Mechanism and Treatment of Sympathetically Maintained Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by The Cleveland Clinic
Sponsor:
Collaborator:
NHMRC - Murdoch University
Information provided by (Responsible Party):
Michael Stanton Hicks, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01813149
First received: March 12, 2013
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Complex Regional Pain Syndrome (CRPS)
Drug: phenylephrine and clonidine
Other: punch biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • expressed pain in patients with sensitivity following nerve trauma [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Determine whether this neural expression is altered in the skin of a subgroup of patients whose pain is associated with increased adrenergic sensitivity after nerve trauma.

  • expression of pain association with chronic inflammation in patients with sympathetically maintained pain [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Determine whether heightened expression of cutaneous 1-adrenoceptors is associated with signs of chronic inflammation in patients with sympathetically maintained pain

  • decrease in pain after topical adrenoceptor blockade. [ Time Frame: 2 weeks after blockade ] [ Designated as safety issue: No ]
    To determine whether pain decreases in this subgroup after topical 1-adrenoceptor blockade.


Estimated Enrollment: 75
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phenylephrine and clonidine
Subjects will be injected with phenylephrine and clonidine at affected and unaffected sites.
Drug: phenylephrine and clonidine
Subjects will be injected with phenylephrine and clonidine at both affected and unaffected sites.
Other: punch biopsy
Other Name: After local anesthetic, subjects will receive punch biopsy (1/8"diameter and 1/8" deep) from both affected and unaffected sites.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01813149

Contacts
Contact: Michael Stanton Hicks, MD 216-445-5995 stantom@ccf.org
Contact: Gretchen Upton 216-445-6500 uptong@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Michael Stanton Hicks, M.D.         
Sponsors and Collaborators
The Cleveland Clinic
NHMRC - Murdoch University
  More Information

No publications provided

Responsible Party: Michael Stanton Hicks, M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01813149     History of Changes
Other Study ID Numbers: 12-400
Study First Received: March 12, 2013
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:
Complex Regional Pain Syndrome (CRPS)

Additional relevant MeSH terms:
Complex Regional Pain Syndromes
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Anesthetics, Local
Clonidine
Phenylephrine
Oxymetazoline
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents

ClinicalTrials.gov processed this record on July 23, 2014