Spirituality and Spiritual Distress in Parkinson's Disease Caregivers: A Scoping Review.

Despite recognition that spiritual concerns contribute to caregiver burden, little is known about spirituality, spiritual well-being, and spiritual distress in Parkinson's disease caregivers. In this scoping review of the literature through October 2022, we searched PubMed, PsychINFO, Embase, and CINAHL. From an initial pool of 328 studies, 14 were included. Caregiver factors (e.g., depression, age) and patient factors (e.g., faith, motor function) affected caregiver spirituality and spiritual well-being. Caregivers experienced loss of meaning, existential guilt, and loneliness, and coped through acquiescence, cultural beliefs, prayer, and gratitude. Future research should focus on the specific spiritual needs of Parkinson's disease caregivers and interventions to address them.

Dialysis Decision Making, Dialysis Experiences, and Illness Perceptions: A Qualitative Study of Pakistani Patients Receiving Maintenance Hemodialysis.

Rationale & Objective: The incidence and prevalence of patients with kidney failure requiring dialysis are increasing in Pakistan. However, in-depth perspectives on kidney care from Pakistani people requiring maintenance dialysis are lacking. Study Design: Qualitative interview study. Setting & Participants: Between September 2020 and January 2021, we interviewed 20 adults receiving maintenance hemodialysis in 2 outpatient dialysis units in Pakistan. We asked open-ended questions to explore their experiences with various aspects of kidney care. Analytical Approach: We recorded, transcribed, and then, using a phenomenological approach, thematically analyzed interviews. Results: We observed the following 6 main themes: (1) Patients perceived various supernatural phenomena as causes of their illness and chose traditional medicine for chronic kidney disease (CKD) treatment. (2) Patients expressed dissatisfaction with their physicians' communication. They felt poorly informed and resented their decision to initiate dialysis. (3) Family members tried to dissuade patients away from dialysis but also provided support once dialysis was initiated. (4) Patients and families found it challenging to afford dialysis and transplantation and also to arrange for transportation. (5) Women found it challenging to fulfill their obligations as wives and mothers while receiving maintenance dialysis. (6) Patients seemed reluctant to discuss end-of-life care. Limitations: We collected data from only 2 hospitals in neighboring cities. Additionally, patients on peritoneal dialysis were not included. Conclusions: Our findings shed light on patients' perspectives on kidney care in Pakistan and call for financially feasible solutions to raise kidney disease awareness and improve patients' experiences with dialysis. Physician training in communication and shared dialysis decision making along with the development of culturally adapted decision aids are needed to improve CKD knowledge and shared decision making. Although financial challenges preclude many from receiving long-term dialysis, cost-effective strategies to improve the availability of other options (eg, supportive kidney care, peritoneal dialysis, and transplantation) are still warranted.

What's in the Sauce? The Specific Benefits of Palliative Care for Parkinson's Disease.

CONTEXT: Increasing evidence demonstrates the benefits of palliative care among individuals with Parkinson's disease and related disorders (PDRD), but the critical components that contribute to therapeutic effects are not well understood. OBJECTIVES: To determine the specific items most responsive to a palliative care intervention in PDRD and identify key correlates of improvement in patient and care partner outcomes. METHODS: The main trial was a pragmatic comparative effectiveness trial of outpatient integrated palliative care compared to standard care among participants with PDRD (NCT02533921), showing significantly higher patient QOL at six months and lower care partner burden at 12 months. We used longitudinal regression models to analyze changes in subdomains of patient QOL and care partner burden and Spearman correlations to evaluate key correlates of change scores in patient and care partner outcomes. We performed a secondary analysis of data from 210 patients and 175 care partners. RESULTS: Compared to controls, patients in the intervention reported greater improvement in perceptions of the "self as a whole" at six months (coeff = 0.22, P < 0.05) and care partners reported greater reduction in stress, anger, and loss of control at 12 months (coeff = -.40, -0.25, -0.31, P < 0.05). Positive change in numerous patient non-motor symptoms and grief correlated with improved patient QOL, reduced patient anxiety, and increased care partner spirituality. Alleviation of care partner anxiety and depression correlated with reduced care partner burden. CONCLUSION: Specific benefits of an integrated palliative approach in PDRD include improvement in patient holistic self-impressions, care partner self-efficacy, and non-motor symptoms.

Predictors of Spiritual Well-Being in Family Caregivers for Individuals with Parkinson's Disease.

Background: Parkinson's disease (PD) is a common neurodegenerative illness that causes disability through both motor and nonmotor symptoms. Family caregivers provide substantial care to persons living with PD, often at great personal cost. While spiritual well-being and spirituality have been suggested to promote resiliency in caregivers of persons living with cancer and dementia, this issue has not been explored in PD. Objective: The aim of this study was to identify predictors of spiritual well-being in PD patients' caregivers. Design: A cross-sectional analysis was performed. Our primary outcome measure, the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp), was measured in caregivers alongside measures of patient quality of life, symptom burden, global function, grief, and spiritual well-being and caregiver mood, burden, and perceptions of patient quality of life. Univariate correlation and multiple regression were used to determine associations between predictor variables and caregiver FACIT-Sp. Setting/Subjects: PD patient/caregiver dyads were recruited through three academic medical centers in the United States and Canada and regional community support groups. Results: We recruited 183 dyads. Patient faith, symptom burden, health-related quality of life, depression, motor function, and grief were significant predictors of caregiver spiritual well-being. Predictive caregiver factors included caregiver depression and anxiety. These factors remained significant in combined models, suggesting that both patient and caregiver factors make independent contributions to caregiver spiritual well-being. Conclusions: The present study suggests that both patient and caregiver factors are associated with spiritual well-being in PD. Further study is needed to understand the causal relationship of these factors and whether interventions to support caregiver spiritual well-being improve outcomes for caregivers or patients. Clinicaltrials.gov registration NCT02533921.

Randomized controlled trial of neurologic music therapy in Parkinson's disease: research rehabilitation protocols for mechanistic and clinical investigations.

BACKGROUND: Presently available medications and surgical treatments for Parkinson's disease have limited effects on fine motor problems and often leave patients with significant fine motor disability. Standard of care occupational therapy (OT) yields low efficacy, potentially due to a lack of standard protocols. Neurologic music therapy (NMT) techniques, especially rhythmic auditory stimulation which relies on interaction between rhythm and movement, have shown to be effective in PD gait rehabilitation possibly through their reliance on neural pathways that are not affected by PD. Therapeutic instrumental music performance (TIMP) is one other NMT technique that holds promise but which mode of action and efficacy has not been investigated in PD yet. METHODS: One hundred PD participants will be randomly assigned to receive 15 sessions of either TIMP with rhythm or TIMP without rhythm, standard of care OT, or to be waitlisted (control) over 5 consecutive weeks. Brain oscillatory responses will be collected using magnetoencephalography during an auditory-motor task to understand the underlying mechanisms. The Grooved Pegboard, the UPDRS III finger tap, and the finger-thumb opposition will be assessed to investigate clinical changes related to fine motor function. This project will also serve to confirm or refute our pilot data findings suggesting NMT relies on compensatory brain networks utilized by the PD brain to bypass the dysfunctional basal ganglia. DISCUSSION: This study aims to use standardized TIMP and OT research protocols for investigating the neuronal pathways utilized by each intervention and possibly study their efficacy with respect to fine motor rehabilitation via a randomized control trial in the PD population. TRIAL REGISTRATION: ClinicalTrials.gov NCT03049033 . Registered on September 29, 2020.

The presence of a caregiver is associated with patient outcomes in patients with Parkinson's disease and atypical parkinsonisms.

INTRODUCTION: Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver. Although caregivers can play a key role in supporting patients, little is known about how and whether PD patients with and without caregivers differ in terms of physical, cognitive, and mood outcomes. This study explored whether caregiver presence was associated with variations in patient presentation and outcomes in a palliative PD and atypical PD population. METHODS: Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada. Measures included: MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale. RESULTS: Of 210 participants, 175 (83%) had a caregiver. Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale. Despite poorer cognitive and motor function, those with caregivers had higher QOL as measured by the Quality of Life in Alzheimer Disease and less spiritual distress. There were no group differences on anxiety, depression, or grief. Caregiver presence moderated the association between lower MoCA score and worse motor symptoms. CONCLUSION: Findings of the present study highlight the influence of caregiver engagement on PD patient outcomes. These findings have implications for clinical practice and suggest that presence of a caregiver may be an important modifying variable on patient outcomes to examine in future research.

