Innes 2018 Evid Based Complement Alternat Med

Hindawi
Evidence-Based Complementary and Alternative Medicine

Volume 2018, Article ID 7683897, 19 pages
https://doi.org/10.1155/2018/7683897
Research Article
Effects of Mantra Meditation versus Music Listening on
Knee Pain, Function, and Related Outcomes in Older
Adults with Knee Osteoarthritis: An Exploratory Randomized
Clinical Trial (RCT)
Kim E. Innes ,1 Terry Kit Selfe,2 Sahiti Kandati,1,3 Sijin Wen ,4 and Zenzi Huysmans5
1
Department of Epidemiology, School of Public Health, West Virginia University, Morgantown, WV, USA
2
Department of Biomedical and Health Information Services, Health Science Center Libraries, University of Florida,
Gainesville, FL, USA
3
School of Dentistry, SUNY-Buffalo, Buffalo, NY, USA
4
Department of Biostatistics, School of Public Health, West Virginia University, Morgantown, WV, USA
5
College of Physical Activity and Sport Sciences, West Virginia University, Morgantown, WV, USA
Correspondence should be addressed to Kim E. Innes; [email protected]
Received 26 April 2018; Revised 31 July 2018; Accepted 8 August 2018; Published 30 August 2018
Academic Editor: Mark Moss
Copyright © 2018 Kim E. Innes et al. This is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective. Disease-modifying treatments for OA remain elusive, and commonly used medications can have serious side effects.
Although meditation and music listening (ML) have been shown to improve outcomes in certain chronic pain populations, research
in OA is sparse. In this pilot RCT, we explore the effects of two mind-body practices, mantra meditation (MM) and ML, on knee
pain, function, and related outcomes in adults with knee OA. Methods. Twenty-two older ambulatory adults diagnosed with knee
OA were randomized to a MM (N=11) or ML program (N=11) and asked to practice 15-20 minutes, twice daily for 8 weeks. Core
outcomes included knee pain (Knee Injury and Osteoarthritis Outcome Score [KOOS] and Numeric Rating Scale), knee function
(KOOS), and perceived OA severity (Patient Global Assessment). Additional outcomes included perceived stress (Perceived Stress
Scale), mood (Profile of Mood States), sleep (Pittsburgh Sleep Quality Index), and health-related quality of life (QOL, SF-36).
Participants were assessed at baseline and following completion of the program. Results. Twenty participants (91%) completed the
study (9 MM, 11 ML). Compliance was excellent; participants completed an average of 12.1±0.83 sessions/week. Relative to baseline,
participants in both groups demonstrated improvement post-intervention in all core outcomes, including knee pain, function, and
perceived OA severity, as well as improvement in mood, perceived stress, and QOL (Physical Health) (p’s≤0.05). Relative to ML,
the MM group showed greater improvements in overall mood and sleep (p’s≤0.04), QOL-Mental Health (p<0.07), kinesiophobia
(p=0.09), and two domains of the KOOS (p’s<0.09). Conclusions. Findings of this exploratory RCT suggest that a simple MM and,
possibly, ML program may be effective in reducing knee pain and dysfunction, decreasing stress, and improving mood, sleep, and
QOL in adults with knee OA.
1. Introduction of life (QOL) [5]. OA of the knee, the joint most commonly
affected in OA patients, accounts for 83% of total OA burden
Osteoarthritis (OA) is the most common form of arthritis [10, 11]. Approximately 45% of adults are projected to develop
and a leading cause of chronic pain and disability in the symptomatic knee OA by age 85, and an estimated two-thirds
U.S., affecting at least 30.8 million American adults [1]. OA is of those who are obese will develop symptomatic knee OA in
also associated with increased risk for medical comorbidity their lifetime [12].
[2, 3], falls [4], and mortality [2, 5, 6] and with significant There is currently no cure for OA, and there are no
deterioration in mood [7, 8], sleep quality [7, 9], and quality effective treatments available for modifying the course of
2 Evidence-Based Complementary and Alternative Medicine
the disease [13]. Rather, current recommended treatment 2. Subjects and Methods
approaches focus on symptom management and functional
restoration [13]. Although pharmaceuticals remain the treat- In this community-based pilot RCT, we investigated the
ment mainstay for the vast majority of patients with OA effects of a simple mantra meditation (MM) program versus
[14, 15], medications used to alleviate OA pain can be a music listening (ML) program on knee pain, function, and
costly and carry substantial side effects that are both more related indices in 22 ambulatory older adults with physician-
common and more problematic in older adults [16–19]. confirmed OA of the knee.
For example, while the existing literature and guideline
recommendations do not support the use of opioids for the 2.1. Study Participants: Participant Recruitment, Character-
management of knee OA, these medications are frequently istics, Screening, and Enrollment. The study was approved
used [15, 20]. A recent analysis of U.S. commercial and by the West Virginia University Institutional Review Board.
Medicare claims data from over 6 million privately insured Independently living, ambulatory adults aged ≥50 years with
patients aged 40-75 years (2009-15) indicated that opioid OA were recruited using flyers and brochures posted in com-
use is elevated among those with knee OA (33-35%) and munity, healthcare, and workplace settings, and advertise-
that likelihood of narcotic use was 6- to 8-fold higher in ments posted on the university intranet and listservs. Study
this population relative to those without diagnosed knee OA eligibility criteria included: at least 50 years of age; physician-
[20]. confirmed diagnosis of OA of the knee; knee pain for at least
Of particular concern is the trend of increasing opioid 6 months, rated as moderately severe or worse (defined as a
prescription for OA during the past decade. For example, score > 3 on an 11-point numeric pain rating scale) for most
opioid use among U.S. adults 65 and older with knee OA rose days in the month prior to enrollment; and willingness and
from 31% in 2003 to 40% in 2009 [13], despite overwhelming ability to abide by the protocol. Exclusion criteria were as
evidence that opioid therapy for chronic noncancer pain in follows: began or stopped medications, physical therapy, or
older adults carries significant risks. Notably, these medica- supplements for the knee within 2 months preceding study
tions are addictive, carry serious side effects, can increase risk enrollment; intra-articular corticosteroid or hyaluronic acid
for falls, disability, and all-cause mortality, and are ineffective injection into the knee within 3 months preceding the study;
for long-term pain control in most [ca 75%] OA patients significant injury to the knee within the past 6 months;
[19, 21–23]. arthroscopy of the knee within the past year; use of assistive
The American College of Rheumatology clinical guide- devices other than a cane or knee brace; presence of an
lines recommend the use of nonpharmacologic therapies uncontrolled comorbid condition affecting the knee (e.g.,
for first-line management of knee OA [24]. Moreover, the rheumatoid arthritis); disease of the spine or other lower-
Osteoarthritis Research Society International (OARSI) prac- extremity joints or poor general health interfering with com-
tice guidelines emphasize patient-driven therapies and self- pliance or assessment; a regular meditation practice within
help strategies in the initial stages of OA management [25]. the past year; and/or history of psychotic or schizophrenic
Identifying safe, sustainable self-management interventions episodes.
that are effective in addressing not only pain and dysfunction, Potential participants provided written informed consent
but the associated impairment in mood, sleep, and quality of and underwent a full screening and baseline assessment at
life is of clear importance. the WVU Health Research Center. We enrolled participants
Movement-based mind-body therapies such as yoga and on a rolling basis in two waves over a total of 6 months in
tai chi, as well as conventional physical exercise, have been 2015-16. Upon completion of the 8-week program, partic-
shown to decrease pain and improve physical function in ipants returned for follow-up assessments (see below). All
older adults with OA [22]. There is also growing evidence that participants were encouraged to continue stable use of any
meditation and music-based interventions, including simple, supplements/medications that were currently being taken
passive music listening, may reduce pain [26–29], improve for knee pain and to avoid beginning any new drugs or
mood [26–30], and enhance QOL [28, 29] in adults with OA treatments for knee pain during the study period.
and other musculoskeletal [26–28] and chronic noncancer
pain conditions [27, 28, 30]. In our recent uncontrolled
trial of mantra meditation in older adults with knee OA, 2.2. Randomization. Following provision of consent and
participants showed marked and significant improvements confirmation of eligibility and collection of baseline data
in pain and physical function, mood, and a proxy measure (see below), participants were randomized to the meditation
for sleep following completion of a simple 8-week mantra or music listening group, based on an allocation sequence
meditation program [31]. However, despite the promise and generated by the study statistician and using a block ran-
apparent therapeutic potential of these simple therapies, domization method to ensure equal distribution between
rigorous studies regarding the effects of meditation or music treatment groups. The statistician, who had no contact with
in adults with OA are lacking. Building on our promising the participants, generated an assignment master list and pro-
preliminary findings, this exploratory randomized clinical vided sequentially numbered opaque envelopes containing
trial (RCT) compared the effects of a mantra meditation the group assignment. The consenting team member gave the
versus a music listening program on pain, function, and next envelope in sequence to the participant. The participant
related psychosocial factors in older adults with symptomatic opened the envelope to discover his/her intervention group
OA of the knee. assignment.
Evidence-Based Complementary and Alternative Medicine 3
2.3. Interventions 2.4. Measures and Assessment. All participant assessments

were performed by research staff blinded to participant
2.3.1. Training. Following randomization, each participant treatment assignment.
received 30-45 minutes of in-person training in his/her
respective program and received a brief, illustrated reference
guide, a program CD, and a portable CD player for home 2.4.1. Baseline Data. These data were collected following
use. Each program CD included 15-minute and 20-minute provision of written informed consent. Information gathered
tracks. The training was provided by a team member familiar included that on demographics; lifestyle factors (alcohol
with both programs and experienced in teaching a variety consumption, smoking status, caffeine consumption, and
of relaxation techniques; training included presentation of engagement in physical activity); body mass index (BMI,
the instructions for each program (described below), intro- calculated as height(m)/weight(kg)2 ); and medical history,
duction to the operation of the CD player and various including current use of medications and supplements. At
CD tracks, and use of the practice log. The participant follow-up, participants were also specifically queried regard-
then performed their first practice session and recorded it ing any changes during the study period in medication and/or
on the log sheet while the trainer observed and provided supplement use; caffeine or alcohol consumption, smoking
any guidance required by the participant to perform the status, or physical activity.
intervention at home with proficiency. In addition, the trainer
followed up with each participant by phone during the first 2.4.2. Outcomes. All outcomes were assessed at baseline
week of the study, and periodically thereafter as needed to and within 2 weeks following completion of the 8-week
address any concerns or questions arising during the course intervention. Core outcomes included knee pain, assessed
of the trial. using the Knee Injury and Osteoarthritis Outcome Score
Both interventions entailed sitting comfortably, eyes [KOOS] [32] and the Numeric Rating Scale [NRS] [33],
closed, for 15-20 minutes twice daily every day for 8 weeks (112 knee function (KOOS), and perceived OA severity (Patient
sessions total) and documenting each session, including any Global Assessment) [34] as consistent with the OMERACT
comments, daily on the practice log provided. All participants recommended core set outcomes [35]. All scales are reliable,
were encouraged to begin the program with the 15-minute well-validated instruments widely used for evaluating knee
version and move on to the 20-minute version when they OA and shown to be sensitive to change with behavioral and
felt comfortable. All participants were instructed to select other nonpharmacologic interventions [36–40].
a quiet environment where there would be no disturbances The KOOS is a self-administered, condition-specific
for approximately 20 minutes (see below). Upon completing questionnaire developed as an extension of the Western
the 15-20-minute session, participants were instructed to take Ontario and McMaster Universities Osteoarthritis Index
as much time as necessary to gently return to full alertness (WOMAC). In addition to the 17-item subscale to assess knee
before standing up and resuming normal activities. function in activities of daily living (ADL) (equivalent to the
WOMAC knee function subscale), the KOOS includes an
2.3.2. Mantra Meditation Program (MM). The meditation expanded 9-item pain subscale and 7-item ”other symptoms”
technique was a simple, easy-to-learn mantra meditation subscale that incorporate, respectively, the WOMAC knee
practice. A list of possible mantras (sounds or words) was pain (5 items) and knee stiffness (2 items) subscales; the
provided in the instruction sheet. Each participant was KOOS also includes two additional subscales to evaluate
instructed to select a mantra that appealed to him/her based function in recreational/sport activities and knee-related
on the sound or vibrational quality, and to avoid mantras that quality of life (QOL). Higher scores indicate worse outcomes.
might precipitate trains of thought or emotional responses. Extensive psychometric testing has shown the KOOS to
The meditation CD contained both guided and silent ses- be a valid, reliable, and responsive instrument in a range
sions, including soft chimes to announce the beginning and of populations and across multiple languages [37, 41]. As
end of a 15-20-minute session. Participants were instructed aggregate scores are not recommended in scoring the KOOS
to take a few deep breaths, releasing any stress or tension [42], the total score (KOOS-WOMAC total) was calculated
during exhalation, then to begin silently repeating the chosen as the sum of the WOMAC pain, stiffness, and function
mantra, gently letting go of all other thoughts for 15–20 subscale scores as per WOMAC scoring guidelines [43]. An
minutes. Emphasis was placed on the practice being easy and 11-point NRS (ranging from 0 (“no pain”) to 10 (“worst
effortless. After 15–20 minutes had passed, the participants pain possible”)) was used to rate current, average, least, and
were to stop repeating their mantras and sit quietly for worst pain for the previous week. NRS scales have shown
approximately 2 minutes before opening their eyes. excellent reliability and validity for a range of populations,
are easier to use, and have shown higher compliance and
2.3.3. Music Listening Program (ML). The ML program CD greater responsiveness to change with treatment than the
contained selections of relaxing instrumental music from visual analog scale (VAS), especially in older adults [44–48].
each of six composers, including Mozart, Bach, Vivaldi, Additional outcomes included OA-related quality of life,
Beethoven, Pachelbel, and Debussy (a total of 15 tracks). symptoms, and function in leisure activities/sports, assessed
Participants were allowed to choose which musical selections using the KOOS subscales for these domains. In addition,
to listen to on a daily basis but were asked to try each we evaluated perceived stress (10-item Perceived Stress Scale
composer at least once during the study. (PSS) [49]), mood (65-item Profile of Mood States [50]),
well-being (Psychological Well-Being Scale (PWBS) [51]), with effect sizes, point estimates, and measures of variability
sleep quality (Pittsburgh Sleep Quality Index (PSQI) [52]), to allow readers to draw their own conclusions regarding the
and health-related quality of life (36-item MOS Short Form- findings.
