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

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
tension night splint
standard practice - a structured rehabilitation programme
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospitals of Leicester NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention

control

Arm Description

standard practice (structured rehabilitation programme) + TNS

standard practice (structured rehabilitation programme)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2015
Last Updated
February 28, 2020
Sponsor
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT02546115
Brief Title
RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis
Official Title
Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis, a Single-blinded Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
standard practice (structured rehabilitation programme) + TNS
Arm Title
control
Arm Type
Active Comparator
Arm Description
standard practice (structured rehabilitation programme)
Intervention Type
Device
Intervention Name(s)
tension night splint
Intervention Description
this is the use of a commercially available tension night splint device, to be worn by the patient
Intervention Type
Other
Intervention Name(s)
standard practice - a structured rehabilitation programme
Intervention Description
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 Outcome Measure Information:
Title
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
Time Frame
primary outcome time = 3 months
Secondary Outcome Measure Information:
Title
improvement in function as assessed by validated PROMs as described below
Description
several validated Patient rated Outcome Measures (PROMS) are used in this study, including: FFI-r, FAAM, and MOXFQ
Time Frame
3 months - end point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Wheeler
Organizational Affiliation
UHL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29259809
Citation
Wheeler PC. The addition of a tension night splint to a structured home rehabilitation programme in patients with chronic plantar fasciitis does not lead to significant additional benefits in either pain, function or flexibility: a single-blinded randomised controlled trial. BMJ Open Sport Exerc Med. 2017 Jun 13;3(1):e000234. doi: 10.1136/bmjsem-2017-000234. eCollection 2017.
Results Reference
derived
Links:
URL
http://bmjopensem.bmj.com/content/3/1/e000234
Description
publication - open access

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

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