Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial

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. Identifier: NCT01118715
Recruitment Status : Terminated (Impractical to enroll the #s needed for statistical significance; project manager relocated)
First Posted : May 7, 2010
Results First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Information provided by (Responsible Party):
Michael Shuler, J&M Shuler

Brief Summary:

Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications. Previously proposed preventive strategies have questionable efficacy and may impose additional risks on the patient. Because many complications secondary to distal radius fractures are associated with excessive swelling, a prophylactic means for edema reduction could dramatically reduce morbidity among this population. A compression glove is a non-invasive, non-pharmacological way to reduce edema. Previous studies have confirmed its utility in edema reduction after hand trauma and among patients with chronic inflammatory conditions, but none have sufficiently investigated the application to patients with distal radius fractures, a population in which this intervention could have a large impact. The investigators propose a randomized controlled trial to evaluate use of a compression glove during recovery among patients who have sustained an unstable distal radius fracture. The investigators hypothesize that patients who wear a compression glove after a distal radius fracture:

  • Will experience less edema
  • Will demonstrate greater functionality
  • Will recover more quickly
  • Will have lower incidence rates of carpal tunnel syndrome
  • Will have lower incidence rates of complex regional pain syndrome

Condition or disease Intervention/treatment Phase
Post-traumatic Carpal Tunnel Syndrome Complex Regional Pain Syndrome Edema Device: Compression glove Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
Study Start Date : April 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Compression glove
Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.
Device: Compression glove
A compression glove worn during recovery from distal radius fracture

No Intervention: Control
Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.

Primary Outcome Measures :
  1. Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS) [ Time Frame: 2 wks-24 wks ]
    Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)

Secondary Outcome Measures :
  1. Edema [ Time Frame: 2 wks- 24 weeks ]
    Circumference of Wrist/Finger by Glove or No Glove

  2. Range of Motion [ Time Frame: 2 wks-24 wks ]
    Count of participants (by group) that were capable or full extension or flexion at each encounter.

  3. Grip Strength [ Time Frame: 5 wks-24 wks ]
    Grip strength measured using a hand dynamometer at each visit except @ 2-weeks; grip strength was not measured at 2-weeks because of post-op activity restrictions recommended by the treating physician

  4. DASH Score [ Time Frame: 2 wks- 24 wks ]
    Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) is 30-item questionnaire designed to quanitfy functional outcomes of the upper extremity and measure symptoms of pain, physical, emotional, and social domains associated with musculoskeletal disorders of the upper limb. Scores can range from 0-100 with 0 indicating NO disability and 100 indicating extreme disability.

  5. Pain on Numerical Rating Scale [ Time Frame: 2 wks- 24 wks ]
    Assessment of pain using a numerical rating scale of 0-10, where 0=no pain and 10=worst possible pain

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female
  • Between the ages of 18-85
  • Patients with unstable unilateral distal radius fractures (requiring surgical stabilization)

Exclusion Criteria:

  • Pre-existing cases of carpal tunnel syndrome and/or complex regional pain syndrome
  • Nerve or tendon laceration
  • Decompression of carpal tunnel concomitant with surgical stabilization
  • Additional fractures, including carpal fractures, more proximal fractures of the radius, and finger injuries will be excluded from the study (Ulnar styloid and ulnar head and neck fractures will be included)
  • Uncontrolled rheumatoid arthritis patients
  • Bilateral fractures
  • Unable or unwilling to provide written informed consent.

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 identifier (NCT number): NCT01118715

Layout table for location information
United States, Georgia
Athens Orthopedic Clinic
Athens, Georgia, United States, 30606
Sponsors and Collaborators
J&M Shuler
Layout table for investigator information
Principal Investigator: Michael S Shuler, MD J&M Shuler
Layout table for additonal information
Responsible Party: Michael Shuler, Hand and Upper Extremity Specialist, J&M Shuler Identifier: NCT01118715    
Other Study ID Numbers: DRF-001
First Posted: May 7, 2010    Key Record Dates
Results First Posted: November 4, 2020
Last Update Posted: November 4, 2020
Last Verified: October 2020
Keywords provided by Michael Shuler, J&M Shuler:
distal radius fracture
post-traumatic carpal tunnel syndrome
complex regional pain syndrome
compression glove
edema glove
Additional relevant MeSH terms:
Layout table for MeSH terms
Carpal Tunnel Syndrome
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Radius Fractures
Pathologic Processes
Fractures, Bone
Wounds and Injuries
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Forearm Injuries
Arm Injuries
Autonomic Nervous System Diseases