The study shows that this new, noninvasive cortical electrostimulation device is effective at reducing fibromyalgia symptoms, with researcher Jeffrey B. Hargrover, PhD, and colleagues explaining how neuroimaging studies to identify areas of abnormal pain processing in patients with fibromyalgia allowed the development of this targeted treatment. Significant benefits were found for those suffering from neck pain, generalized pain, fatigue, dysfunction and sleep disruption from the condition.
Twenty-Two Sessions Greatly Improve Fibromyalgia Symptoms
Hargrove and his team have name the technology RINCE, or Reduced Impedance Noninvasive Cortical Electrostimulation. The device works by attaching electrodes to the scalp and sending high-frequency signals into the deeper cortex to alter the aberrant brain activity connected to fibromyalgia pain. Seven-seven patients with the condition were recruited for the trial with thirty-nine each receiving biweekly treatments with RINCE over an eleven week period. A control group of thirty-eight patients had a sham treatment, with the patients unable to tell which group they were in due to the lack of cutaneous sensation experienced with the therapy. Each session lasted eleven minutes and patients were assessed prior to the study’s commencement and at the end of the eleven week programme.
What is Fibromyalgia?
The varied symptoms of fibromyalgia are thought to be linked to abnormal pain processing and augmented neural connectivity in pain networks. Most treatments rely on helping patients to manage pain, numb the pain with medications, or reduce exacerbating conditions such as spinal problems, addiction to smoking, or depression. The new fibromyalgia treatment under investigation at Kettering University could provide an additional weapon against the painful and debilitating disease.
Tender Point Improvements in Fibromyalgia
All of the patients in the study had been diagnosed with primary fibromyalgia according to guidelines from the American College of Rheumatology and all were evaluated using the Fibromyalgia Impact Questionnaire (FIQ), the Short-Form-36, and tender-point assessment. Patients in the treatment arm of the study had a significant improvement in reported pain, fatigue, function and sleep, demonstrated by a 15.5 point reduction on the FIQ scale (vs. -5.6 for the control group). Tender points also improved with fibromyalgia patients treated with the electrostimulation device having an average of 7.4 less tender points compared to 0.2 less in the sham group. Many patients with fibromyalgia suffer from tender points in the neck, shoulders and upper back, which can cause confusion during diagnosis. Those patients included in this study had primary fibromyalgia, meaning that a cervical spine condition was not considered the primary cause of their neck pain or other symptoms.
Long-Term Benefits of New Fibromyalgia Treatment
Happily, the benefits of the new fibromyalgia treatment continued after the study ended with follow-up FIQ scores actually reducing after forty-five months. Some 64% of respondents from the study group reported FIQ scores of 53 at baseline, 36 at the conclusion of the study and 32 at follow-up. Just a single course of twenty-two noninvasive electrostimulation treatments for fibromyalgia over eleven weeks had patients still feeling the benefits years later.
Three Quarters of Fibromyalgia Patients Reduced Medication
A majority (68%) of patients undergoing RINCE treatment for fibromyalgia reported improvements lasting two years or more for pain; 56% had improved sleep, 60% were suffering less fatigue, and 76% had reduced their reliance on pain medications or eliminated these drugs entirely. Almost three-quarters (71%) of the respondents reported less need (or no need) to see their physicians for fibromyalgia-related queries or assistance. Only a single patient had begun a new drug for their condition after the therapy, with the others apparently feeling no need to do so.
Adverse Effects of New Fibromyalgia Treatment
In terms of adverse effects of the therapy, around 5% of patients reported an initial headache that rapidly resolved. This percentage was similar for the sham group, however. Hopefully, the lack of side-effects and the significant improvements reported in this study will help patients access RINCE treatment for fibromyalgia and have their insurance cover such therapy. Currently, treatment using repetitive transcranial magnetic stimulation (rTMS), to which RINCE has been compared, is not usually covered by insurance. There are, however, significant differences between rTMS and RINCE.
RINCE vs rTMS for Fibromyalgia
rTMS is approved for drug-resistant depression and attempts to induce current in the cortical tissue through the use of magnetic pulses. RINCE uses direct application of current and so avoids the problems that accompany the large magnets required in rTMS. rTMS is not approved for use in pain syndromes whereas this latest study suggests RINCE could be a helpful addition to current treatments for pain disorders. Electrostimulation for fibromyalgia may help patients with neck pain from fibromyalgia and generalized musculoskeletal pain reduce their symptoms, reduce or eliminate pain medications, lessen the frequency of visits to their physician and claim back some of their independence and quality of life. Although this research provides hope for patients, larger studies of RINCE treatment for fibromyalgia are likely to be carried out before FDA approval is forthcoming.
American Academy of Pain Management (AAPM) 23rd Annual Clinical Meeting. Poster Abstract 42. Presented September 22, 2012.