Walking Aids in the Management of Hip Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

Walking Aids in the Management of Hip Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506714
• Other study ID #: 2007-030430
• Status: Completed
• Phase: N/A
• First received: July 20, 2007
• Last updated: September 28, 2012
• Start date: July 2007
• Est. completion date: September 2009

Study information

• Verified date: September 2012
• Source: Arthritis Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• single point cane
Adjustable single point cane with SureGrip handle

Locations

Country	Name	City	State
United States	VA West Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Arthritis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Velocity		Baseline	No
Secondary	Gait Velocity With a Cane in Hip OA Subjects	Measured gait velocity when hip OA subjects walked with a cane at the baseline visit.	Baseline	No
Secondary	Gait Velocity	Gait velocity when adults with symptomatic hip osteoarthritis walked with a cane after four weeks of cane use	4 weeks	No