Volar Plate Injury of the Proximal Interphalangeal JointNCT02536157
Volar Plate Injury: A Comparison of Two Splinting Methods
A study testing Thermoplastic splinting in people with Volar Plate Injury of the Proximal Interphalangeal Joint, run by National Health Service, United Kingdom at 1 site in United Kingdom.
Trial summary
Which splinting method produces the best outcomes (in range of movement, pain and function) in the non-operative treatment of stable volar plate injuries in adults? The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint - PIPJ) of the finger. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Volar Plate Injury of the Proximal Interphalangeal Joint
- What is being tested?
- Thermoplastic splinting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Jan 2017
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All stable volar plate injuries.
- Aged 16 and older.
- Male and female.
- Acute presentation within 2 weeks of injury.
- All ethnic groups speaking English.
Who cannot join
- Vulnerable patient groups or those lacking capacity.
- Previous injury or pathology involving the same digit.
- Surgical intervention
- Unstable proximal interphalangeal joint.
- Concomitant tendon or additional bony injury outside the traditional Eaton classification types of volar plate injury.
- The DASH outcome measure is available and validated in 27 languages. However, those who do not speak/understand English well will unfortunately be excluded. This is an educational project and therefore there is no funding to use a translator service.
- Volar plate injuries are just as common in children and teenagers as adults. But under 16s will be excluded from this study as the DASH questionnaire has only been assumed valid in adults. There is no research investigating its use in younger age-groups.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,
Wakefield, West Yorkshire, WF1 4DG
About this study
Official title: A Randomised Controlled Trial Investigating the Effectiveness of Two Splinting Methods in the Non-operative Management of Volar Plate Injuries at the Proximal Interphalangeal Joint
Which splinting method produces the best outcomes (in range of movement, pain and function) in the non-operative treatment of stable volar plate injuries in adults?
The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint - PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using thermoplastic material. However, there is a potential risk of developing permanent stiffness of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk, the study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰ flexion (straight), which still prevents hyperextension, achieves better outcomes. There is no existing high-quality evidence comparing these two methods.
This is a randomised controlled trial. For the purposes of this study, the current treatment of a 20° dorsal block splint will act as the control group. The intervention group will be the volar gutter splint group. A convenience sample will be used and all patients (over 16 years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be invited to participate in the study, with consideration to inclusion/exclusion criteria. Participants will be randomised into one of two groups through the use of a random number generator. The outcomes assessed will be range of movement, pain and function. These will be measured at initial assessment, four and twelve weeks. These are all average normal time intervals that patients are seen. Each splint is worn for four weeks and participants will receive standardised advice, exercises and treatment.
- Being tested
- Thermoplastic splinting
- Keywords
- Volar plate, Splint, Proximal interphalangeal joint, Palmar plate, Hyperextension injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermoplastic splintingDevice
| Study group | Role | What they receive |
|---|---|---|
| Dorsal block splint | Active comparator | Thermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ. Receives: Device: Thermoplastic splinting |
| Volar gutter splint | Experimental | Thermoplastic splint in 0 degrees flexion applied to the volar surface of the finger. Receives: Device: Thermoplastic splinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Measured: One week
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Measured: Four weeks
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Measured: Twelve weeks
Secondary outcomes (2)
Pain measured using a 100mm visual analogue scale.
Measured using a 100mm visual analogue scale.
Measured: One, four and twelve weeks
Function of the upper limb measured using the DASH questionnaire.
Disabilities of the Shoulder, Arm and Hand Questionnaire.
Measured: One, four and twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volar Plate Injury of the Proximal Interphalangeal JointStudies 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
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Service, United Kingdom
- Sponsor type
- Other government
- Collaborators
- University of Bradford
- Responsible party
- Principal investigator, Claire Paxman, National Health Service, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536157
- Sponsor's protocol ID
- 12020625
- Status last verified
- Mar 2019
- First submitted
- 21 Aug 2015
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Investigating the Effectiveness of Two Splinting Methods in the Non-operative Management of Volar Plate Injuries at the Proximal Interphalangeal Joint
- ClinicalTrials.gov ID
- NCT02536157
- Acronym / sponsor ID
- 12020625
- Keywords
- Volar plate, Splint, Proximal interphalangeal joint, Palmar plate, Hyperextension injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Health Service, United KingdomOther government
- Collaborators
- University of Bradford
- Study start
- Jul 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 31 Aug 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.
Which splinting method produces the best outcomes (in range of movement, pain and function) in the non-operative treatment of stable volar plate injuries in adults?
The volar plate is a ligament located at the middle knuckle (proximal interphalangeal joint - PIPJ) of the finger. It is commonly injured through hyperextension, for example a ball hitting the fingertip. Current treatment in the Hand Therapy Unit involves splinting the injured joint dorsally (on the back of the finger) into 20⁰ flexion (bent) using thermoplastic material. However, there is a potential risk of developing permanent stiffness of the PIPJ into straightening, once the volar plate ligament heals. To reduce this risk, the study aims to investigate if using a volar (on the front of the finger) gutter splint in 0⁰ flexion (straight), which still prevents hyperextension, achieves better outcomes. There is no existing high-quality evidence comparing these two methods.
This is a randomised controlled trial. For the purposes of this study, the current treatment of a 20° dorsal block splint will act as the control group. The intervention group will be the volar gutter splint group. A convenience sample will be used and all patients (over 16 years old) presenting to the Mid Yorkshire Hospitals NHS Trust's Hand Therapy Unit will be invited to participate in the study, with consideration to inclusion/exclusion criteria. Participants will be randomised into one of two groups through the use of a random number generator. The outcomes assessed will be range of movement, pain and function. These will be measured at initial assessment, four and twelve weeks. These are all average normal time intervals that patients are seen. Each splint is worn for four weeks and participants will receive standardised advice, exercises and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorsal block splint | Active comparator | Device: Thermoplastic splintingThermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ. |
| Volar gutter splint | Experimental | Device: Thermoplastic splintingThermoplastic splint in 0 degrees flexion applied to the volar surface of the finger. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All stable volar plate injuries.
- Aged 16 and older.
- Male and female.
- Acute presentation within 2 weeks of injury.
- All ethnic groups speaking English.
Key exclusion criteria (7 listed)
- Vulnerable patient groups or those lacking capacity.
- Previous injury or pathology involving the same digit.
- Surgical intervention
- Unstable proximal interphalangeal joint.
- Concomitant tendon or additional bony injury outside the traditional Eaton classification types of volar plate injury.
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 |
|---|---|---|
| Thermoplastic splinting | Device | Dorsal block splint, Volar gutter splint |
Primary outcome
Range of movement measured with a Jamar finger goniometer.
Time frame: One week
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Time frame: Four weeks
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Time frame: Twelve weeks
Range of movement measured with a Jamar finger goniometer.
2 secondary outcomes
Pain measured using a 100mm visual analogue scale.
Time frame: One, four and twelve weeks
Function of the upper limb measured using the DASH questionnaire.
Time frame: One, four and twelve weeks
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 21 Mar 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermoplastic splinting in people with Volar Plate Injury of the Proximal Interphalangeal Joint, run by National Health Service, United Kingdom 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 5 inclusion and 7 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 21 Mar 2019. 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?
Range of movement measured with a Jamar finger goniometer. (time frame: One week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2019.