New Options for Treating Knee Osteoarthritis Pain

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Behavioral: Sham Reiki; Behavioral: Mindfulness Meditation; Behavioral: Reiki

• Registration Number: NCT05541718
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-23
• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-05
• Last Update Posted: 2024-02-06
• Primary Completion: 2024-09-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Reiki	Sham Reiki	-
Mindfulness Meditation	Mindfulness Meditation	-
Reiki	Reiki	-

Primary Outcome Measures

Name	Time	Method
Change in Osteoarthritis symptoms	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 Outcome Measures

Name	Time	Method
Change in Pain Catastrophizing	One week before treatment to one week after treatment, which comprises a 6 week span	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 Quality of Life	One week before treatment to one week after treatment, which comprises a 6 week span	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	Immediately before to after the first and last treatment session, which comprises a 20 minute span	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.
Change in Anxiety	One week before treatment to one week after treatment, which comprises a 6 week span	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 Depression	One week before treatment to one week after treatment, which comprises a 6 week span	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 Sleep	One week before treatment to one week after treatment, which comprises a 6 week span	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

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States