Intermittent Theta Burst Stimulation in Fibromyalgia Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIzmir Katip Celebi University
About this trial
Research on repetitive transcranial magnetic stimulation therapy in fibromyalgia syndrome (FMS) is increasing rapidly. High-frequency rTMS administration to FMS patients is reported to restore intracortical facilitation and provide successful pain relief. This finding supports restoration of cortical stimulation as one of the possible mechanisms of action for rTMS. One treatment protocol is intermittent theta burst stimulation (iTBS, a variant of excitatory rTMS). Although there are many treatment protocols, there are few widely accepted treatment schemes in the literature. In fibromyalgia syndrome, there is no study in the literature. It was planned to include at least 30 patients aged 18-65 years who were admitted to İzmir Katip Çelebi University Atatürk Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic or hospitalized in the ward and diagnosed with fibromyalgia syndrome according to the 2016 criteria. This study has a prospective, parallel group, randomized, sham-controlled study design. A total of 30 fibromyalgia patients will be randomized into 2 groups and will receive a total of 10 sessions of transcranial magnetic stimulation to the primary motor cortex with intermittent theta bust stimulation technique or sham application. Patients will continue their current fibromyalgia treatment.Numeric Rating Scale-pain intensity (NRS-pain), revised Fibromyalgia Impact Questionnaire (FIQR), Pain Catastrophizing Scale (PCS), Hospital Depression Anxiety Scale (HADS) will be used in the evaluation of the patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Being between the ages of 18-65
Being diagnosed with fibromyalgia syndrome (according to 2016 criteria)
Average pain intensity of NRS ≥ 4/10
Fibromyalgia treatment was stable for the last 3 months and no treatment change was planned during the study
Disqualifiers
Having a clinical condition that would constitute a contraindication for TMS (metallic implant, cardiac pacing, pregnancy, epilepsy, head trauma, history of cranial operation...)
Presence of malignancy
Systemic rheumatologic diseases
Major orthopedic problems limiting activities of daily living (gait disturbance or fracture sequelae limiting joint mobility, prostheses, nerve-tendon injuries)
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent theta-burst stimulation
DeviceNeuro-MS/D (Neurosoft) rTMS device will be used for stimulation with an angulated figure-of-eight coil. Neuronavigation system will be used to determine the application site. Before each session, active motor threshold (aMT) will be determined by obtaining a motor evoked potential with an amplitude of \>200μV in the EMG recording of the first dorsal interosseous muscle (FDI), which is slightly contracted (10-20% of maximum contraction) in at least five out of 10 stimuli delivered to the primary motor cortex. The handle will be held at a 45° angle to the sagittal plane, pointing backwards and laterally to create posterior-anterior current flow in the brain. The stimulation parameters are as follows: Parameters: Stimulation type:Burst Stimulus amplitude (% MT): 80 Burst frequency in sequence (Hz):5 Pulse frequency within burst (Hz):50 Number of bursts in the sequence: 10 Number of series:20 Interval between sequences: 8 sec Total time: 3min 47sec Total number of pulses: 600
Sham Intermittent theta-burst stimulation
DeviceIn the sham application, the probe of the transcranial magnetic stimulation device will be placed in the vertical position and held perpendicular to the vertex and applied at an ineffective dose so that the patient hears the same sound. In order for the device to produce the same sound and warning sounds as the active application, it will be operated at the lowest operating power of 1 power. In the device operating at this power, there is no possibility of any warning due to the upright position of the probe.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Active stimulation groupExperimental treatment 1 intervention
Group B: Sham stimulation groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in the Numeric Rating Scale
The numeric rating scale for pain that is a unidimensional measure of pain intensity in adults, including those with chronic pain.The common format is a horizontal bar or line. Similar to the visual analog scale, the numeric rating scale for pain is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from 0 representing one pain extreme (e.g. "no pain") to 11 representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time frame
(1) at the beginning of the treatment (T0), (2) at the 1st week (T1), (3) at the 2nd week (T2), (4) four weeks after the end of the treatment (T3).Secondary outcomes
1
Change from baseline in the Revised Fibromyalgia Impact Questionnaire
The Revised Fibromyalgia Impact Questionnaire (FIQR) has 21 individual questions. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'. As in the FIQ, all questions are framed in the context of the past 7 days. Following the convention used in the FIQ, the FIQR is divided into three linked sets of domains: (a) 'function' (contains 9 questions versus 11 in the FIQ), (b) 'overall impact' (contains 2 questions, as in the FIQ) but the questions now relate to the overall impact of FM on functioning and the overall impact symptom severity, and (c) 'symptoms' (contains 10 questions versus 7 in the FIQ)
Time frame
(1) at the beginning of the treatment (T0), (2) at the 2nd week (T2), (3) four weeks after the end of the treatment (T3).2
Change from baseline in the Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain.13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time. Higher score indicates higher level of catastrophizing. Item scores are summed into a total score (PCS-T) and three subscale scores: * Rumination (PCS-R): Items 8, 9, 10, and 11 * Magnification (PCS-M): Items 6, 7, 13 * Helplessness (PCS-H): Items 1, 2, 3, 4, 5, and 12 Minimum total score = 0, maximum total score = 52 Subscale score ranges: PCS-R: 0-16; PCS-M: 0-12; PCS-H: 0-24 A total score above 30 indicates clinically relevant level of catastrophizing
Time frame
(1) at the beginning of the treatment (T0), (2) at the 2nd week (T2), (3) four weeks after the end of the treatment (T3).3
Change from baseline in the Hospital Anxiety and Depression Scale
The hospital anxiety and depression scale (HADS) was developed to screen for depression and anxiety in hospitalized patients. The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).
Time frame
(1) at the beginning of the treatment (T0), (2) four weeks after the end of the treatment (T3).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov