Tag: Complementary & Alternative Medicine

Prevalence and Patterns of Marijuana Use among Patients Diagnosed with Multiple Sclerosis

Title:Prevalence and Patterns of Marijuana Use among Patients Diagnosed with Multiple Sclerosis
Status:Completed
Topic:Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source:State of Connecticut: Biomedical Research Trust Fund
Funding Period:2018-2019
Study Design:Qualitative research survey
Purpose:The PRC collaborated on this study with neurologist Joseph Guarnaccia, MD of the Multiple Sclerosis Treatment Center (MSTC) at Griffin Hospital. The goal was to better understand the use of marijuana by people who have been diagnosed with multiple sclerosis (MS) through the use of a cross-sectional survey. The results could provide valuable information for clinicians who currently refer their patients with MS to medical marijuana programs, have considered referring them, or have been reluctant to refer them. The study data could also be useful in setting new research agendas and tailoring health policies on the use of medical marijuana as a therapy or adjuvant therapy in managing patients with MS.
Further Study Details:The study team developed a 36-question survey that was estimated to take 10 to 15 minutes to complete. It was made available to be completed either as paper version of the survey, or as an online version available through an encrypted link. The survey elicited demographic data from survey respondents, including their age, gender, education level, employment status, household composition, type of MS, and degree of disability. It also included questions regarding: their patterns of marijuana use; their use of prescription medications, including opioid and benzodiazepines, tobacco products, and alcohol; their MS symptoms; and the perceived benefits and/or adverse effects of their medical marijuana use.  An invitation to complete the survey was sent to 317 adults with MS, most of whom were patients at the MSTC at Griffin Hospital.
Findings:A total of 115 surveys were completed and included in the analysis. Respondents were predominantly female (73.0%). The majority (72.2%) had relapsing and remitting MS. Most (63.5%) were on at least 3 prescription medications for MS. The use of medical marijuana more than once a day was associated with reported improvement of at least two of their MS-related symptoms. Although medical marijuana use was reportedly associated with feeling slightly “high” by the survey respondents, they felt that medical marijuana use was more effective than other MS medications.
Eligibility:Multiple sclerosis patients from the MSTC who are enrolled in the State of Connecticut’s Medical Marijuana (CTMMP) Program
Changed at:3/27/2020 3:45 PMChanged by:
Created at:11/27/2018 9:40 AMCreated by:Lisa Seaberg

Meditation and Massage in End of Life (MIEL)

Title:Meditation and Massage in End of Life (MIEL)
Status:Completed
Topic:Complementary & Alternative Medicine
Funding Source:National Institutes of Health (NIH)
Funding Period:11/01- 12/03
Study Design:Randomized, Double-Blind, Controlled 2 x 2 Factorial Designs
Purpose:To determine the effects of meditation, with and without massage, on quality of life among late-stage AIDS patients.
Further Study Details:Depending on the group to which they were assigned, participants received either a 30-minute massage 5 days/week, a tape of guided loving-kindness and forgiveness meditations for daily use, both massage and the meditations, or none of the above. An end-of-life quality of life measure (survey) was taken at 2, 4, 8, 12, 16, and 20 weeks, and then every 3 months until the patient expired or the study ended.
Findings:This study showed significant improvement in overall and spiritual quality of life in patients with AIDS near the end-of-life who received the combined meditation and massage intervention.
Eligibility:Adult men and women residing at a long term care facility in New Haven, CT (Leeway, Inc.) with a diagnosis of end-stage AIDS.
Changed at:1/18/2011 6:49 AMChanged by:Judy Treu
Created at:8/31/2010 10:49 AMCreated by:Griffin Hospital

IVMT for Fibromyalgia Syndrome: A Pilot Study

Title:IVMT for Fibromyalgia Syndrome: A Pilot Study
Status:Completed
Topic:Complementary & Alternative Medicine
Funding Source:National Institutes of Health/NCCAM
Funding Period:12/03-12/07
Study Design:Randomized, Double-Blind, Placebo-Controlled Pilot Study
Purpose:To assess the effectiveness and safety of the use of intravenous micronutrient therapy (IVMT) for the treatment of fibromyalgia.
Further Study Details:Approximately 40 adults with a diagnosis of fibromyalgia were enrolled in this pilot study. Half of the group was assigned to the active treatment (Intravenous Micronutrient Therapy, or IVMT), the other half to placebo. Participants received the treatment once a week for 8 consecutive weeks. The primary outcomes of interest were pain, functional status, and quality of life.
Findings:The study results suggested that IVMT for fibromyalgia demonstrated a therapeutic effect, but did not definitively establish the extent of the effect because the placebo group also showed improvement. The lack of significant differences between the active group and the placebo group was likely due to a placebo effect of IV treatment, small sample size, and attenuation of treatment effects with cessation of weekly infusions. Further study with requisite sample size is warranted.
Eligibility:Adult men and women previously diagnosed with fibromyalgia.
Changed at:1/18/2011 6:47 AMChanged by:Judy Treu
Created at:8/31/2010 9:56 AMCreated by:Griffin Hospital