36 (SF-36) [51]). These self-report measures are established, To assess the potential relationship of treatment
well-validated instruments that have been used in a broad expectancy scores and practice adherence to change over
range of populations, including those with OA [53–56]. We time in knee pain, function, and related outcomes, as well
also measured pain-related catastrophizing using the 13-item as to changes in mood, sleep, well-being, stress, QOL, fear
Pain Catastrophizing Scale (PCS) [57] and fear of movement of movement, and pain catastrophizing, bivariate and age-
using the 6-item Tampa Scale for Kinesiophobia (TSK-6) [58] and sex-adjusted correlations were performed using Pearson
to assess change over time in these potential mediators. product-moment correlation. To evaluate the potential
influence of treatment expectancy on change over time
in core outcomes, we also conducted additional analyses
2.4.3. Treatment Expectancy, Adherence, and Participant Sat-
adjusting for this factor.
isfaction. To assess expectation of benefit, participants com-
pleted an abridged Credibility/Expectancy Questionnaire
(CEQ) following their first intervention practice session;
derived from the original 6-item questionnaire [59], the CEQ 3. Results
included 2 items scored on a 0-10 scale: ”How confident
Twenty-two eligible adults with symptomatic OA of the knee
are you this program will be beneficial?” and ”What is the
were enrolled in the study. As illustrated in Table 1, study
degree of improvement that you expect from this relaxation
participants were predominantly non-Hispanic white (82%)
program?”. Participants were provided with home practice
and female (68%), with an average age of 58.5±1.4 (range 50-
logs to complete daily, recording the time and any comments
74) years. Engagement in physical activity was low overall,
regarding the daily session; practice logs were collected at the
with over 40% reporting none at all, and 68% indicating
follow-up assessment. Finally, upon completion of the 8-week
less than the recommended 150 minutes/week. BMI averaged
intervention or leaving the study, participants completed an
34±1.5, and prevalence of comorbidity was high in this
exit questionnaire adapted from that used in our previous
sample; 82% of participants reported at least one, and 45%
trials [31, 60–62] and including both structured and open-
indicated at least 2 chronic comorbid conditions (Table 1).
ended questions regarding the participants’ experience with
Common comorbid conditions included obesity (68%) and
the study, perceived benefits and problems with the interven-
hypertension (68%). Prescription medication use was also
tions, barriers to adherence, and other concerns.
high, with 86% reporting using 1-2 and almost 60% at least 3
medications. Most (68%) were on analgesics, with 32% using
2.5. Data Analysis. All data analyses were performed using opioids or muscle relaxants and 59% reporting regular use of
IBM SPSS for Windows, Version 23. Differences in base- NSAIDs. Clinically significant sleep impairment, defined as
line characteristics by intervention group assignment were PSQI>5 [52, 68], was present in over 95% of participants at
assessed using chi square (for categorical variables), Stu- baseline, and psychosocial measures indicated high baseline
dent's independent samples t-tests (for continuous variables levels of distress in this population (Table 2). Treatment
with a normal distribution), or Mann–Whitney U tests (for expectancy scores indicated positive expectations overall,
ordinal or continuous variables with evidence of skewing). with both items averaging over 7 on a scale of 1-10 (means
Potential differences between treatment groups in treat- ± SE=7.8±0.3, 7.2±0.4).
ment expectancies, retention, and adherence were analyzed Participants in the MM group averaged higher baseline
using chi square (attrition) and one-way ANOVA (adher- BMI and were more likely to indicate absence of physical
ence, treatment expectancies). In preliminary assessments, activity and to report higher analgesic (and specifically
within-group changes over time at 8 weeks were assessed NSAID) use than those of the ML group. The two groups
using ANCOVA with baseline scores as covariates; between- did not differ significantly in other demographic character-
group differences in treatment outcomes were assessed using istics, lifestyle factors, medical history, or medication use
Repeated Measures ANOVA, with factors that differed at (Table 1). Likewise, there were no significant between-group
baseline (p<0.1) included as covariates. Variables with a differences in baseline scores on core or secondary outcome
nonnormal distribution were log-transformed for analysis, measures (Table 2) or in measures of kinesiophobia or pain
using the addition of a constant in the case of zero or catastrophizing (p’s >0.1).
negative values. We used multiple imputation to replace any Each participant received the intervention as allocated.
missing data in our intention-to-treat (ITT) analyses [63, 64]. Participant retention was high, with 20/22 (91%) participants
Effect sizes were calculated using Cohen’s d. As this was an (9/11 MM, 11 ML) completing the 8-week intervention.
exploratory study designed to assess feasibility and to evaluate Drop-out occurred early in the study, with one participant
preliminary efficacy for a range of interrelated outcomes of withdrawing in week one due to a job change and the second
direct clinical relevance to OA management, the alpha was in week two due to an injury unrelated to the intervention.
set at 0.05 (two-sided) and we did not adjust for multiple Adherence was also high, with participants completing an
comparisons. While a cut-point of 0.05 can be considered average of 94% of the 112 possible sessions (91% MM,
conservative given the small sample size and objectives of this 96% ML) and an average of 13.1±0.4 sessions/week (12.8±8
exploratory study [65–67], we provide exact p values, along MM, 13.5±0.3 ML). There were no significant between-group
Table 1: Participant baseline characteristics: pilot RCT of an 8-week mantra meditation (MM) and an 8-week music listening (ML) program
in 22 adults with symptomatic osteoarthritis of the knee.
