Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? (MTF)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborators:
University of California, Davis
Rambam Health Care Campus
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01268631
First received: December 29, 2010
Last updated: December 30, 2010
Last verified: December 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Fibromyalgia |
Drug: Duloxetine Drug: Pregabalin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Mechanism-based Choice of Therapy: Can Treatments Success in Fibromyalgia Patients be Coupled to Psychophysical Pain Modulation Profile? |
Resource links provided by NLM:
Further study details as provided by Tel-Aviv Sourasky Medical Center:
Primary Outcome Measures:
- correlations between pain modulation and drug effect [ Time Frame: 2 years ] [ Designated as safety issue: No ]This will be explored for each stage, and in relation to clinical pain and the other pain variables such as hyperalgesia
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
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 |
| Study First Received: | December 29, 2010 |
| Last Updated: | December 30, 2010 |
| Health Authority: | Israel: Ministry of Health |
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 Duloxetine Pregabalin Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Analgesics Sensory System Agents Peripheral Nervous System Agents Anticonvulsants |
ClinicalTrials.gov processed this record on June 17, 2013