Associated Joint Pain With Controlled Ankle Movement (CAM) Walker Boot Wear
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|ClinicalTrials.gov Identifier: NCT03312933|
Recruitment Status : Completed
First Posted : October 18, 2017
Results First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease|
|Pain Ankle Injuries|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Associated Joint Pain With CAM Walking Boot Wear|
|Actual Study Start Date :||March 19, 2015|
|Actual Primary Completion Date :||March 18, 2016|
|Actual Study Completion Date :||March 18, 2016|
Duration of boot >2 weeks
All patients who were placed into a CAM walker boot for >2 weeks were prospectively enrolled. Patients were placed by an orthopedic cast technician into either a tall or short CAM walker boot, based upon the appropriate boot type needed for treatment. Inclusion criteria included anticipated boot wear for at least two weeks, and weightbearing as tolerated weightbearing restrictions. Exclusion criteria included transitioning into a CAM walker boot as part of a postoperative protocol, injury requiring restricted weightbearing, or an additional acute injury to the lower back or lower extremity. Those who subsequently reported wearing the boot for less than two weeks or had a treatment plan change were removed from the study.
- The Presence and Severity of Secondary Site Pain [ Time Frame: At the time of transitioning out of the boot ]The primary outcome was the presence of secondary site pain that developed or worsened during CAM walker boot wear. Surveys inquired about the presence of secondary site pain, defined as lower back, ipsilateral hip, contralateral hip, ipsilateral knee, contralateral knee, contralateral ankle, and contralateral foot. Severity of pain was assessed using a 100-point visual analog scale (VAS), with zero indicating no pain and 100 representing the worst pain imaginable.
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): NCT03312933
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02130|
|Principal Investigator:||Jeremy T Smith, MD||Brigham and Women's Hospital|