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

February 28, 2020 updated by: University Hospitals, Leicester

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom
        • University Hospitals of Leicester NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention
standard practice (structured rehabilitation programme) + TNS
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
Active Comparator: control
standard practice (structured rehabilitation programme)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
Time Frame: primary outcome time = 3 months
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
Time Frame: 3 months - end point
several validated Patient rated Outcome Measures (PROMS) are used in this study, including: FFI-r, FAAM, and MOXFQ
3 months - end point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Investigators

  • Principal Investigator: Patrick Wheeler, UHL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHL - 11335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Plantar Fasciitis

Clinical Trials on tension night splint

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe