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

Study Overview
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Brief Summary
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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.

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: tension night splint
* Other: standard practice - a structured rehabilitation programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age >18 with symptoms of plantar fasciitis for >3 months Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable) Exclusion Criteria: Current or previous partial or full-thickness tear of the Achilles tendon or plantar fascia (either clinically suspected or proven on imaging) Current or previous calf muscle injury Previous use of tension night splint Diabetic neuropathy, or other sensory / sensorimotor disturbance Lower limb vascular compromise Fragile skin, or skin wounds on lower leg Subjects with impaired mobility which prevents safe and effective application of the Tension Night Splint Any other condition which it is thought may be aggravated by the use of a tension night splint Subjects unable to give valid consent for the study Subjects who state that they are unable or unwilling to undergo the home-based structured rehabilitation programme as a part of the study process Subjects who are unable to attend the follow-up appointment required at the end of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>standard practice (structured rehabilitation programme) + TNS | Device: tension night splint<br>* this is the use of a commercially available tension night splint device, to be worn by the patient<br>Other: standard practice - a structured rehabilitation programme<br>* 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<br>|
| Active Comparator: control<br>standard practice (structured rehabilitation programme) | Other: standard practice - a structured rehabilitation programme<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain as assessed by a 0-10 visual analogue scale (VAS) |  | primary outcome time = 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |