An interventional study of experimental pain induction in Fibromyalgia, sponsored by Centre Hospitalier Esquirol. Completed at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-19.
Sponsored by Centre Hospitalier Esquirol · Not applicable, Interventional, and Other
The principal study aims at evaluating the efficiency of rTMS maintenance sessions on the clinical effect of a rTMS cure in fibromyalgic subjects. This complementary study consists in the evaluation of the experimental sensitivity to mechanical pain (pressure application on the forearm) of subjects presenting fibromyalgia before and after rTMS treatment (21 days), and to put the results in relation to the clinical improvement and the psychometric evaluations (depression,fibromyalgia impact questionnaire, catastrophism).
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 72 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Centre Hospitalier Esquirol is the lead sponsor of 25 studies on the registry; 7 are open to participants now.
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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.
known latex allergy, peripheral neuropathy, nerve lesion or dermatosis at the upper extremities, muscular lesion or pathology at the upper members, use of illicit drugs 48 hours before experimental pain test, use of antalgic or analgesic drug aiming at a punctual treatment during the prior 24 hours.
application of a pre-fixed pressure (160 kPa) on the forearm
Other: experimental pain induction
application of a pre-fixed pressure (160 kPa) on the forearm.
Variation in the Visual Analogic Scale (VAS)score after fixe pressure application (160 kPa) between the first rTMS session (T0) and the last rTMS session (T21)in relation to clinical improvement
The clinical improvement is defined as : 30% decrease in the general painful state evaluated by VAS between T0 and T21 and response to the Patient's Global Impression of Change ≥ 6 at T21
Time frame: 21 days
variation in the experimental pain feeling (VAS) between T0 and T21 in relation to treatment group
Time frame: 21 days
variation in experimental pain feeling between T0 and T210 (the end of rTMS maintenance sessions)
Time frame: 210 days
variation in Beck Depression Inventory scores between T0 and T21
Time frame: 21 days
variation in Fibromyalgia Impact Questionnaire score between T0 and T21
Time frame: 21 days
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Esquirol