Pain Sensitivity of Subjects With Fibromyalgia Before and After Repetitive Transcranial Magnetic Stimulation Treatment

Fibromyalgia Clinical Trial

Official title:

Experimental Pain Sensitivity of Subjects With Fibromyalgia Before and After rTMS Treatment in Relation to the Clinical Improvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992822
• Other study ID #: 2013-A01508-37
• Status: Completed
• Phase: N/A
• First received: November 19, 2013
• Last updated: September 18, 2017
• Start date: November 2013
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• 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.

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• experimental pain induction
application of a pre-fixed pressure (160 kPa) on the forearm.

Locations

Country	Name	City	State
France	Centre Hospitalier esquirol	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	21 days
Secondary	variation in the experimental pain feeling (VAS) between T0 and T21 in relation to treatment group		21 days
Secondary	variation in experimental pain feeling between T0 and T210 (the end of rTMS maintenance sessions)		210 days
Secondary	variation in Beck Depression Inventory scores between T0 and T21		21 days
Secondary	variation in Fibromyalgia Impact Questionnaire score between T0 and T21		21 days