CRPS (Complex Regional Pain Syndromes)NCT00560131
Evaluation of Autonomic Cardiac Function in Patients With CRPS
An observational study of CRPS (Complex Regional Pain Syndromes), run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
To evaluate the autonomic cardiac function in patients with complex regional pain syndrome Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CRPS (Complex Regional Pain Syndromes)
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2007to Jan 2008
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Age: 18 or older.
- Pain > 3 months.
- Diagnosed with CPRS acc. to diagnostic research criteria (Harder et al., 2005).
- Inclusion of healthy subjects: age-, gender-, and BMI-matched.
Who cannot join
- Other significant disease affecting the parameters measured, including cardiovascular disease.
- Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Evaluation of Autonomic Cardiac Function in Patients With Complex Regional Pain Syndrome
To evaluate the autonomic cardiac function in patients with complex regional pain syndrome
Read the detailed description
Tilt table testing in patients with complex regional pain syndrome: Effects on heart rate variability and baroreceptor sensitivity.
Primary outcome parameter: Autonomic cardiac function
- Conditions
- CRPS (Complex Regional Pain Syndromes)
- Medical subject headings
- Complex Regional Pain Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic cardiac function
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2007 (estimated)
- Study startJun 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRPS (Complex Regional Pain Syndromes)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Investigators
- Troels S Jensen, MD, DMSc, Study chair, Danish Pain Research Center, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560131
- Sponsor's protocol ID
- Cardiac function in CRPS
- Status last verified
- Oct 2008
- First submitted
- 16 Nov 2007
- Last updated
- 13 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic Cardiac Function in Patients With Complex Regional Pain Syndrome
- ClinicalTrials.gov ID
- NCT00560131
- Acronym / sponsor ID
- Cardiac function in CRPS
- Conditions
- CRPS (Complex Regional Pain Syndromes)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Nov 2007 (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.
To evaluate the autonomic cardiac function in patients with complex regional pain syndrome
Detailed description
Tilt table testing in patients with complex regional pain syndrome: Effects on heart rate variability and baroreceptor sensitivity.
Primary outcome parameter: Autonomic cardiac function
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- Age: 18 or older.
- Pain > 3 months.
- Diagnosed with CPRS acc. to diagnostic research criteria (Harder et al., 2005).
- Inclusion of healthy subjects: age-, gender-, and BMI-matched.
Key exclusion criteria (2 listed)
- Other significant disease affecting the parameters measured, including cardiovascular disease.
- Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Autonomic cardiac function
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2008.
Related trials for CRPS (Complex Regional Pain Syndromes)
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Evaluation of IV AMBTX-01 (Neridronate) for Treatment of CRPS Type 1 (CRPS-RISE)
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Recruiting
The Effectiveness of Conservative Treatment in Patients With Complex Regional Pain Syndrome.
CRPS (Complex Regional Pain Syndromes)
RecruitingPhase 3
Phase 3, Open-Label Extension Study of AMBTX-01 (Neridronate) for Complex Regional Pain Syndrome Type 1
Complex Regional Pain Syndrome Type I
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
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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.
Troels S Jensen, MD, DMSc study chair
Danish Pain Research Center, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRPS (Complex Regional Pain Syndromes), run by Danish Pain Research Center at 1 site in Denmark.
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 2 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: finished, as of the sponsor's last update on 13 Oct 2008. 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 Denmark. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic cardiac function (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2008.