New Options for Treating Knee Osteoarthritis Pain

NCT ID: NCT05541718

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-13

Study Completion Date

2024-08-23

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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Reiki

Group Type EXPERIMENTAL

Reiki

Intervention Type 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

Group Type SHAM_COMPARATOR

Sham Reiki

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Mindfulness Meditation

Intervention Type 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.

Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reiki

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

Intervention Type 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

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Adam Hanley

Principal Investigator, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB_00153103

Identifier Type: -

Identifier Source: org_study_id