Neuronavigated Repetitive Transcranial Magnetic Stimulation (nrTMS) of the Dorsolateral Prefrontal and Primary Motor Cor-tex for the Treatment of Chronic Pain: a Randomized Place-bo-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pain
- Sponsor
- Medical University of Graz
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study investigated the effects of navigated repetitive Transcranial Magnetic Stimulation on nociception and quality of life in patients suffering from chronic pain conditions. Two cortical targets (dorsolateral prefrontal cortex/DLPFC and M1 area) were stimulated and compared to Sham stimulation.
Detailed Description
From 34 patients, 24 completed the study. The M1-area was stimulated with 10 Hz rTMS while the DLPFC received a 5Hz stimulation. In total, 13 session were administered over a period of 36 weeks with most frequent stimulation in the first 4 weeks of the trial. Results were compared to Sham-TMS over the M1 area at the same schedule than the actual therapy. Outcome parameters included the German Pain Questionnaire (GPQ), the Depression, Anxiety and Stress Scale" (DASS) and quality of life (QoL) with the SF-12 questionnaire.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age between 18 and 80 years
- •clinical diagnosis of chronic LBP (low back pain) and or neck pain
- •average resting pain-level \> than 3 in the Numeric Rating Scale (0-10)
- •no changes in pain medication 4 weeks at baseline
- •no surgical procedures in the last 2 years
Exclusion Criteria
- •metallic and electronic implants in the head, neck and chest
- •medication e.g. tetracyclic antidepressants, antiviral, antipsychotic, opioid doses \> 100mg orally/d
- •history of frequent headache or tinnitus
- •alcohol or drug abuse
- •pregnant patients
- •breastfeeding patients
Outcomes
Primary Outcomes
Numeric Rating Scale
Time Frame: 36 weeks
0-10 0 = no pain, 10 = worst pain
Secondary Outcomes
- Self-reported "Depression, Anxiety and Stress Scale" (DASS) questionnaire.(36 weeks)