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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
Sponsor:
Information provided by (Responsible Party):
Jeremy Smith, 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.

Condition or disease
Pain Ankle Injuries

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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. Those who subsequently reported wearing the boot for less than two weeks or had a treatment plan change were removed from the study.

Demographic information was gathered, including age, sex, race or ethnicity, body mass index (BMI), history of lower extremity or lower back injury, history of chronic pain (e.g. fibromyalgia, chronic opiate use, chronic regional pain syndrome), and cigarette smoking history. The diagnosis was recorded for which the CAM walker boot was required.

Criteria

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).

Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Jeremy T Smith, MD Brigham and Women's Hospital

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Responsible Party: Jeremy Smith, Jeremy T Smith, MD., Principal Investigator, Instructor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03312933     History of Changes
Other Study ID Numbers: 2015P000327/BWH
First Posted: October 18, 2017    Key Record Dates
Results First Posted: January 18, 2019
Last Update Posted: January 18, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthralgia
Ankle Injuries
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Leg Injuries
Wounds and Injuries