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Completed

NCT Number: NCT02536157

Volar Plate Injury: A Comparison of Two Splinting Methods

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,

Wakefield, West Yorkshire, WF1 4DG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thermoplastic splinting

Device

Primary outcomes

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

    Time frame: One week

    Range of movement measured with a Jamar finger goniometer.

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

    Time frame: Four weeks

    Range of movement measured with a Jamar finger goniometer.

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

    Time frame: Twelve weeks

    Range of movement measured with a Jamar finger goniometer.

Secondary outcomes

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

    Time frame: One, four and twelve weeks

    Measured using a 100mm visual analogue scale.

  2. 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.

Sponsors and collaborators

Lead sponsor

National Health Service, United Kingdom

Other Gov

Collaborators

  • University of Bradford

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2015
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.