Actipol® : survey
A large survey conducted by the Fibromyalgia Association France on more than 2000 patients presented at the 21st World Fibromyalgia Day in May 2014 showed that fatigue and sleep were considered disabling and very disabling in more than 80% of cases! Indeed, since the studies of sleep deprivation generating a fibromyalgia-like pain state by Professor H Moldofsky in 1976, we know that sleep is the cornerstone of the quality of life issue for fibromyalgia patients.
Non-regenerative sleep induces chronic fatigue and diffuse pain by lowering the pain perception threshold.
Three rheumatologists, specialists in fibromyalgia syndrome, Dr. Dominique Baron, Dr. Jean-François Marc and Dr. Jean-Luc Renevier, agreed to participate in an observational study to measure the impact of the ACTIPOL device from AURIS (France), on sleep in fibromyalgia patients. The ACTIPOL medical device is composed of 2 magnetic plates each using 14 ceramic magnets with a field value of 2.5 Gauss (unit of measurement of the magnetic induction of therapeutic magnets) measured at 20 cm from a plate.
Acting on 3 levels
Restoring the north/south axis: we are not all equal when it comes to sleep quality: age, stress, modern living conditions, etc., alter it. When sleep is weakened, the north/south orientation becomes essential. The ACTIPOL medical device places the bed in the correct N/S magnetic axis without moving it, regardless of its actual position.
Homogeneous and balanced field: a bed, even when oriented N/S, is often in a very disturbed magnetic field: metallic elements (box springs or mattresses), reinforced concrete, wires and electrical appliances, televisions... However, we do not suspect the importance of a stable and homogeneous magnetic field on the quality of the sleep The ACTIPOL medical device provides effective protection by placing the sleeper in a continuous field, which has a high preponderance over stray fields.
Elimination of harmful points: the earth's surface is covered by a vast invisible net: the Hartmann network. Unstable and fluctuating, its nodes become very harmful when they are also activated by disturbances in the subsoil (faults, springs, etc.). It is imperative to avoid these pathogenic zones, especially during sleeping hours. The field created by the ACTIPOL medical device removes these harmful points, making the bed a neutral space at all times. The same applies to parasitic magnetic fields such as WiFi relay antennas and high-voltage lines.
This is a multicenter, observational, prospective study with a 3-month follow-up.
The inclusion criteria were :
- Patients aged 18 years and older.
- Patients who gave written consent to participate after receiving oral and written information about the study.
- Patients with a proven diagnosis of fibromyalgia syndrome.
- Patients who were able to understand and respond to the assessment questionnaires.
Exclusion criteria were:
- Patients with a Pace-Maker.
- Patients with pathologies or conditions that, according to the investigator, would limit their ability to participate fully in the study or to respect all the requirements of the study: Dr BARON in Lannion, Dr MARC in Roanne and Dr RENEVIER in Mantes-La-Jolie. The duration of the inclusion period was 3 months, with a 3-month follow-up per patient, and each rheumatologist reported his or her study data in an observation notebook at inclusion, then after 1 week (to check that the system was properly understood) and at 3 months.
The sleep of fibromyalgia patients is clearly improved for the Spiegel and Vis Morgen tests
This improvement is twofold, mainly qualitative, directly linked to a significant reduction in night-time awakenings with ease of falling back to sleep. But also quantitative in relation with the global increase of the sleep time induced by the disappearance of the fractional character of the sleep and a better induction of the sleep lifting the apprehension to go to bed.
Among the elements of improvement reported by the patients, we can retain :
The strong decrease of nights with the impression of sleeping badly, the importance of a summation of good nights, the decrease of hypnophobia.
According to the patients, the ACTIPOL study allowed a reduction in the consumption of benzodiazepines, hypnotics and analgesics. However, this sleep study did not allow for the quantification of this patient perception (this was not the aim) and therefore to know the impact on treatment in terms of cost and public health.
It is also interesting to note a very pertinent remark by Dr. Dominique Baron... He asked each patient in the study to find out their head position at bedtime (some used a compass to answer!). The result was that 4 were already sleeping with their head to the north and 6 in another direction. For the 6 who did not have their head to the north, sometimes by ignorance, sometimes by impossibility to do otherwise (window to the north, preventing to position the bed according to a North-South configuration), they had better results than the others and if we only retained these patients, the improvement is spectacular!
And if finally, our "elders" were right, because for a long time we have always heard that we should sleep with our heads to the north...it is still necessary that the magnetic field be continuous and homogeneous such as the one obtained with ACTIPOL.