Fibromyalgia
Conditions
Brief summary
The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.
Detailed description
Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component. Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals: 1. To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain. 2. To investigate tDCS induced functional changes in the brain by using fMRI.
Interventions
DEVICEtDCS NeuroConn DC-stimulator plus
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
DEVICEsham tDCS
similar montage and time as active. Stimulation fades out after 20 sec.
Sponsors
Stiftelsen Helse og Rehabilitering
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Fibromyalgia (ACR-90 criteria, M79.7 ICD10) * Mean VAS \> 4 daily 2 weeks prior to study).
Exclusion criteria
* Severe mental disease * CNS disease * Mental retardation * Age \< 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceived pain | Change in VAS from baseline up to 49 days. | Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\\sham tDCS on pain. 2 levels of group (active tDCS\\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral pain processing | Change from baseline to post treatment. 7 days. | Phillps tesla 1.5 fMRi, pathway pain stimulator (Medoc, Israel) fMRI under pain stimulation for 60 participants. 20 recieve active tDCS, 20 recieve sham-tDCS, 20 age and gender matched (matched to active tDCS group) healthy controls. Baseline scan, post treatment scan. |
| Rating scales (HADS, SCL90, SF36, FIQ) | Change from baseline to post treatment. 30 days post treatment. Up to 65 days. | Time from inclusion to treatment start determines 30\\14 days. Rating scales on Samsung Galaxy tab 10.1. HADS mesure anxiety and depression, SCL 90 measure symtoms of mental illness, SF36 mesure health related life quality, FIQ mesure symptom severity in fibromyalgia. |
| Perceived pain, natural history | Baseline compared to post-treatment. Up to 65 days | Pain (intensity and unpleasentness) measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period. |
| Perceived stress and activation | Change in VAS from baseline to during treatment and after treatment. Up to 49 days. | Stress and activation measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\\sham tDCS on stress and activation. 2 levels of group (active tDCS\\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) Measured using the same instrumet as the primary outcome. |
| Perceived stress and activation, natural history | Baseline compared to post-treatment. Up to 65 days | Stress and activation measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period. |
Countries
Norway
Outcome results
None listed