Evaluation of a Hyperbaric Oxygen Therapy Intervention in Individuals with Fibromyalgia K. Curtis, PhD,* J. Katz, PhD, †,‡ C. Djaiani, BSc, § G. O’Leary, MD, FRCPC, ‡ J. Uehling, MS, CCRP, § J. Carroll, BHA, ‡ D. Santa Mina, PhD, ‡,¶ H. Clarke, MD, PhD, FRCPC, ‡,§ M. Gofeld, MD, PhD, FRCPC, k and R. Katznelson, MD, FRCPC ‡,§ *Toronto Western Hospital, University Health Network, Toronto, Ontario; † Department of Psychology, York University, Toronto, Ontario; ‡ Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, Ontario; § Hyperbaric Medicine Unit, Toronto General Hospital, University Health Network, Toronto, Ontario; ¶ Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario; k Silver Medical Group, North York, Toronto, Ontario, Canada Correspondence to: Rita Katznelson, MD, FRCPC, Hyperbaric Medicine Unit, Toronto General Hospital, 200 Elizabeth St, Toronto, ON, M5G2C4, Canada. Tel: 416-340-4800 ext. 6873; Fax: 416-340-4481; E-mail: rita.katznelson@uhn.ca. Funding sources: Funding for this study was received from the Department of Anesthesia and Pain Management, University Health Network, Toronto, Ontario, Canada. Conflicts of interest: None of the authors declare any conflicts of interest. Trial registration: ClinicalTrials.gov identifier NCT02467218. Abstract 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 ¼ 9) or HBOT after a 12-week waiting period (n ¼ 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 vari- ables, 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. Key Words: Hyperbaric Oxygen; Fibromyalgia Introduction Fibromyalgia (FM) is a chronic pain disorder affecting 1.2% of the Canadian population [1]. It is characterized by widespread body pain and symptoms such as fatigue, cognitive impairment, disturbed (nonrestorative) sleep, depression, anxiety, stiffness, tenderness, and functional limitations [2]. FM is a potentially devastating disorder leading to disability, emotional distress, and significant personal, social, and economic burden [3]. The diagnosis of FM relies on an evaluation of the individual’s self-reported symptoms, past medical history and physical examination, and the clinical judgment of V C The Author(s) 2021. Published by Oxford University Press on behalf of the American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com 1324 Pain Medicine, 22(6), 2021, 1324–1332 doi: 10.1093/pm/pnaa416 Advance Access Publication Date: 16 February 2021 Original Research Article Downloaded from https://academic.oup.com/painmedicine/article/22/6/1324/6140166 by guest on 17 July 2022