Mechanism and Treatment of Sympathetically Maintained Pain
Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Complex Regional Pain Syndrome (CRPS)
Intervention: phenylephrine and clonidine (Drug); punch biopsy (Other)
Phase: N/A
Status: Recruiting
Sponsored by: The Cleveland Clinic Overall contact: Michael Stanton Hicks, MD, Phone: 216-445-5995, Email: stantom@ccf.org
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 lgometer iction 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.
Clinical Details
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: expressed pain in patients with sensitivity following nerve traumaexpression of pain association with chronic inflammation in patients with sympathetically maintained pain decrease in pain after topical adrenoceptor blockade.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- CRPS patients
Exclusion Criteria:
- <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
Locations and Contacts
Michael Stanton Hicks, MD, Phone: 216-445-5995, Email: stantom@ccf.org
Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting Michael Stanton Hicks, M.D., Principal Investigator
Additional Information
Starting date: August 2012
Last updated: February 12, 2015
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