Volar Plate Injury: A Comparison of Two Splinting Methods
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|ClinicalTrials.gov Identifier: NCT02536157|
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : March 21, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Volar Plate Injury of the Proximal Interphalangeal Joint||Device: Thermoplastic splinting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Active Comparator: Dorsal block splint
Thermoplastic splint in 20 degrees flexion applied to the dorsum of the PIPJ.
Device: Thermoplastic splinting
Experimental: Volar gutter splint
Thermoplastic splint in 0 degrees flexion applied to the volar surface of the finger.
Device: Thermoplastic splinting
- 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.
- Pain measured using a 100mm visual analogue scale. [ Time Frame: One, four and twelve weeks ]Measured using a 100mm visual analogue scale.
- Function of the upper limb measured using the DASH questionnaire. [ Time Frame: One, four and twelve weeks ]Disabilities of the Shoulder, Arm and Hand Questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536157
|Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,|
|Wakefield, West Yorkshire, United Kingdom, WF1 4DG|