Research Project Abstracts

Phase I and Pilot Phase II Trial of the Ondamed Biofeedback System in Patients with Pain Disorders

Principal Investigator: Joel S. Edman, DSc.

Although the Ondamed Biofeedback System (Ondamed) has been used internationally for many years as a therapeutic device with many anecdotal reports of benefit, it has not yet been systematically researched.  This pilot study was therefore undertaken to:  (a) examine the safety of Ondamed under more controlled circumstances; and (b) collect pilot data regarding the effectiveness of Ondamed for treating chronic pain.

Eleven subjects with various chronic pain disorders were enrolled in this pilot study.  This has included 10 females and 1 male; average age 62.2 years (range 39-68); with pain disorders varying from fibromyalgia syndrome and migraine headaches to inflammatory disorders such as interstitial cystitis and polymyalgia rheumatica, to pain syndromes of the low back, spine, neck and hand, stemming from a variety of causes.  For pain management, subjects were taking a variety of medications at specified doses.

There were three Ondamed therapy sessions for each subject at weekly intervals (approximate treatment duration 30 minutes each).  Treatments included standard individualized organ specific frequencies and 2 pre-set programs, using the specified vascular autonomic signal (VAS) technique.

The results of the subjects’ treatments were that there were no outward signs of adverse events in the eight subjects who were treated in the Phase I trial.  Also, results for the pilot efficacy study were that 3 of the 11 subjects reported significant improvement in pain levels.  These results suggest that the Ondamed Biofeedback System appears to be safe for the treatment of pain under stable conditions.  Ondamed treatment is also helpful for pain in a percentage of subjects that suggests that it is a viable treatment option.  Significant future research is required to:  (a) identify those patients who are most likely to benefit from Ondamed treatment; (b) clarify mechanisms through which Ondamed is helpful; and (c) develop specific and reliable clinical treatment protocols.