M79.7
Conditions
Interventions
Group 1: Anodal transcranial direct current stimulation of the left primary motor cortex over 5 days (3 times a day for 20 minutes)
Group 2: Anodal transcranial direct current stimulation over the le
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
Female
Age
25 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Stable disease for at least 6 months prior to participation 2. No new treatment approaches over the preceding 3 months 3.Stable allowed fibromyalgia related medications (see below) for = 4 weeks prior to the study. List of allowed medications: -Intake of NSAIDs and coxibs as required (bei Bedarf), but participants must not take it 24 hours prior to study visits. - Commonly used antidepressants for FMS will be allowed. -Low dose (<25 mg THC content/day) of medical oromucosal cannabinoid therapy (e.g. dronabinol, nabiximols, extracts). The participant has to refrain from taking it up to 24 hours prior to study visits. -Corticosteroids for comorbid conditions if the dose was constant within the last four weeks before baseline and if the dose will likely remain constant for the duration of this trial.
Exclusion criteria
Exclusion criteria: 1. Treatment with any of the following medications: - Strong opioids, or taking more than three medications for fibromyalgia symptom relief. - Carbamazepine, benzodiazepines, phenytoin, gabapentin, pregabalin; calcium channel antagonists (e.g. flunarizine), NMDA receptor antagonists (e.g. dextromethorphan, memantine), anticholinergics. - Therapeutic local anesthetic infiltration of the spinal column within the last 4 weeks before baseline and/or planned during the trial period. - Topically administered medication with influence on the study target during the study -Inhaled or smoked cannabinoids for medical use. 2. presence of any major, acute or unstable medical, neurological or psychiatric disorder, diagnosis of severe or uncontrolled comorbid rheumatic disease, non-treated tumors, ongoing chemo- or radiation therapy, clotting disorders or anticoagulant therapy 3. Chronic migraine (at least 15 headache days/months, with at least 8 fulfilling criteria for migraine 4. Alcohol/drug addiction, abuse of any substance (except nicotine and caffeine) currently and/or within the last 12 months prior to randomization 5. Pregnancy or breastfeeding 6. History of unexplained or repeated loss of consciousness 7. Implanted metallic devices in head, neck or chest 8. Participation in another scientific or clinical study within 12 weeks prior to study inclusion 9. History of major surgery in the last three months 10. Planned or ongoing pension proceedings 11. Any planned surgery or inpatient treatment which might conflict with or influence the participation or results of the study. 12.History or suspicion of unreliability, poor co-operation or non-compliance with medical treatment 13. Mental condition, legal incapacity, and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the study 14. Acupuncture or chiropractic manipulations within the last 4 weeks before baseline and/or during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Numerical rating scale (NRS) with values between 0-10 (0= no pain; 10= worst pain imaginable) is used for pain intensity. Pain intensity will be rated daily for two weeks before the start of the intervention, during the stimulation, two weeks following the intervention, two weeks following both the one-month and two-month follow-ups. 2. The overall impact of the disease is recorded using the German version of the Fibromyalgia Impact Questionnaire (FIQ,0: no impact; 100: maximum impact). The FIQ will be administered two weeks before the stimulation (baseline) as well as immediately after, one month after and two months following the last stimulation session. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of the sensory and affective components of pain with the Pain Description List 2. Multidimensionality of pain with the Brief Pain Inventory 3. The extent of catastrophizing pain with the Pain Catastrophizing Scale 4. Neuropathic pain components with the PainDETECT questionnaire 5. Quality of life using the Short Form Survey (SF-36) 6. Assessment of fatigue using the Modified Fatique Impact Scale 7. Sleep quality using the Medical Outcomes Study scale (MOS) 8. Depression, anxiety and stress levels using the Depression, Anxiety and Stress Scale. 9. Transcranial magnetic stimulation-EEG measures to find biomarkers for the categorization of fibromyalgia patients 10. Quantitative sensory testing to investigate pain processing mechanisms 11. Transcranial Doppler examination to investigate blood flow in the brain Clinical outcomes and pain mechanisms using quantitative sensory testing will be assessed at baseline, immediately after, one-month and two-month following the accelerated stimulation intervention. The TMS-EEG is measured only at baseline and the Doppler examination takes place at the training session for the home-based stimulation protocol. | — |
Countries
Germany
Contacts
Public ContactAndrea Antal
Klinik für Neurologie, Universitätsmedizin Göttingen
Outcome results
None listed