RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis
NCT ID: NCT02546115
Last Updated: 2020-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2014-09-30
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Novel Stretching Device Versus Night Splints
NCT05216679
Dynamic Versus Static Night Splinting of Plantar Fasciitis
NCT05432895
Treatment of Plantar Fasciitis With Dorsiflexion Night Splints and Medial Arch Supports
NCT00222911
Efficacy of a Self-managed Versus a Predetermined Resistance Training Protocol in Reducing Pain in Individuals With Plantar Fasciopathy
NCT03304353
Observation on the Efficacy of Improving Ankle Dorsiflexion Limitation in Patients With Plantar Fasciitis
NCT06542211
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
standard practice (structured rehabilitation programme) + TNS
tension night splint
this is the use of a commercially available tension night splint device, to be worn by the patient
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
control
standard practice (structured rehabilitation programme)
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
tension night splint
this is the use of a commercially available tension night splint device, to be worn by the patient
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)
Exclusion Criteria
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
18 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospitals, Leicester
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Wheeler
Role: PRINCIPAL_INVESTIGATOR
UHL
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospitals of Leicester NHS Trust
Leicester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
publication - open access
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UHL - 11335
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.