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Capsaicin-Evoked Pain in Patients With CRPS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00468390
Recruitment Status : Completed
First Posted : May 2, 2007
Last Update Posted : October 13, 2008
Sponsor:
Information provided by:
Danish Pain Research Center

Tracking Information
First Submitted Date May 1, 2007
First Posted Date May 2, 2007
Last Update Posted Date October 13, 2008
Study Start Date April 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Capsaicin-Evoked Pain in Patients With CRPS
Official Title Capsaicin-Evoked Pain in Patients With Complex Regional Pain Syndrome
Brief Summary To evaluate the effect of capsaicin in patients with Complex Regional Pain Syndrome.
Detailed Description

Primary outcome parameters: Capsaicin-induced pain and inflammation.

Secondary outcome parameters: Peripheral sensory and autonomic function.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinic
Condition CRPS (Complex Regional Pain Syndromes)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2007)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Age: 18 or older.
  • Pain in arm or hand > 3 months.
  • Diagnosed with CRPS 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT00468390
Other Study ID Numbers Capsaicin in CRPS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Danish Pain Research Center
Collaborators Not Provided
Investigators
Study Chair: Troels S Jensen, MD, DMSc Danish Pain Research Center, Aarhus University Hospital
PRS Account Danish Pain Research Center
Verification Date October 2008