Volar Plate Injury: A Comparison of Two Splinting Methods
Primary Purpose
Volar Plate Injury of the Proximal Interphalangeal Joint
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Thermoplastic splinting
Sponsored by
About this trial
This is an interventional treatment trial for Volar Plate Injury of the Proximal Interphalangeal Joint focused on measuring Volar plate, Splint, Proximal interphalangeal joint, Palmar plate, Hyperextension injury
Eligibility Criteria
Inclusion Criteria:
- All stable volar plate injuries.
- Aged 16 and older.
- Male and female.
- Acute presentation within 2 weeks of injury.
- All ethnic groups speaking English.
Exclusion Criteria:
- 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.
Sites / Locations
- Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Dorsal block splint
Volar gutter splint
Arm Description
Thermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ.
Thermoplastic splint in 0 degrees flexion applied to the volar surface of the finger.
Outcomes
Primary Outcome Measures
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Range of movement measured with a Jamar finger goniometer.
Secondary Outcome Measures
Pain measured using a 100mm visual analogue scale.
Measured using a 100mm visual analogue scale.
Function of the upper limb measured using the DASH questionnaire.
Disabilities of the Shoulder, Arm and Hand Questionnaire.
Full Information
NCT ID
NCT02536157
First Posted
August 21, 2015
Last Updated
March 19, 2019
Sponsor
National Health Service, United Kingdom
Collaborators
University of Bradford
1. Study Identification
Unique Protocol Identification Number
NCT02536157
Brief Title
Volar Plate Injury: A Comparison of Two Splinting Methods
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Health Service, United Kingdom
Collaborators
University of Bradford
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Volar Plate Injury of the Proximal Interphalangeal Joint
Keywords
Volar plate, Splint, Proximal interphalangeal joint, Palmar plate, Hyperextension injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dorsal block splint
Arm Type
Active Comparator
Arm Description
Thermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ.
Arm Title
Volar gutter splint
Arm Type
Experimental
Arm Description
Thermoplastic splint in 0 degrees flexion applied to the volar surface of the finger.
Intervention Type
Device
Intervention Name(s)
Thermoplastic splinting
Primary Outcome Measure Information:
Title
Range of movement measured with a Jamar finger goniometer.
Description
Range of movement measured with a Jamar finger goniometer.
Time Frame
One week
Title
Range of movement measured with a Jamar finger goniometer.
Description
Range of movement measured with a Jamar finger goniometer.
Time Frame
Four weeks
Title
Range of movement measured with a Jamar finger goniometer.
Description
Range of movement measured with a Jamar finger goniometer.
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Pain measured using a 100mm visual analogue scale.
Description
Measured using a 100mm visual analogue scale.
Time Frame
One, four and twelve weeks
Title
Function of the upper limb measured using the DASH questionnaire.
Description
Disabilities of the Shoulder, Arm and Hand Questionnaire.
Time Frame
One, four and twelve weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All stable volar plate injuries.
Aged 16 and older.
Male and female.
Acute presentation within 2 weeks of injury.
All ethnic groups speaking English.
Exclusion Criteria:
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.
Facility Information:
Facility Name
Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,
City
Wakefield
State/Province
West Yorkshire
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Volar Plate Injury: A Comparison of Two Splinting Methods
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