NCT05541718

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

November 13, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

September 9, 2022

Last Update Submit

November 10, 2025

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Depression

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

  • Change in Anxiety

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

  • Change in Pain Catastrophizing

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

  • Change in Sleep

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

  • Change in Quality of Life

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

  • +1 more secondary outcomes

Other Outcomes (7)

  • Change in State Self-Transcendence

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

  • Change in State Decentering

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

  • Change in Trait Self-Transcendence

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

  • +4 more other outcomes

Study Arms (4)

Reiki

EXPERIMENTAL
Behavioral: Reiki

Sham Reiki

SHAM COMPARATOR
Behavioral: Sham Reiki

Mindfulness Meditation

ACTIVE COMPARATOR
Behavioral: Mindfulness Meditation

Waitlist Control

NO INTERVENTION

Interventions

ReikiBEHAVIORAL

Reiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body.

Reiki
Sham ReikiBEHAVIORAL

Sham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing

Sham Reiki
Mindfulness MeditationBEHAVIORAL

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.

Mindfulness Meditation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Knee arthroplasty in the previous year
  • Have cognitive impairment as determined by clinical interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Therapeutic TouchMindfulness

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 15, 2022

Study Start

January 13, 2023

Primary Completion

August 13, 2024

Study Completion

August 23, 2024

Last Updated

November 13, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)