Evaluation of Autonomic Cardiac Function in Patients With... | NCT00560131

Studies
Evaluation of Autonomic Cardiac Function in Patients With CRPS

NCT00560131

Sponsor

Danish Pain Research Center

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

CRPS (Complex Regional Pain Syndromes)

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Jan 2008Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 10, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Measure	Description	Time Frame
Autonomic cardiac function		2 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Other significant disease affecting the parameters measured, including cardiovascular disease.
Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Troels S Jensen, MD, DMSc	Danish Pain Research Center, Aarhus University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Pain Research Center, Aarhus University Hospital		Aarhus		8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided