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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598181
• Other study ID #: 2010/2256/REK n
• Secondary ID: UNorthNorway
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: February 15, 2017
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: June 2016
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• tDCS NeuroConn DC-stimulator plus
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
• sham tDCS
similar montage and time as active. Stimulation fades out after 20 sec.

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsoe

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of North Norway	Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	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