M79.7
Conditions
Interventions
Group 1: Experimental: Real transcranial direct current stimulation concurrently combined with mindfulness meditation (stimulation protocol: a total of 10 daily 20-min sessions over 5 consecutive days
active stimulation: 2 mA direct current with 15 s ramp up at the start and 15 s ramp down at the end of stimulation).
Group 2: Sham comparator: Sham transcranial direct current stimulation concurrent
sham stimulation: 15s ramp up from 0 mA to 2 mA at the start of stimulation followed by an immediate 15s ramp down, the current is at 0 mA for the rest of the stimulation)
Group 3: Control: no interv
Sponsors
Universitätsmedizin Göttingen
Eligibility
Sex/Gender
Female
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Fibromyalgia, characterized by chronic widespread pain, fatigue and cognitive symptoms for more than 6 months. Stable disease with no current diagnostic and new treatment approaches over last 4 months. Allowed would be ongoing physiotherapy (up to 2x/week) and psychotherapy (1-2x/month). 2. Ability to give free-willing consent to participate in study. 3. If patients are taking analgesic or psychotropic medication, medications must have been stabilized for >= 4 weeks prior to the study.
Exclusion criteria
Exclusion criteria: 1. Age 70 years old. 2. Severe cognitive impairment such as severe attentional deficits. 3. Treatments with strong opioids and more than three medications for fibromyalgia. 4. Evidence of other neurological or psychiatric diseases (acute or history) including epilepsy, migraine, schizophrenia or mania. 5. Comorbid rheumatic disease. 6. Alcohol, medication, or drug addiction. 7. Diagnosis of major cardiovascular, pulmonary, or musculoskeletal disorders including diabetes, arrhythmia, or paralysis. 8. Metal implants in head or pacemakers, ferromagnetic objects, or other objects with risk of contact with the electrodes. 9. Pregnancy or breastfeeding. 10. Receptive or global aphasia (disruption of language comprehension or additional speech) 11. Participation in another scientific or clinical study within 12 weeks prior to study inclusion. 12. Any planned surgery, procedure, or hospitalization that may conflict with or otherwise influence participation in study. 13. History of loss of consciousness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale- Pain (Time Frame: throughout 8 weeks of study) Participants will rate their pain level in a pain diary, at the same time twice daily at least 2 weeks before, during and at least 4 weeks after the stimulation, using a 10 cm visual analogue scale (Total score: 0-10; 0= no pain, 10 = worst imaginable pain). Higher scores mean a worse outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pain-pressure threshold will be measured at 8 body sites (bilateral mid-trapezius, lateral epicondyle, midthigh and tibalis anterior muscles) using a somedic algometer at week 0, 5 and 9 and overall average will be calculated. - Cortical excitability assessed using single pulse transcranial magnetic stimulation at week 0, 5 and 9. • Resting and active motor threshold of the right first dorsal interosseous muscle • Recruitment curves with intensity of TMS pulses at 110%, 120%, 130% and 140% of the resting motor threshold. • Intracortical inhibition measured by applying two TMS pulses with 4, 6 and 10 ms break each. - Quality of life assessed using the Fibromyalgia Impact Questionnaire (German version) at weeks 0, 5 and 9. - Depression, stress, and anxiety levels assessed using the Depression Anxiety Stress Scale (German version) at weeks 0, 5 and 9. - Mindfulness before the first session and following the last session of the 5-day daily mindfulness meditation training will be assessed using the Freiburg Mindfulness Inventory (German version). - Personality trait assessed at week 0 using the NEO Five-Factor Inventory (German version). | — |
Countries
Germany
Contacts
Public ContactAndrea Antal
Klinik für Neurologie, Universitätsmedizin Göttingen
Outcome results
None listed