PRECISE trial (Pain RElief Combination Intervention StratEgies): protocol for the clinical trial of a pregabalin–melatonin combination for fibromyalgia Article Swipe
Ian Gilron
,
Chris DeBow
,
Hala Elkerdawy
,
James S. Khan
,
Tim V. Salomons
,
D. W. Scott
,
Dongsheng Tu
,
Ronald R. Holden
,
Roumen Milev
,
D. Norman Buckley
,
Dwight E. Moulin
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2024-087180
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1136/bmjopen-2024-087180
Introduction Fibromyalgia is associated with chronic widespread pain and disturbed sleep. Multidisciplinary, multimodal management often includes pharmacotherapy; however, current drugs used to treat fibromyalgia provide meaningful benefit to only 30–60% of treated individuals. Combining two or more different drugs is common in clinical practice with the expectation of better efficacy, tolerability or both; however, further research is needed to identify which combinations actually provide added benefit. Thus, we are planning a clinical trial to evaluate melatonin (MLT)–pregabalin (PGB) combination in participants with fibromyalgia. Methods and analysis This will be a single-centre, double-blind, randomised, double-dummy, three-period, crossover trial comparing a MLT–PGB combination to each monotherapy in 54 adult participants satisfying the 2016 American College of Rheumatology criteria for fibromyalgia. Participants will receive maximally tolerated doses of MLT, PGB and MLT–PGB combination for 6 weeks. The primary outcome will be daily pain intensity (0–10); secondary outcomes will include the Fibromyalgia Impact Questionnaire, SF-36 survey, Medical Outcomes Study Sleep Scale, Beck Depression Inventory (BDI-II), adverse events and other measures. Analysis of the primary and secondary outcomes will involve a linear mixed model with sequence, period, treatment, the first-order carryover and baseline pain score as fixed effects and participant as a random effect to test whether there are any treatment differences among three treatments and to estimate the least square mean of the mean daily pain intensity for each treatment, adjusting for carryover as well as period effects (ie, stability of pain levels). Ethics and dissemination This trial has been registered with the International Standard Randomised Controlled Trial Number Registry, ISRCTN #18278231, has been granted ethical approval by the Queen’s University Health Sciences Research Ethics Board (Queen’s HSREB Protocol #6040998) and is currently under review for a Clinical Trial Application to Health Canada Natural and Non-prescription Health Products Directorate. All participants will provide written informed consent prior to trial participation. Following trial completion, results will be disseminated in one or more biomedical journal publications and presented at one or more scientific meetings. Trial registration number This trial has been registered with the International Standard Randomised Controlled Trial Number Registry, ISRCTN18278231 .
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/bmjopen-2024-087180
- https://bmjopen.bmj.com/content/bmjopen/14/6/e087180.full.pdf
- OA Status
- gold
- Cited By
- 5
- References
- 82
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4399927959
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4399927959Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1136/bmjopen-2024-087180Digital Object Identifier
- Title
-
PRECISE trial (Pain RElief Combination Intervention StratEgies): protocol for the clinical trial of a pregabalin–melatonin combination for fibromyalgiaWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-06-01Full publication date if available
- Authors
-
Ian Gilron, Chris DeBow, Hala Elkerdawy, James S. Khan, Tim V. Salomons, D. W. Scott, Dongsheng Tu, Ronald R. Holden, Roumen Milev, D. Norman Buckley, Dwight E. MoulinList of authors in order
- Landing page
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https://doi.org/10.1136/bmjopen-2024-087180Publisher landing page
- PDF URL
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https://bmjopen.bmj.com/content/bmjopen/14/6/e087180.full.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://bmjopen.bmj.com/content/bmjopen/14/6/e087180.full.pdfDirect OA link when available
- Concepts
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Medicine, Fibromyalgia, Pregabalin, Melatonin, Clinical trial, Physical therapy, Alternative medicine, Intervention (counseling), Randomized controlled trial, Protocol (science), Psychiatry, Internal medicine, PathologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
5Total citation count in OpenAlex
- Citations by year (recent)
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2025: 4, 2024: 1Per-year citation counts (last 5 years)
- References (count)
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82Number of works referenced by this work
- Related works (count)
-
10Other works algorithmically related by OpenAlex
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