Associated Joint Pain With Controlled Ankle Movement (CAM) Walker Boot Wear

Completed

• Conditions: Pain; Ankle Injuries

• Registration Number: NCT03312933
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

This study evaluates the location, frequency and duration of secondary site pain relating to immobilization in a CAM walker boot.

Detailed Description

Patients wearing a CAM walker boot for treatment of a foot or ankle injury were prospectively enrolled and evaluated for new or worsened secondary site pain. Surveys at four time points were completed to evaluate the presence of secondary site pain, its severity, and its impact on overall function.

Study Timeline

• Study Start: 2015-03-19
• Primary Completion: 2016-03-18
• Study Completion: 2016-03-18
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Results First Submitted: 2017-10-26
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-02
• Last Update Submitted: 2018-08-02
• Results First Posted: 2019-01-18
• Last Update Posted: 2019-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients enrolled in the study must have an injury that requires wear of a CAM walking boot for at least two weeks and have ambulation ad libitum without other aids (e.g crutches, canes, scooters, wheelchairs, etc.).

Exclusion Criteria

• Patients will be excluded from the study if they are a recent post-operative patient for lower extremity injury, have an additional acute injury to a lower extremity or back other than the foot or ankle injury being treated by the CAM walking boot at the time of initiation of treatment, have an ongoing or history of lower extremity joint injury, arthritis, or back pain or have restricted weightbearing as instructed by a physician (i.e. for ankle fracture that cannot weightbear).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Presence and Severity of Secondary Site Pain	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States