Hey everyone, I’m going to keep this intro short! Below is the third quarter summary of all of the new fibromyalgia and Lyme studies added to the ClinicalTrials.gov research database over the past three months.
This time, we have a potential drug trial for fibromyalgia and studies testing out transcranial electrical stimulation, white light therapy, Bowen therapy, mindfulness and more as possible fibro treatments.
Lyme research is still sadly lacking. Over the past two years, I’ve posted links to a number of articles announcing millions of dollars in federal funding for Lyme research. Unfortunately, that hasn’t translated into more projects being added to ClinicalTrials.gov yet. I’m starting to question where is all that money going?!?
We only have one, lone, solitary Lyme study in this quarterly update but it is an important one funded by the National Institute of Allergy and Infectious Diseases, so at least there’s that…
After you read through the summaries, let me know in the comments below if you’re excited or hopeful about any of these upcoming studies!
Nearly 500 fibromyalgia patients from more than 30 clinical sites around the United States will test out TNX-102 SL, a new low-dose sublingual version of cyclobenzaprine, a muscle relaxer commonly prescribed off-label for fibromyalgia.
Taipei Medical University researchers in Taiwan will study the use of transcranial electrical stimulation in 24 fibromyalgia patients.
“Transcranial electrical stimulation is a noninvasive and safe treatment, which uses a low direct current or alternating current to change the excitability of the cerebral cortex,” reads the ClinicalTrials.gov summary. “The investigators developed a wearable high-definition transcranial electrical stimulation (HD-tCES) with special waveforms. This novel stimulation system will result in more precise and focal stimulation of selected brain regions with special waveforms to display better neuromodulation performance. In this study, the investigators will preliminarily examine the effects and safety of the HD-tCES in patients with fibromyalgia. The investigators expect that the HD-tCES will relief pain [and] improve sleep quality, emotion and [the] general health of the patients.”
Taipei Medical University researchers in Taiwan will “examine the effects of light therapy on sleep quality, depressive symptoms, psychomotor vigilance performance and overall symptom severity in patients with fibromyalgia. Light therapy can improve sleep quality and sleep architecture, advance sleep phases and reduce pain sensitivity and that the effect of light therapy on mood and cognitive function have been widely supported,” reads the ClinicalTrials.gov summary.
Researchers from Alice Ho Miu Ling Nethersole Hospital in Hong Kong plan to “explore the effectiveness of Bowen therapy in pain management for patients with fibromyalgia,” reads the study description on ClinicalTrials.gov. “In Hong Kong, Bowen Therapy is a noninvasive technique and one of the treatment modalities adopted by occupational therapists. Bowen Therapy uses specific sequences of gentle cross-fiber moves over muscles, tendons, ligaments and fascia to stimulate or improve the flow of blood and lymph, and thus activate the body’s healing mechanisms that enhances tissue repair. As a result, it can lessen pain and tension, restore more optimal body function and subsequently alleviate emotional and psychological stress associated with the pain.”
(Read more: What is Bowen Therapy?)
Los Angeles-based physician Susan Pekarovics will “investigate the effect of the amino acid-based blend on growth hormone levels and clinical symptoms in [around 100] individuals with treatment-resistant fibromyalgia and low-normal human growth hormone.”
Around 60 Italian women with fibromyalgia will test out the effectiveness of micronized palmitoylethanolamide (PEA) and ultra-micronized PEA using a supplement product called Normast® MPS.
Swiss researchers will determine if Mindfulness-Oriented Recovery Enhancement (MORE), a mindfulness-based group intervention, can “restore dopamine function in fibromyalgia patients, in particular with regard to dopamine responses to reward and to reduce pain and mood complaints in fibromyalgia.” Around 80 women with fibromyalgia will participate.
Around 80 women will take part in a Spanish study to learn more about the link between traumatic events, post-traumatic stress disorder and fibromyalgia.
Turkish researchers from Ege University will determine the effectiveness of group psychotherapy for fibromyalgia. “At the end of the study, individuals are expected to show less depressive symptoms and anxiety symptoms compared to the beginning of the study, and it is thought that their complaints about pain will decrease,” predicts the ClinicalTrials.gov summary.
Istanbul University researchers in Turkey will “evaluate and compare the effects of low-intensity aerobic exercise training with blood flow restriction and without blood flow restriction on pain, functional status, quality of life and catecholamine and melatonin metabolite levels in 24-hour urine in adults with fibromyalgia,” according to ClinicalTrials.gov.
One Lyme study
Around 200 Lyme disease patients will take part in “a natural history study which has the objective of developing a rigorously defined population of patients with Lyme disease and other tick-borne illnesses, per Centers for Disease Control and Prevention case definitions, to serve as the basis for research in multiple aspects of the infections. These research sub-projects have emphasis in exploring the biological markers of tick-borne infections, developing new diagnostic tests for these infections, assessing the clinical course and outcome of patients with these tick-borne infections and defining the immunological response to the pathogens.” This study is sponsored by the National Institute of Allergy and Infectious Diseases.