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.

Preliminary investigation of absent nociceptive flexion reflex responses among more symptomatic women with fibromyalgia syndrome.

Fibromyalgia syndrome (FMS) is a widespread musculoskeletal pain condition with unclear physiologic mechanisms. The purpose of this investigation was to compare the responsiveness of nociceptive flexion reflex (NFR) pathways between women with and without FMS. A secondary purpose was to examine the influence of depression, fibromyalgia symptom severity, and cardiovascular health on NFR responses among women with FMS. Fifteen women with FMS and 14 healthy controls participated in an experimental session to assess NFR responses to sural nerve stimulation, resting mean arterial pressure (MAP) and heart rate (HR), and scores on the Beck Depression Inventory (BDI) and Fibromyalgia Impact Questionnaire (FIQ). NFR responses were successfully elicited from all healthy individuals, but only eight (53 %) of the women with FMS. These women did not differ in the minimum stimulus intensity required to elicit an NFR response compared to healthy controls (p ≥ 0.35). Further, these women had lower BDI (p = 0.04) and FIQ (p = 0.02) scores compared to women with FMS from whom NFR responses could not be elicited. Resting HR was higher in both groups of women with FMS compared to healthy individuals (p < 0.05), and MAP was strongly associated with NFR thresholds only among women with FMS (r = 0.88, p < 0.01). Findings from this preliminary investigation suggest that NFR pathways are impaired in women who are more severely impacted by symptoms of depression and fibromyalgia, potentially due to desensitization of NFR pathways with chronic autonomic arousal.

Patients' perspectives of a pharmacist-provided clinical pharmacogenomics service.

Aim: To assess the perspectives and experiences of patients who participated in a pharmacist-provided clinical pharmacogenomics (PGx) service. Methods: We conducted individual semistructured interviews with 16 patients who received a pharmacist-provided PGx service. Qualitative data were analyzed to identify pertinent themes. Results: The major themes identified were: heterogeneity of patient PGx experiences and preferences, pharmacists as appropriate providers of PGx services, considerations regarding the use of PGx results in routine healthcare and perceived applications of PGx testing. Theme-derived considerations included the need to establish appropriate pre-genotyping expectations, individualize patient education, facilitate collaboration with patients' providers and sustainably update patients' PGx information over time. Conclusion: Patient-specific perspectives such as these are important to consider when providing clinical PGx services, with intention of optimizing patient experiences.

Mediating role of physical activity in the relationship between exercise-induced muscle pain and symptom severity in women with fibromyalgia.

BACKGROUND: Individuals with fibromyalgia (FM) exhibit generalized hyperalgesia to pain stimuli, and physical activity (PA) is critical to manage FM symptoms. PURPOSE: This study examined the relationship between exercise-induced muscle pain, symptom severity, and PA in 28 women with FM. METHODS: Muscle pain rating (MPR) was assessed during 3 minutes of submaximal isometric handgrip exercise, whereas PA and symptom severity were evaluated via self-report questionnaires. The analysis examined the relationship between the variables, with the specific interest in the mediating role of PA in the relationship between exercise-induced muscle pain and symptom severity. RESULTS: MPR was positively associated with symptom severity (b = 1.89; 95% CI = 0.01, 3.76; P = .048) and inversely associated with PA levels (b = -0.16; 95% CI = -0.30, -0.03; P = .021). PA levels were inversely associated with symptom severity (b = -7.94; 95% CI = -12.46, -3.42; P = .001). After statistically controlling for PA levels, the relationship between MPR and symptom severity was no longer significant (b = 0.60; Wald 95% CI = -1.05, 2.25; P = .474). CONCLUSION: Results show the link between the variables, and specifically demonstrate that PA mediates the relationship between exercise-induced muscle pain and symptom severity.

Implementation of a pharmacist-provided pharmacogenomics service in an executive health program.

