Mechanism and Treatment of Sympathetically Maintained Pain

NCT ID: NCT01813149

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-12-31

Brief 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.

Detailed Description

Patients diagnosed with CRPS and control subjects will be enrolled in the study. The CRPS participants will be administered with phenylephrine (day 1) and clonidine (day 2). The control participants will not receive any intervention.

The aim of this study is to determine if expression of α1-adrenoceptors (α1-AR) altered in the skin of a subgroup of patients whose pain is associated with increased adrenergic sensitivity after nerve trauma. Increased adrenergic sensitivity will be determined by assessing pain in patients after administration of phenylephrine on day 1. Expression of α1-AR will be determined by taking skin biopsies on day 2 after administration of clonidine. Then, we will compare the expression of α1-AR in patients who were classified as having increased adrenergic sensitivity versus those who were not.

Conditions

Complex Regional Pain Syndrome (CRPS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

phenylephrine and clonidine

Subjects will be injected with phenylephrine and clonidine at affected and unaffected sites.

Group Type: EXPERIMENTAL

phenylephrine and clonidine

Intervention Type: DRUG

Subjects will be injected with phenylephrine and clonidine at both affected and unaffected sites.

punch biopsy

Intervention Type: OTHER

Interventions

phenylephrine and clonidine

Subjects will be injected with phenylephrine and clonidine at both affected and unaffected sites.

Intervention Type: DRUG

punch biopsy

Intervention Type: OTHER

Other Intervention Names

After local anesthetic, subjects will receive punch biopsy (1/8"diameter and 1/8" deep) from both affected and unaffected sites.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Murdoch University

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

12-400

Identifier Type: -

Identifier Source: org_study_id