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New Options for Treating Knee Osteoarthritis Pain

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reiki
Sham Reiki
Mindfulness Meditation
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Active Comparator

No Intervention

Arm Label

Reiki

Sham Reiki

Mindfulness Meditation

Waitlist Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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
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
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
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.

Full Information

First Posted
September 9, 2022
Last Updated
September 12, 2022
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05541718
Brief Title
New Options for Treating Knee Osteoarthritis Pain
Official Title
New Options for Treating Knee Osteoarthritis Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Reiki
Arm Type
Experimental
Arm Title
Sham Reiki
Arm Type
Sham Comparator
Arm Title
Mindfulness Meditation
Arm Type
Active Comparator
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Reiki
Intervention Description
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
Intervention Name(s)
Sham Reiki
Intervention Description
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
Intervention Name(s)
Mindfulness Meditation
Intervention Description
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 Outcome Measure Information:
Title
Change in Osteoarthritis symptoms
Description
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
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Secondary Outcome Measure Information:
Title
Change in Depression
Description
The Patient Health Questionnaire-2 will be used to measure depression. Scores range from 0 to 6, with higher scores reflect worse depression
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Anxiety
Description
The Generalized Anxiety Disorder 2-item will be used to measure anxiety. Scores range from 0 to 6, with higher scores reflect worse anxiety.
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Pain Catastrophizing
Description
The Pain Catastrophizing Scale will be used to measure pain catastrophizing. Scores range from 0 to 52, with higher scores reflect worse pain catastrophizing
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Sleep
Description
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
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Quality of Life
Description
The WHOQOL-BREF will measure quality of life. Scores range from 0 to 100, with higher scores reflect better quality of life
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Acute Pain Intensity
Description
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.
Time Frame
Immediately before to after the first and last treatment session, which comprises a 20 minute span
Other Pre-specified Outcome Measures:
Title
Change in State Self-Transcendence
Description
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.
Time Frame
Immediately before to after the first and last treatment session, which comprises a 20 minute span
Title
Change in State Decentering
Description
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.
Time Frame
Immediately before to after the first and last treatment session, which comprises a 20 minute span
Title
Change in Trait Self-Transcendence
Description
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.
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Trait Decentering
Description
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.
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Change in Prescription Pain Medication Misuse
Description
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.
Time Frame
One week before treatment to one week after treatment, which comprises a 6 week span
Title
Pleasant Sensation Ratio
Description
Pleasant sensation ratio as measured by Sensation Manikin, a measure comprised of a visual body map to demonstrate the location and distribution of sensations.
Time Frame
Immediately before to after the first and last treatment session, which comprises a 20 minute span
Title
Quantitative sensory testing
Description
Pain threshold and tolerance, temporal summation, and conditioned pain modulation
Time Frame
Immediately before the first treatment session and immediately after the last treatment session, which comprises a 4 week span

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adam Hanley
Phone
801-213-4191
Email
adam.hanley@utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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New Options for Treating Knee Osteoarthritis Pain

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