Clinical Trial: RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis, a Single-blinded Randomised Controlled Trial

Brief Summary: To assess whether the provision of a tension night splint (TNS) device has any additional benefit in patients with chronic plantar fasciitis, compared to routine care comprising physiotherapy & podiatry alone.

Detailed Summary:
Sponsor: University Hospitals, Leicester

Current Primary Outcome: Reduction in pain as assessed by a 0-10 visual analogue scale (VAS) [ Time Frame: primary outcome time = 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: improvement in function as assessed by validated PROMs as described below [ Time Frame: 3 months - end point ]

several validated Patient rated Outcome Measures (PROMS) are used in this study, including: FFI-r, FAAM, and MOXFQ


Original Secondary Outcome: Same as current

Information By: University Hospitals, Leicester

Dates:
Date Received: June 15, 2015
Date Started: September 2014
Date Completion: September 2017
Last Updated: September 7, 2015
Last Verified: September 2015