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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: Clinical Trial NA study, sponsored by The Cleveland Clinic.
NCT01813149 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 128 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To investigate adrenergically evoked pain, 50 mg of the a1-AR agonist phenylephrine in 0.1 mL normal saline (equivalent to 2.5mMconcentration was injected intradermally into the most painful region of the dorsal and or foot and into a mirror-image site in the contralateral limb. Pain induced by the intradermal injection of phenylephrine into the contralateral limb of patients with CRPS usually resolved within 5 to 10 minutes. Therefore, pain that persisted for 15 minutes or longer (in the CRPS-a
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 |
Why NCT01813149 stopped before completion
NCT01813149 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which punch biopsy is the first listed.
NCT01813149 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01813149's enrollment target sits among peer trials
128 744th of 2000 higher than 1,252 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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