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Clonidine Versus Adenosine to Treat Neuropathic Pain

Phase 2
Completed
Conditions
Pain
Interventions
Registration Number
NCT00349921
Lead Sponsor
Wake Forest University Health Sciences
Brief Summary

The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.

Detailed Description

This study is part of a pain center grant that focuses on how pain, especially chronic neuropathic pain, alters the response to traditional and non-traditional analgesics (pain medications).

Clonidine-a drug commonly used to treat high blood pressure-has been shown to effectively treat neuropathic pain, is FDA-approved for administration via epidural (an injection given in the lower back), and is the third most commonly prescribed drug for chronic intrathecal (an injection into the cerebrospinal fluid) use in people with chronic pain.

Adenosine-a drug commonly administered intravenously (into a vein) to treat certain types of abnormal heart rhythms-has been found to reduce areas of allodynia (pain caused by a stimulus that does not normally cause pain) after intrathecal, but not intravenous administration in people with neuropathic pain.

Intrathecal clonidine relieves pain by actions on a2-adrenoceptors in the spinal cord, whereas adenosine relieves pain by actions on A1 adenosine receptors. Researchers believe that intrathecal adenosine and clonidine may prove to be excellent painkillers for nerve pain. Therefore, the goal of this study is to determine the effects of clonidine and adenosine on nerve pain.

After initial screening, baseline measurements, and training to learn to estimate pain accurately using thermal heat testing, a sample of spinal fluid will be taken from each participant. Participants then will be randomly chosen to receive either clonidine, adenosine, or placebo. After receiving the study medication, participants will be monitored, with their vital signs checked at 30, 60, 120, 180, and 240 minutes.

Duration of the study for participants is 2 weeks, and includes two visits to the research center, each lasting approximately 6 hours.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
24
Inclusion Criteria
  • Patients with complex regional pain syndrome (CRPS), type I involving a lower extremity
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Exclusion Criteria
  • Pregnancy
  • Allergy to clonidine
  • Currently taking clonidine or other direct a2-adrenergic agonists, or taking cholinesterase inhibitors
  • Patients with any serious or unstable medical problems (heart, lung, liver, kidney, or nervous system disease)
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
adenosine first, then clonidineadenosineadenosine given in first injection clonidine given in second injection
clonidine given first, then placeboplaceboplacebo
adenosine given first, then placeboplaceboplacebo
clonidine first, then adenosineclonidineclonidine given in first injection adenosine given in second injection
Primary Outcome Measures
NameTimeMethod
Number Meeting Success Criterionbaseline and 2 hours

Verbal pain report 2 hours post injection compared to baseline verbal pain scores prior to injection

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

The Center for Clinical Research, 145 Kimel Park Drive

🇺🇸

Winston-Salem, North Carolina, United States

Wake Forest University School of Medicine, Medical Center Boulevard

🇺🇸

Winston-Salem, North Carolina, United States

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