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

• Sponsor: University Hospitals, Leicester (Other)
• Overall Status: Completed
• CT.gov ID: NCT02546115
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Plantar Fasciitis	Device: tension night splint; Other: standard practice - a structured rehabilitation programme	N/A

Study Design

• Study Type: Interventional
• 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: Sep 1, 2014
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

1. improvement in function as assessed by validated PROMs as described below [3 months - end point]

   several validated Patient rated Outcome Measures (PROMS) are used in this study, including: FFI-r, FAAM, and MOXFQ

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals of Leicester NHS Trust	Leicester		United Kingdom

Sponsors and Collaborators

• University Hospitals, Leicester

Investigators

• Principal Investigator: Patrick Wheeler, UHL

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• publication - open access

Publications

None provided.

• Responsible Party: University Hospitals, Leicester
• ClinicalTrials.gov Identifier: NCT02546115
• Other Study ID Numbers: UHL - 11335
• First Posted: Sep 10, 2015
• Last Update Posted: Mar 3, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Fasciitis; Fasciitis, Plantar

Study Results

No Results Posted as of Mar 3, 2020