Plantar Fasciitis
Conditions
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.
Interventions
DEVICEtension night splint
this is the use of a commercially available tension night splint device, to be worn by the patient
OTHERstandard 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
Sponsors
University Hospitals, Leicester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in pain as assessed by a 0-10 visual analogue scale (VAS) | primary outcome time = 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement in function as assessed by validated PROMs as described below | 3 months - end point | several validated Patient rated Outcome Measures (PROMS) are used in this study, including: FFI-r, FAAM, and MOXFQ |
Countries
United Kingdom
Outcome results
None listed