PURPOSE: We describe the implementation of a pharmacist-provided pharmacogenomics (PGx) service in an executive health program (EHP) at an academic medical center. SUMMARY: As interest in genomic testing grows, pharmacists have the opportunity to advance the use of PGx in EHPs, in collaboration with other healthcare professionals. In November 2018, a pharmacist-provided PGx service was established in the EHP at the University of Colorado Hospital. The team members included 3 physicians, a pharmacist trained in PGx, a registered dietitian/exercise physiologist, a nurse, and 2 medical assistants. We conducted 4 preimplementation steps: (1) assessment of the patient population, (2) selection of a PGx test, (3) establishment of a visit structure, and (4) selection of a billing model. The PGx consultations involved two 1-hour visits. The first visit encompassed pretest PGx education, review of the patient's current medications and previous medication intolerances, and DNA sample collection for genotyping. After this visit, the pharmacist developed a therapeutic plan based on the PGx test results, discussed the results and plan with the physician, and created a personalized PGx report. At the second visit, the pharmacist reviewed the PGx test results, personalized the PGx report, and discussed the PGx-guided therapeutic plan with the patient. Overall, the strategy worked well; minor challenges included evaluation of gene-drug pairs with limited PGx evidence, communication of information to non-EHP providers, scheduling issues, and reimbursement. CONCLUSION: The addition of a PGx service within an EHP was feasible and provided pharmacists the opportunity to lead PGx efforts and collaborate with physicians to expand the precision medicine footprint at an academic medical center.

Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer: a randomized trial.

BACKGROUND: Small studies of variable quality suggest that massage therapy may relieve pain and other symptoms. OBJECTIVE: To evaluate the efficacy of massage for decreasing pain and symptom distress and improving quality of life among persons with advanced cancer. DESIGN: Multisite, randomized clinical trial. SETTING: Population-based Palliative Care Research Network. PATIENTS: 380 adults with advanced cancer who were experiencing moderate-to-severe pain; 90% were enrolled in hospice. INTERVENTION: Six 30-minute massage or simple-touch sessions over 2 weeks. MEASUREMENTS: Primary outcomes were immediate (Memorial Pain Assessment Card, 0- to 10-point scale) and sustained (Brief Pain Inventory [BPI], 0- to 10-point scale) change in pain. Secondary outcomes were immediate change in mood (Memorial Pain Assessment Card) and 60-second heart and respiratory rates and sustained change in quality of life (McGill Quality of Life Questionnaire, 0- to 10-point scale), symptom distress (Memorial Symptom Assessment Scale, 0- to 4-point scale), and analgesic medication use (parenteral morphine equivalents [mg/d]). Immediate outcomes were obtained just before and after each treatment session. Sustained outcomes were obtained at baseline and weekly for 3 weeks. RESULTS: 298 persons were included in the immediate outcome analysis and 348 in the sustained outcome analysis. A total of 82 persons did not receive any allocated study treatments (37 massage patients, 45 control participants). Both groups demonstrated immediate improvement in pain (massage, -1.87 points [95% CI, -2.07 to -1.67 points]; control, -0.97 point [CI, -1.18 to -0.76 points]) and mood (massage, 1.58 points [CI, 1.40 to 1.76 points]; control, 0.97 point [CI, 0.78 to 1.16 points]). Massage was superior for both immediate pain and mood (mean difference, 0.90 and 0.61 points, respectively; P < 0.001). No between-group mean differences occurred over time in sustained pain (BPI mean pain, 0.07 point [CI, -0.23 to 0.37 points]; BPI worst pain, -0.14 point [CI, -0.59 to 0.31 points]), quality of life (McGill Quality of Life Questionnaire overall, 0.08 point [CI, -0.37 to 0.53 points]), symptom distress (Memorial Symptom Assessment Scale global distress index, -0.002 point [CI, -0.12 to 0.12 points]), or analgesic medication use (parenteral morphine equivalents, -0.10 mg/d [CI, -0.25 to 0.05 mg/d]). LIMITATIONS: The immediate outcome measures were obtained by unblinded study therapists, possibly leading to reporting bias and the overestimation of a beneficial effect. The generalizability to all patients with advanced cancer is uncertain. The differential beneficial effect of massage therapy over simple touch is not conclusive without a usual care control group. CONCLUSION: Massage may have immediately beneficial effects on pain and mood among patients with advanced cancer. Given the lack of sustained effects and the observed improvements in both study groups, the potential benefits of attention and simple touch should also be considered in this patient population.

Family Medicine Resident Perspectives on Curricula in Herbal Medicine.

BACKGROUND AND OBJECTIVES: Despite widespread patient use, herbal and dietary supplement education is not required in US-accredited medical schools. Thus, physicians are unprepared to address supplement use with patients. Our objectives were to assess perceived adequacy of medical education on supplements, determine resident perspectives on appropriate placement of curricula in their longitudinal medical education, and evaluate the effects of an innovative workshop on family medicine resident knowledge about supplements and intentions to address this topic with patients. METHODS: Family medicine residents (N=65) participated in an hour-long workshop covering basic concepts about herbal and dietary supplements, including regulations, literature review techniques, and risk/benefit analysis. The participants completed pre/postworkshop surveys to assess need for increased education and evaluate efficacy of the workshop. RESULTS: Most participants (91.9%) thought they should have received more education than provided on supplements and perceived greater need for curricula in undergraduate medical education than in graduate medical education. Only 47.6% received required education on supplements, significantly less than the 72.6% who thought this education should be required (P<0.05). The workshop increased the proportion of residents planning to address patients' supplement use, increased the frequency residents intend to ask about supplements, and improved resident perceptions of the efficacy of some supplements when used with physician guidance. CONCLUSIONS: Residents perceived a lack of adequate medical education on the use of herbal and dietary supplements. Results showed a brief workshop increased resident intentions to discuss supplement use with patients. Further education on supplement use may be warranted.

The Effect of Curanderismo on Chronic Non-malignant Pain: A Case Report.

This case study describes the effects of the use of curanderismo, an indigenous healing modality combining techniques in massage, sound, and aromatherapy, on a patient with chronic pain. Despite being a commonly used health practice in certain populations, little is reported in the medical literature about the use of curanderismo. Case report as part of a larger randomized trial of curanderismo for chronic pain. Setting was a community-based hospital affiliated primary care clinic. An adult patient with chronic, opioid dependent back pain following an injury, and subsequent spinal fusion was treated. Intervention was the patient received 33 curanderismo treatment sessions over 10 months in addition to ongoing conventional treatment at a community-based chronic pain management clinic. Main outcomes measures were self-reported assessments of pain, functional ability, mood, insomnia, and narcotic usage. Secondary outcome measure was qualitative interview. Although there was no change in quantitative self-reported pain measures, the patient reported improved function, mood, and sleep as well as decreased narcotic usage. Curanderismo, in addition to conventional pain management, improved patient reported symptoms and functional ability, led to healthy lifestyle changes, and decreased narcotic usage. Controlled studies are needed to confirm the benefit of curanderismo as safe, non-interventional, and cost-effective adjunct for chronic pain management.

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.

Pain mediates the association between physical activity and the impact of fibromyalgia on daily function.

This study quantified the association between recreational physical activity and daily function in women with fibromyalgia, and determined if this association is mediated by symptoms of pain, depression, or body mass. Twenty-three women diagnosed with fibromyalgia participated in an observational survey study. Recreational physical activity and the impact of fibromyalgia on daily function were assessed using the sport and leisure time physical activity subscales of the Baecke Physical Activity Questionnaire (BPAQ) and the Fibromyalgia Impact Questionnaire (FIQ), respectively. Potential mediators of the association between physical activity and daily function were assessed using the Visual Analogue Scale for pain intensity (VAS-Pain), the Beck Depression Inventory (BDI), and body mass index (BMI). BPAQ was inversely associated with FIQ (R (2) = 0.20) and VAS-Pain (R (2) = 0.39). VAS-Pain was positively associated with FIQ (R (2) = 0.23). The inverse association between BPAQ and FIQ was no longer significant after controlling for VAS-Pain. BDI was positively associated with FIQ (R (2) = 0.37), whereas BMI was not. BPAQ was not significantly associated with either BDI or BMI. These results indicate that the intensity of musculoskeletal pain, rather than depressive symptoms or body mass, mediates the association between physical activity and daily function among women with fibromyalgia.