Exploring Massage Benefits for ARthritis of the Knee (EMBARK)

Title:Exploring Massage Benefits for ARthritis of the Knee (EMBARK)
Status:Completed
Topic:Complementary & Alternative Medicine
Funding Source:National Institutes of Health/NCCAM grant to Duke University. Sites included Duke University, Yale-Griffin PRC, and University of Medicine and Dentistry of New Jersey (later the Barnabas Health Ambulatory Care Center in Livingston, NJ)
Funding Period:2009-2014
Study Design:Multi-site, randomized, dose-ranging trial
Purpose:2009-2011 study: to determine the optimal dose of massage for osteoarthritis (OA) of the knee. 2011-2014 study: to verify the efficacy of 8 weeks of Swedish massage, at an optimized dose, and assess a maintenance dose, for reducing pain and increasing function compared to an active (light touch bodywork) control, and passive (usual care) control, in adults with OA of the knee.
Further Study Details:Validated instruments, including standardized questionnaires known as the Western Ontario and McMaster Universities Arthritis Index (WOMAC), were used to assess pain, stiffness, flexibility, and physical function of the joints.
Findings:The 2009-2011 study found that a 60-minute massage offered once a week over an 8-week period was most effective and practical, compared to 60 minutes twice a week, or 30 minutes once or twice a week, thus establishing a standard for future trials. The 2011-2014 study found that all groups (Swedish massage, light touch bodywork, and usual care) improved with regard to outcome measures, with the massage group showing greater improvement than the others. At 8 weeks, the massage group saw a significantly greater reduction in WOMAC global scores than did the light touch and usual care groups. In the massage group, large initial improvements were maintained among those who received maintenance treatment. By 52 weeks, improvement was seen in all groups, but any improvement differences between the groups were no longer statistically significant.  I.e., all groups showed comparable improvement in the long run.
Eligibility:Adults aged 35 years or older with confirmed osteoarthritis of the knee as diagnosed by x-ray
Changed at:3/2/2017 7:05 AMChanged by:Lisa Seaberg
Created at:8/31/2010 9:55 AMCreated by:Griffin Hospital

Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial

Title:Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Complementary & Alternative Medicine;Diabetes / Insulin Resistance
Funding Source:Fos Biomedical, Inc.
Funding Period:2021-2022
Study Design:Randomized controlled double-blind crossover trial
Purpose:This study tested the effects of a phototherapy product on certain measures of health in people at risk for type 2 diabetes. According to recent research, certain wavelengths of light appear to activate an enzyme in the mitochondria of cells, which in turn appears to activate signaling pathways in the body.  A recent study of mice with diabetes showed that elevated activity of this enzyme led to reduced blood glucose levels and insulin resistance. 
Further Study Details:This study compared the effects of 12 weeks each of a phototherapy patch product vs. placebo patches on markers of cardio-metabolic risk and sleep quality.  The product used 2 small patches worn on the skin that, when activated by body heat, reflected low levels of infrared and visible light to stimulate the skin’s surface.  They did not contain any drugs or herbal compounds, and did not put any chemicals in the body. All tests and study products were provided free of charge.Outcome measures included hemoglobin A1C, insulin sensitivity, serum lipids, C-reactive protein, endothelial function (blood flow measured in the right arm using ultrasound), body composition, and sleep quality. For each of the two treatment periods, measures were assessed at baseline and 12 weeks.
Findings:Data analysis has not been completed.
Eligibility:Adults who met the following criteria:were older than 40 years of age (if women, they must be postmenopausal)were non-smokerswere overweighthad higher-than-normal blood glucose levels, but not diabeteswere willing to do the following over an 8-month period: visit the PRC at Griffin Hospital 5 times for clinical testswear 2 small patches on their abdomen each day for about 6 monthsreport their food and beverage intake on certain days 
Changed at:4/12/2023 4:42 PMChanged by:Christian Meagher
Created at:12/21/2021 12:41 PMCreated by:

Complementary/Alternative Medicine (CAM) Outcomes Research Project (CORP)

Title:Complementary/Alternative Medicine (CAM) Outcomes Research Project (CORP)
Status:Completed
Topic:Complementary & Alternative Medicine
Funding Source:Centers for Disease Control and Prevention
Funding Period:10/00 – 12/03
Study Design:Literature Review
Purpose:To identify best research methods for the evaluation of complementary and alternative medicine (CAM).
Further Study Details:The scope of the CORP project incorporated a comprehensive systematic review of the published CAM literature and creation of an “evidence matrix”, as well as the development and implementation of four pilot studies in areas where evidence is needed, as identified by the first phase of the project (the literature review and evidence matrix). Criteria were developed to guide the planning of pilot studies so that evidence would be generated where most useful. Pilots were deemed most useful if they addressed the any of the following:gaps in the evidence base;high priority condition/treatment pairs;a methodological challenge;and/or providing preliminary evidence of treatment effect.View pilot studies »
Eligibility:The CORP activities were guided by a 13-member Expert Panel of nationally recognized CAM authorities and a subcommittee of CAM practitioners representing the following disciplines: acupuncture/Chinese medicine, chiropractic, energy therapy, massage therapy, mind-body therapy, naturopathy/homeopathy, and traditional osteopathy.
Changed at:1/18/2011 6:48 AMChanged by:Judy Treu
Created at:8/31/2010 10:09 AMCreated by:Griffin Hospital

