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

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ClinicalTrials.gov Identifier: NCT01992822
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dominique Malauzat, Centre Hospitalier Esquirol

Brief 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).

Condition or disease Intervention/treatment Phase
Fibromyalgia Other: experimental pain induction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Experimental Pain Sensitivity of Subjects With Fibromyalgia Before and After rTMS Treatment in Relation to the Clinical Improvement
Study Start Date : November 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: experimental pain induction
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 21 days ]

    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



Secondary Outcome Measures :
  1. variation in the experimental pain feeling (VAS) between T0 and T21 in relation to treatment group [ Time Frame: 21 days ]
  2. variation in experimental pain feeling between T0 and T210 (the end of rTMS maintenance sessions) [ Time Frame: 210 days ]
  3. variation in Beck Depression Inventory scores between T0 and T21 [ Time Frame: 21 days ]
  4. variation in Fibromyalgia Impact Questionnaire score between T0 and T21 [ Time Frame: 21 days ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992822


Locations
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France
Centre Hospitalier esquirol
Limoges, France, 87000
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
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Principal Investigator: Dominique Malauzat, MD CH Esquirol

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Responsible Party: Dominique Malauzat, MD, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01992822     History of Changes
Other Study ID Numbers: 2013-A01508-37
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Keywords provided by Dominique Malauzat, Centre Hospitalier Esquirol:
rTMS
fibromyalgia
experimental pain

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases