Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
This study is currently recruiting participants.
Verified January 2013 by J&M Shuler
Sponsor:
J&M Shuler
Information provided by (Responsible Party):
Michael Shuler, J&M Shuler
ClinicalTrials.gov Identifier:
NCT01118715
First received: April 30, 2010
Last updated: January 28, 2013
Last verified: January 2013
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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
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 ]
- Circumferential measurements taken at the wrist and mid-aspect of proximal phalanx from four fingers.
- 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
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 Edema Radius Fractures Somatoform Disorders Complex Regional Pain Syndromes Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Nerve Compression Syndromes Cumulative Trauma Disorders Sprains and Strains Wounds and Injuries Signs and Symptoms Forearm Injuries Arm Injuries Fractures, Bone Mental Disorders Autonomic Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013