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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reiki | Experimental |
| |
| Sham Reiki | Sham Comparator |
| |
| Mindfulness Meditation | Active Comparator |
| |
| Waitlist Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reiki | Behavioral | Reiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One week before treatment to one week after treatment, which comprises a 6 week span |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One week before treatment to one week after treatment, which comprises a 6 week span |
| Change in Anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| Change in State Self-Transcendence | Change in self-transcendent state will be measured with the Nondual Awareness Dimensional Assessment - State Version. Scores range from 0 to 10, with higher scores reflecting greater self-transcendence. | Immediately before to after the first and last treatment session, which comprises a 20 minute span |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2022 | Nov 10, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2022 | Nov 1, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019124 | Therapeutic Touch |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Sham Reiki | Behavioral | Sham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing |
|
| Mindfulness Meditation | Behavioral | 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. |
|
The Generalized Anxiety Disorder 2-item will be used to measure anxiety. Scores range from 0 to 6, with higher scores reflect worse anxiety. |
| 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 | 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 | 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 | 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. | Immediately before to after the first and last treatment session, which comprises a 20 minute span |
| Change in State Decentering |
Change in state decentering will be measured with the Metacognitive Processes of Decentering Scale - State Version. Scores range from 0 to 10, with higher scores reflecting greater state decentering. |
| Immediately before to after the first and last treatment session, which comprises a 20 minute span |
| Change in Trait Self-Transcendence | Change in trait self-transcendence will be assessed with the Nondual Awareness Dimensional Assessment - Trait Version. Scores range from 0 to 10, with higher scores reflecting greater trait self-transcendence. | One week before treatment to one week after treatment, which comprises a 6 week span |
| Change in Trait Decentering | Change in trait decentering will be assessed with the Metacognitive Processes of Decentering Scale - Trait Version. Scores range from 0 to 10, with higher scores reflecting greater trait decentering. | One week before treatment to one week after treatment, which comprises a 6 week span |
| Change in Prescription Pain Medication Misuse | The PROMIS Prescription Pain Medication Misuse v1.0 - Short Form 7a will measure prescription pain medicine misuse. Scores range from 0 to 35, with higher scores reflecting greater misuse. | One week before treatment to one week after treatment, which comprises a 6 week span |
| Pleasant Sensation Ratio | Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations. | Immediately before to after the first and last treatment session, which comprises a 20 minute span |
| Quantitative sensory testing | Pain threshold and tolerance, temporal summation, and conditioned pain modulation | Immediately before the first treatment session and immediately after the last treatment session, which comprises a 4 week span |
| D012216 |
| Rheumatic Diseases |
| D015928 |
| Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |