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

Purpose

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	Intervention
Post-traumatic Carpal Tunnel Syndrome Complex Regional Pain Syndrome Edema	Device: Compression glove


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Arm Injuries and Disorders Carpal Tunnel Syndrome Complex Regional Pain Syndrome Edema Fractures

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Complex Regional Pain Syndrome Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome

U.S. FDA Resources

Further study details as provided by J&M Shuler:

Primary Outcome Measures:

Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 2 wks ] [ Designated as safety issue: No ]
Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 5 wks ] [ Designated as safety issue: No ]
Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 3 mos ] [ Designated as safety issue: No ]
Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests
Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) [ Time Frame: 6 mos ] [ Designated as safety issue: No ]
Suspected CTS will be evaluated using Durkans' test, with confirmation via nerve conduction tests

Secondary Outcome Measures:

Incidence of Complex Regional Pain Syndrome [ Time Frame: 2 wks, 5 wks, 3 mos, 6 mos ] [ Designated as safety issue: No ]
Using reserach diagnostic criteria proposed by IASP (Budapest, 2003).
Edema [ Time Frame: 2 wks, 5 wks, 3 mos, 6 mos ] [ Designated as safety issue: No ]
1. Circumferential measurements taken at the wrist and mid-aspect of proximal phalanx from four fingers.
2. Figure-of-eight measurement of hand size
Grip strength [ Time Frame: 5 wks, 3 mos, 6 mos ] [ Designated as safety issue: No ]
measured in kgs, using a Jamar dynamometer
Disabilities of the Arm, Shoulder, & Hand questionnaire [ Time Frame: 2 wks, 5 wks, 3 mos, 6 mos ] [ Designated as safety issue: No ]
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.
Pain [ Time Frame: Baseline, 2wks, 5wks, 3mos, 6mos ] [ Designated as safety issue: No ]
Using a 1-10 pain scale
Time-to-recovery [ Time Frame: Time point when patient is discharged from occupational therapy ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	460
Study Start Date:	April 2010
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118715

Contacts


Contact: Michael S Shuler, MD	706-433-4031	msimmss@hotmail.com

Locations


United States, Georgia
Athens Orthopedic Clinic	Recruiting
Athens, Georgia, United States, 30606
Principal Investigator: Michael S Shuler, MD

Sponsors and Collaborators

J&M Shuler

Investigators


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

More Information

No publications provided


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
Study First Received:	April 30, 2010
Last Updated:	January 28, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 Radius Fractures Reflex Sympathetic Dystrophy Syndrome Arm Injuries Autonomic Nervous System Diseases Cumulative Trauma Disorders Disease Forearm Injuries	Fractures, Bone Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Pathologic Processes Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

ClinicalTrials.gov processed this record on February 26, 2015