Clinical trial NCT00223795: Walking Aids in the Management of Knee Osteoarthritis
Official title: Walking Aids in the Management of Obesity-Related Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Osteoarthritis
Keywords: Cane
Gait
Obesity
Osteoarthritis
Walking Aids
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-22
Enrollment: 53
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 ipsilateral and contralateral to the affected limb 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 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

Primary outcomes:
measure: Peak Vertical Force on Affected Limb
timeFrame: Baseline and end of first intervention period (2 months)
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West LA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West LA
name: Meika Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fang MA, Heiney C, Yentes JM, Harada ND, Masih S, Perell-Gerson KL. Effects of contralateral versus ipsilateral cane use on gait in people with knee osteoarthritis. PM R. 2015 Apr;7(4):400-6. doi: 10.1016/j.pmrj.2014.09.018. Epub 2014 Oct 8.
citation: Harada N, Fong S, Heiney C, Yentes JM, Perell-Gerson KL, Fang MA. Evaluation of two cane instruments in older adults with knee osteoarthritis. J Rehabil Res Dev. 2014;51(2):275-83. doi: 10.1682/JRRD.2013.06.0140.