Evaluation of a Hyperbaric Oxygen Therapy Intervention in Individuals with Fibromyalgia.

OBJECTIVE: To evaluate the feasibility and safety of hyperbaric oxygen therapy (HBOT) in patients with fibromyalgia (FM). DESIGN: A cohort study with a delayed treatment arm used as a comparator. SETTING: Hyperbaric Medicine Unit, Toronto General Hospital, Ontario, Canada. SUBJECTS: Eighteen patients diagnosed with FM according to the American College of Rheumatology and a score ≥60 on the Revised Fibromyalgia Impact Questionnaire. METHODS: Participants were randomized to receive immediate HBOT intervention (n = 9) or HBOT after a 12-week waiting period (n = 9). HBOT was delivered at 100% oxygen at 2.0 atmospheres per session, 5 days per week, for 8 weeks. Safety was evaluated by the frequency and severity of adverse effects reported by patients. Feasibility was assessed by recruitment, retention, and HBOT compliance rates. Both groups were assessed at baseline, after HBOT intervention, and at 3 months' follow-up. Validated assessment tools were used to evaluate pain, psychological variables, fatigue, and sleep quality. RESULTS: A total of 17 patients completed the study. One patient withdrew after randomization. HBOT-related adverse events included mild middle-ear barotrauma in three patients and new-onset myopia in four patients. The efficacy of HBOT was evident in most of the outcomes in both groups. This improvement was sustained at 3-month follow-up assessment. CONCLUSION: HBOT appears to be feasible and safe for individuals with FM. It is also associated with improved global functioning, reduced symptoms of anxiety and depression, and improved quality of sleep that was sustained at 3-month follow-up assessment.

Hyperbaric oxygen and focused rehabilitation program: a feasibility study in improving upper limb motor function after stroke.

Neuroplasticity and recovery after stroke can be enhanced by a rehabilitation program pertinent to upper limb motor function exercise and mental imagery (EMI) as well as hyperbaric oxygen therapy (HBOT). We assessed feasibility and safety of the combined approach utilizing both HBOT and EMI, and to derive preliminary estimates of its efficacy. In this randomized controlled trial, 27 patients with upper extremity hemiparesis at 3-48 months after stroke were randomized to receive either a complementary rehabilitation program of HBOT-EMI (intervention group), or EMI alone (control group). Feasibility and safety were assessed as total session attendance, duration of sessions, attrition rates, missing data, and intervention-related adverse events. Secondary clinical outcomes were assessed with both objective tools and self-reported measures at baseline, 8 weeks (end of treatment), and 12-weeks follow-up. Session attendance, duration, and attrition rate did not differ between the groups; there were no serious adverse events. Compared with baseline, there were significant sustained improvements of objective and subjective outcomes' measures in the intervention group, and a single improvement in an objective measure in the control group. Between-group outcome comparisons were not statistically significant. This study demonstrated that the combination HBOT-EMI was a safe and feasible approach in patients recovering from chronic stroke. There were also trends for improved motor function of the affected upper limb after the treatments. ClinicalTrials.gov registration no.: NCT02666469. Novelty HBOT combined with an upper limb exercise and mental imagery rehabilitation program is feasible and safe in chronic stroke patients. This combined approach showed trends for improved functional recovery.