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NCT01813149 · ClinicalTrials.gov registry record · NA
Mechanism and Treatment of Sympathetically Maintained Pain
A NA study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- NA
- Development phase
- 128
- Enrollment target
NCT01813149 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 128 participants.
The verdict
NCT01813149, a NA study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- NA
- Development phase
- 128 participants
- Enrollment target
Study Summary
40 CRPS patients will be recruited over a three-year period (target of 160 patients at all sites). Assessment of exclusion criteria will be undertaken during initial recruitment. Exclusion criteria are: \<18 years; a second chronic pain syndrome that would interfere with pain rating; psychiatric comorbidity; pain in both hands or feet; pregnancy or breastfeeding; sympathectomy in the affected limb; use of topical medication; known sensitivity to alpha 1- adrenoceptor agonists or other contraindications. Patients will maintain their regular oral medications throughout the study period. Assessment of sympathetically maintained pain (SMP) will require an intradermal dose of Phenylephrine to rekindle SMP and mechanical hyperalgesia. Clonidine will be used to control for affects of algometer fiction and may inhibit SMP by inhibiting the release of more norepinephrine from sympathetic nerve terminals. Skin biopsies will be obtained under sterile conditions from a site of mechanical or thermal hyperalgesia using a 3mm diameter skin biopsy punch under local anesthesia. Samples from a mirror image site on the contralateral body side will also be taken.
Interventions
- OTHER punch biopsy
- DRUG phenylephrine and clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01813149
The ClinicalTrials.gov registry entry for NCT01813149 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which punch biopsy is the first listed.
NCT01813149 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01813149 about?
NCT01813149 is a clinical study titled "Mechanism and Treatment of Sympathetically Maintained Pain". 40 CRPS patients will be recruited over a three-year period (target of 160 patients at all sites). Assessment of exclusion criteria will be undertaken during initial recruitment. Exclusion criteria are: \<18 years; a second chronic pain syndrome that would interfere with pain rating; psychiatric com...
What is the current status of trial NCT01813149?
This trial is currently terminated. It is a NA study. The enrollment target is 128 participants. The study started on 2012-08. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01813149?
The interventions under investigation include: punch biopsy (OTHER), phenylephrine and clonidine (DRUG).
Who is sponsoring clinical trial NCT01813149?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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