Chronic Pain
Conditions
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.
Interventions
DEVICEnavigated repetitive Transcranial Stimulation
High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Sham stimulation was provided by turning the TMS coil to the non-stimulating side.
Intervention model description
The study was conducted in a single-blinded, randomized, placebo-controlled design
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale | 36 weeks | 0-10 0 = no pain, 10 = worst pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Depression, Anxiety and Stress Scale (DASS) questionnaire. | 36 weeks | 0- 21 for each item, higher scores indicate worse symptoms. Lower scores indicate a better outcome |
Countries
Austria
Outcome results
None listed