Walking Aids in the Management of Hip Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meika A. Fang, MD, Arthritis Foundation
ClinicalTrials.gov Identifier:
NCT00506714
First received: July 20, 2007
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Osteoarthritis
Device: single point cane

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Walking Aids in the Management of Hip Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Arthritis Foundation:

Primary Outcome Measures:
  • Gait Velocity [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Gait Velocity With a Cane in Hip OA Subjects [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.

  • Gait Velocity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use


Enrollment: 26
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adult subjects with hip osteoarthritis
Walk with and without a single point cane at baseline and after four weeks
Device: single point cane
Adjustable single point cane with SureGrip handle
No Intervention: Healthy Subjects
Healthy adults walking without a cane at baseline

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506714

Locations
United States, California
VA West Los Angeles
Los Angeles, California, United States, 90073
Sponsors and Collaborators
Arthritis Foundation
Investigators
Principal Investigator: Meika A Fang, MD VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine
  More Information

No publications provided

Responsible Party: Meika A. Fang, MD, Rheumatology, Arthritis Foundation
ClinicalTrials.gov Identifier: NCT00506714     History of Changes
Other Study ID Numbers: 2007-030430
Study First Received: July 20, 2007
Results First Received: February 6, 2012
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Arthritis Foundation:
Osteoarthritis
Walking Sticks
Canes

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014