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Clinical Trials/NCT05541718
NCT05541718
Completed
Not Applicable

New Options for Treating Knee Osteoarthritis Pain

University of Utah1 site in 1 country164 target enrollmentJanuary 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of Utah
Enrollment
164
Locations
1
Primary Endpoint
Change in Osteoarthritis symptoms
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2023
End Date
August 23, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adam Hanley

Principal Investigator, Assistant Professor

University of Utah

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in Pain Catastrophizing(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)
  • Change in Acute Pain Intensity(Immediately before to after the first and last treatment session, which comprises a 20 minute span)
  • Change in Anxiety(One week before treatment to one week after treatment, which comprises a 6 week span)
  • Change in Depression(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)

Study Sites (1)

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