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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy T Smith, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02130 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Eliteâ„¢ or short Aircast AirSelectâ„¢ 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Eliteâ„¢ or short Aircast AirSelectâ„¢ 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | At the time of transitioning out of the boot |
|
Patients were followed until three months after transitioning out of the boot.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Eliteâ„¢ or short Aircast AirSelectâ„¢ 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy T. Smith | Brigham and Women's Hospital | (617) 983-7295 | jsmith42@bwh.harvard.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007869 | Leg Injuries |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | A BMI was calculated for each patient. The were then separated into Normal (below 25 kg/m^2), Overweight (25-30 kg/m^2), and Obese (above 30 kg/m^2). | Number | participants |
|
| Injury Type | Count of Participants | Participants |
|
| Secondary Site Pain | Count of Participants | Participants |
|
| Type of CAM walker boot | Count of Participants | Participants |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
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| D014947 | Wounds and Injuries |