Correlates of spiritual wellbeing in persons living with Parkinson disease.

BACKGROUND: Spirituality influences chronic disease coping skills through both positive and negative means. Although previous research notes similar associations between faith and Parkinson disease (PD) management, little is known about spirituality in the context of PD management in a palliative setting. The purpose of this paper is to gain a better understanding of the association between spirituality and PD management to best maximize the effect of spiritual counseling in treatment of the disease. METHODS: This is a cross-sectional analysis of the baseline data of a larger randomized, controlled trial. Individuals with PD and their caregivers were recruited from three study sites with currently-operating outpatient movement disorders and palliative care programs. Correlations were conducted between FACIT total scores and subscales with hypothesized associative factors, such as quality of life (QOL), mood and cognition, advance care planning, and physical symptoms. RESULTS: Two-hundred and ten PD patients and 175 caregivers participated in the study. FACIT scores correlated positively with older age, existence of a caregiver, and involvement in support groups. Higher spirituality was associated with less impairment in QOL, lower anxiety, lower depression, fewer non-motor symptoms, reduced palliative symptoms, and less prolonged grief. There was no significant association between patient FACIT scores and the MDS UPDRS or MoCA scores. CONCLUSIONS: These results highlight the influences of spirituality in PD management and further support the holistic, interdisciplinary care provided to PD patients through palliative care teams offering chaplaincy support to patients.

Feasibility of Home-Based Neurologic Music Therapy for Behavioral and Psychological Symptoms of Dementia: A Pilot Study.

Family caregivers often feel ill-equipped to handle bothersome behavioral and psychological symptoms of dementia, such as agitation, apathy, and sleep disturbances, leading to increased caregiver distress and nursing home placement for people with dementia. Therapies for such symptoms are currently limited and non-pharmacological options are preferred, given potential side effects of medications. Neurologic music therapy (NMT) could provide an additional treatment option for managing behavioral and psychological symptoms for community-dwelling people with dementia and their caregivers. This pilot study sought to evaluate the feasibility, acceptability, and effectiveness of home-based NMT for behavioral and psychological symptoms of dementia. Eighteen persons with dementia-caregiver dyads were enrolled to receive one-hour weekly sessions of home-based NMT for 6 weeks. Demographic, quality of life, neuropsychiatric symptom, and caregiver burden and self-efficacy information was collected at baseline, 6 weeks, and 12 weeks. Seven dyads (38.9%) withdrew from therapy before completing all sessions; these participants had higher Neuropsychiatric Inventory scores and were of older age at baseline. For those who completed therapy, neuropsychiatric symptom scores improved at 6 weeks, an effect that was sustained at 12 weeks. No other outcome measures changed significantly after therapy. Initiating NMT too late in the course of dementia, when behavioral symptoms are already present, may be impractical for people with dementia and increase caregiver stress, even when provided within the home. Introducing and incorporating the principles of NMT earlier in the course of dementia could allow for increased comfort and benefit for people with dementia and their caregivers.

Auditory entrainment of motor responses in older adults with and without Parkinson's disease: An MEG study.

Medical therapies applied to Parkinson's disease (PD) have advanced tremendously since the 1960's based on advances in our understanding of the underlying neurophysiology. Behavioral therapies, such as rhythmic auditory stimulation (RAS), have been developed more recently and demonstrated efficacy. However, the neural mechanisms of RAS are only vaguely understood. In this study, we examined the neurophysiology of RAS using magnetoencephalography (MEG) in a sample of older adults with (21 people) and without PD (23 participants). All participants underwent high-density MEG during a beat-based cued tapping task with rhythmic and non-rhythmic patterns, and the resulting data were analyzed using a Bayesian image reconstruction method. Complex wavelet based time-frequency decomposition was used to compute inter-trial phase locking factor (PLF) to auditory stimuli for left and right signal space projection vectors. Tapping with a rhythm compared to a non-rhythmic sequence resulted in differential brain activity in each group: (i) a greater activation of temporal, motor and parietal areas was found in healthy adults; (ii) a greater reliance on parietal and frontal gyri was found in PD participants. During rhythmic tapping, older adults without PD had significantly stronger neural activity in bilateral frontal, supplementary and primary motor areas compared to those with PD. Conversely, older adults with PD exhibited significantly stronger activity in the bilateral parietal regions, as well as the rolandic operculum and bilateral supramarginal gyri, relative to their healthy peers. These data suggest that RAS mobilizes diverse oscillatory networks; Healthy controls may shift to frontal areas mobilization whereas PD patients rely on parietal areas to a greater extent, which may reflect frontal network dysfunction with compensation in PD, and could serve as specific regions of interest for further RAS studies.

Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease.

Neurologic Music Therapy (NMT) is a novel impairment-focused behavioral intervention system whose techniques are based on the clinical neuroscience of music perception, cognition, and production. Auditory Stimulation (RAS) is one of the NMT techniques, which aims to develop and maintain a physiological rhythmic motor activity through rhythmic auditory cues. In a series of breakthrough studies beginning in the mid-nineties, we discovered that RAS durably improves gait velocity, stride length, and cadence in Parkinson's disease (PD). No study to date reports the neurophysiological evidence of auditory-motor frequency entrainment after a NMT intervention in the Parkinson's community. We hypothesized that NMT-related motor improvements in PD are due to entrainment-related coupling between auditory and motor activity resulting from an increased functional communication between the auditory and the motor cortices. Spectral analysis in the primary motor and auditory cortices during a cued finger tapping task showed a simultaneous increase in evoked power in the beta-range along with an increased functional connectivity after a course of NMT in a small sample of three older adults with PD. This case study provides preliminary evidence that NMT-based motor rehabilitation may enhance cortical activation in the auditory and motor areas in a synergic manner. With a lack of both control subjects and control conditions, this neuroimaging case-proof of concept series of visible changes suggests potential mechanisms and offers further education on the clinical applications of musical interventions for motor impairments.

Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior.

It is well established clinically that rhythmic auditory cues can improve gait and other motor behaviors in Parkinson's disease (PD) and other disorders. However, the neural systems underlying this therapeutic effect are largely unknown. To investigate this question we scanned people with PD and age-matched healthy controls using functional magnetic resonance imaging (fMRI). All subjects performed a rhythmic motor behavior (right hand finger tapping) with and without simultaneous auditory rhythmic cues at two different speeds (1 and 4 Hz). We used spatial independent component analysis (ICA) and regression to identify task-related functional connectivity networks and assessed differences between groups in intra- and inter-network connectivity. Overall, the control group showed greater intra-network connectivity in perceptual and motor related networks during motor tapping both with and without rhythmic cues. The PD group showed greater inter-network connectivity between the auditory network and the executive control network, and between the executive control network and the motor/cerebellar network associated with the motor task performance. We interpret our results as indicating that the temporal rhythmic auditory information may assist compensatory mechanisms through network-level effects, reflected in increased interaction between auditory and executive networks that in turn modulate activity in cortico-cerebellar networks.

Minimal clinically important difference of the Modified Fatigue Impact Scale in Parkinson's disease.

OBJECTIVE: Fatigue is a common and debilitating symptom of Parkinson's disease (PD) with no evidence-based treatments. While several fatigue scales are partially validated in PD the minimal clinically important difference (MCID) is unknown for any scale but is an important psychometric value to design and interpret therapeutic trials. We thus sought to determine the MCID for the Modified Fatigue Impact Scale (MFIS). METHODS: This is a secondary data analysis from 94 PD participants in an acupuncture trial for PD fatigue. Standard psychometric approaches were used to establish validity and an anchor-based approach was used to determine the MCID. RESULTS: The MFIS demonstrated good concurrent validity with other outcome measures and high internal consistency. MCIDs values were found to be 13.8, 6.8 and 6.2 for the MFIS total, MFIS cognitive, and MFIS physical subscores respectively. CONCLUSIONS: The MFIS is a valid multidimensional measure of fatigue in PD with demonstrable MCID.

Acupuncture for Symptomatic Treatment of Fatigue in Parkinson's Disease: Trial Design and Implementation.