Overall (N=22) MM (N=11) ML (N=11)

P
N % N % N %
Demographic characteristics
Age (range 50-74 years) 1.00
50-59 years 14 63.64% 7 63.64% 7 63.64%
60+ years 8 36.36% 4 36.36% 4 36.36%
Mean±SE 58.46±1.37 58.09±1.60 58.82±2.23 0.73
Gender 0.22
Female 15 68.18% 9 81.82% 6 54.55%
Male 7 31.82% 2 18.18% 5 45.45%
Race/Ethnicity
Non-Hispanic White 18 81.82% 9 81.82% 9 81.82% 1.00
Minority 4 18.18% 2 18.18% 2 18.18%
Education 0.37
12 years or less 2 9.09% 1 9.09% 1 9.09%
Some post-high school education 8 36.36% 6 54.55% 2 18.18%
4 years of college or more 12 54.55% 4 36.36% 8 72.73%
Mean±SE in years 15.46±0.42 15.09±0.64 15.82±0.57 0.41
Employment status 0.72
Employed full time 15 68.18% 8 72.73% 7 63.64%
Other 7 31.82% 3 27.27% 4 36.36%
Marital status 0.54
Married/co-habiting 16 72.73% 7 63.64% 9 81.82%
Divorced/Widowed 6 27.27% 4 36.36% 2 18.18%
Lifestyle and health-related factors
Smoking status 1.00
Never smoked 18 81.82% 9 81.82% 9 81.82%
Ever smoker 4 18.18% 2 18.18% 2 18.18%
Caffeinated beverage consumption 0.39
0-16 oz/d 14 63.64% 8 72.73% 6 54.55%
17+ oz/day 8 36.36% 3 27.27% 5 45.45%
Mean oz consumed/day±SE 14.52±2.46 13.82±3.67 15.22±3.46 0.78
Physical activity 0.04
None 9 40.91% 7 63.64% 2 18.18%
10-149 min/week 6 27.27% 3 27.27% 3 27.27%
150+ min/week 7 31.82% 1 9.09% 6 54.55%
Mean minutes/week±SE 148.64.64±50.74 129.09±96.57 168.18±37.53 0.71
Mean times/week±SE 3.07±0.63 2.00±0.88 4.14±0.81 0.09
Body mass index (BMI): Mean±SE 34.02±1.45 37.03±1.91 31.01±1.82 0.03
Obese 15 68.18% 9 81.82% 6 54.55% 0.17
History of diagnosed:
Diabetes 1 4.55% 0 0.00% 1 9.09% 0.72
Hypertension 15 68.18% 8 72.73% 7 63.64% 0.65
High cholesterol 7 31.82% 4 36.36% 3 27.27% 0.65
Depression 6 27.27% 4 36.36% 2 18.18% 0.34
Anxiety disorder 4 18.18% 2 18.18% 2 18.18% 1.00
Table 1: Continued.
Overall (N=22) MM (N=11) ML (N=11)
P
N % N % N %
Number of comorbid conditions 0.66
None 4 18.18% 2 18.18% 2 18.18%
One 8 36.36% 3 27.27% 5 45.45%
Two or more 10 45.45% 6 54.55% 4 36.36%
Medications
Analgesic Medications 15 68.18% 10 90.91% 5 45.45% 0.03
Opioids/Muscle relaxants 7 31.82% 3 27.27% 4 36.36% 0.45
NSAIDS 13 59.09% 9 81.82% 4 36.36% 0.03
Anti-depressant/anti-anxiety
8 36.36% 5 45.45% 3 27.27% 0.38
medications
Anti-hypertensive medications 15 68.18% 8 72.73% 7 63.64% 0.65
Statins, other lipid-lowering
7 31.82% 3 27.27% 4 36.36% 0.65
medications
Other medications∗ 12 54.55% 6 54.55% 6 54.55% 0.72
Total medications 0.23
None 3 13.64% 0 0.00% 3 27.27%
1-2 6 27.27% 3 27.27% 3 27.27%
Three or more 13 59.09% 8 72.73% 5 45.45%
∗
Including medications for gastrointestinal reflux, diabetes, thyroid disorders, and osteoporosis.
differences in adherence (p’s≥0.4). Similarly, there were no severity (PGA, p’s≤0.04), as well as in current, average, and
significant differences between the two groups in treatment least knee pain (NRS, p’s≤0.03). In addition, the MM group
expectancy (p’s≥0.7). Treatment expectancy scores were neg- demonstrated significant gains in knee function (p<0.02),
atively related to improvements over time in one measure sport and recreation-related function (p=0.04), and knee-
of pain (NRS, average pain), overall mood, depression, and related quality of life (p<0.03). Although both effect sizes
quality of life (r’s ranging from -0.4 to -0.6, p’s<0.05). No and absolute improvements in most measures were substan-
adverse events were observed or reported. tially larger in the MM than in the ML group, between-
Responses on the exit questionnaires (N=20) also indi- group differences were marginally significant for only the
cated overall high satisfaction with the study and study overall total (WOMAC) score and two KOOS subscales,
interventions. Eighty percent of participants (78% MM, 82% sport/recreational function and knee-related QOL (Table 3).
ML) indicated that they were likely or very likely to continue Using the OARSI/OMERACT criteria for treatment response
practicing. In response to the question “What did you like in clinical trials of OA [69], the percentage of responders
most about the study?”, 65% (78% MM, 55% ML) reported was also greater in the MM than in the ML group (67%
they enjoyed taking time for themselves; 80% (78% MM, versus 54%, respectively), but differences were not statistically
82% ML) indicated that they found the practice to be significant.
soothing, calming, and/or relaxing; a number also noted Participants in both the MM and ML group also demon-
their practice to help with pain (40%) and/or sleep (30%). strated improvements in perceived stress (p’s ≤0.04) and QOL
Several (4 MM, 1 ML) noted experiencing increased focus, (Physical Health Component, p<0.01), as well as reductions
clarity, and/or awareness. In response to questions regarding in fear of movement (TKS, p≤0.05) and pain catastrophizing
challenges/barriers experienced in the study or program, 7 (PCS, MM, p<0.09, ML p<0.01) (Table 3). In addition,
participants (3 MM, 4 ML) indicated no difficulties/barriers; the MM group showed significant improvements in sleep
others noted difficulty finding time to complete the practice quality (p<0.02 for overall, p’s≤0.03 for sleep disturbance
and daytime dysfunction), overall QOL-MH (p=0.01), overall
(3 MM, 4 ML), with some (N=4) noting they felt the practice
mood (p<0.01), and multiple individual domains of both
was too or a bit too long.
mood (confusion, depression, anger/hostility, and fatigue
(p’s≤0.04)) and QOL (energy/vitality, emotional well-being,
3.1. Change over Time in Knee Pain-Related Outcomes, Psy- and pain (p’s≤0.04)).
chological Status, Sleep Quality, and Quality of Life. As illus- Relative to ML, the MM group showed significantly
trated in Table 3, participants in both groups demonstrated greater improvements in overall sleep quality and mood
improvement at 8 weeks in primary outcomes, including (p’s≤0.04) and in two individual mood domains, including
knee pain (KOOS, p’s≤0.03; NRS, p’s<0.05) and perceived OA tension/anxiety and anger/hostility (p’s=0.01). Participants
Table 2: Mean baseline scores on osteoarthritis (OA) knee pain, function, and related outcomes and on sleep, stress, mood, well-being, quality
of life, and other factors in a sample of older adults with symptomatic OA of the knee, stratified by treatment group.
