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

NHS Trust

Status: Completed

Conditions: Plantar Fasciitis

Treatments: Device: tension night splint; Other: standard practice - a structured rehabilitation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT02546115

UHL - 11335

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention

Active Comparator group

Description:

standard practice (structured rehabilitation programme) + TNS

Treatment:

Other: standard practice - a structured rehabilitation programme

Device: tension night splint

control

Active Comparator group

Description:

standard practice (structured rehabilitation programme)

Treatment:

Other: standard practice - a structured rehabilitation programme