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!
Fibromyalgia studies
1.
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.
2.
High-definition transcranial electrical stimulation 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.”
3.
Effects of blue-enriched white light therapy in patients with fibromyalgia
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.
4.
Effectiveness of Bowen Therapy for pain management in patients with fibromyalgia
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?)
5.
Effect of an amino-acid-based blend on human growth hormone (hGH) and fibromyalgia symptoms
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.”
6.
Micronized and ultramicronized palmitoylethanolamide in fibromyalgia patients
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.
(Read more: Palmitoylethanolamide (PEA) – A medical food for fibromyalgia and ME/CFS?)

7.
Understanding and restoring dopaminergic function in fibromyalgia patients (FIBRODOPA)
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.
(Read more: An overview of Mindfulness-Oriented Recovery Enhancement)
8.
Prevalence of traumatic events in women with fibromyalgia
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.
(Read more: Trauma and chronic illness | A summary of the science)
9.
Effectiveness of group psychotherapy in patients with fibromyalgia syndrome
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.
10.
Effects of aerobic exercise training with and without blood flow restriction in fibromyalgia
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
Evaluation and followup of people with tick-borne diseases
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.

Wow! I see some great studies on here. There are two that caught my interest: 5. Amino-based acid blend on growth hormones; and ESPECIALLY 8. Which studies the prevalence of traumatic events in women with fibromyalgia.
I have often believed that my own fibromyalgia onset is directly related to end of 3-4 years of traumatic events. I was on “fight or flight” for so long, along with resurfacing abuse memories, nightmares and night terrors, PTSD and others; that when they finally began to ease up, my body crashed. Perhaps other brain factors that regulate where corrisole, sleep regularion and other serotonin and norepinephrine regulators; were rewired during the trauma and never reverted back to normal levels.
I have heard many other similar stories as mine relating abuse trauma (specifically sexual abuse) to the onset of fibromyalgia. Which is usually accompanied by severe fatigue and hyper-somnolence issues, such as in my case as well.
I see that you have lots of information on Lyme disease. What about West Nile virus? I had a near fatal case of West Nile meningoencephalitis in 2002, and can find little on it. Thanks!!!
Sorry I haven’t discussed West Nile on my site. I mostly write about fibromyalgia and Lyme b/c I live w/ those conditions.
Thank you for an in-depth and informative post. So much of this information is new to me, and it’s so encouraging to read about non-pharmaceutical therapies.
How Can I Sign Up For The Trials
I would click the link to the trial you’re interested in and see if there’s any recruitment or contact information included on ClinicalTrials.gov.