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

NCT01268631 | Unknown

• 1 other identifier: 0368-10-TLV
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Pain modulation

Outcome Measures

Primary Outcomes (1)

• correlations between pain modulation and drug effect

  This will be explored for each stage, and in relation to clinical pain and the other pain variables such as hyperalgesia

  2 years

Study Arms (2)

Duloxetine

ACTIVE COMPARATOR

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; Drug: Pregabalin

Pregabalin

ACTIVE COMPARATOR

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; Drug: Pregabalin

Interventions

Duloxetine DRUG

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.

Duloxetine; Pregabalin

Pregabalin DRUG

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.

Duloxetine; Pregabalin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• University of California, Davis: collaborator
• Rambam Health Care Campus: collaborator

Study Sites (1)

Rheumatology Institute, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (5)

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 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.

  PMID: 16540248 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.

  PMID: 12621382 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.

  PMID: 2306288 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.

  PMID: 8724306 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine Hydrochloride; Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jacob N Ablin, MD

CONTACT

97236973668; kobby.ablin@gmail.com

David Yarnitsky, MD

CONTACT

972-4-8542605; d_yarnitsky@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: December 31, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 31, 2010

Record last verified: 2010-12

Locations

IL (1)