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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
164
Reiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body.
Sham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing
The mindfulness meditation intervention will be adapted from a standardized mindfulness induction script validated in prior research. The mindfulness practice will guide patients to focus attention on breath and body sensations while monitoring and accepting discursive thoughts, negative emotions, and pain. The MM interventionist will be a trained mindfulness provider and have experience using MM in medical settings.
University of Utah
Salt Lake City, Utah, United States
Change in Osteoarthritis symptoms
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
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Depression
The Patient Health Questionnaire-2 will be used to measure depression. Scores range from 0 to 6, with higher scores reflect worse depression
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Anxiety
The Generalized Anxiety Disorder 2-item will be used to measure anxiety. Scores range from 0 to 6, with higher scores reflect worse anxiety.
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Pain Catastrophizing
The Pain Catastrophizing Scale will be used to measure pain catastrophizing. Scores range from 0 to 52, with higher scores reflect worse pain catastrophizing
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Sleep
The PROMIS Sleep Disturbance - Short Form 6a will measure changes in sleep. Scores range from 0 to 30, with higher scores reflect greater sleep disturbance
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Quality of Life
The WHOQOL-BREF will measure quality of life. Scores range from 0 to 100, with higher scores reflect better quality of life
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Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Acute Pain Intensity
Single item assessing pain intensity ("How much pain do you have?") scored on an 11-point (0=Not at all, 10=Very much) numeric rating scale. Higher scores indicate greater pain intensity.
Time frame: Immediately before to after the first and last treatment session, which comprises a 20 minute span