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

• Sponsor: J&M Shuler
• Information provided by (Responsible Party): Michael Shuler, J&M Shuler

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 139 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
• Estimated Study Completion Date: December 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 2 wks ]
   Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests
2. Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 5 wks ]
   Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests
3. Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 3 mos ]
   Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests
4. Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 6 mos ]
   Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests

Secondary Outcome Measures :

1. Incidence of Complex Regional Pain Syndrome [ Time Frame: 2 wks, 5 wks, 3 mos, 6 mos ]
   Using reserach diagnostic criteria proposed by IASP (Budapest, 2003).
2. Edema [ Time Frame: 2 wks, 5 wks, 3 mos, 6 mos ]
   1. Circumferential measurements taken at the wrist and mid-aspect of proximal phalanx from four fingers.
   2. Figure-of-eight measurement of hand size
3. Grip strength [ Time Frame: 5 wks, 3 mos, 6 mos ]
   measured in kgs, using a Jamar dynamometer
4. Disabilities of the Arm, Shoulder, & Hand questionnaire [ Time Frame: 2 wks, 5 wks, 3 mos, 6 mos ]
   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.
5. Pain [ Time Frame: Baseline, 2wks, 5wks, 3mos, 6mos ]
   Using a 1-10 pain scale
6. Time-to-recovery [ Time Frame: Time point when patient is discharged from occupational therapy ]
   Time at which occupational therapist decrees that the patient has reached a recovery point beyond which a home exercise program is sufficient to complete their rehabilitation.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Georgia

Athens Orthopedic Clinic

Athens, Georgia, United States, 30606

Sponsors and Collaborators

J&M Shuler

Investigators

• Principal Investigator: Michael S Shuler, MD; J&M Shuler

More Information

• Responsible Party: Michael Shuler, Hand and Upper Extremity Specialist, J&M Shuler
• ClinicalTrials.gov Identifier: NCT01118715 History of Changes
• Other Study ID Numbers: DRF-001
• First Posted: May 7, 2010
• Last Update Posted: February 24, 2016
• Last Verified: February 2016

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:

Carpal Tunnel Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Radius Fractures; Disease; Pathologic Processes; Fractures, Bone; Wounds and Injuries; Median Neuropathy; Mononeuropathies; 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