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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546115
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospitals, Leicester

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Device: tension night splint Other: standard practice - a structured rehabilitation programme Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Reduction in pain as assessed by a 0-10 visual analogue scale (VAS) [ Time Frame: primary outcome time = 3 months ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546115


Locations
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United Kingdom
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Sponsors and Collaborators
University Hospitals, Leicester
Investigators
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Principal Investigator: Patrick Wheeler UHL
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Hospitals, Leicester
ClinicalTrials.gov Identifier: NCT02546115    
Other Study ID Numbers: UHL - 11335
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases