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Volar Plate Injury: A Comparison of Two Splinting Methods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02536157
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
University of Bradford
Information provided by (Responsible Party):
Claire Paxman, National Health Service, United Kingdom

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.


Condition or disease Intervention/treatment Phase
Volar Plate Injury of the Proximal Interphalangeal Joint Device: Thermoplastic splinting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Hand Therapy Unit, Mid Yorkshire Hospitals NHS Trust, Pinderfields General Hospital, Aberford Road,
Wakefield, West Yorkshire, United Kingdom, WF1 4DG
Sponsors and Collaborators
National Health Service, United Kingdom
University of Bradford
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Responsible Party: Claire Paxman, Senior Physiotherapist, National Health Service, United Kingdom
ClinicalTrials.gov Identifier: NCT02536157    
Other Study ID Numbers: 12020625
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Keywords provided by Claire Paxman, National Health Service, United Kingdom:
Volar plate
Splint
Proximal interphalangeal joint
Palmar plate
Hyperextension injury
Additional relevant MeSH terms:
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Wounds and Injuries