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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 trauma

expression 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

Page last updated: August 23, 2015

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