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Trial record 22 of 110 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Centre Hospitalier Esquirol
Sponsor:
Information provided by (Responsible Party):
Dominique Malauzat, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01992822
First received: November 19, 2013
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention
Fibromyalgia
Other: experimental pain induction

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Experimental Pain Sensitivity of Subjects With Fibromyalgia Before and After rTMS Treatment in Relation to the Clinical Improvement

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Esquirol:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • variation in the experimental pain feeling (VAS) between T0 and T21 in relation to treatment group [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • variation in experimental pain feeling between T0 and T210 (the end of rTMS maintenance sessions) [ Time Frame: 210 days ] [ Designated as safety issue: No ]
  • variation in Beck Depression Inventory scores between T0 and T21 [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • variation in Fibromyalgia Impact Questionnaire score between T0 and T21 [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: November 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992822

Contacts
Contact: Murielle Girard, PhD 0033555431028 murielle.girard@ch-esquirol-limoges.fr

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

No publications provided

Responsible Party: Dominique Malauzat, MD, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01992822     History of Changes
Other Study ID Numbers: 2013-A01508-37
Study First Received: November 19, 2013
Last Updated: May 13, 2014
Health Authority: France: Committee for the Protection of Personnes
France : Agence Nationale de Sécurité du Médicament

Keywords provided by Centre Hospitalier Esquirol:
rTMS
fibromyalgia
experimental pain

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

ClinicalTrials.gov processed this record on November 20, 2014