NCT02546115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 3, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

June 15, 2015

Last Update Submit

February 28, 2020

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

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

    primary outcome time = 3 months

Secondary Outcomes (1)

  • improvement in function as assessed by validated PROMs as described below

    3 months - end point

Study Arms (2)

Intervention

ACTIVE COMPARATOR

standard practice (structured rehabilitation programme) + TNS

Device: tension night splintOther: standard practice - a structured rehabilitation programme

control

ACTIVE COMPARATOR

standard practice (structured rehabilitation programme)

Other: standard practice - a structured rehabilitation programme

Interventions

tension night splintDEVICE

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

Intervention
standard practice - a structured rehabilitation programmeOTHER

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

Interventioncontrol

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age \>18 with symptoms of plantar fasciitis for \>3 months
  • Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 29259809DERIVED

Related Links

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Study Officials

  • Patrick Wheeler

    UHL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

September 10, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 3, 2020

Record last verified: 2020-02

Locations

GB(1)