Walking Aids in the Management of Knee Osteoarthritis
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Purpose
The purpose of this study is to assess whether the single point cane will relieve pain and disability in overweight or obese people with knee OA through altered joint biomechanics and what factors influence acceptance of cane use.
| Condition | Intervention |
|---|---|
|
Obesity Osteoarthritis |
Device: Walking with a cane or without a cane (Guardian offset handled cane) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Walking Aids in the Management of Obesity-Related Knee Osteoarthritis |
- Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2006 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Cane device intervention
|
Device: Walking with a cane or without a cane (Guardian offset handled cane)
Guardian offset handled cane with sure grip
|
Detailed Description:
Knee OA is an important cause of disability and falls in overweight or obese individuals and limits their attempts at exercise and subsequent weight loss. Walking aids such as canes have been recommended in the management of knee OA in order to decrease pain by reducing loading across the knee and to increase physical activity. Little information is available regarding the impact of walking aids on psychosocial function and quality of life in individuals with limited mobility. No randomized controlled trials have studied the efficacy of walking aids on quality of life, pain, and function in overweight or obese individuals with symptomatic knee OA (5,6). The proposed research will evaluate the effects of walking aids in knee OA by testing the following hypothesis that the use of a single-point cane will decrease pain from knee OA by altering gait biomechanics and will improve walking function and quality of life in overweight or obese individuals with symptomatic knee OA.
Eligibility| Ages Eligible for Study: | 45 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 45-85 years old
- Able to walk 30 feet without postural sway and able to stand unaided
- Unilateral knee pain on movement with a WOMAC pain subscale of >35mm
- Documented osteoarthritis based on clinical and radiographic criteria
- Body Mass Index (BMI) > 25.0 - 29.9
- Ability to understand verbal and written instructions
- Ability to give informed consent determined by assessment of cognitive status
Exclusion Criteria:
- Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy. History of knee trauma or surgery, including arthroscopic surgery, in the past six months
- Severe obesity (weight > 300lbs)
- Upper body weakness
- Injury or amputation of the lower extremity joints
- History of other types of arthritis
- Spine, foot, or hip pain of sufficient magnitude to interfere with the evaluation of the index joint.
- Isolated patellofemoral disease manifested by primarily anterior knee pain in the absence of tibiofemoral radiographic finding.
- History of significant collateral or anterior cruciate ligament or meniscal injury to the index joint requiring at least one week of non weight bearing (minor ligamentous injury prior to 6 months is not an exclusion).
- Poor health that would impair compliance or assessment such as shortness of breath with exertion
- Neurological disease including vestibular dysfunction, or impaired vision
- Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
- Is unable to understand and complete the study questionnaires including visual analog scale (VAS) responses.
- Is unable to understand the study procedures.
- Investigator feels the patient is otherwise inappropriate for the study. The patient is participating in another clinical trial that would interfere with participation in this study
- Investigator feels the patient is otherwise inappropriate for the study.
- The patient is participating in another clinical trial that would interfere with participation in this study
Contacts and Locations| United States, California | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| Principal Investigator: | Meika Fang, MD | VA Greater Los Angeles Healthcare System, West LA |
More Information
No publications provided
| Responsible Party: | Fang, Meika - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00223795 History of Changes |
| Other Study ID Numbers: | F3873R |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 3, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Cane Gait Obesity Osteoarthritis Walking Aids |
Additional relevant MeSH terms:
|
Obesity Osteoarthritis Osteoarthritis, Knee Overnutrition Nutrition Disorders Overweight |
Body Weight Signs and Symptoms Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013