Mechanism and Treatment of Sympathetically Maintained Pain
Stopped early · Not applicable
Conditions studied: Complex Regional Pain Syndrome (CRPS)
In brief
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.
Key facts
- Study ID
- NCT01813149
- Run by
- The Cleveland Clinic
- People needed
- 128
- Starts
- 2012-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2021-01-13
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CRPS patients
You may not qualify if…
- <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
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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