A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis

Title:A Randomized, Placebo-Controlled Study of Mindfulness Meditation in Treating Insomnia in Multiple Sclerosis
Status:Completed
Topic:Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source:State of Connecticut: Biomedical Research Trust Fund
Funding Period:2016-2020
Study Design:Randomized controlled trial
Purpose:The purpose of this study was to examine whether mindfulness meditation would be more effective than standard sleep hygiene counseling in treating insomnia and improving quality of life in MS patients. Many MS patients suffer from chronic insomnia, leading to daytime impairment. Pharmacological treatments for MS may also contribute to insomnia, and may have adverse side effects. A potential alternative treatment involves mindfulness – focusing one’s attention on the present moment without judgment. Mindfulness is hypothesized to increase the ability to tolerate, thoughts and emotions, which in turn can reduce perceptions of stress, anxiety, and pain. Prior research has shown some benefits of mindfulness in treating insomnia in general, and some benefits of stress reduction techniques in managing MS-related insomnia.
Further Study Details:Each participant was randomly assigned to one of two groups. One group attended 10 weekly sessions of mindfulness-based training for insomnia. The other group attended a single group session on sleep hygiene. During the study, members of both groups wore Fitbit devices each day for several weeks to record their sleep data. At two study time points, they completed a set of questionnaires and visited the PRC for clinical assessments.Study outcome measures included sleep efficency using collected from Fitbit Charge 2 devices; self-reported sleep quality (Pittsburgh Sleep Quality Index); self-reported insomnia (Insomnia Severity Index); self-reported quality of life (MS Quality of Life Inventory, and self-reported quality of life (MS Quality of Life Inventory, a set of questionnaires to measure self-reported overall health status, fatigue, pain, sexual satisfaction, bladder control, bowel control, visual impairment, cognitive dysfunction, mental health, and social support). Participants were also monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events.
Findings:Mindfulness training led to significant improvements in self-reported sleep quality, insomnia severity, fatigue, cognitive function and mental health, which were all secondary outcome measures. It did not lead to a significant improvement in sleep efficiency, which was the primary outcome measure.
Eligibility:Men and women age 18 years or older diagnosed with MS, and with a history of chronic insomnia, but no known history of obstructive sleep apnea or narcolepsy.
Evaluation:Study outcome measures included objective sleep quality (using data collected from Fitbit Charge 2 devices); self-reported sleep quality (Pittsburgh Sleep Quality Index); self-reported insomnia (Insomnia Severity Index); self-reported quality of life (MS Quality of Life Inventory). Participants were also monitored for any progression of MS symptoms, muscle spasticity, restless legs syndrome, and any adverse events.
Changed at:4/12/2023 4:40 PMChanged by:Christian Meagher
Created at:11/30/2017 5:24 AMCreated by:Lisa Seaberg

A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis

Title:A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis
Status:Current
Topic:Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source:State of Connecticut: Biomedical Research Trust Fund
Funding Period:2018-2023
Study Design:Investigational pilot study
Purpose:This study will examine whether changing the bacteria in the gut through a fecal microbial transplant (FMT) can affect the autoimmune process that leads to the development of multiple sclerosis (MS). Using oral capsules approved by the Food and Drug Administration (FDA) for other uses, we will transfer fecal material from healthy persons to persons with MS. The FDA has granted permission for this investigational pilot study.
Further Study Details:The PRC is conducting this study in collaboration with neurologist Joseph Guarnaccia, MD of the Multiple Sclerosis Treatment Center (MSTC) at Griffin Hospital, who is the principal investigator.Each participant will make 8 visits to Griffin Hospital in Derby, CT. These will include: a clinical screening; a single procedure of 30 FMT capsules taken by mouth; and 5 other visits for blood and stool samples, medical exams, and surveys. FMT capsules and all study procedures and tests will be provided free of charge.
Eligibility:Study participants must: (1) be 18 to 55 years of age; (2) have been clinically diagnosed as having MS; (3) be able to walk with without stopping to rest for up to 100 meters (about 300 feet) or able to walk 20 meters (about 60 feet) without stopping to rest while using 2 canes, 2 crutches, or a walker; (4) not be on immunotherapy (except for interferon beta or glatiramer acetate); and (5) be willing to visit Griffin Hospital 8 times over a 4-month period.
Evaluation:The study team will measure the following: (1) ability to tolerate FMT capsules without vomiting or adverse side effects; (2) changes in immune markers found in blood samples; (3) changes in microbiome of stool samples; (4) changes in self-reported quality of life, mental health status, and levels of fatigue; and (5) changes in MS disease status.
Changed at:4/12/2023 4:16 PMChanged by:Christian Meagher
Created at:3/27/2020 2:56 PMCreated by: