Fatigue Syndrome, ChronicNCT01154647
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
A study testing citalopram and 1 ml 0.9 % NaCl in people with Fatigue Syndrome, Chronic and Fibromyalgia, run by Vrije Universiteit Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue Syndrome, Chronic, Fibromyalgia, Arthritis, Rheumatoid
- What is being tested?
- citalopram and 1 ml 0.9 % NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Jo Nijs, PhD contact
Belgium1 site
University Hospital Antwerp
Edegem, Antwerp, 2650
Mira Meeus, PhD, 0032 485 58 21 14, mmeeus@vub.ac.be
Mira Meeus, PhD
About this study
Official title: Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission
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.
- Being tested
- citalopram, 1 ml 0.9 % NaCl
- Medical subject headings
- Fatigue Syndrome, Chronic, Fibromyalgia, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopramDrug
intravenous
1 ml 0.9 % NaClDrug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| selective serotonin reuptake inhibitor | Experimental | intravenous, acute, 20mg/ml Receives: Drug: citalopram |
| 1 ml 0.9 % NaCl | Placebo comparator | Not described Receives: Drug: 1 ml 0.9 % NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes before and after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, Universiteit Antwerpen, University Hospital, Antwerp, Artesis University College, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154647
- Sponsor's protocol ID
- EudraCT 2010-020498-17
- Status last verified
- Apr 2010
- First submitted
- 28 Jun 2010
- Last updated
- 1 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Meeus M, Hermans L, Ickmans K, Struyf F, Van Cauwenbergh D, Bronckaerts L, De Clerck LS, Moorken G, Hans G, Grosemans S, Nijs J. Endogenous pain modulation in response to exercise in patients with rheumatoid arthritis, patients with chronic fatigue syndrome and comorbid fibromyalgia, and healthy controls: a double-blind randomized controlled trial. Pain Pract. 2015 Feb;15(2):98-106. doi: 10.1111/papr.12181. Epub 2014 Feb 17.
PubMed 24528544
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling Impaired Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes: a Series of Experiments Targeting Brain Neurotransmission
- ClinicalTrials.gov ID
- NCT01154647
- Acronym / sponsor ID
- EudraCT 2010-020498-17
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, Universiteit Antwerpen, University Hospital, Antwerp, Artesis University College, Antwerp
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| selective serotonin reuptake inhibitor | Experimental | Drug: citalopramintravenous, acute, 20mg/ml |
| 1 ml 0.9 % NaCl | Placebo comparator | Drug: 1 ml 0.9 % NaCl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| citalopramintravenous | Drug | selective serotonin reuptake inhibitor |
| 1 ml 0.9 % NaClintravenous | Drug | 1 ml 0.9 % NaCl |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2010.
- Derived from this study: PubMed 24528544Meeus M, Hermans L, Ickmans K, Struyf F, Van Cauwenbergh D, Bronckaerts L, De Clerck LS, Moorken G, Hans G, Grosemans S, Nijs J. Endogenous pain modulation in response to exercise in patients with rheumatoid arthritis, patients with chronic fatigue syndrome and comorbid fibromyalgia, and healthy controls: a double-blind randomized controlled trial. Pain Pract. 2015 Feb;15(2):98-106. doi: 10.1111/papr.12181. Epub 2014 Feb 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Nijs, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citalopram and 1 ml 0.9 % NaCl in people with Fatigue Syndrome, Chronic and Fibromyalgia, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mira Meeus, PhD (0032 485 58 21 14, mmeeus@vub.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01154647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2010.