New Options for Treating Knee Osteoarthritis Pain

Study Overview
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Brief Summary
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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.

Official Title
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New Options for Treating Knee Osteoarthritis Pain

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Reiki
* Behavioral: Sham Reiki
* Behavioral: Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reiki<br> | Behavioral: Reiki<br>* Reiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body.<br>|
| Sham Comparator: Sham Reiki<br> | Behavioral: Sham Reiki<br>* Sham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing<br>|
| Active Comparator: Mindfulness Meditation<br> | Behavioral: Mindfulness Meditation<br>* 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.<br>|
| No Intervention: Waitlist Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |