New Options for Treating Knee Osteoarthritis Pain

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 Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Reiki; Behavioral: Sham Reiki; Behavioral: Mindfulness Meditation

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adam Hanley; Phone Number: 801-213-4191; Email: adam.hanley@utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
      • Contact: Adam W Hanley, PhD; Phone Number: 801-581-6192; Email: adam.hanley@utah.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: September 9, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IRB_00153103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No