Mantra Meditation Music Listening

Outcomes (N=11) (N=11) P
Mean (SE) Mean (SE)
Knee Pain-Related (Core) Outcomes
Knee Injury and OA Outcome Score (KOOS)
Total-WOMAC∗(range 0-240) 106.64 (6.54) 119.73 (12.70) 0.37
Pain (range 0-90) 41.91 (2.41) 49.82 (4.38) 0.16
Pain-WOMAC (range 0-50) 20.90 (0.96) 25.82 (2.92) 0.14
Symptoms (range 0-70) 32.64 (2.90) 33.73 (3.09) 0.89
Stiffness-WOMAC (range 0-20) 10.82 (0.93) 12.45 (1.03) 0.25
Function (range 0-170) 74.90 (5.57) 81.46 (9.43) 0.56
Sports/Recreation (range 0-50) 35.73 (3.58) 34.91 (4.08) 0.88
Quality of Life (range 0-40) 29.82 (1.83) 29.18 (2.45) 0.84
Numeric Rating Scale (range 0-10)
Pain now 3.90 (0.50) 4.27 (0.69) 0.67
Average pain (last week) 4.91 (0.31) 5.91 (0.56) 0.15
Worst pain (last week) 7.20 (0.57) 7.82 (0.0.62) 0.47
Least pain (last week) 2.80 (0.36) 2.73 (0.0.78) 0.93
Patient Global Assessment (range 0-10) 6.00 (0.36) 6.36 (0.53) 0.57
Secondary Outcomes
Stress, Sleep Quality, Mood, and Well-being
Perceived Stress Scale 17.30 (3.24) 15.33 (1.32) 0.25
Pittsburgh Sleep Quality Index 9.78 (3.24) 8.09 (2.21) 0.23
Profile of Mood States (total score) 30.90 (11.19) 29.37 (11.19) 0.93
Psychological Well-being Scale 84.73 (3.70) 82.64 (5.05) 0.74
Health related Quality of Life (SF-36)
Mental Health Composite Score 60.20 (6.92) 70.00 (6.43) 0.31
Physical Health Composite Score 45.74 (4.85) 47.90 (5.62) 0.77
Potential mediators
Tampa Scale for Kinesiophobia 17.30 (1.02) 16.82 (0.76) 0.71
Pain Catastrophizing Scale 15.10 (3.92) 22.27 (3.98) 0.21
Treatment Expectancy(CEQ)
How confident that tx will be beneficial (1-10) 7.73 (0.41) 7.82 (1.25) 0.78
Degree improvement expected (1-10) 7.00 (0.49) 7.27 (0.45) 0.96
∗
Calculated as the sum of the WOMAC Pain, Stiffness, and Function subscale scores.
CEQ= Credibility Expectancy Questionnaire (higher numbers indicate higher expectancy).
assigned to MM also tended to show greater gains in for pain unrelated to OA (1)) and 1 ML participant (pre-
QOL-Mental Health (MH) (p<0.07), as well as in certain scribed narcotic analgesic). Neither adjusting for change
individual domains of mood (depression (p=0.06), confusion in medication nor eliminating these individuals from the
(p=0.09)) and QOL-PH (pain, general health (p’s<0.09)). analyses substantively altered the within-group or between-
ITT analyses using multiple imputation yielded similar group findings.
results, as did analyses adjusting for baseline physical activity.
Additional adjustment for treatment expectancy modestly 3.2. Relation of Changes over Time in Knee Pain and Related
strengthened the between-group differences in mood (overall Outcomes to Those in Psychological Status, Sleep Quality, Qual-
and depression (p’s≤0.03), sleep (p=0.02), and QOL-MH ity of Life, and Other Factors. As illustrated in part in Table 4,
(p=0.04)) but did not otherwise appreciably alter findings in improvements in mood, both overall and in specific domains,
age-adjusted analyses. Three participants reported a change were significantly correlated with declines in current pain
in medication, including two MM (lowered dose of ACE (NRS, r’s=0.5 overall; 0.4-0.5, tension, vigor; p’s<0.05) and
inhibitor (1), given a 3-day prescription for muscle relaxant improvements in patients’ assessment of their condition
Table 3: Change over time in knee pain, function, perceived stress, sleep, mood, and related outcomes in older adults with knee osteoarthritis
assigned to a mantra meditation or music listening program.
Mantra Meditation Music Listening

Change at 2 months Change at 2 months
(Mean ± SE) P∗ ES (Mean ± SE) P∗ ES P
Knee Pain-Related (Core) Outcomes
KOOS
Total (WOMAC)∗∗ -38.00 (12.27) 0.015 2.2 -19.00 (8.82) 0.06 0.5 0.07
Pain -13.33 (4.45) 0.02 0.7 -9.36 (3.77) 0.03 0.7 0.16
WOMAC pain -8.00 (2.74) 0.02 2.3 -4.82 (2.47) 0.08 0.5 0.26
Symptoms -5.22 (2.67) 0.08 0.7 -2.55 (1.98) 0.23 0.3 0.42
Stiffness (WOMAC) -2.00 (1.35) 0.18 0.4 -1.91 (0.78) 0.03 0.5 0.95
Function (ADL) -28.00 (8.91) 0.02 0.8 -12.27 (6.67) 0.10 0.4 0.45
Sports/Recreation -17.00 (7.06) 0.04 0.9 -2.91 (4.96) 0.57 0.2 0.09
Knee-related Quality of Life -8.67 (3.19) 0.03 0.8 -1.91 (1.52) 0.24 0.2 0.06
Numeric Rating Scale
Knee pain now -1.63 (0.50) 0.01 1.0 -1.73 (0.66) 0.03 0.8 0.58
Average knee pain -2.13 (0.79) 0.03 1.6 -1.45 (0.47) 0.01 0.8 0.90
Worst knee pain -1.38 (0.53) 0.04 0.7 -1.18 (0.50) 0.12 0.6 0.94
Least knee pain -1.63 (0.42) 0.01 1.3 -1.64 (0.66) 0.03 0.6 0.65
Patient Global Assessment -2.00 (0.87) 0.025 1.0 -1.18 (0.50) 0.04 0.7 0.19
Secondary Outcomes
Stress, mood, well-being and sleep quality
Perceived Stress Scale -4.78 (2.00) 0.04 0.7 -3.45 (1.08) 0.01 0.4 0.56
Profile of Mood States (total score) -34.11 (9.64) 0.008 1.5 -10.91 (5.19) 0.06 0.2 0.04
Psychological Well-being Scale 4.00 (3.09) 0.23 0.4 2.45 (2.44) 0.34 0.2 0.74
Pittsburgh Sleep Quality Index (total score) -2.38 (0.80) 0.02 0.7 -0.36 (0.49) 0.48 0.1 0.04
Mental Health Component 17.96 (5.61) 0.01 0.9 5.30 (3.63) 0.18 0.2 0.07
Physical Health Component 20.69 (5.11) 0.004 1.0 11.59 (3.76) 0.01 0.5 0.16
Potential Mediators
Tampa Scale for Kinesiophobia-6 (total) -4.22 (1.53) 0.03 1.1 -1.45 (0.65) 0.05 0.7 0.09
Pain Catastrophizing Scale Total -4.78 (2.48) 0.09 0.5 -7.64 (2.24) 0.007 0.7 0.25
∗
Repeated measures ANOVA (RM) Between group difference at 2 months, adjusted for age.
