Walking Aids in the Management of Hip Osteoarthritis

• ClinicalTrials.gov Identifier: NCT00506714
• Recruitment Status: Completed
• First Posted: July 25, 2007
• Results First Posted: September 28, 2012
• Last Update Posted: October 4, 2012
• Sponsor: Arthritis Foundation
• Information provided by (Responsible Party): Meika A. Fang, MD, Arthritis Foundation

Tracking Information

• First Submitted Date: July 20, 2007
• First Posted Date: July 25, 2007
• Results First Submitted Date: February 6, 2012
• Results First Posted Date: September 28, 2012
• Last Update Posted Date: October 4, 2012
• Study Start Date: July 2007
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 29, 2012): Gait Velocity [ Time Frame: Baseline ]
• Original Primary Outcome Measures (submitted: July 20, 2007): Gait biomechanics - changes in center of pressure and the vertical ground reaction force, kinematic, and spatiotemporal data

Current Secondary Outcome Measures (submitted: September 28, 2012)

• Gait Velocity With a Cane in Hip OA Subjects [ Time Frame: Baseline ]
  Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.
• Gait Velocity [ Time Frame: 4 weeks ]
  Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use

• Original Secondary Outcome Measures (submitted: July 20, 2007): Changes in pain measured by VAS and the WOMAC subscales
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Walking Aids in the Management of Hip Osteoarthritis
• Official Title: Walking Aids in the Management of Hip Osteoarthritis
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

Device: single point cane

Adjustable single point cane with SureGrip handle

Study Arms

• Experimental: Adult subjects with hip osteoarthritis
  Walk with and without a single point cane at baseline and after four weeks
  Intervention: Device: single point cane
• No Intervention: Healthy Subjects
  Healthy adults walking without a cane at baseline

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2012): 26
• Original Estimated Enrollment (submitted: July 20, 2007): 50
• Actual Study Completion Date: September 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00506714
• Other Study ID Numbers: 2007-030430
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Meika A. Fang, MD, Arthritis Foundation
• Original Responsible Party: Not Provided
• Current Study Sponsor: Arthritis Foundation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Meika A Fang, MD; VA Greater Los Angeles Healthcare System Department of Medicine; UCLA Department of Medicine

• PRS Account: Arthritis Foundation
• Verification Date: September 2012