Abstract
BackgroundElectrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief. To avoid the risks and side effects of surgery, transcranial direct current stimulation is an option to electrically stimulate the motor cortex through the skull. Previous research has shown that transcranial direct current stimulation relieves pain in patients with fibromyalgia, chronic neuropathic pain and chronic pelvic pain. Evidence indicates that the method is pain free, safe and inexpensive.Methods/DesignA randomised controlled trial has been designed to evaluate the effect of transcranial direct current stimulation over the motor cortex for pain reduction in patients with chronic low back pain. It will also investigate whether transcranial direct current stimulation as a prior treatment enhances the symptom reduction achieved by a cognitive-behavioural group intervention. Participants will be randomised to receive a series of 5 days of transcranial direct current stimulation (2 mA, 20 mins) or 20 mins of sham stimulation; followed by a cognitive-behavioural group programme. The primary outcome parameters will measure pain (Visual Analog Scale) and disability (Oswestry Disability Index). Secondary outcome parameters will include the Fear Avoidance Beliefs Questionnaire, the Funktionsfragebogen Hannover (perceived function), Hospital Anxiety Depression Scale, bothersomeness and Health Related Quality of Life (SF 36), as well as Patient-Perceived Satisfactory Improvement. Assessments will take place immediately prior to the first application of transcranial direct current stimulation or sham, after 5 consecutive days of stimulation, immediately after the cognitive-behavioural group programme and at 4 weeks, 12 weeks and 24 weeks follow-up.DiscussionThis trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back pain and whether it can further enhance the effects of a cognitive behavioural pain management programme. Trial registration: Current Controlled Trials ISRCTN89874874.
Highlights
Electrical stimulation of central nervous system areas with surgically implanted stimulators has been shown to result in pain relief
This trial will help to determine, whether transcranial direct current stimulation is an effective treatment for patients with chronic low back pain and whether it can further enhance the effects of a cognitive behavioural pain management programme
A literature review [1] on the epidemiology and economic burden of non-specific chronic low back pain reported estimates of prevalence ranging from 6% to 11%
Summary
The proposed study presents the first high quality randomised controlled trial on tDCS for the reduction of chronic pain. Pain, accepted), only 8 studies have investigated tDCS for chronic pain reduction [16,17,18,19,20,21,22,23] None of these was adequately powered to allow valid conclusions on it’s effectiveness. A range of identified measurement tools was monitored over a 3 month period in the back pain clinic These included the Short Form McGill Pain Questionnaire [53], the Visual Analog Scale, the Roland Morris Disability Questionnaire [54] and the Oswestry Disability Index [34]. AM conceived of the study, and participated in its design and coordination and helped to draft the manuscript.
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