∗∗
Calculated as the sum of the WOMAC Pain, Stiffness, and Function subscale scores.
Abbreviations: ES= effect size; KOOS=Knee Injury and Osteoarthritis Outcome Score; SE=standard error.
overall (PGA) (fatigue, r=0.65, p<0.005). Reductions in NRS (emotional well-being, energy/vitality, social function physi-
measures of knee pain and OA-related symptoms (KOOS) cal function)), and knee-related QOL (r’s=0.4-0.5 overall; 0.4-
were significantly correlated with several individual domains 0.5, emotional well-being, physical function). In addition,
of sleep quality (r’s=0.5-0.6, sleep latency, quality, duration, decline in fear of movement was significantly correlated with
and disturbance) and with increases in mean hours of sleep improvements in average pain scores (r=0.6), OA severity
(r’s=0.5). Positive changes in mental and physical health- (r=0.6), and all KOOS measures except knee pain (r’s 0.4-0.6),
related quality of life, both overall and specific domains, were supporting a possible mediating influence of kinesiophobia.
significantly correlated with improvements in several knee Declines in pain catastrophizing (PCS) were correlated only
pain related outcomes, including overall knee-related symp- with improvements in the KOOS symptoms subscale (r=0.5)
toms and function (KOOS-WOMAC total score) and KOOS (Table 4).
knee function (r’s 0.5-0.6 overall; 0.4-0.5, individual domains Baseline scores on perceived stress, mood, well-being,
(emotional well-being, energy/vitality, social function, pain, sleep quality, and overall QOL were significantly intercorre-
and physical function)), current and average knee pain (NRS, lated (r’s ranging from 0.4 to 0.9). As illustrated in Table 5,
r’s=0.4-0.5 overall; 0.5-0.7, emotional well-being, physical improvements in mood, perceived stress, sleep quality, and
function), PGA (r’s=0.4-5 overall and individual domains both the mental and physical health components of QOL
Table 4: Relation of changes over time in knee pain-related outcomes to mood, sleep, well-being, and quality of life and to pain-related fear and catastrophizing in older adults with
symptomatic osteoarthritis of the knee.
Change over time at 2 months
Change from baseline
KOOS
KOOS KOOS KOOS KOOS KOOS NRS Pain NRS Pain NRS Pain NRS Pain
Total- PGA
Function Symptoms Pain Sport QOL now average worst least
WOMAC
Stress, sleep, mood, and QOL
Perceived stress (PSS) 0.39(∗)
Evidence-Based Complementary and Alternative Medicine
Mood (Profile of Mood States: total score) 0.38(∗) 0.42(∗) 0.47∗ 0.39(∗)
Sleep Quality (Pittsburgh Sleep Quality Index)
Total Score 0.41 (∗) 0.40(∗)
Mean number hours sleep -0.40(∗) -0.46∗ -0.47∗ -0.52∗∗
Mental Health component -0.53∗∗∗ -0.61 -0.46∗ -0.43∗ -0.49∗∗
Physical Health component -0.53∗ -0.53∗∗ -0.39(∗) -0.44∗ -0.47∗ 0.39(∗)
Pain-related Fear/Catastrophizing
Tampa Scale Kinesiophobia (total score) 0.52∗∗ 0.52∗∗ 0.51∗∗ 0.41(∗) 0.44∗ 0.63† 0.56∗∗∗ 0.55∗∗∗
Pain Catastrophizing Scale (total score) 0.54∗∗∗
Abbreviations: NRS=Numerical Rating Scale; PGA=Patient Global Assessment; QOL=quality of life.
(∗) p<0.1, ∗ p<0.05; ∗∗ p <0.025; ∗∗∗ p<0.01; p<0.005.
9
Table 5: Relation between changes over time in mood, sleep, perceived stress, and quality of life in adults with knee osteoarthritis.
Change over time at 2 months

Change from baseline
Mood Perceived Stress Sleep Quality QOL, Mental Health QOL, Physical Health
Mood (Profile of Mood States) 0.66 0.54∗∗ -0.75 -0.57∗∗∗
Perceived stress (Perceived Stress Scale) 0.66 0.48∗ -0.44∗ -0.56∗∗∗
Sleep quality (Pittsburgh Sleep Quality
0.54∗∗ 0.48∗
Index)
Health-related OOL (SF-36)
Mental Health Component -0.75 -0.44∗
Physical Health Component -0.57∗∗∗ -0.56∗∗∗
∗p
<0.05; ∗∗ P<0.025; ∗∗∗ p<0.01; p<0.005; p<0.001.
Abbreviations: QOL=quality of life.
were likewise strongly interrelated at 2 months (r’s from 0.4 strength and cardiovascular fitness, and pain sensitization) as
to 0.8), with the strongest correlations observed between well as psychosocial and behavioral factors (e.g., sleep impair-
changes in mood and those in stress and the mental health ment, mood disturbance, low social support, pain-related
composite score (r’s from 0.7 to 0.8). Improvements in fear, avoidant coping strategies, and sedentary behavior) [31,
sleep quality were likewise correlated strongly with those in 76–78]. OA pain and dysfunction have been bidirectionally
mood and perceived stress (r’s=0.5). No statistically signif- linked to distressful states and maladaptive behaviors, includ-
icant relationships were observed between changes in pain ing psychologic stress [8, 79–81], depression and anxiety [79,
catastrophizing or kinesiophobia scores and any measure of 82–84], sleep impairment [7, 9, 85–87], fatigue [8, 84, 88],
psychosocial status. pain-related fear, [79, 89, 90], and catastrophizing [79, 91–
94]. Consistent with both the biopsychosocial [95] and fear-
4. Discussion avoidance models of knee OA [92, 96, 97], these reciprocal
relationships contribute to a vicious cycle of increasing
In this pilot RCT, participants assigned to both MM and distress, sleep disturbance, fatigue, pain and pain sensitivity,
ML demonstrated significant reductions in knee pain and sedentary behavior, and physical dysfunction, further ampli-
overall OA severity. The MM group also showed significant fying risk for disability, morbidity, and mortality [8, 86, 91, 92,
improvements in multiple domains of knee function and 98, 99]. Thus, therapies which address the key psychosocial
greater gains than the ML group in two of these domains dimensions of knee OA, in turn, strong determinants of
(knee-related QOL and sports/recreation-related function), OA pain and dysfunction, may be of particular benefit in
as well as in overall (KOOS-WOMAC) score. Although cri- the management of this serious and common chronic pain
teria for minimal clinically important improvements (MCII) disorder.
