Plantar FasciitisNCT02546115
RCT - Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis
A study testing tension night splint and standard practice - a structured rehabilitation programme in people with Plantar Fasciitis, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- tension night splint and standard practice - a structured rehabilitation programme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age >18 with symptoms of plantar fasciitis for >3 months
- Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester
About this study
Official title: Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis, a Single-blinded Randomised Controlled Trial
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.
- Conditions
- Plantar Fasciitis
- Being tested
- tension night splint, standard practice - a structured rehabilitation programme
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tension night splintDevice
this is the use of a commercially available tension night splint device, to be worn by the patient
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | standard practice (structured rehabilitation programme) + TNS Receives: Device: tension night splint; Other: standard practice - a structured rehabilitation programme |
| control | Active comparator | standard practice (structured rehabilitation programme) Receives: Other: standard practice - a structured rehabilitation programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
Measured: primary outcome time = 3 months
Secondary outcomes (1)
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
Measured: 3 months - end point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wheeler, Principal investigator, UHL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546115
- Sponsor's protocol ID
- UHL - 11335
- Status last verified
- Feb 2020
- First submitted
- 15 Jun 2015
- Last updated
- 3 Mar 2020
- Results posted
- No
Publications
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.
PubMed 29259809
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Benefits of the Use of a Tension Night Splint in Patients With Plantar Fasciitis, a Single-blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02546115
- Acronym / sponsor ID
- UHL - 11335
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: tension night splint, Other: standard practice - a structured rehabilitation programmestandard practice (structured rehabilitation programme) + TNS |
| control | Active comparator | Other: standard practice - a structured rehabilitation programmestandard practice (structured rehabilitation programme) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age >18 with symptoms of plantar fasciitis for >3 months
- Diagnostic imaging confirming plantar fasciitis (either US or MRI acceptable)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tension night splintthis is the use of a commercially available tension night splint device, to be worn by the patient | Device | Intervention |
| standard practice - a structured rehabilitation programmethis is the standardised structured rehabilitation programme of home exercises given to patients, with supporting literature, and instructions on how to progress the regime themselves | Other | Intervention, control |
Primary outcome
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS)
Time frame: primary outcome time = 3 months
1 secondary outcome
improvement in function as assessed by validated PROMs as described below
Time frame: 3 months - end point
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 29259809Wheeler 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.
- publication - open accessLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Wheeler principal investigator
UHL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tension night splint and standard practice - a structured rehabilitation programme in people with Plantar Fasciitis, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain as assessed by a 0-10 visual analogue scale (VAS) (time frame: primary outcome time = 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02546115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.