A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol... (2022) Chipon et al.

[Milo]

Full title:
A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial

This is a study protocol about the use of a device and coaching.

Abstract:

Background

Fibromyalgia is a form of chronic widespread pain that is defined as a syndrome of chronic symptoms of moderate to severe intensity, including diffuse pain, fatigue, sleep disturbance, cognitive impairment, and numerous somatic complaints. To date, there is no specific drug treatment for fibromyalgia but only symptomatic treatments. A drug free solution based on a wristband that emits millimeter waves associated with a therapeutic coaching program was developed. The application of millimeter waves on an innervated area has been described to have a neuromodulating effect, due to endorphin release stimulation and parasympathetic activation. Coaching is carried out to improve the patient’s adherence and to increase compliance and effectiveness of the treatment. Regular use of this solution by fibromyalgia patients is expected to improve sleep quality, reduce anxiety and pain levels, and, at the end, increase the quality of life.

Methods
This trial is performed over 8 French inclusion centers for a total of 170 patients. The effectiveness of the solution is evaluated according to the primary objective, the improvement of the quality of life measured through the dedicated Fibromyalgia Impact Questionnaire after 3 months. Patients are randomized in two groups, Immediate or Delayed. The Immediate group has access to the solution just after randomization in addition to standard care, while Delayed has access to the standard of care and waits for 3 months to have the solution. The purpose of this methodology is to limit deception bias and facilitate inclusion. The solution consists in using the device for three sessions of 30 min per day and four coaching sessions spread over the first 2 months of wristband usage.

Discussion
The objective is to confirm the effect of the integrative approach based on endorphin stimulation and a therapeutic coaching program in nociplastic pain and specifically for the patient suffering from fibromyalgia. If the effectiveness of the solution is demonstrated, we will be able to respond to the demand of fibromyalgia patients for access to an effective non-medicinal treatment to improve their quality of life.

Trial registration
ClinicalTrials.gov NCT05058092

Link to paper here

The weakness of this study design is that it is not a double blind, placebo controlled intervention, as the authors have decided there was no way to get a placebo (ie sham treatment)
I am also concerned about the coaching part of the intervention.

 

[Sean]

Manipulating the Response Bias for Fun and Profit.

 

[Peter T]

The article says:

The wristband emits millimeter waves (MMW) that stimulate the nerve endings located in the skin [6]. This stimulation induces a series of coordinated physiological actions, which in turn induce the synthesis and release of endogenous opioids (endorphins) that have a hypoalgesic effect [7, 8]. The effectiveness of MMW therapy on different types of pain has been demonstrated in several animal [9,10,11] and human studies [12,13,14,15,16]. Pre-clinical studies have shown that endogenous opioids play a role in the balance of sympathetic/parasympathetic activities, towards an inhibition of the sympathetic system and an activation of the parasympathetic system [17,18,19,20] and thereby participate in the modulation and regulation of stress [21]. The increase in parasympathetic activity also facilitates sleep onset and improves the quality of sleep [22]. Pain and sleep disorders are central symptoms in FM and are intimately linked. Indeed, experimental studies in humans and animals show that there is a relationship between disorders of the sleep-wake cycle and diffuse musculoskeletal pain [23].

Is it me or is it odd to talk about waves of a presumably specific wavelength without specifying what the waves are, sound, pressure, light, electromagnetic, etc? The paper almost seems to treat their wrist worn wave emitter as a magic black box. A web search for MMW did give me this:

A millimeter wave device that generates radio-frequency power from an enclosed, orbiting electron cloud excited by a radio-frequency field when subjected to a strong, pulsed magnetic field.

… … …

Millimeter waves are electromagnetic (radio) waves typically defined to lie within the frequency range of 30–300 GHz. The microwave band is just below the millimeter-wave band and is typically defined to cover the 3–30-GHz range.

see https://www.sciencedirect.com/topics/engineering/millimeter-wave

So given they are looking, in part at electromagnetic radiation, are they able to say that the electromagnetic soup we all to varying degrees live our life in is something they don’t need to control for? Further by asserting that fibromyalgia is only treatable by a mixed BPS approach

However, chronic pain could not be addressed by taking into account the only physiological dimension. Chronic pain is a multi-dimension situation, physiological, psychological, and social [25]. It is why most advance clinical research in that field insists on the need to consider each of its dimensions.

they ensure that any impact of their intervention fails to distinguish between their wrist worn device and their ‘coaching’. But I guess none of this matters given, as pointed out above, this is an uncontrolled open label trial with subjective outcomes, which can not tell us anything meaningful from the start.

 

[rvallee]

Complete pseudoscience. As if the added coaching didn't say it out loud enough. I assume balance bracelets are next, batteries and life coach not included.

Again following the trend that medical professionals seem to think it's OK to push pseudoscience on some patients as long they believe that the patients have a pseudoillness. So it really is dependent on beliefs, just not the patient's.

 

[rvallee]

Seems to mostly slightly heat up wherever the light is shone. Locally, so maybe affecting soft tissue locally could have its use if heating up a specific area by very little is of any use, but its relevance to fibromyalgia is ridiculous. Probably that's the notable effect people have, it feels slightly warm and the idea is probably the same old tired attempt to make the placebo into something it isn't.

Millimeter waves alter DNA secondary structures and modulate the transcriptome in human fibroblasts
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9203081/