Clinical trial NCT03909009: Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia
Official title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Pain, Fatigue, Quality of Life, Cognitive Function and Mood in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia, neuronavigated-rTMS, pain, stiffness, fatigue
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effectiveness of 10 Hz neuronavigated repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) on pain, stiffness, fatigue, depression/anxiety, quality of life and cognitive functions in fibromyalgia syndrome (FMS).

Detailed description: This is a single-center, prospective, randomized, double-blind, sham-controlled study in two-arm parallel-group design. Twenty participants will be randomized into 2 groups. Randomization will be performed using computer-generated block randomization with 1:1 allocation between the active rTMS group (Group 1) and the sham-control group (Group 2). Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS)-A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks). Group 2 will receive sham stimulation-A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).All patients will be evaluated with pain severity (VAS-10mm),stiffness severity (VAS-10mm), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS), Hospital Depression Anxiety Scale (HADS), Addenbrook Cognitive Examination-revised version (ACE-R).Patients will be questioned for the safety of treatment. Available drug therapies will be continued in both groups. Patients and clinical raters will be blinded to treatment. All patients will be reviewed by the investigator in terms of rTMS treatment safety and motor threshold determination before each treatment session and observed for possible side effects after treatment. All side effects will be recorded. Magnetic stimulation will be applied using Neurosoft-Neuro MS/D with a figure-of-eight-shaped coil. rTMS therapy will be applied under the guide of neuronavigation with the following parameters: target-left DLPFC, with the %90 of the RMT, 10 Hz stimulation for 5 seconds intervals (on) with 25 seconds inter-train intervals (off), 15 minutes, 1500 pulses.

Eligibility criteria: Inclusion Criteria:

* Adults (age between 18-65 years)
* Diagnosis of fibromyalgia syndrome according to 2016 Fibromyalgia diagnostic criteria
* The mean pain intensity is VAS ≥ 4/10
* Stable treatment for at least last 3 months
* Patients accepting participation by signing an informed consent form

Exclusion Criteria:

* To have a clinical condition to be contraindicated for TMS (metallic implant, cardiac pace, pregnancy, lactation, epilepsy, head trauma, history of cranial operation...)
* The presence of malignancy
* Systemic rheumatic diseases
* Major orthopedic / neurological problems that limit daily life activities
* Alcohol or drug addiction
* Major depression / personality disorder history
* Have received TMS treatment before
* Pregnancy or breastfeeding

Primary outcomes:
measure: Visual Analog Scale-Pain
timeFrame: in the second week
Secondary outcomes:
measure: Visual Analog Scale-Pain
timeFrame: in the sixth week
measure: Fibromyalgia Impact Questionnaire
timeFrame: in the sixth week
Other outcomes:
measure: Visual Analog Scale-Stiffness
timeFrame: in the second week
measure: Fibromyalgia Impact Questionnaire
timeFrame: in the second week
measure: Fatigue Severity Scale
timeFrame: in the sixth week
measure: Hospital Anxiety and Depression Scale
timeFrame: in the sixth week
measure: Addenbrook Cognitive Examination Revised
timeFrame: in the sixth week
Locations:
city: İzmir
country: Turkey
facility: Izmir Katip Çelebi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Izmir Katip Çelebi University Faculty of Medicine
name: Ayhan Aşkın, Assoc. Prof.
role: STUDY_DIRECTOR
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