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Completed

NCT Number: NCT02546115

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

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tension night splint

Device

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

standard practice - a structured rehabilitation programme

Other

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

Primary outcomes

  1. Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)

    Time frame: primary outcome time = 3 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2015
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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