Novel Stretching Device Versus Night Splints

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

The attached recruitment brochure 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 tssfad1 device for 5 to 10 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. The investigators 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 standard night splints. Those with an even number will be provided with a TESS unit to be used at home a minimum of 5 minutes twice per day. 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. The investigators will not be using patient identifiable information such as name, date of birth, medical record number, or other personal information for the record. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05216679
Study type	Interventional
Source	SAE Orthopedics
Contact	Mike Davis, MD
Phone	618-525-3505
Email	mdavis1060@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	June 14, 2022
Completion date	December 1, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02546115` - RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis	N/A
Terminated	`NCT01996111` - Dehydrated Human Amnion/Chorion Membrane Micrografts(dHACM) Injectable in the Treatment of Recalcitrant Plantar Fasciitis	N/A
Unknown status	`NCT01882894` - Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment	N/A
Completed	`NCT01659827` - Comparative Study of Amniotic Membrane Injectable in the Treatment of Recalcitrant Plantar Fasciitis	N/A
Completed	`NCT00888394` - Effectiveness of Podiatry on Plantar Pain	Phase 4
Completed	`NCT00758641` - Platelet Rich Plasma to Treat Plantar Fasciitis	Phase 4
Terminated	`NCT00527748` - Foot and Ankle Range of Motion (Stretching) Apparatus	N/A
Recruiting	`NCT05584046` - A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF	N/A
Completed	`NCT04088383` - Amnios™ RT Outcomes Study	N/A
Completed	`NCT01994759` - Optimal Treatment of Plantar Fasciitis: Physical Training, Glucocorticoid Injections or a Combination Thereof.	Phase 4
Completed	`NCT02646579` - Effects of Dry Needling Using Spinal and Peripheral Sites Versus Peripheral Sites Only	N/A
Completed	`NCT05592808` - Comparison of Taping Techniques in Plantar Fasciitis	N/A
Not yet recruiting	`NCT04125264` - Intense Therapeutic Ultrasound (ITU) to Treat Plantar Fasciitis	N/A
Completed	`NCT02546089` - ABI v Dry Needling for Plantar Fasciitis	N/A
Completed	`NCT00765843` - A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain	N/A
Completed	`NCT00155324` - Change and Clinical Significance of Plantar Fascia Thickness After ESWT	N/A
Completed	`NCT04941469` - Effectiveness of Specifically Optimized Off-the-counter Foot Orthosis for the Subtle Cavus Foot	N/A
Completed	`NCT06055933` - Effect of Kinesio Taping and Extracorporeal Shock Wave Therapy on Plantar Fasciitis
Recruiting	`NCT02539082` - the Safety and Efficacy of Collagen Injection in Patients With Plantar Fasciitis	Phase 4
Enrolling by invitation	`NCT01786057` - Effect of Extracorporeal Shock Wave Therapy of Gastrosoleus Trigger Points in Patients With Plantar Fasciitis	Phase 2/Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.