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Completed

NCT Number: NCT01598181

Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia

The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway

Tromsø, Tromsoe, 9038, Norway

About this study

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:

  • To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
  • To investigate tDCS induced functional changes in the brain by using fMRI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS NeuroConn DC-stimulator plus

Device

Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.

Other names: model 0021, serial-no 0337

Sham tDCS

Device

similar montage and time as active. Stimulation fades out after 20 sec.

Primary outcomes

  1. Perceived pain

    Time frame: 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 outcomes

  1. Cerebral pain processing

    Time frame: 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.

  2. Rating scales (HADS, SCL90, SF36, FIQ)

    Time frame: 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.

  3. Perceived pain, natural history

    Time frame: 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.

  4. Perceived stress and activation

    Time frame: 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.

  5. Perceived stress and activation, natural history

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Stiftelsen Helse og Rehabilitering

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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