Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
Recruitment status was Not yet recruiting
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.
Fatigue Syndrome, Chronic
Drug: 1 ml 0.9 % NaCl
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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|
- 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 ] [ Designated as safety issue: Yes ]
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.
|Study Start Date:||September 2010|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: selective serotonin reuptake inhibitor
intravenous, acute, 20mg/ml
|Placebo Comparator: 1 ml 0.9 % NaCl||
Drug: 1 ml 0.9 % NaCl
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154647
|Contact: Mira Meeus, PhD||0032 485 58 21 email@example.com|
|Contact: Jo Nijs, PhDfirstname.lastname@example.org|
|University Hospital Antwerp||Not yet recruiting|
|Edegem, Antwerp, Belgium, 2650|
|Contact: Mira Meeus, PhD 0032 485 58 21 14 email@example.com|
|Principal Investigator: Mira Meeus, PhD|
|Sub-Investigator: Jo Nijs, PhD|