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

Associated Joint Pain With CAM Walking Boot Wear

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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Presence and Severity of Secondary Site Pain	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.	At the time of transitioning out of the boot

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Jeremy T Smith, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2015
• Primary Completion (Actual): March 18, 2016
• Study Completion (Actual): March 18, 2016

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Leg Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Ankle Injuries
• Other Study ID Numbers: 2015P000327/BWH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No