Background: Acupuncture use is increasing worldwide for many conditions, including movement disorders. Clinical research in acupuncture has also increased to test anecdotal reports of clinical benefits empirically and investigate potential mechanisms. Method: This article describes considerations for designing a double-blinded, randomized, placebo-controlled clinical trial of acupuncture for fatigue in Parkinson's disease (PD) and describes the current authors' experience in the implementation and early conduct of this trial. Relevant literature is also reviewed to provide guidance for other researchers seeking to perform clinical research relevant to PD and related disorders. Results: Trial design should be driven by a well-defined research question and sufficient detail to meet Standards for Reporting Interventions in Clinical Trials of Acupuncture criteria when a trial is complete. Important items for review include: randomization and blinding; recruitment and participant selection; sham methodology choice; staff training; and practical implementation of study procedures. Sample forms used for the current authors' trial are shared. Conclusions: High-quality clinical trials of acupuncture can provide valuable information for clinicians, patients, and policymakers. Acupuncture trials differ in critical ways from pharmaceutical trials and might require additional considerations regarding design and implementation. Adequate preparation for the unique challenges of acupuncture studies can improve trial implementation, design, efficiency, and impact.

Randomized, Controlled Trial of Acupuncture for Fatigue in Parkinson's Disease.

BACKGROUND: Fatigue is a common and debilitating nonmotor symptom of PD. Because preliminary evidence suggests that acupuncture improves fatigue in other conditions, we sought to test its efficacy in PD. METHODS: Ninety-four PD patients with moderate-to-high fatigue were randomized to receive 6 weeks of biweekly real or sham acupuncture. The primary outcome was change on the Modified Fatigue Impact Scale at 6 weeks. Secondary outcomes included sleep, mood, quality of life, and maintenance of benefits at 12 weeks. RESULTS: Both groups showed significant improvements in fatigue at 6 and 12 weeks, but with no significant between-group differences. Improvements from baseline in mood, sleep, and quality of life were noted without between-group differences. Overall, 63% of patients reported noticeable improvements in their fatigue. No serious adverse events were observed. CONCLUSIONS: Acupuncture may improve PD-related fatigue, but real acupuncture offers no greater benefit than sham treatments. PD-related fatigue should be added to the growing list of conditions that acupuncture helps primarily through nonspecific or placebo effects. © 2016 International Parkinson and Movement Disorder Society.

Palliative care for Parkinson's disease: has the time come?

Although Parkinson's disease (PD) is traditionally viewed as a movement disorder which affects quality of life, recent literature has revealed an increased mortality, a high burden of difficult-to-manage non-motor symptoms (e.g., pain, fatigue), high caregiver distress, and a high utilization of medical services especially in the last year of life. Current medical systems have yet to adequately respond to this mounting evidence through the adoption of palliative care practices and through the provision of palliative care services to both PD patients and to affected families. This holistic, interdisciplinary approach to practice would enhance care delivery, identify and address unmet needs, and avoid interventions and hospitalizations especially in the last months of life. As we approach an era of increased life expectancy, increasing comorbidities among patients, and escalating healthcare costs, physicians must be proactive in focusing on quality of life, reducing medical interventions, and respecting patient autonomy.

Self-reported efficacy of cannabis and other complementary medicine modalities by Parkinson's disease patients in colorado.

Introduction. Complementary and alternative medicine (CAM) is frequently used by Parkinson's disease (PD) patients. We sought to provide information on CAM use and efficacy in PD patients in the Denver metro area with particular attention to cannabis use given its recent change in legal status. Methods. Self-administered surveys on CAM use and efficacy were completed by PD patients identified in clinics and support groups across the Denver metro area between 2012 and 2013. Results. 207 patients (age 69 ± 11; 60% male) completed the survey. Responses to individual CAM therapy items showed that 85% of respondents used at least one form of CAM. The most frequently reported CAMs were vitamins (66%), prayer (59%), massage (45%), and relaxation (32%). Self-reported improvement related to the use of CAM was highest for massage, art therapy, music therapy, and cannabis. While only 4.3% of our survey responders reported use of cannabis, it ranked among the most effective CAM therapies. Conclusions. Overall, our cross-sectional study was notable for a high rate of CAM utilization amongst PD patients and high rates of self-reported efficacy across most CAM modalities. Cannabis was rarely used in our population but users reported high efficacy, mainly for nonmotor symptoms.

