Suspended

Mechanism and Treatment of Sympathetically Maintained Pain

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What is being tested

phenylephrine and clonidine

+ punch biopsy

DrugOther
Who is being recruted

Autonomic Nervous System Diseases+2

+ Nervous System Diseases

+ Neuromuscular Diseases

From 18 to 80 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorThe Cleveland Clinic
Last updated: January 13, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01813149
Principal SponsorThe Cleveland Clinic
Last updated: January 13, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

128 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autonomic Nervous System DiseasesNervous System DiseasesNeuromuscular DiseasesPeripheral Nervous System DiseasesComplex Regional Pain Syndromes

Criteria

1 inclusion criteria required to participate
CRPS patients
8 exclusion criteria prevent from participating
18 years
a second chronic pain syndrome that would interfere with pain rating
known sensitivity to alpha 1- adrenoceptor agonists or other contraindications
pain in both hands or feet
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cleveland Clinic

Cleveland, United StatesOpen Cleveland Clinic in Google Maps
SuspendedOne Study Center