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

NCT ID: NCT03312933

Last Updated: 2019-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-19

Study Completion Date

2016-03-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Ankle Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Smith

Jeremy T Smith, MD., Principal Investigator, Instructor, Harvard Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy T Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2015P000327/BWH

Identifier Type: -

Identifier Source: org_study_id

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