Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes

Fibromyalgia Clinical Trial

Official title:

Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01154647
• Other study ID #: EudraCT 2010-020498-17
• Status: Not yet recruiting
• Phase: N/A
• First received: June 28, 2010
• Last updated: June 30, 2010
• Start date: September 2010

Study information

• Verified date: April 2010
• Source: Vrije Universiteit Brussel
• Contact: Mira Meeus, PhD
• Phone: 0032 485 58 21 14
• Email: mmeeus[@]vub.ac.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fatigue Syndrome, Chronic
• Fibromyalgia
• Syndrome

Intervention

Drug:
• citalopram
intravenous
• 1 ml 0.9 % NaCl
intravenous

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (5)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel	Artesis University College, Antwerp, Research Foundation Flanders, Universiteit Antwerpen, University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain rates according to a visual analogue scale upon repeated pulses at pressure pain detection threshold intensity	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.	5 minutes before and after exercise	Yes