New Options for Treating Knee Osteoarthritis Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Change in Osteoarthritis symptoms
Study Overview
Brief Summary
This study will be a single-site, four-arm, randomized, placebo-controlled clinical trial. Knee osteoarthritis patients (N=164) will be randomized to Reiki, Sham Reiki (placebo control), mindfulness meditation (active control), or a waitlist control condition. The three active interventions will be applied for 20 minutes, once a week, for four consecutive weeks in a university laboratory setting.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Osteoarthritis in at least one knee
- •Report a WOMAC pain score average >/= 2
- •Not using any kind of energy therapy different from the proposed study
- •Ability to read, understand and speak English
Exclusion Criteria
- •Knee arthroplasty in the previous year
- •Have cognitive impairment as determined by clinical interview
Arms & Interventions
Reiki
Intervention: Reiki (Behavioral)
Sham Reiki
Intervention: Sham Reiki (Behavioral)
Mindfulness Meditation
Intervention: Mindfulness Meditation (Behavioral)
Waitlist Control
Outcomes
Primary Outcomes
Change in Osteoarthritis symptoms
Time Frame: One week before treatment to one week after treatment, which comprises a 6 week span
The Western Ontario and McMaster Universities Arthritis Index will be used to measure change in osteoarthritis symptoms. Scores range from 0 to 96, with higher scores reflect worse pain, stiffness and physical function
Secondary Outcomes
- Change in Pain Catastrophizing(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Quality of Life(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Acute Pain Intensity(Immediately before to after the first and last treatment session, which comprises a 20 minute span)
- Change in Anxiety(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Depression(One week before treatment to one week after treatment, which comprises a 6 week span)
- Change in Sleep(One week before treatment to one week after treatment, which comprises a 6 week span)
Investigators
Adam Hanley
Principal Investigator, Assistant Professor
University of Utah