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TerminatedNCT01261650Updated Jul 3, 2014

Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome

A Phase 4 interventional study of transcranial direct current stimulation and sham treatment in Fibromyalgia, sponsored by Karl Landsteiner Institute of Remobilization and Functional Health. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-03.

Sponsored by Karl Landsteiner Institute of Remobilization and Functional Health · Phase 4, Interventional, and Treatment

Why this study was terminated
There could not be enough patients recruited
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.

02

Conditions studied

  • Fibromyalgia

Keywords

  • widespread chronic pain, transcranial direct current stimulation, fibromyalgia
03

In context

Fibromyalgia

1,338 studies on the registry are indexed under Fibromyalgia; 268 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 1,037 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Karl Landsteiner Institute of Remobilization and Functional Health is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Inclusion criteria

  • Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
  • Symptoms have been present at a similar level for at least 3 months
  • Stable medication for at least 2 months
  • visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
  • The patient does not have a disorder that would otherwise explain the pain

Exclusion criteria

Exclusion Criteria:

  • Alcohol/substance abuse
  • Pregnancy
  • Neuropsychiatric disorders
  • Metal implants near stimulation area
  • Cardiac pace maker
  • Local injuries
  • Inflammatory rheumatic disease
  • Acute tumor
  • Acute fracture
  • Well-defined neuropathic induced pain
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    transcranial direct current stimulation

    transcranial direct current stimulation of the primary motor cortex

    Device: transcranial direct current stimulation

  • Sham comparator
    sham treatment

    Device: sham treatment

Interventions

  • Devicetranscranial direct current stimulation
  • Devicesham treatment
06

What researchers measure

Primary outcomes

  1. Visual Analoge Scale

    Time frame: Difference Baseline - after treatment

Secondary outcomes

  1. Quality of Life - SF-36

    Time frame: baseline / after treatment / 1 , 2, 3 months after treatment

  2. Fibromyalgia Impact Questionaire

    Time frame: baseline / after treatment / 1,2,3, months after treatment

  3. IL-10 ELISA

    Time frame: baseline / after treatment / 1,2,3, months after treatment

  4. Visual analog scale

    Time frame: 1,2,3 months after treatment

  5. IL-6 ELISA

    Time frame: baseline / after treatment / 1,2,3, months after treatment

  6. IL-4 ELISA

    Time frame: baseline / after treatment / 1,2,3, months after treatment

  7. TNF-alpha ELISA

    Time frame: baseline / after treatment / 1,2,3, months after treatment

07

Study locations

1 site
  • Karl Landsteiner Institute of Remobilisation and Functional Health
    Vienna, 1100, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01261650
Lead sponsor
Karl Landsteiner Institute of Remobilization and Functional Health
First posted
Dec 16, 2010
Start date
Dec 2010
Last update
Jul 3, 2014

Study contacts

Michael Quittan, PhD
principal investigator · Karl Landsteiner Institute of Remobilisation and functional Health

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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