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Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? (MTF)

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ClinicalTrials.gov Identifier: NCT01268631
Recruitment Status : Unknown
Verified December 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2010
Last Update Posted : December 31, 2010
Sponsor:
Collaborators:
University of California, Davis
Rambam Health Care Campus
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief 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.


Condition or disease Intervention/treatment
Fibromyalgia Drug: Duloxetine Drug: Pregabalin

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile?
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Duloxetine
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks. The assessing person will contact patients by phone every week during the treatment period to receive the pain score for the last 24 hours, so we will have an indication of the effect among patients will discontinue medication. Patients will be asked to visit the clinic during the last week of treatment, for assessment of clinical pain (questionnaires) and pain modulation.
Drug: Duloxetine
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks. The assessing person will contact patients by phone every week during the treatment period to receive the pain score for the last 24 hours, so we will have an indication of the effect among patients will discontinue medication. Patients will be asked to visit the clinic during the last week of treatment, for assessment of clinical pain (questionnaires) and pain modulation.
Drug: Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 4 weeks. Drug should not be taken with meals. Same protocol will be applied as for Duloxetine.
Active Comparator: Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 4 weeks. Drug should not be taken with meals. Same protocol will be applied as for Duloxetine.
Drug: Duloxetine
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks. The assessing person will contact patients by phone every week during the treatment period to receive the pain score for the last 24 hours, so we will have an indication of the effect among patients will discontinue medication. Patients will be asked to visit the clinic during the last week of treatment, for assessment of clinical pain (questionnaires) and pain modulation.
Drug: Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 4 weeks. Drug should not be taken with meals. Same protocol will be applied as for Duloxetine.



Primary Outcome Measures :
  1. correlations between pain modulation and drug effect [ Time Frame: 2 years ]
    This will be explored for each stage, and in relation to clinical pain and the other pain variables such as hyperalgesia



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibromyalgia patients. All patients will undergo physical examination and tender point evaluation to ascertain fulfillment of the ACR 1990 criteria for classification of fibromyalgia (Wolfe et al 1990) i.e. the presence of widespread pain lasting at least 3 months and the presence of tenderness in at least 11 of 18 tender points.

Exclusion Criteria:

  • Age below 18 and above 80
  • Patients with cognitive dysfunction precluding use of psychophysics, those who cannot communicate in Hebrew, abnormal renal function with creatinine above 1.5, and elevated liver enzymes >x3 upper limit. Since the duloxetine has the potential to act as both substrate and an inhibitor of cytochrome P4502D6 (CYP2D6) inhibiting, caution should be used when other CYP2D6 substrates and inhibitors (some tricyclic antidepressants and SSRIs) are coadministered with duloxetine (Skinner et al., 2003). Patients currently treated with Douloxetine, Pregabalin, Gabapentin, Milnacipran, amitryptiline or other SSRIs, NSRIs or tricyclic medications will not be recruited unless they consent to discontinue prior medications for three weeks before enrolment to the study. During this period the use of NSAIDS and common analgesic medication will be permitted.
  • Patients not currently treated with such medications can be recruited.
  • Patients suffering from chronic pain due to a known active malignancy or other localized cause (e.g. fracture, Herpes Zoster etc.) will not be recruited.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268631


Contacts
Contact: Jacob N Ablin, MD 97236973668 kobby.ablin@gmail.com
Contact: David Yarnitsky, MD 972-4-8542605 d_yarnitsky@rambam.health.gov.il

Locations
Israel
Rheumatology Institute, Tel Aviv Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Jacob Ablin, MD    972-3-6973668      
Principal Investigator: Jacob N Ablin, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
University of California, Davis
Rambam Health Care Campus

Publications:
Responsible Party: Jacob Ablin, MD, Director Fibromyalgia clinic, Tel Aviv Sourasky Medical Center, Tel Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01268631     History of Changes
Other Study ID Numbers: 0368-10-TLV
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: December 31, 2010
Last Verified: December 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Fibromyalgia
Pain modulation

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Duloxetine Hydrochloride
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Antidepressive Agents
Dopamine Agents