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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Device: tDCS NeuroConn DC-stimulator plus; Device: sham tDCS

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Tromsoe, Norway, 9038
    • University Hospital of North Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: active tDCS	Device: tDCS NeuroConn DC-stimulator plus; Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.; Other Names: model 0021; serial-no 0337
Sham Comparator: sham tDCS; tDCS fades out after 20 sec. administered double blind by coded program.	Device: tDCS NeuroConn DC-stimulator plus; Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.; Other Names: model 0021; serial-no 0337; Device: sham tDCS; similar montage and time as active. Stimulation fades out after 20 sec.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived pain	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).	Change in VAS from baseline up to 49 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral pain processing	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.	Change from baseline to post treatment. 7 days.
Rating scales (HADS, SCL90, SF36, FIQ)	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.	Change from baseline to post treatment. 30 days post treatment. Up to 65 days.
Perceived pain, natural history	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.	Baseline compared to post-treatment. Up to 65 days
Perceived stress and activation	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.	Change in VAS from baseline to during treatment and after treatment. Up to 49 days.
Perceived stress and activation, natural history	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.	Baseline compared to post-treatment. Up to 65 days

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Stiftelsen Helse og Rehabilitering
• Investigators: Study Chair: Per Aslaksen, ph.d, University of Tromso

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: May 11, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2010/2256/REK n; UNorthNorway (UNorthNorway)