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

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

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).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: experimental pain induction

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87000
    • Centre Hospitalier Esquirol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Esquirol
• Investigators: Principal Investigator: Dominique Malauzat, MD, CH Esquirol

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: fibromyalgia; rTMS; experimental pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2013-A01508-37