Ankle Injuries, Pain
Conditions
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.
Interventions
None listed
Sponsors
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CAM Walker Boot for >2 Weeks All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled in the study. At the time of initiation of boot wear, patients were placed by an orthopedic cast technician into either a tall Aircast AirSelect Elite™ or short Aircast AirSelect™ CAM walker boot, based upon the diagnosis and appropriate boot type needed for treatment. Inclusion criteria included minimum age of 18 years, 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 were excluded. Additionally, patients who had a treatment plan change, such as proceeding with lower extremity surgery during the study period, were removed from the study. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 36 |
| Overall Study | Protocol Violation | 15 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | CAM Walker Boot for >2 Weeks |
|---|---|
| Age, Continuous | 49 years |
| Body Mass Index Normal (below 25) | 24 participants |
| Body Mass Index Obese (above 30) | 12 participants |
| Body Mass Index Overweight (25-30) | 10 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Injury Type Fracture | 17 Participants |
| Injury Type Other | 5 Participants |
| Injury Type Sprain | 7 Participants |
| Injury Type Tendon Problem | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Region of Enrollment United States | 46 participants |
| Secondary Site Pain No secondary site pains | 19 Participants |
| Secondary Site Pain One or more secondary site pains | 27 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 31 Participants |
| Type of CAM walker boot Short CAM Boot | 15 Participants |
| Type of CAM walker boot Tall CAM Boot | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
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.
Time frame: At the time of transitioning out of the boot
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duration of CAM Walking Boot Wear >2 Weeks | The Presence and Severity of Secondary Site Pain | 31 Participants |