Clinical trial NCT05541718: New Options for Treating Knee Osteoarthritis Pain
Official title: New Options for Treating Knee Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Osteoarthritis symptoms
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
Secondary outcomes:
measure: Change in Depression
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Anxiety
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Pain Catastrophizing
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Sleep
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Quality of Life
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Acute Pain Intensity
timeFrame: Immediately before to after the first and last treatment session, which comprises a 20 minute span
Other outcomes:
measure: Change in State Self-Transcendence
timeFrame: Immediately before to after the first and last treatment session, which comprises a 20 minute span
measure: Change in State Decentering
timeFrame: Immediately before to after the first and last treatment session, which comprises a 20 minute span
measure: Change in Trait Self-Transcendence
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Trait Decentering
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Change in Prescription Pain Medication Misuse
timeFrame: One week before treatment to one week after treatment, which comprises a 6 week span
measure: Pleasant Sensation Ratio
timeFrame: Immediately before to after the first and last treatment session, which comprises a 20 minute span
measure: Quantitative sensory testing
timeFrame: Immediately before the first treatment session and immediately after the last treatment session, which comprises a 4 week span
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: