Volar Plate Injury of the Proximal Interphalangeal Joint Clinical Trial
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
| NCT number | NCT02536157 |
| Other study ID # | 12020625 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2015 |
| Est. completion date | January 2017 |
| Verified date | March 2019 |
| Source | National Health Service, United Kingdom |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 16 Years and older |
| Eligibility |
Inclusion Criteria: 1. All stable volar plate injuries. 2. Aged 16 and older. 3. Male and female. 4. Acute presentation within 2 weeks of injury. 5. All ethnic groups speaking English. Exclusion Criteria: 1. Vulnerable patient groups or those lacking capacity. 2. Previous injury or pathology involving the same digit. 3. Surgical intervention 4. Unstable proximal interphalangeal joint. 5. Concomitant tendon or additional bony injury outside the traditional Eaton classification types of volar plate injury. 6. 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. 7. 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road, | Wakefield | West Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| National Health Service, United Kingdom | University of Bradford |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Range of movement measured with a Jamar finger goniometer. | Range of movement measured with a Jamar finger goniometer. | One week | |
| Primary | Range of movement measured with a Jamar finger goniometer. | Range of movement measured with a Jamar finger goniometer. | Four weeks | |
| Primary | Range of movement measured with a Jamar finger goniometer. | Range of movement measured with a Jamar finger goniometer. | Twelve weeks | |
| Secondary | Pain measured using a 100mm visual analogue scale. | Measured using a 100mm visual analogue scale. | One, four and twelve weeks | |
| Secondary | Function of the upper limb measured using the DASH questionnaire. | Disabilities of the Shoulder, Arm and Hand Questionnaire. | One, four and twelve weeks |