Novel Stretching Device Versus Night Splints

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Number of participants who will attend follow up appointment and describe their symptoms and pain using a standard 0-10 pain chart. — 6 weeks
  The participant will return their device and fill out a questionnaire (the same as the original questionnaire from the first visit) that will ask them to describe their symptoms and pain levels using a standard 0-10 pain scale chart. The investigators will then use a Mixed ANCOVA statistical test to compare the effectiveness of the AcuFlex device to night splints in symptom relief.

Trial sites (1)

Other trials for the same condition