in the KOOS total score and in the KOOS pain and QOL To our knowledge, this is the first RCT to assess the
subscales have not yet been established, improvements in effects of a simple meditation practice on pain, function, or
the MM group in both the overall KOOS-WOMAC score related outcomes in patients with OA of the knee. Previous
and in all subscales far exceeded cutoffs proposed using a controlled studies in mixed and other pain populations
variety of different methods and anchors, including effect size suggest other meditation based interventions may improve
(minimum 0.5) [70] and absolute change [71]. Similarly, the pain and certain psychosocial outcomes in adults with mus-
mean KOOS pain and function scores in the ML group also culoskeletal disorders, although observed effects have been
met or exceeded proposed cutoffs for MCIIs for knee pain modest overall. Notably, in a recent meta-analysis of 38 RCTs
and function, although effect sizes were substantially smaller of mindfulness-based interventions in adults with chronic
overall than in the MM group. Using the more stringent pain, including 3 studies with a small percentage (4-7%) of
criteria for the WOMAC pain and function subscales, the participants with OA or nonspecific arthritis, authors found
MM group achieved clinically significant improvement and low quality evidence for an overall small reduction in pain
an acceptable symptom state for pain and function, whereas and for modest improvements in depression and QOL [28].
the ML group did not [72, 73]. Likewise, only the MM Likewise, this study is among the first to assess the effects
group showed clinically important improvement in pain as of ML on OA pain and the first to evaluate potential benefits
measured by PGA, although both groups met criteria for of ML for improving other outcomes of relevance to OA.
clinically important reductions in the NRS [45, 74]. Only one controlled trial has assessed the potential benefit of
Although knee OA is a complex condition that remains ML for OA, an RCT of 66 community-dwelling elders with
incompletely understood [75], multiple interrelated factors symptomatic OA [100]. Consistent with our findings, elders
likely contribute to the etiology and progression of OA. These randomized to a 14-day daily ML program showed significant
include physical, neurobiological, and physiologic factors reductions in pain over time relative to those randomized to
(e.g., altered neurologic structure and function, inflamma- daily quiet sitting [100]. Our findings are also in agreement
tion, joint degeneration, obesity, deterioration in muscular with those from a recent meta-analysis of 14 RCTs of music
listening (N=13) and other music interventions (N=1) for a catastrophizing and fear of movement are thought to con-
range of chronic pain conditions, which indicated significant, tribute to the development and persistence of chronic pain;
moderate reductions in pain overall [27]. these factors may influence pain severity both directly and
Observed improvements in OA pain and function in this indirectly, and are significant predictors of physical per-
study were also comparable or superior to those reported formance and pain-related disability in those with chronic
in studies of other nonpharmacologic therapies for knee pain [79, 91, 92, 132, 133]. However, although kinesiophobia
OA, including acupuncture [101, 102], massage [103], yoga and pain-related catastrophizing have been recommended
[40, 104–108], t’ai chi [109–111], and other forms of exercise for inclusion in clinical trials of lifestyle interventions for
[102, 112]. Notably, effect sizes for knee pain and function in OA [134], published RCTs regarding the effects of medita-
the MM group were large (range 0.7-1.6), comparable to those tion, ML, yoga, or other mind-body interventions on these
reported for 8 weeks of physical therapy in patients with knee endpoints remain sparse. Moreover, findings from studies
OA [41]. in other chronic pain populations have been mixed. In
In addition, the reductions in pain and overall improve- broad agreement with our findings, some studies suggest that
ments in function observed in this study were also similar to certain yoga [135], mindfulness [136–139], and exercise-based
or greater than those reported in previous trials of medica- interventions [140, 141] can be effective in lowering fear of
tions commonly prescribed for OA, including nonsteroidal movement [135, 136, 140, 141] and/or catastrophizing [137–
anti-inflammatory drugs [113], acetaminophen [114], and 139] in those with chronic pain, although other studies have
opioids [113, 115]. Moreover, drug side effects can significantly reported modest or no effects [142–144].
mitigate the benefits of pharmaceuticals for OA management.
For example, in a recent Cochrane review of oral and trans- Possible Underlying Mechanisms. While the mechanisms
dermal opioids for OA, the authors concluded that the small underlying the improvements in knee-related pain and func-
to moderate effects of these medications were outweighed tion observed with MM and, albeit to a lesser extent, ML
by potential side effects and cautioned clinicians to discuss remain speculative, these simple mind-body therapies likely
alternative treatments with patients [115]. Likewise, Machado act via several pathways. Both meditation and music have
et al. concluded that acetaminophen provides minimal short been shown to decrease stress and stress reactivity, sleep
term benefit for OA, effects that are offset by significantly impairment, anxiety, depression, fatigue, and sympathetic
increased risk for elevated liver enzymes [114]. arousal [28, 121, 122, 145–151], factors linked to increased
In this study, both the MM and ML groups also indi- pain sensitivity and severity [8, 152–155]. As indicated above,
cated significant improvements in perceived stress, overall there is a growing literature supporting the importance of
mood, and QOL-Physical Health component. Relative to sleep [9, 85, 86], mood [8, 84, 154], and other psychosocial
those assigned to ML, the MM group participants showed factors [8, 79, 98] as both sequelae and determinants of OA
significantly greater improvement in mood and greater gains associated pain, dysfunction, and disability. Consistent with
in QOL-MH. No published RCTs in OA patients have yet these bidirectional relationships, improvements in knee pain,
assessed the potential benefits of meditation or ML on function, and other OA-related outcomes were positively
psychosocial outcomes of relevance to OA. However, the correlated with improvements in mood, sleep, and QOL in
improvements in mood and QOL observed in this study were this study.
similar to or greater than the effects documented in previous Likewise, meditation and music may improve OA-related
studies of yoga [116], tai chi [117, 118], physical therapy [117], pain and function by reducing pain-associated fear of move-
exercise [112], and other nonpharmacologic therapies [119, ment, a factor linked to the development and progression of
120] in adults with OA. Likewise, effect sizes in the MM chronic pain and associated disability, to the adverse mood
group were comparable to or greater than those observed in and functional alterations associated with OA [132], and to
controlled trials of mindfulness meditation [28] and music the reluctance to engage in physical activity that is common
listening [27, 29] in other chronic pain populations. among those with OA [90, 92, 156]. In this study, declines in
In addition, those randomized to MM but not to ML fear of movement were greater in the MM than in the ML
showed significant improvements in sleep quality in this group and were strongly correlated with improvements in
exploratory trial (p for between-group difference<0.04). pain and function and, albeit more modestly, with those in
Although there is evidence that music listening, meditation, mood, supporting a potential functional relationship. These
yoga, and other mind-body and physical activity interven- findings suggest that reductions in kinesiophobia may in part
tions may improve sleep in older adults [121–127], few trials mediate the observed beneficial effects of these simple mind-
of patients with OA or other chronic pain conditions have body practices on OA-related pain, function, symptoms, and
measured sleep as an outcome, and findings of these studies mood changes, consistent with both the biopsychosocial and
have been mixed [116, 128–131]. For example, evidence to date fear-avoidance models of chronic pain [92, 95–97, 132].
