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

NCT01992822 | Completed

• 1 other identifier: 2013-A01508-37
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

rTMS; fibromyalgia; experimental pain

Outcome Measures

Primary Outcomes (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

  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 Outcomes (4)

• variation in the experimental pain feeling (VAS) between T0 and T21 in relation to treatment group

  21 days

• variation in experimental pain feeling between T0 and T210 (the end of rTMS maintenance sessions)

  210 days

• variation in Beck Depression Inventory scores between T0 and T21

  21 days

• variation in Fibromyalgia Impact Questionnaire score between T0 and T21

  21 days

Study Arms (1)

experimental pain induction

EXPERIMENTAL

application of a pre-fixed pressure (160 kPa) on the forearm

Other: experimental pain induction

Interventions

experimental pain induction OTHER

application of a pre-fixed pressure (160 kPa) on the forearm.

experimental pain induction

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Esquirol: lead

Study Sites (1)

Centre Hospitalier esquirol

Limoges, 87000, France

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dominique Malauzat, MD

  CH Esquirol

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

FR (1)