Fibromyalgia (FM) is a debilitating and chronic condition affecting up to 10 million adults in the United States alone, and an estimated 225 million adults worldwide. Of those afflicted, 75% are women who are diagnosed between the age of 20 and 50 years (National Fibromyalgia and Chronic Pain Association [NFMCPA], 2013). Individuals with FM typically experience widespread and exaggerated pain as well as cognitive difficulties, sleep disturbances, fatigue, headaches, dizziness, depression, and impaired coordination. These individuals often report comorbidities such as irritable bowel syndrome, interstitial cystitis, migraines, and restless leg syndrome (NFMCPA, 2013). In an internally supervised, private, and unpublished study, Vital Motion Inc. sought to assess the effects of plantar stimulation therapy, using the company’s VM-100, or ‘Hummingbird’™ device with FM subjects referred for the study by local FM support group leaders from multiple locations in the U.S.
Following completion of extensive survey questionnaires and satisfaction of exclusion and inclusion criteria, FM subjects were supplied with identical Vital Motion plantar stimulation devices and a research protocol that included 1 to 2 sessions daily of 30 minutes each using the device. Some subjects completed 4 weeks of daily use, others completed 6 weeks. Each subject agreed to wear a pedometer during all waking hours during the weeks of the study. Each week, either via the internet or via email each subject completed surveys assessing activity, symptom frequency and severity, anxiety/depression, impact of symptoms on function, sleep quality and orthostatic tolerance. In addition, a quantitative assessment of activity was measured via pedometer readings showing the number of steps taken in each previous week. Survey questions as noted above included the following validated questionnaires: Hospital Anxiety and Depression Scale (HADS), Symptom Inventory (measuring frequency and severity of symptoms), Symptom Impact Questionnaire –Revised (SIQR), Wood Mental Fatigue Inventory (WMFI), PROMIS sleep quality scale (PSQ), SF-36 Physical Function Subscale ((SF-36 PF) and an Orthostatic Grading scale (OGS). Survey results were logged each week and degree of improvement or non-improvement of each symptom set was recorded and compared with pre-study readings or answers.
A total of 31 fibromyalgia subjects were invited to join the study. 20 subjects participated and completed at least 4 weeks of the protocol. 8 subjects declined to participate, and the other 3 failed to complete 2 weeks of the study protocol, although 2 of these 3 showed symptom improvements during the one week they did participate. Of the 20 subjects completing the study, each answered at least 4 weekly surveys containing a cumulative total over the weeks of the study of 151 questions about symptom status or improvement. 120 of the subjects’ answers to these 151 questions reported symptom improvement and only 31 answers reported no improvement. Of the 20 subjects completing at least 4 weeks, all 20 showed symptom improvement, with an average reported degree of symptom improvement as measured by the SIQR of 34.7% compared to their answers prior to beginning the study protocol. When averaging the reported results from only the 15 subjects experiencing the most improvements, the average reported SIQR degree of improvement was 43.2%. The quantitative results from the pedometers worn during waking hours by each subject and measuring their steps taken were as follows: 17 of the 20 subjects reported their pedometer readings each week. The average increase in the number of reported steps taken in the last week of the study compared to week 1 was a 56.3% increase. The average for only the 12 of these subjects reporting the greatest increase in steps was a 72.0% increase in the number of steps taken in the last week compared with the first week.
The company, Vital Motion Inc., achieved its goals, in this privately conducted study, of verifying the appropriateness of the unique design and functional features of its Class I medical device invented and designed solely for use as a plantar stimulation device to induce stimulation of the soleus muscles in the calf. The outcomes reported by participating subjects, to the extent that the common features this private study shared with some of the features of the earlier published clinical study by Binghamton University’s Nursing School using a predecessor device on fibromyalgia subjects for plantar stimulation, yielded comparable results to those reported in the Binghamton study. Use of this device for users with symptoms common to fibromyalgia symptoms was supported by the private study’s results. Erik Hiester, M.S., D.O., who was a principal investigator of the published Binghamton study, designed the protocols for this study and supervised the conduct of the study with each participating subject.
(This company-sponsored study was not independently supervised nor was it published in any research journal. It was conducted to test and to derive suggestions for improvement in the company’s plantar and soleus muscle stimulation product, and does not qualify, therefore, as a clinical research study and no claims are made based upon the data collected or upon the study results.)