Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
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|ClinicalTrials.gov 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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- Edema [ Time Frame: 2 wks- 24 weeks ]Circumference of Wrist/Finger by Glove or No Glove
- 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.
- 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
- 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.
- 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
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): NCT01118715
|United States, Georgia|
|Athens Orthopedic Clinic|
|Athens, Georgia, United States, 30606|
|Principal Investigator:||Michael S Shuler, MD||J&M Shuler|