentially treat their plantar fasciitis symptoms. Measurements will be taken and recorded by sensors beneath the participants heels.
Primary outcome measures
- Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart. [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- age 18 years and older
- diagnosis of plantar fasciitis
- ability to understand the purpose of the study
- ability to safely use the device they are assigned after education and return demonstration.
Exclusion criteria
- patients with ankle fusion
- significant balance impairment which would prohibit safe use of the AcuFlex device
- corticosteroid injection within last 60 days
- pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- SAE Orthopedics — Carterville
Identifiers
NCT: NCT05216679 · AcuFlex