Immune-Pineal Axis Function in Fibromyalgia

January 17, 2014 updated by: Hospital de Clinicas de Porto Alegre

Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects

Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .

Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .

The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.

The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 900035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Contact:
          • Simone de Azevedo Zanette, MD
          • Phone Number: 555133598430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women 18-65 years old
  • Fibromyalgia according to the criteria of the American College of Rheumatology (Wolfe 2010)
  • Sign the informed consent
  • Patients can take medication for chronic pain ( antidepressants , antiepileptics, for example), since there are at least two months

Exclusion criteria:

  • patients who did not understand the Portuguese
  • diagnosis of malignancies, severe psychiatric disorders , sleep disorders not related to fibromyalgia (apnea , sleepwalking , restless leg syndrome), Alzheimer's disease or any disease (rheumatologic, neurological, etc.) that can modify the evaluations or outcomes
  • alcohol abuse or drug addiction
  • patients who are performing acupuncture
  • BMI greater than 35 ( BMI = body mass index) .
  • Patients with history of allergy to amitriptyline or/and melatonin or any other contraindication for the use of these drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Melatonin and Placebo
Melatonin 10mg and placebo, once in the evening, for 6 weeks.
Drug: Melatonin and Placebo
Experimental: Amitriptyline and placebo
Amitriptyline 25mg and placebo, once in the evening, for 6 weeks.
Drug: Amitriptyline and Placebo
Active Comparator: Melatonin and Amitriptylin
Melatonin 10mg and Amitriptylin 25mg, once in the evening, for 6 weeks.
Drug: Melatonin and Amitriptylin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in pain on Fibromyalgia Impact Questionnaire (FIQ) at week 6
Time Frame: Baseline, week 6
Baseline, week 6
Change from Baseline in Pain Pressure Threshold (PPT) at week 6
Time Frame: Baseline, week 6
Pain Pressure Threshold by Fischer algometer on the tender points.
Baseline, week 6
Change from Baseline Brain-derived neurotrophic factor at week 6
Time Frame: Baseline, week 6
Baseline, week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline of the Pittsburgh Sleep Quality Index (PSQI) at week 6
Time Frame: Baseline, week 6
Baseline, week 6
Change from Baseline of the Pain Catastrophizing Scale at week 6
Time Frame: Baseline; week 6
Catastrophic thinking related to pain
Baseline; week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Study Director: Wolnei d Caumo, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

January 16, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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