Knee OsteoarthritisNCT05541718
New Options for Treating Knee Osteoarthritis Pain
A study testing Reiki and Mindfulness Meditation in people with Knee Osteoarthritis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Reiki and Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 23 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Knee arthroplasty in the previous year
- Have cognitive impairment as determined by clinical interview
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Reiki, Sham Reiki, Mindfulness Meditation
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiBehavioural
Reiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body.
Sham ReikiBehavioural
Sham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing
Mindfulness MeditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reiki | Experimental | Not described Receives: Behavioral: Reiki |
| Sham Reiki | Sham comparator | Not described Receives: Behavioral: Sham Reiki |
| Mindfulness Meditation | Active comparator | Not described Receives: Behavioral: Mindfulness Meditation |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: One week before treatment to one week after treatment, which comprises a 6 week span
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Immediately before to after the first and last treatment session, which comprises a 20 minute span
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start13 Jan 2023
- Primary completion13 Aug 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541718
- Sponsor's protocol ID
- IRB_00153103
- Status last verified
- Jun 2025
- First submitted
- 9 Sep 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Options for Treating Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT05541718
- Acronym / sponsor ID
- IRB_00153103
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Reiki | Experimental | Behavioral: Reiki |
| Sham Reiki | Sham comparator | Behavioral: Sham Reiki |
| Mindfulness Meditation | Active comparator | Behavioral: Mindfulness Meditation |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Knee arthroplasty in the previous year
- Have cognitive impairment as determined by clinical interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiReiki will be provided by a trained Reiki master with the aim of balancing the flow of energy in the patient's body. | Behavioural | Reiki |
| Sham ReikiSham Reiki will be delivered by an individual trained to simulate the Reiki interventionist's movements, but they will not visualize patient healing | Behavioural | Sham Reiki |
| Mindfulness MeditationThe 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. | Behavioural | Mindfulness Meditation |
Primary outcome
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
6 secondary outcomes
Change in Depression
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Anxiety
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Pain Catastrophizing
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Sleep
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Quality of Life
Time frame: One week before treatment to one week after treatment, which comprises a 6 week span
Change in Acute Pain Intensity
Time frame: Immediately before to after the first and last treatment session, which comprises a 20 minute span
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki and Mindfulness Meditation in people with Knee Osteoarthritis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Osteoarthritis symptoms (time frame: One week before treatment to one week after treatment, which comprises a 6 week span). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.