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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546115
• Other study ID #: UHL - 11335
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: October 2016

Study information

• Verified date: February 2020
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

1. Patients age >18 with symptoms of plantar fasciitis for >3 months

2. Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)

Exclusion Criteria:

1. Current or previous partial or full-thickness tear of the Achilles tendon or plantar fascia (either clinically suspected or proven on imaging)

2. Current or previous calf muscle injury

3. Previous use of tension night splint

4. Diabetic neuropathy, or other sensory / sensorimotor disturbance

5. Lower limb vascular compromise

6. Fragile skin, or skin wounds on lower leg

7. Subjects with impaired mobility which prevents safe and effective application of the Tension Night Splint

8. Any other condition which it is thought may be aggravated by the use of a tension night splint

9. Subjects unable to give valid consent for the study

10. Subjects who state that they are unable or unwilling to undergo the home-based structured rehabilitation programme as a part of the study process

11. Subjects who are unable to attend the follow-up appointment required at the end of the study

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• tension night splint
this is the use of a commercially available tension night splint device, to be worn by the patient

Other:
• standard practice - a structured rehabilitation programme
this is the standardised structured rehabilitation programme of home exercises given to patients, with supporting literature, and instructions on how to progress the regime themselves

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)		primary outcome time = 3 months
Secondary	improvement in function as assessed by validated PROMs as described below	several validated Patient rated Outcome Measures (PROMS) are used in this study, including: FFI-r, FAAM, and MOXFQ	3 months - end point

External Links

•   publication - open access