The therapeutic potential of cannabinoids for movement disorders.

There is growing interest in the therapeutic potential of marijuana (cannabis) and cannabinoid-based chemicals within the medical community and, particularly, for neurological conditions. This interest is driven both by changes in the legal status of cannabis in many areas and increasing research into the roles of endocannabinoids within the central nervous system and their potential as symptomatic and/or neuroprotective therapies. We review basic science as well as preclinical and clinical studies on the therapeutic potential of cannabinoids specifically as it relates to movement disorders. The pharmacology of cannabis is complex, with over 60 neuroactive chemicals identified to date. The endocannabinoid system modulates neurotransmission involved in motor function, particularly within the basal ganglia. Preclinical research in animal models of several movement disorders have shown variable evidence for symptomatic benefits, but more consistently suggest potential neuroprotective effects in several animal models of Parkinson's (PD) and Huntington's disease (HD). Clinical observations and clinical trials of cannabinoid-based therapies suggests a possible benefit of cannabinoids for tics and probably no benefit for tremor in multiple sclerosis or dyskinesias or motor symptoms in PD. Data are insufficient to draw conclusions regarding HD, dystonia, or ataxia and nonexistent for myoclonus or RLS. Despite the widespread publicity about the medical benefits of cannabinoids, further preclinical and clinical research is needed to better characterize the pharmacological, physiological, and therapeutic effects of this class of drugs in movement disorders.

Mechanisms for alternative treatments in Parkinson's disease: acupuncture, tai chi, and other treatments.

At least 40% of patients with Parkinson's disease (PD) use one or more forms of alternative therapy (AT) to complement standard treatments. This article reviews the commonest forms of AT for PD, including acupuncture, tai chi, yoga, mindfulness, massage, herbal medicine, and cannabis. We discuss the current evidence for the clinical efficacy of each AT and discuss potential mechanisms, including those suggested by animal and human studies. With a few notable exceptions, none of the treatments examined were investigated rigorously enough to draw definitive conclusions about efficacy or mechanism. Tai chi, acupuncture, Mucuna pruriens, cannabinoids, and music therapy have all been proposed to work through specific mechanisms, although current evidence is insufficient to support or refute these claims, with the possible exception of Mucuna pruriens (which contains levodopa). It is likely that most ATs predominantly treat PD patients through general mechanisms, including placebo effects, stress reduction, and improved mood and sleep, and AT may provide patients with a greater locus of control regarding their illness.

Does prior acupuncture exposure affect perception of blinded real or sham acupuncture?

OBJECTIVE: To determine if acupuncture-exposed and naïve participants differ in their perceptions of real and sham acupuncture under blinded conditions. METHODS: The setting was an outpatient clinic at the Colorado School of Traditional Chinese Medicine. Participants were between the ages of 18 and 90 years. Acupuncture-exposed participants had at least five prior acupuncture treatments, with one treatment in the month prior to the study date. Acupuncture-naïve participants had experienced no prior acupuncture treatments. Participants with dementia, cognitive impairment, or neuropathy were excluded. In total, 61 acupuncture-exposed and 59 acupuncture-naïve participants were blindfolded and received either real acupuncture or toothpick sham acupuncture treatment. Following treatment, participants completed a questionnaire rating the realness of the acupuncture and were asked how they made this determination. We used a previously developed scale rating treatments from 1 (definitely real needle) to 5 (definitely imitation needle) to assess outcome. RESULTS: Perceptions of the real treatment were rated as more real than sham treatments for all participants. Further analysis revealed that prior acupuncture exposure did not influence ratings of real treatments, but exposed participants rated sham treatments as significantly less real than naïve participants. CONCLUSIONS: Acupuncture-naïve and exposed participants both reported different perceptions of real and sham acupuncture using a blindfolded toothpick protocol. This suggests that future trials should carefully monitor participant perceptions of treatments received, even for naïve individuals. Differences between groups further suggest that participants with significant and/or recent exposure to real acupuncture may introduce bias to blinded clinical acupuncture trials.