Chronic neuropathic pain can be a debilitating symptom of damage to the spinal cord that occurs in transverse myelitis, neuromyelitis optica spectrum disorder, and acute disseminated encephalomyelitis. Treatment for neuropathic pain includes medications such as antidepressants, antiepileptic drugs, opioids, and patches/creams, physical therapy, psychological therapy, and stimulation techniques. Despite using many of these treatment options, some individuals still experience chronic neuropathic pain, so additional research is needed to develop new treatments.
Scrambler Therapy was developed by Giuseppe Marineo, a biophysicist.1 This therapy is thought to re-organize the pain system. It does this through transcutaneous electrical stimulation that activates C fibers. C nerve fibers carry sensory information and are thought to play a role in neuropathic pain. Scrambler Therapy’s electrical stimulation replaces the pain signals with “non-pain” signals, and it is thought that this retrains the brain to think areas that are painful are not painful anymore.1 This therapy has been studied as a treatment for chronic neuropathic pain in chemotherapy-induced peripheral neuropathy, post-herpetic neuralgia and post-surgical neuropathic pain. In these studies, patients report sustained relief after undergoing daily treatment sessions for 10 consecutive weekdays.
To study this therapy in individuals with neuromyelitis optica spectrum disorder (NMOSD), Dr. Michael Levy and his team at the NMO Clinic at Johns Hopkins are conducting a randomized single blinded, sham-controlled trial of patients with NMOSD who have central neuropathic pain. They will use Scrambler Therapy and patient reported outcomes to determine if Scrambler Therapy is a feasible and effective add-on treatment of chronic neuropathic pain.
This trial will recruit twenty-two adult patients diagnosed with NMOSD who have chronic neuropathic pain despite empiric treatment with an anti-epileptic, antidepressant, opioid and/or an NSAID medication. Patients will be randomized 1:1 to undergo Scrambler Therapy or blinded sham daily for 10 days. The sham group will serve as the “control” group and will not receive the therapy, although they will not know that they are not receiving the therapy. The control group and the experimental group’s outcomes will be compared to assess the efficacy of the treatment. This study is randomized, meaning the researchers will randomly select who is in the control group and who is in the group receiving Scrambler Therapy. This is done to increase the chances that the effects seen in the study are the result of the treatment and not other factors.
The primary outcomes of the study will be acceptability and feasibility. The secondary outcome will be efficacy. This will be measured as a change in pain scores of more than two points recorded daily by the patient using an 11-point visual analog scale. Quality of life (QoL), neurologic function, anxiety, depression, sleep disturbance, and pain will also be evaluated at baseline, at the end of therapy, and at 4 and 8 weeks following completion of treatment. It is hypothesized that Scrambler Therapy will be an acceptable, feasible, and efficacious intervention that significantly reduces pain in patients with NMOSD.
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- Majithia N, Smith TJ, Coyne PJ et al. Scrambler Therapy for the management of chronic pain. Support Care Cancer. 2016 Jun;24(6):2807-14.