Fibromyalgia Clinical Trial
Official title:
Nitrous Oxide as Treatment for Fibromyalgia
The purpose of this study is to explore a potential role of nitrous oxide in treating pain associated with fibromyalgia.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 1, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 2016 American College of Rheumatology Revised criteria for fibromyalgia (2016-ACR) - Subjects 18 -75 years of age. - Self-reported pain of at least 4 on the Numeric Pain Rating Scale (NPRS) at screening and baseline. - Subject receives and agrees to remain on their stable fibromyalgia treatment plan established at least 4 weeks prior to dosing. Stable means no change in dose or any pain medication. - Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments - If currently on psychotherapy, it must have been maintained at the same frequency for 4 weeks prior to treatment. Exclusion Criteria: - Unstable doses of allowed antidepressants or muscle relaxants or dosages for any other medical condition. - Pain due to concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, or other chronic widespread pain condition(s) that may confound fibromyalgia pain. - Psychiatric or cognitive disorder (e.g., current schizophrenia, severe depression, suicidal ideation, dementia, etc.) that the investigator or sponsor considers significant for this study. - Clinically significant alcohol or other substance abuse within the last 2 years, in the opinion of the investigator. - Current or recent history of medically inappropriate or illegal use of drugs of abuse including benzodiazepines, opiates, cocaine, cannabinoids, and amphetamines. - Current treatment with N-methyl-D-aspartate receptor (NMDAR) ligands including ketamine, amantadine, dextromethorphan, memantine, methadone, or dextropropoxyphene. - Subjects who are pregnant, breast feeding, or planning to become pregnant during the course of the study and for 28 days after the final administration of investigational product. - Any other serious medical condition affecting heart, lung or any other organ system. - Any impairment, activity or situation that in the judgment of the investigator would prevent satisfactory completion of the study protocol. |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Arnold LM, Clauw DJ, Dunegan LJ, Turk DC; FibroCollaborative. A framework for fibromyalgia management for primary care providers. Mayo Clin Proc. 2012 May;87(5):488-96. doi: 10.1016/j.mayocp.2012.02.010. — View Citation
Clauw DJ, Arnold LM, McCarberg BH; FibroCollaborative. The science of fibromyalgia. Mayo Clin Proc. 2011 Sep;86(9):907-11. doi: 10.4065/mcp.2011.0206. — View Citation
Graven-Nielsen T, Kendall SA, Henriksson KG, Bengtsson M, Sorensen J, Johnson A, Gerdle B, Arendt-Nielsen L. Ketamine reduces muscle pain, temporal summation, and referred pain in fibromyalgia patients. Pain. 2000 Apr;85(3):483-491. doi: 10.1016/S0304-3959(99)00308-5. — View Citation
Jevtovic-Todorovic V, Todorovic SM, Mennerick S, Powell S, Dikranian K, Benshoff N, Zorumski CF, Olney JW. Nitrous oxide (laughing gas) is an NMDA antagonist, neuroprotectant and neurotoxin. Nat Med. 1998 Apr;4(4):460-3. doi: 10.1038/nm0498-460. — View Citation
Nagele P, Metz LB, Crowder CM. Nitrous oxide (N(2)O) requires the N-methyl-D-aspartate receptor for its action in Caenorhabditis elegans. Proc Natl Acad Sci U S A. 2004 Jun 8;101(23):8791-6. doi: 10.1073/pnas.0402825101. Epub 2004 May 24. — View Citation
Noppers I, Niesters M, Swartjes M, Bauer M, Aarts L, Geleijnse N, Mooren R, Dahan A, Sarton E. Absence of long-term analgesic effect from a short-term S-ketamine infusion on fibromyalgia pain: a randomized, prospective, double blind, active placebo-controlled trial. Eur J Pain. 2011 Oct;15(9):942-9. doi: 10.1016/j.ejpain.2011.03.008. Epub 2011 Apr 11. — View Citation
Sorensen J, Bengtsson A, Ahlner J, Henriksson KG, Ekselius L, Bengtsson M. Fibromyalgia--are there different mechanisms in the processing of pain? A double blind crossover comparison of analgesic drugs. J Rheumatol. 1997 Aug;24(8):1615-21. — View Citation
Sorensen J, Bengtsson A, Backman E, Henriksson KG, Bengtsson M. Pain analysis in patients with fibromyalgia. Effects of intravenous morphine, lidocaine, and ketamine. Scand J Rheumatol. 1995;24(6):360-5. doi: 10.3109/03009749509095181. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | AEs such as nausea and vomiting; or any other AEs determined probably, possibly, or unrelated to the study intervention.
Study patient safety is monitored by the investigators (MD) with experience in critical care anesthesia, as well as an experienced clinical research team responsible for recording and reporting events. |
Over 8-weeks (length of study participation) | |
Primary | Monitor changes in NPRS score | Monitoring changes in 'Numeric Pain Rating Scale' (NPRS) diagnostic score to determine effectiveness a 60-minute session of inhaled 50% nitrous oxide vs placebo has on symptoms associated with fibromyalgia.
The NPRS is a validated self-report diagnostic asking patients to indicate the intensity of current, best, and worst pain levels over the past 24 hours on a scale of 0 (no pain) to 10 (worst pain imaginable). Response and remission will be based on a 30% improvement in average daily mean (max and min) NPRS score. |
Over 8-weeks from baseline (length of study participation) | |
Secondary | Changes in FIQR | Evaluation of response and remission will be based on 'Fibromyalgia Impact Questionnaire-Revised' (FIQR).
This validated self-report diagnostic contains 21-questions to rate fibromyalgia effects over the prior 7-days. Domain 1: 9-questions rating function: 'No difficulty = 0' to 'Very difficult = 10' Domain 2: 2-questions rating overall impact: 'Never = 0' to 'Always = 10' Domain 3: 10-questions rating symptom intensity: 'None = 0' to 'Worst = 10' First: Sum the scores for each of the 3 domains (function, overall, and symptoms). Second: Divide domain 1 score by 3, leave domain 2 score unchanged, and divide domain 3 score by 2. Third: Add the 3 resulting domain scores to obtain the total FIQR score. |
Over 8-weeks from baseline (length of study participation) | |
Secondary | Changes in Global Impression of Change Scale | The Global Impression of Change Scale (PGI-C), a two question, self-report diagnostic evaluating the patients belief of treatment efficacy.
- Patients rate their neuropathic pain ['No pain = 0' to 'Worst = 10'], and evaluate treatment effectiveness ['Very Much Improved'; 'Much Improved'; 'Minimally'; 'Improved'; 'No Change'; 'Minimally Worse'; 'Much Worse'; 'Very Much Worse'] |
Over 8-weeks from baseline (length of study participation) | |
Secondary | Computerize Adaptive Testing - Mental Health (CAT-MH) measurements | This CAT-MH is a validated self-reporting diagnostic that adaptively selects a small optimal set of items from a large bank of approximately 1,500 items, targeted to individuals current or historical level of severity and likelihood of 'depression'.
Generated scores include severity and liklihood percentile: depression = (%) normal, mild, moderate, severe |
Over 8-weeks from baseline | |
Secondary | Hospital Anxiety and Depression Scale | The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire comprising of 14-questions (7-anxiety and 7-depression), with response scores ranging: '0' to '3'
Sum Depression scores = 0 to 21 Sum Anxiety scores = 0 to 21 Score range for each item (depression and anxiety): 0-7 = Normal 8-10 = Borderline abnormal (mild) 11-14 = Abnormal (moderate) 15-21 = Severe |
Over 8-weeks from baseline (length of study participation) |
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