Fibromyalgia
Conditions
Keywords
rTMS, fibromyalgia, sham, maintenance session, pain
Brief summary
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
Detailed description
In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.
Interventions
DEVICErTMS
one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold
DEVICEsham rTMS
same session as defined with the real rTMS, but with a coil not delivering magnetic field.
Sponsors
Centre Hospitalier Esquirol
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis, * painful state for more than six months, * visual analogic scale evaluation \> or = 5, * age between 18 and 70, * no modification in therapeutic treatment one month before and during the protocol * presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic * residence in Limoges or the periphery, or the ability to come to the hospital for the treatment
Exclusion criteria
* presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble), * active epilepsy, * previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension, * pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging. * clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...), * pregnancy, or administrative and judiciary protection, absence of health insurance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months | 210 days | = number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions. clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change. effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions. |
Secondary
| Measure | Time frame |
|---|---|
| number of rTMS responders at 3week-rTMS treatment | 21 days |
Countries
France
Outcome results
None listed