N/A
N=53
Walking Aids in the Management of Knee Osteoarthritis
Obesity · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00223795 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Peak Vertical Force on Affected Limb — 9.5; 8.5; 8.8; 7.5 N/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single point cane (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Vertical Force on Affected Limb |
9.5; 8.5; 8.8; 7.5; 9.1; 8.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 45-85 years old
- Able to walk 30 feet without postural sway and able to stand unaided
- 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
Data sourced from ClinicalTrials.gov (NCT00223795). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.