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Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes

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ClinicalTrials.gov Identifier: NCT01154647
Recruitment Status : Unknown
Verified April 2010 by Vrije Universiteit Brussel.
Recruitment status was:  Not yet recruiting
First Posted : July 1, 2010
Last Update Posted : July 1, 2010
Research Foundation Flanders
Universiteit Antwerpen
University Hospital, Antwerp
Artesis University College, Antwerp
Information provided by:
Vrije Universiteit Brussel

Brief Summary:

Both patients with peripheral structural pathologies, like rheumatoid arthritis (RA)-patients, or patients with central sensitivity syndromes (CSS) suffer chronic pain. CSS are characterized by an increased responsiveness of central pain neurons. An impaired endogenous pain inhibition is already demonstrated in CSS. In the present study the investigators want to evaluate the efficacy of pain inhibition in response to physical stressors and whether the efficacy is opioid-mediated in two chronic pain populations (RA & CCS) compared to controls.

Therefore a triple-blinded randomized controlled trial (RCT) with cross-over design will be performed. The efficacy of wind-up of pain and spatial summation of pain is evaluated before and after a submaximal exercise, while the experimental group receives a selective serotonin reuptake inhibitor. Participants are 20 RA-patients and 20 CSS-patients, more specific patients with fibromyalgia and chronic fatigue syndrome, and 30 healthy controls. This way, the investigators analyze how pain inhibition reacts on different types of physical stressors in different pain patients and if pain inhibition is opioid-mediated.

Condition or disease Intervention/treatment Phase
Fatigue Syndrome, Chronic Fibromyalgia Arthritis, Rheumatoid Drug: citalopram Drug: 1 ml 0.9 % NaCl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012

Arm Intervention/treatment
Experimental: selective serotonin reuptake inhibitor
intravenous, acute, 20mg/ml
Drug: citalopram

Placebo Comparator: 1 ml 0.9 % NaCl Drug: 1 ml 0.9 % NaCl

Primary Outcome Measures :
  1. Pain rates according to a visual analogue scale upon repeated pulses at pressure pain detection threshold intensity [ Time Frame: 5 minutes before and after exercise ]

    Temporal summation is elicited with 10 pulses of the algometer at pressure pain detection threshold intensity on the dorsal surface of the right hand middle finger midway between the first and the second digital joints, and at the trapezius. Subjects are instructed to rate the pain level of the 1st, 5th and 10th pulse according to a visual analogue scale (VAS).

    To assess spatial summation an occlusion cuff inflated to a painful intensity and maintained at that level while repeated algometer pulses are administered and pain ratings are recorded again.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Each study participant should be aged between 18 and 65 years. All three groups will be comparable for age, gender, education level and socioeconomic status; both patient groups will be comparable for illness duration.
  • The Central Sensitivity Syndrome (CSS) group will comply with the diagnostic criteria for Fibromyalgia (FM) as defined by the American College of Rheumatology and the Centre of Disease Control criteria for Chronic Fatigue Syndrome (CFS).
  • At the time of study participation, healthy control subjects cannot suffer any pain complaints. Sedentary is defined as a sedentary job and < 3 h moderate physical activity/week. Moderate physical activity is defined as activity demanding at least the threefold of the energy spent passively.
  • Patients have to be able to cycle on a bicycle ergometer.

Exclusion Criteria:

  • In order to preclude confounding factors, participants cannot be pregnant (pregnancy test) or until 1 year postnatal and will be asked to stop medication two weeks prior to study participation, not to undertake physical exertion, and to refrain from consuming caffeine, alcohol or nicotine on the day of the experiment. For ethical reasons, Rheumatoid arthritis(RA)-patients are able to take non-opioid pain medication as described in the 1st step of the World Health Organization analgesic ladder (Non-Steroidal Anti-Inflammatory Drugs and paracetamol).

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): NCT01154647

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Contact: Mira Meeus, PhD 0032 485 58 21 14 mmeeus@vub.ac.be
Contact: Jo Nijs, PhD jo.nijs@vub.ac.be

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University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Contact: Mira Meeus, PhD    0032 485 58 21 14    mmeeus@vub.ac.be   
Principal Investigator: Mira Meeus, PhD         
Sub-Investigator: Jo Nijs, PhD         
Sponsors and Collaborators
Vrije Universiteit Brussel
Research Foundation Flanders
Universiteit Antwerpen
University Hospital, Antwerp
Artesis University College, Antwerp
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meeus, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT01154647    
Other Study ID Numbers: EudraCT 2010-020498-17
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Fatigue Syndrome, Chronic
Arthritis, Rheumatoid
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Virus Diseases
Central Nervous System Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents