Osteoarthritis
Conditions
Keywords
Osteoarthritis, Walking Sticks, Canes
Brief summary
The purpose of this study is to determine whether or not the use of a nonpharmacologic intervention (single point cane) is effective in the treatment of knee osteoarthritis.
Detailed description
Osteoarthritis (OA), the most common joint disease in humans, is a significant cause of pain and disability. Non-pharmacological treatments for hip OA include education, exercise, appliances (walking sticks or insoles), and weight reduction if obese or overweight. Canes are often recommended to reduce adverse forces across joints although there is currently no research evidence regarding the efficacy of walking sticks for hip OA. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with hip OA. This study will evaluate the effects of walking aids in hip OA by examining gait biomechanics, quality of life, pain, and opinions regarding using a cane. Comparisons: Compare gait biomechanics in people with symptomatic unilateral hip OA while walking with and without a cane at baseline and after 4 weeks of cane use. Compare gait biomechanics in people with symptomatic unilateral hip OA with and without a cane to those of healthy, age-matched controls. Compare pain and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use. Determine the association between changes in gait biomechanics, pain, and health-related quality of life in people with symptomatic unilateral hip OA following 4 weeks of cane use.
Interventions
DEVICEsingle point cane
Adjustable single point cane with SureGrip handle
Sponsors
Arthritis Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. hip OA (grades II-IV) of the Kellgren/Lawrence classification 2. with pain in one hip for most days of the prior month 3. Ability to walk 30 feet without postural sway 4. Ability to stand unaided 5. Ability to understand verbal instructions 6. Ability to give informed consent
Exclusion criteria
1. History of hip or knee trauma or surgery including arthroscopic surgery in the past six months 2. Severe obesity (\> 300 pounds) 3. Neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy, vestibular dysfunction or poor vision 4. Injury or amputation to the lower extremity joints 5. History of other types of arthritis or fibromyalgia 6. Pain from spine, knee, ankle, or foot disease that would interfere with assessment of the hip 7. Poor health that would impair compliance or assessment such as shortness of breath with exertion, chest pain 8. Foot deformities such as hallux rigidus, valgus deformity of the midfoot, previous ankle arthrodesis 9. Greater trochanteric pain syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait Velocity | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity With a Cane in Hip OA Subjects | Baseline | Measured gait velocity when hip OA subjects walked with a cane at the baseline visit. |
| Gait Velocity | 4 weeks | Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Healthy adults | 13 |
| Group 2 Adults with symptomatic hip osteoarthritis | 13 |
| Total | 26 |
Baseline characteristics
| Characteristic | Group 2 | Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 7 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Age Continuous | 67 years STANDARD_DEVIATION 5.9 | 65 years STANDARD_DEVIATION 4.4 | 66 years STANDARD_DEVIATION 5.2 |
| Region of Enrollment United States | 13 participants | 13 participants | 26 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 11 Participants | 11 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
Primary
Gait Velocity
Time frame: Baseline
Population: Analysis was per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Gait Velocity | 107.5 cm/s | Standard Deviation 14.3 |
| Group 2 | Gait Velocity | 79.7 cm/s | Standard Deviation 9.9 |
Secondary
Gait Velocity
Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use
Time frame: 4 weeks
Population: Analysis was per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Gait Velocity | 74.5 cm/s | Standard Deviation 14.2 |
Secondary
Gait Velocity With a Cane in Hip OA Subjects
Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
Time frame: Baseline
Population: Analysis was per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 | Gait Velocity With a Cane in Hip OA Subjects | 68.7 cm/s | Standard Deviation 15.4 |