An observational study in Pain and Ankle Injuries, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-18.
Sponsored by Brigham and Women's Hospital · Observational
This study evaluates the location, frequency and duration of secondary site pain relating to immobilization in a CAM walker boot.
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 301 observational studies indexed under Pain.
Browse Pain studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
| Milestone | CAM Walker Boot for >2 Weeks |
|---|---|
| Started | 100 |
| Completed | 46 |
| Not completed | 54 |
| Withdrew: Protocol violation | 15 |
| Withdrew: Lost to follow-up | 36 |
| Withdrew: Withdrawal by subject | 3 |
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.
| Participants | Duration of CAM Walking Boot Wear >2 Weeks |
|---|---|
| The Presence and Severity of Secondary Site Pain | 31 |
Collected over Patients were followed until three months after transitioning out of the boot.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CAM Walker Boot for >2 Weeks | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | CAM Walker Boot for >2 Weeks |
|---|---|
| Mean | 49 (22 to 77) |
| Sex: Female, Male(Participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| Female | 15 |
| Male | 31 |
| Ethnicity (NIH/OMB)(Participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 42 |
| Unknown or Not Reported | 2 |
| Race (NIH/OMB)(Participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 39 |
| More than one race | 0 |
| Unknown or Not Reported | 4 |
| Region of Enrollment(participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| United States | 46 |
| Body Mass Index(participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| Normal (below 25) | 24 |
| Overweight (25-30) | 10 |
| Obese (above 30) | 12 |
| Injury Type(Participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| Fracture | 17 |
| Sprain | 7 |
| Tendon Problem | 17 |
| Other | 5 |
| Secondary Site Pain(Participants) | CAM Walker Boot for >2 Weeks |
|---|---|
| One or more secondary site pains | 27 |
| No secondary site pains | 19 |
1 further baseline measures are reported on the registry.
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2015 to primary completion in Mar 2016, 11 months.
Results were first posted in Jan 2019, 2 years 10 months after primary completion.
Of 147 non-industry observational studies under Pain, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 71. This study's 11 months is below that.
Counting every sponsor, half of 154 studies reached it within 23 months; a quarter within 11 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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