Examination of contraction-induced muscle pain as a behavioral correlate of physical activity in women with and without fibromyalgia.

PURPOSE: This study aimed to compare muscle pain intensity during a sustained isometric contraction in women with and without fibromyalgia (FM), and examine the association between muscle pain and self-reported levels of physical activity. METHODS: Fourteen women with FM and 14 healthy women completed the study, where muscle pain ratings (MPRs) were obtained every 30 s during a 3 min isometric handgrip task at 25% maximal strength, and self-reported physical activity was quantified using the Baecke Physical Activity Questionnaire. RESULTS: Women with FM were less physically active than healthy controls. During the isometric contraction, MPR progressively increased in both groups at a comparable rate, but women with FM generally reported a greater intensity of muscle pain than healthy controls. Among all women, average MPR scores were inversely associated with self-reported physical activity levels. CONCLUSIONS: Women with FM exhibit augmented muscle pain during isometric contractions and reduced physical activity than healthy controls. Furthermore, contraction-induced muscle pain is inversely associated with physical activity levels. These observations suggest that augmented muscle pain may serve as a behavioral correlate of reduced physical activity in women with FM. Implications for Rehabilitation Women with fibromyalgia experience a greater intensity of localized muscle pain in a contracting muscle compared to healthy women. The intensity of pain during muscle contraction is inversely associated with the amount of physical activity in women with and without fibromyalgia. Future studies should determine whether exercise adherence can be improved by considering the relationship between contraction-induced muscle pain and participation in routine physical activity.

Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice.

Researchers conducting multi-site studies of interventions for end-of-life symptom management face significant challenges with respect to obtaining an adequate sample and training and retaining on-site study teams. The purpose of this paper is to describe the strategies and responses to these challenges in a multi-site randomized clinical trial (RCT) of the efficacy of massage therapy for decreasing pain among patients with advanced cancer in palliative care/hospice settings. Over a period of 36 months, we enrolled 380 participants across 15 sites; 27% of whom withdrew prior to study completion (less than the anticipated 30% rate). We saw an average of 68% turnover amongst study staff. Three key qualities characterized successful on-site study teams: (1) organizational commitment; (2) strong leadership from on-site study coordinators; and (3) effective lines of communication between the on-site study coordinators and both their teams and the university-based research team. Issues of recruitment, retention and training should be accounted for in hospice-based research study design and budgeting.

Safety and efficacy of massage therapy for patients with cancer.

BACKGROUND: As the popularity of complementary/alternative medicine (CAM) grows, patients are incorporating more CAM therapies into their conventional cancer care. Massage therapy, a CAM therapy known primarily for its use in relaxation, may also benefit patients with cancer in other ways. Massage can also be associated with risks in the oncology population. Risks can be minimized and benefits maximized when the clinician feels comfortable discussing CAM with his or her patients. This article reviews and summarizes the literature on massage and cancer to help provide the clinician with information to help facilitate discussions with patients. METHODS: MEDLINE and CINAHL databases were searched to identify relevant articles. These were reviewed for content and other pertinent references. RESULTS: Significant information was extracted from these resources to provide this overview of the use of massage for patients with cancer. CONCLUSIONS: Conventional care for patients with cancer can safely incorporate massage therapy, although cancer patients may be at higher risk of rare adverse events. The strongest evidence for benefits of massage is for stress and anxiety reduction, although research for pain control and management of other symptoms common to patients with cancer, including pain, is promising. The oncologist should feel comfortable discussing massage therapy with patients and be able to refer patients to a qualified massage therapist as appropriate.