drugset / Trial / NCT01268631
Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile?
Unknown
150 enrolled
Tel-Aviv Sourasky Medical Center
Rambam Health Care Campus · collabUniversity of California, Davis · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
Hypothesis: Response to therapy in fibromyalgia can be improved by coupling of specific medications to the individual patterns of dysfunctional pain modulation. Individuals exhibit wide range of pain modulating capabilities that can be assessed by dynamic psychophysical testing. Those that exhibit less efficient endogenous analgesia and/or increased pain summation are known to be more prone to suffer from pain. Tailoring medications to compensate for the specific dysfunctioning modulatory mechanism will improve pain control.
Timeline
- Start
- 2011-01
- Primary completion
- 2013-01
- Completion
- 2013-01
Publications
- Background Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background Granot M, Granovsky Y, Sprecher E, Nir RR, Yarnitsky D. Contact heat-evoked temporal summation: tonic versus repetitive-phasic stimulation. Pain. 2006 Jun;122(3):295-305. doi: 10.1016/j.pain.2006.02.003. Epub 2006 Mar 15.
- Background Skinner MH, Kuan HY, Pan A, Sathirakul K, Knadler MP, Gonzales CR, Yeo KP, Reddy S, Lim M, Ayan-Oshodi M, Wise SD. Duloxetine is both an inhibitor and a substrate of cytochrome P4502D6 in healthy volunteers. Clin Pharmacol Ther. 2003 Mar;73(3):170-7. doi: 10.1067/mcp.2003.28.
- Background Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL, Tugwell P, Campbell SM, Abeles M, Clark P, et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum. 1990 Feb;33(2):160-72. doi: 10.1002/art.1780330203.
- Background Buskila D, Neumann L. Assessing functional disability and health status of women with fibromyalgia: validation of a Hebrew version of the Fibromyalgia Impact Questionnaire. J Rheumatol. 1996 May;23(5):903-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Duloxetine | Small molecule | 60 mg | — |
| Comparator | Pregabalin | Small molecule | 150 mg | — |