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

Pain Clinical Trial

Official title:

Associated Joint Pain With CAM Walking Boot Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312933
• Other study ID #: 2015P000327/BWH
• Status: Completed
• Start date: March 19, 2015
• Est. completion date: March 18, 2016

Study information

• Verified date: August 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 18, 2016
• Est. primary completion date: March 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ankle Injuries
• Arthralgia
• Pain

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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