Arthralgia, Trouble Balancing
Conditions
Keywords
Joint pain, Ankle fracture, Leg length discrepancy, CAM boot, Even-Up
Brief summary
Evaluating impact of use of Even-Up shoe wear device for patients treated in CAM boot walker for an ankle fracture. Randomized controlled trial, randomizing patients into control group with boot treatment only versus boot treatment with Even-Up device on contralateral extremity.
Detailed description
A variety of foot and ankle injuries can be treated effectively through the use of a controlled ankle movement (CAM) walker boot. CAM walker boots protect the injured area by restricting foot and ankle motion, providing a stable platform to distribute forces while bearing weight, and allowing the user to rollover the foot during ambulation because of a rocker bottom-shaped sole. Such qualities lend the CAM walker boot to provide ankle support that can be advantageous compared with other commonly used methods. Despite their utility, CAM walker boots create a simulated leg-length discrepancy (LLD), which can result in altered biomechanics during ambulation. Additionally, a LLD can be associated with lower back and joint pain. We have previously conducted a study that suggests a relationship exists between CAM walker boot treatment and pain at sites other than the extremity being treated. There have been several randomized controlled trials (RCTs) examining a relationship between the correction of inherent LLD with insole inserts and lower back pain. Furthermore, there has been a past RCT and there is a current RCT examining a relationship between the use of the EVENup orthotic shoe lift to correct CAM walker boot simulated LLD and pain at sites other than the extremity being treated. However, these studies were not conducted with patient populations with uniform injuries. To the best of our knowledge, an RCT has not been conducted with the EVENup orthotic shoe lift to examine this relationship in a uniform patient population with nonoperative ankle fractures. This RCT aims to assess the efficacy of the EVENup orthotic shoe lift, towards reducing and even preventing such pain that may be associated with this common course of treatment.
Interventions
DEVICEEven-Up
Orthotic shoe lift worn on contralateral foot to increase leg length
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Both patients and providers are aware that patients are being assigned to either control or experimental group.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Non-operative Treatment of Ankle Fracture * CAM boot as treatment for injury * Weight bearing ad lib
Exclusion criteria
* Pregnancy * Non-English speaking * Recent surgery for lower extremity or back * Recent other injury to lower extremity or back * Restricted weight bearing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Pain (VAS) | 0-24 weeks | Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from No Pain at the far left to Worst Pain at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain). |
| Patient Reported Outcome (FAAM-ADL, 0 - 100) | 0-24 weeks | FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, \[0 -100\]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group I: CAM Walker Boot Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks. | 3 |
| Group II: CAM+EVENup Orthotic Shoe Lift Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks. | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Group I: CAM Walker Boot | Total | Group II: CAM+EVENup Orthotic Shoe Lift |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 3 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 17.1 | 42 years STANDARD_DEVIATION 18.8 | 48 years STANDARD_DEVIATION 21.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| FAAM (0 - 100) | 33.7 units on a scale STANDARD_DEVIATION 14.1 | 40.3 units on a scale STANDARD_DEVIATION 19.1 | 46.8 units on a scale STANDARD_DEVIATION 24.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 5 Participants | 3 Participants |
| Region of Enrollment United States | 3 participants | 6 participants | 3 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
Patient Reported Outcome (FAAM-ADL, 0 - 100)
FAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, \[0 -100\]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100.
Time frame: 0-24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 0 weeks | 33.7 score on a scale | Standard Deviation 14.1 |
| Group I | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 12 weeks | 86.1 score on a scale | Standard Deviation 14.8 |
| Group I | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 24 weeks | 92.9 score on a scale | Standard Deviation 6.2 |
| Group I | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 6 weeks | 59.9 score on a scale | Standard Deviation 4.8 |
| Group II | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 24 weeks | 99.6 score on a scale | Standard Deviation 0.7 |
| Group II | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 12 weeks | 97.2 score on a scale | Standard Deviation 2.5 |
| Group II | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 0 weeks | 46.8 score on a scale | Standard Deviation 24.2 |
| Group II | Patient Reported Outcome (FAAM-ADL, 0 - 100) | 6 weeks | 88.9 score on a scale | Standard Deviation 8.1 |
Primary
Patient Reported Pain (VAS)
Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from No Pain at the far left to Worst Pain at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain).
Time frame: 0-24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group I | Patient Reported Pain (VAS) | 12 weeks - Left Ankle | 6.7 score on a scale | Standard Deviation 11.5 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Right Knee | 2 score on a scale | Standard Deviation 3.5 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Right Foot | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Left Knee | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Left Foot | 2 score on a scale | Standard Deviation 3.5 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Right Ankle | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Right Foot | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Left Ankle | 10.3 score on a scale | Standard Deviation 17.9 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Left Hip | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Left Hip | 11 score on a scale | Standard Deviation 19.1 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Left Ankle | 15.7 score on a scale | Standard Deviation 27.1 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Left Foot | 3.7 score on a scale | Standard Deviation 6.3 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Left Hip | 1.7 score on a scale | Standard Deviation 2.9 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Left Foot | 4 score on a scale | Standard Deviation 6.9 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Left Knee | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Right Foot | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Left Hip | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Right Knee | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Right Knee | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Right Knee | 2 score on a scale | Standard Deviation 3.5 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Left Knee | 9.7 score on a scale | Standard Deviation 16.7 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Left Knee | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Right Ankle | 1.3 score on a scale | Standard Deviation 2.3 |
| Group I | Patient Reported Pain (VAS) | 6 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Left Ankle | 4 score on a scale | Standard Deviation 6.9 |
| Group I | Patient Reported Pain (VAS) | 12 weeks - Right Ankle | 7.7 score on a scale | Standard Deviation 13.3 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Right Foot | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Right Ankle | 12.7 score on a scale | Standard Deviation 21.9 |
| Group I | Patient Reported Pain (VAS) | 24 weeks - Left Foot | 0 score on a scale | Standard Deviation 0 |
| Group I | Patient Reported Pain (VAS) | 0 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Left Foot | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Left Ankle | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Left Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Right Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Left Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Right Foot | 26.7 score on a scale | Standard Deviation 46.2 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Left Foot | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Left Hip | 3.3 score on a scale | Standard Deviation 5.8 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Right Ankle | 3.3 score on a scale | Standard Deviation 5.8 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Left Ankle | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Right Foot | 4.7 score on a scale | Standard Deviation 8.1 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Left Foot | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Left Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Right Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Left Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Right Ankle | 4.7 score on a scale | Standard Deviation 8.1 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Left Ankle | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Right Foot | 5.7 score on a scale | Standard Deviation 9.8 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Left Foot | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 0 weeks - Right Ankle | 29.7 score on a scale | Standard Deviation 30.5 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Right Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 6 weeks - Left Knee | 16.7 score on a scale | Standard Deviation 28.9 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Lower Back | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 12 weeks - Right Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Left Hip | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Right Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Left Knee | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Right Ankle | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Left Ankle | 0 score on a scale | Standard Deviation 0 |
| Group II | Patient Reported Pain (VAS) | 24 weeks - Right Foot | 3.7 score on a scale | Standard Deviation 6.4 |