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CompletedNCT02536157Updated Mar 21, 2019

Volar Plate Injury: A Comparison of Two Splinting Methods

An interventional study of Thermoplastic splinting in Volar Plate Injury of the Proximal Interphalangeal Joint, sponsored by National Health Service, United Kingdom. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-03-21.

Sponsored by National Health Service, United Kingdom · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Volar Plate Injury of the Proximal Interphalangeal Joint

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Keywords

  • Volar plate
  • Splint
  • Proximal interphalangeal joint
  • Palmar plate
  • Hyperextension injury
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 42 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

National Health Service, United Kingdom is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • 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

Interventions

  • DeviceThermoplastic splinting
06

What researchers measure

Primary outcomes

  1. Range of movement measured with a Jamar finger goniometer.

    Range of movement measured with a Jamar finger goniometer.

    Time frame: One week

  2. Range of movement measured with a Jamar finger goniometer.

    Range of movement measured with a Jamar finger goniometer.

    Time frame: Four weeks

  3. Range of movement measured with a Jamar finger goniometer.

    Range of movement measured with a Jamar finger goniometer.

    Time frame: Twelve weeks

Secondary outcomes

  1. Pain measured using a 100mm visual analogue scale.

    Measured using a 100mm visual analogue scale.

    Time frame: One, four and twelve weeks

  2. Function of the upper limb measured using the DASH questionnaire.

    Disabilities of the Shoulder, Arm and Hand Questionnaire.

    Time frame: One, four and twelve weeks

07

Study locations

1 site
  • Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,
    Wakefield, West Yorkshire WF1 4DG, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02536157
Lead sponsor
National Health Service, United Kingdom
Collaborators
University of Bradford
Responsible party
Claire Paxman (Senior Physiotherapist, National Health Service, United Kingdom) — Principal investigator
First posted
Aug 31, 2015
Start date
Jul 2015
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Mar 21, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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