M79.7
Conditions
Interventions
Group 1: Experimental: Anodal transcranial direct current stimulation of the left primary motor cortex (10 daily 20-min sessions, 2 mA) paired with mindfulness meditation. Prior to the combined inter
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
All
Age
30 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. 15.Formal meditation practice of high intensity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Numerical Rating Scale (NRS) for pain intensity (Time frame: 14 weeks of the study). Participants will rate their pain level in a pain diary, twice daily, using a 10 cm visual analogue scale (Total score: 0-10; 0= no pain, 10 = worst imaginable pain). Higher scores mean a worse outcome. 2. Quality of life (Time points: baseline, post mindfulness training, immediately after the last stimulation session of the bimodal therapy, one month after last stimulation) Participants will fill in the Fibromyalgia Impact Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cortical excitability of the left primary motor cortex using transcranial magnetic stimulation (TMS). - Resting motor threshold of the right first dorsal interosseous muscle. - Recruitment curves with intensity of single TMS pulses at 90%, 100%, 110%, 120%, 130% and 140% of the resting motor threshold. - Intracortical facilitation and inhibition using paired pulse TMS. 2. Interaction between brain and heart. - Power analysis of resting state 64-channel EEG - Heart rate and heart rate variability using resting state 3-channel ECG - Heart evoked potential, a marker of cardiac interoception, measured using concurrent EEG and ECG 3. Quality of life using the Fibromyalgia Impact Questionnaire. 4. Mood using the Positive and Negative Affect Schedule. 5. Depression, anxiety and stress levels using the Depression, Anxiety and Stress Scale. 6. Sleep quality assessed with the Pittsburg Sleep Quality Index. 7. Mindfulness level using the Five Facet Mindfulness Questionnaire. 8. Self-management ability using the Selbststeuerungs-Inventar (SSI-K3). This will be used to test any association between responders to the treatment and self-management ability. 9. Word finding ability using the Regensburger word fluency test. All measures will take place at baseline, after the mindfulness training, immediately after the last stimulation session of the bimodal therapy and one month following the last stimulation session. | — |
Countries
Germany
Contacts
Public ContactAndrea Antal
Klinik für Neurologie, Universitätsmedizin Göttingen
Outcome results
None listed