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Completed

NCT Number: NCT05541718

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Change in Depression

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    The Patient Health Questionnaire-2 will be used to measure depression. Scores range from 0 to 6, with higher scores reflect worse depression

  2. Change in Anxiety

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    The Generalized Anxiety Disorder 2-item will be used to measure anxiety. Scores range from 0 to 6, with higher scores reflect worse anxiety.

  3. Change in Pain Catastrophizing

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    The Pain Catastrophizing Scale will be used to measure pain catastrophizing. Scores range from 0 to 52, with higher scores reflect worse pain catastrophizing

  4. Change in Sleep

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    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

  5. Change in Quality of Life

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    The WHOQOL-BREF will measure quality of life. Scores range from 0 to 100, with higher scores reflect better quality of life

  6. Change in Acute Pain Intensity

    Time frame: Immediately before to after the first and last treatment session, which comprises a 20 minute span

    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.

Other outcomes

  1. Change in State Self-Transcendence

    Time frame: Immediately before to after the first and last treatment session, which comprises a 20 minute span

    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.

  2. Change in State Decentering

    Time frame: Immediately before to after the first and last treatment session, which comprises a 20 minute span

    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.

  3. Change in Trait Self-Transcendence

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    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.

  4. Change in Trait Decentering

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    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.

  5. Change in Prescription Pain Medication Misuse

    Time frame: One week before treatment to one week after treatment, which comprises a 6 week span

    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.

  6. Pleasant Sensation Ratio

    Time frame: Immediately before to after the first and last treatment session, which comprises a 20 minute span

    Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.

  7. Quantitative sensory testing

    Time frame: Immediately before the first treatment session and immediately after the last treatment session, which comprises a 4 week span

    Pain threshold and tolerance, temporal summation, and conditioned pain modulation

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2022
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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