Knee Osteoarthritis, Arthritis
Conditions
Brief summary
The goal of this study is to explore the effectiveness of a commercially available, over-the-counter knee brace in the conservative treatment of knee osteoarthritis. Participants will either be fitted with a brace and told to wear it every day during normal activities, fitted with the brace and given instructions on a set of quadriceps strengthening exercises to complete twice daily, every day, or be given the exercise instructions, but not fitted with a brace. Functional and subjective outcomes will be collected preoperatively and at 6 and 12 weeks from baseline, with the goal of informing the effectiveness of bracing alone versus a home exercise program, and whether the combination of those provides the most therapeutic benefit to participants.
Interventions
OTHERExercise Only
This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.
DEVICEBrace Only
This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
OTHERBracing + Exercises
This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
Sponsors
Orthopaedic Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject is being treated for knee joint pain * Subject is willing and able to comply with the evaluation schedule
Exclusion criteria
* Subject is undergoing surgery during the follow-up window that would limit their ability to comply with the evaluation schedule and/or significantly affect the outcomes measures * Subject has current alcohol, opioid, or other drug dependence * Subject is taking prescribed medication for pain other than in the knee joint (e.g. back pain)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain Using the Visual Analog Scale | Baseline and 3-month Visit | The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words No Pain (score of 0) and Pain as bad as it could possibly be (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quadriceps Force | Baseline and 3-month Visit | Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Only Home exercise program.
Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group. | 16 |
| Brace Only Reaction Web brace.
Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living. | 19 |
| Bracing + Exercises Reaction Web brace and home exercises.
Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group. | 14 |
| Total | 49 |
Baseline characteristics
| Characteristic | Bracing + Exercises | Total | Exercise Only | Brace Only |
|---|---|---|---|---|
| Age, Continuous | 66 years | 66 years | 67 years | 64 years |
| Laterality Left | 7 Participants | 25 Participants | 8 Participants | 10 Participants |
| Laterality Right | 7 Participants | 24 Participants | 8 Participants | 9 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — |
| Sex: Female, Male Female | 6 Participants | 21 Participants | 7 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 28 Participants | 9 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 19 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 19 | 0 / 14 |
Outcome results
Primary
Assessment of Pain Using the Visual Analog Scale
The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words No Pain (score of 0) and Pain as bad as it could possibly be (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.
Time frame: Baseline and 3-month Visit
Population: Change from baseline reported in table
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise Only | Assessment of Pain Using the Visual Analog Scale | Baseline Average VAS Pain Score | 48.7 score on a scale |
| Exercise Only | Assessment of Pain Using the Visual Analog Scale | 3-Month Average VAS Pain Score | 27.1 score on a scale |
| Brace Only | Assessment of Pain Using the Visual Analog Scale | Baseline Average VAS Pain Score | 62.6 score on a scale |
| Brace Only | Assessment of Pain Using the Visual Analog Scale | 3-Month Average VAS Pain Score | 20.7 score on a scale |
| Bracing + Exercises | Assessment of Pain Using the Visual Analog Scale | Baseline Average VAS Pain Score | 50.8 score on a scale |
| Bracing + Exercises | Assessment of Pain Using the Visual Analog Scale | 3-Month Average VAS Pain Score | 13.2 score on a scale |
Secondary
Change in Quadriceps Force
Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month.
Time frame: Baseline and 3-month Visit
Population: Normalized quadriceps force values reported in data table by study arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Exercise Only | Change in Quadriceps Force | .25 Newtons (N) |
| Brace Only | Change in Quadriceps Force | .15 Newtons (N) |
| Bracing + Exercises | Change in Quadriceps Force | .31 Newtons (N) |