N/A N=458 Randomized Double-blind Supportive Care

Digital Knee Osteoarthritis Mindset Intervention

Knee Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT05698368 ↗

Enrolled (actual)

458

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale — -0.2; -0.5; -0.1 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Mindset intervention (Behavioral); Active comparator (Other)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Sep 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Knee Pain Measured by Numeric Pain Rating Scale	-0.2; -0.5; -0.1	—
PRIMARY Change From Baseline in Physical Activity Measured by Physical Activity Scale for the Elderly	32.6; 38.9; 10.3	—
PRIMARY Change From Baseline in Mindset About the Process of Health - Physical Activity (MPH-Physical Activity) Scale	0.3; 0.5; 0.1	—
PRIMARY Change From Baseline in Osteoarthritis Mindset by the Illness Mindset Inventory	-0.5; -1.1; -0.2; 0.7; 1.1; 0.2	—
SECONDARY Change From Baseline in Knee Pain and Functioning by the Short Version of Western Ontario and McMaster Universities Arthritis Index (shortMAC)	-0.6; -0.8; -0.4; -0.7; -1.0; -0.5	—
SECONDARY Change From Baseline in Knee Osteoarthritis Knowledge by the Knee Osteoarthritis Knowledge Scale	10.5; 3.1; 0.6	—
SECONDARY Change From Baseline in Perceived Need for Surgery by a Surgery Perception Question	-0.6; -0.2; 0.0	—
SECONDARY Change From Baseline in Symptom Management Strategy by an Osteoarthritis Symptom Management Question. The Variable is Reported as a % of Participants Who Reported Using the Symptom Management Strategy.	-3.8; 4.4; -9.1; -6.2; 3.7; 0.7	—
SECONDARY Change From Baseline in Fear of Movement by the Brief Fear of Movement Scale for Osteoarthritis	-0.4; -0.2; 0.0	—
SECONDARY Change From Baseline in Arthritis Self-efficacy: Pain and Other Symptoms by the Arthritis Self-efficacy Pain and Other Symptoms Subscales	1.4; 0.6; 0.1; 1.1; 0.6; 0.5	—
SECONDARY Change From Baseline in Physical and Mental Health: Global Health: Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (Physical and Mental Health Sub-scales)	0.2; 0.1; 0.0; 0.1; 0.0; 0.0	—
SECONDARY Change From Baseline in Body Mindset by the Illness Mindset Inventory	-0.6; -0.4; -0.1; 1.3; 0.6; 0.2	—
SECONDARY Change From Baseline in Adequacy Mindset by the Adequacy of Activity Mindset Measure	0.3; 0.2; 0.0	—

Summary

The aim of our clinical trial is to test if an online mindset intervention improves mindsets and physical activity levels more than an education intervention in individuals with knee osteoarthritis.

Eligibility Criteria

Inclusion Criteria

Over 45 years of age
Self-reported doctor's diagnosis of knee osteoarthritis OR meets the National Institute for - - Health and Care Excellence osteoarthritis clinical criteria (activity-related knee pain and no knee morning stiffness lasting ≥ 30 minutes)
Knee pain for at least 3 months
Ability to walk unaided
Can read and write in English
Consistent internet access
Willingness and ability to comply with the study requirements

Exclusion criteria

Past total knee arthroplasty or scheduled surgical procedure on any back or lower limb with osteoarthritis within the next 12 months
Recent serious injury (within the past 2 months) on the knee(s) with osteoarthritis
Any condition making it unsafe to participate in physical activity
Intra-articular therapy within the past 6 months (e.g. injections such as corticosteroids and hyaluronic acid)
Participates in physical exercise for 30 minutes or more 5 days per week

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05698368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.