Discussion
fatigue, abdominal pain, Brain Injury, FMS pain, pain, TBI FMS, TBI, non-pain, FMS
CHRONIC DISORDER, SECONDARY, DISORDERS, FMS
The current study presents a prospective, active—control clinical trial, evaluating the effect of HBOT on FMS patients following Traumatic Brain Injury (TBI). We found that HBOT induced significant improvements in all FMS pain measures, quality of life, emotional and social function. The clinical changes were correlated with increased brain activity in the frontal and parietal regions, which extends previous findings and provides additional information regarding the etiology and treatment of FMS.Chronic widespread pain is the central defining feature of FMS and thus pain intensity was chosen as the primary endpoint of the current study. The significant improvement in VAS—pain intensity documented in patients treated with HBOT compared to the standard of pharmacological care, implies a meaningful and significant effect on the core symptom of FMS. Although VAS is a subjective marker which has several limitations, it is considered the standard endpoint in pain—related disorders in general and in FMS studies in particular. While the effect on pain was evident in the primary endpoint, it was also evident in pain-related secondary outcomes, including the FMS diagnostic criteria, SF-36 pain domain and the GPS. Notably, the WPI significantly improved in the HBOT group compared to baseline, while no improvement was notice in the control group, however this improvement did not reach statistical significance on ANOVA analysis (Highly significant improvement was observed following HBOT in outcome measures related to function, including the FIQ, which is the standard tool used for measuring the functional impact of FMS, as well as on the "Social function" component of the SF-36. The physical functioning and physical limitations components of the SF-36 were also significantly improved. Levels of energy and emotional wellbeing were found to be significantly increased as well. Moreover, a significant improvement was found in the Symptom severity scale (SSS), a tool which aggregates the non-pain related functional symptoms of FMS such as fatigue, dyscognition, abdominal pain and others. Taken together, these findings indicate that the beneficial effects of HBOT in the population of post–TBI FMS patients extend well beyond pain–reduction In the current study, we chose both pressure pain threshold (PPT) as well as Conditioned pain modulation (CPM) in order to evaluate the psychophysical effects of HBOT. While PPT has frequently been used in order to diagnose FMS, as well as in order to measure response to treatment [In the current study, functional neuroimaging was performed using brain—SPECT testing with ECD as a marker for brain activity. This method has been used extensively in previous research for evaluating brain activity and perfusion patterns in FMS and changes in response to treatment [SPECT imaging has been used extensively in previous research for evaluating brain activity and perfusion patterns in FMS, and treatment response [Several limitations are worthy of mention regarding the current study. First, we do not have data regarding the long-term effects of HBOT treatment in our patient population. FMS is considered a chronic disorder, and while the effects of HBOT appear to be robust, further information will be necessary regarding the long-term effects of treatment. Second, the HBOT protocol used in this study included 60 daily sessions of HBOT. This protocol was found to have a significant neuroplasticity effect in previous studies; however, it might be possible that different protocols can be used for different patients in order to optimize the outcome per patient and further studies are needed to address this possibility. Third, the comparison group was treated with FMS medications, rather than a sham controlled intervention. Lastly, as the neuroscience of FMS continues to unravel, significant insight is being gained through implementation of additional functional neuroimaging, including fMRI [