Education and activity programs to improve health in people with painful knee osteoarthritis. A randomised controlled trial with cost-effectiveness analysis

Not Applicable

Recruiting

• Conditions: Knee osteoarthritis; Musculoskeletal - Osteoarthritis

• Registration Number: ACTRN12620001041943
• Lead Sponsor: The University of South Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

i)Aged greater than or equal to 50 years
ii)Average knee pain intensity of at least 4/10 (overall and/or while walking) over past week using a 0-10 numerical rating scale, where 0 = no pain at all and 10 = worst pain possible
iii)Moderate disability due to the knee over the past week (greater than or equal to 3 on the Global Disability Rating Scale)
iv)Painful knee OA at least 6 months duration that meets the NICE diagnostic criteria for symptomatic knee OA

Exclusion Criteria

i)Conditions that prevent safe participation in physical activity as listed in the American College of Sports Medicine guidelines (e.g., cardiac or lung disease)
ii)Pain in other body areas that currently limits walking ability (e.g., back pain, foot pain, hip pain)
iii)Neurological disorders affecting lower limb movement (e.g., multiple sclerosis, stroke)
iv)Inflammatory arthritis (including rheumatoid arthritis)
v)Fibromyalgia
vi)Previous knee replacement (on painful knee) or planned knee replacement/surgery (next 6 months) or recent knee replacement on the non- or less-painful knee (<6 months)
vii)Previously operated knee is the most painful knee
viii)Intra-articular therapy use in the 12 weeks preceding enrolment
ix)Any condition impacting decision-making/memory (e.g., Alzheimer’s, dementia)
x)Severe depression (>17 on the 4-item PROMIS depression subscale)
xi)Current moderate/vigorous physical activity levels above guideline recommendations (>150 minutes/week; assessed using the Active Australia Physical Activity Questionnaire)
xii)Current purposeful walking for exercise of 30 mins or more per day on 5 or more days per week.
xiii)Unable to commit to study requirements (unable to attend study appointments or complete study outcomes)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario McMaster Universities OA Index (WOMAC) Total score[Baseline, week 12, week 26, and week 52 (primary timepoint)];Physical activity level: Wrist-based accelerometry (GT9X Actigraph, Pensacola, US) will assess average daily step count over 7 days. [Baseline, week 12, week 26, and week 52 (primary timepoint)]