The Effect of Intermittent Theta Burst Stimulation to the Primary Motor Cortex on Pain Intensity, Pain Catastrophizing, Quality of Life and Mood in Fibromyalgia Patients

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Izmir Katip Çelebi University Atatürk Training and Research Hospital
RECRUITING
Izmir
Contact Information
Primary
Ayhan ASKIN, Professor
ayhan.askin@ikc.edu.tr
902322444444
Backup
Ezgi Ayan, MD
ezgiugurlu45@icloud.com
902322444444
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 30
Treatments
Experimental: Active stimulation group
Patients will receive intermittent theta burst stimulation (iTBS) to the primary motor cortex, one session per day for a total of 10 sessions.
Sham_comparator: Sham stimulation group
Patients will receive sham treatment for one session per day for a total of 10 sessions.
Related Therapeutic Areas
Sponsors
Leads: Izmir Katip Celebi University

This content was sourced from clinicaltrials.gov