has indicated modest or no effects of yoga on sleep in OA [116] Finally, meditation and ML may also reduce pain by
and inconsistent findings for the benefits of tai chi in another promoting beneficial functional and structural changes in
chronic pain syndrome, fibromyalgia [129–131]. brain structures associated with pain processing, attention,
In the current trial, both the MM and ML groups cognition, emotional regulation, and reward [157–165]. These
showed reductions in kinesiophobia, although the effect size alterations may, in turn, lead to a reduction in the central
was greater in the MM group. Pain catastrophizing was pain sensitization and hyperalgesia associated with OA [166–
significantly reduced only in the ML group. Pain-associated 168]. For example, emerging evidence suggests that both
meditation and ML can induce beneficial changes in central effects were unlikely to explain the improvements observed
nervous system dopaminergic and other neurochemical sys- in this study. Although retention was high overall (91%), both
tems [169–171] and enhance autonomic regulation, in part drop-outs were in the MM group, potentially introducing
by modulating activation of the sympathoadrenal system bias. However, in both cases, withdrawal occurred early
and HPA axis and by increasing parasympathetic dominance and for reasons unrelated to the intervention, and ITT
[165, 172, 173]. In addition, recent controlled trials of ML and analyses yielded results (both the within- and between-
meditation suggest these practices can alter activity, increase group) similar to those of our primary analyses, suggest-
grey matter density and/or volume, and promote functional ing that the influence of differential attrition was likely to
connectivity in multiple brain areas involved in the cognitive, be minimal. Our study was also inadequately powered to
affective, and sensory processing of pain, including the assess the role of potential mediators, limiting conclusions
periaqueductal grey matter, hippocampus, prefrontal cortex, regarding potential mechanisms. In addition, we did not
insula, amygdala, orbitofrontal cortex, thalamus, somatosen- include performance-based measures in this exploratory
sory cortex, and anterior cingulate gyrus [157, 158, 163–165, trial, and our study findings were thus reliant on self-
172, 174–180]. reported measures of knee pain and function. However,
given that patient perceptions and symptoms are primary
Strengths and Limitations. Strengths of the study include the drivers of the healthcare burden and disability associated
community-based approach, rigorous, controlled design, and with OA [181, 182], our findings are nonetheless clinically
the use of multiple well-validated outcome measures of direct meaningful. The study population was predominantly female,
relevance to OA, including core outcomes recommended non-Hispanic white, and older, limiting generalizability to
for knee OA trials of lifestyle/behavioral interventions [134]; other populations.
treatment expectancies and program adherence were also
measured. The two interventions were matched in terms
of time, setting, and delivery. Both are easy-to-learn prac- 5. Conclusions
tices that can be performed readily in the home, with
exit questionnaires suggesting high satisfaction with both Findings of this exploratory RCT suggest that a simple MM
programs. Baseline characteristics of the two groups were and, possibly, ML program may be beneficial for reducing
similar overall, indicating the randomization was successful knee pain and dysfunction, decreasing stress, and improving
in this study despite the small sample size. Retention and mood, sleep, and QOL in older adults with knee OA, with
adherence were excellent and study satisfaction was high in improvements in knee function, mood, sleep, QOL-MH,
both groups, further supporting feasibility of both the trial and kinesiophobia that appeared greater in the meditation
and the interventions. group. Improvements in mood, stress, sleep, QOL, and
This exploratory RCT also has several important limi- kinesiophobia were significantly correlated with improve-
tations. The study did not include a long-term follow-up; ments in several knee pain related outcomes, suggesting a
thus, it was not possible to determine if the observed benefits potential mediating influence of these psychosocial factors.
were sustained over time. The sample size was small, reducing However, given the small size and exploratory nature of
our ability to detect between-group differences and limiting this RCT, our findings should be interpreted with caution.
generalizability. However, despite the limited power of the Larger controlled trials in multiethnic populations are clearly
study, the MM group demonstrated both statistically and needed to confirm and extend these preliminary findings,
clinically significant improvements in all core outcomes and to determine the cost-effectiveness of meditation versus
in four of the five secondary outcomes. Participants assigned other commonly used treatments for OA, and to investigate
to MM also demonstrated greater improvements than the ML potential underlying mechanisms.
group in certain domains of knee-related function/QOL, as
well as in mood, sleep, QOL-MH, and fear of movement,
outcomes of clear relevance to OA management. In addition, Data Availability
observed effect sizes in the MM group were comparable to
The data used to support the findings of this study are
or superior to those reported in RCTs of both nonpharmaco-
available from the corresponding author upon request.
logic [40, 41, 101–112] and pharmacologic interventions [113–
115].
As this RCT did not include a usual care group, the Disclosure
relative influence of simple time trends or of the Hawthorne
effect on change in outcomes could not be gauged. Likewise, The contents of this article are solely the responsibility of the
due to the lack of an attention control, the influence of authors and do not necessarily represent the official views of
placebo effects cannot be ruled out. However, in this study, the National Institutes of Health or West Virginia University.
participant treatment expectancies (the primary determinant Preliminary findings of this study were presented in part
of placebo effects) were unrelated or negatively related to as an abstract (IJYT Suppl 2016:29). Data will be shared via
observed improvements; moreover, adjustment for treat- dissemination to the community and professional groups and
ment expectations strengthened between group differences in via publications, presentations, and reports; original data will
several measures, but otherwise did not appreciably affect be available upon completion of all planned papers related to
our findings. Together, these findings suggest that placebo the study.
Conflicts of Interest persons with knee osteoarthritis,” Arthritis Care & Research, vol.
66, no. 10, pp. 1489–1495, 2014.
The authors declare that they have no conflicts of interest. [14] S. R. Kingsbury, E. M. A. Hensor, C. A. E. Walsh, M. C.
Hochberg, and P. G. Conaghan, “How do people with knee
osteoarthritis use osteoarthritis pain medications and does
Acknowledgments this change over time? Data from the osteoarthritis initiative,”
This study was supported by the National Institutes of Health Arthritis Research & Therapy, vol. 15, no. 5, 2013.
(NCCIH 5K01AT004108, NIGMS U54GM104942) and West [15] A. Shewale, L. Barnes, L. Fischbach, S. Ounpraseuth, J. Painter,
Virginia University (Faculty Incentive Award). and B. Martin, “Characterization of initial treatment strategies
used to manage incident knee osteoarthritis,” Value in Health,
vol. 19, no. 3, 2016.
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2.3. Interventions 2.4. Measures and Assessment. All participant assessments

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