Trial · NCT01813149
Mechanism and Treatment of Sympathetically Maintained Pain
NCT01813149, Not applicable, Terminated, The Cleveland Clinic; results first posted 2021-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mechanism and Treatment of Sympathetically Maintained Pain. Trials, record NCT01813149. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01813149
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mechanism and Treatment of Sympathetically Maintained Pain
- NCT number
- NCT01813149
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 128 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Complex Regional Pain Syndrome (CRPS)
- Interventions
- phenylephrine and clonidine, punch biopsy
- First posted
- 2013-03-18
- Last updated
- 2021-01-13
- Results first posted
- 2021-01-13
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Increased Adrenergic Sensitivity | Day 1 | To investigate adrenergically evoked pain, 50 mg of the a1-AR agonist phenylephrine in 0.1 mL normal saline (equivalent to 2.5mMconcentration was injected intradermally into the most painful region of the dorsal and or foot and into a mirror-image site in the contralateral limb. Pain induced by the intradermal injection of phenylephrine into the contralateral limb of patients with CRPS usually resolved within 5 to 10 minutes. Therefore, pain that persisted for 15 minutes or longer (in the CRPS-affected limb) was considered to be atypical. Using this criterion, subjects who reported prolonged pain (a sign of adrenergic sensitivity) following the phenylephrine injection were classified as phenylephrine responders and those who didn't were classified as phenylephrine non-responders. |
| Primary | Expression of α1-adrenoceptors (α1-AR) in Dermal Nerve Bundles in the CRPS-affected Limb of Phenylephrine Responders and Non-responders | Day 2, after clonidine injection | Expression of α1-AR was determined from the skin biopsies using immunohistochemistry. Nerve bundles in the reticular dermis were identified in the affected limb of 25 patients with CRPS \[only 22 of these were classified as phenylephrine responders/non-responders\], in the contralateral limb of 21 patients with CRPS, and in 12 controls. Samples were processed in batches containing sections from 10 controls and from the affected and contralateral limbs of 10 patients. The α1-AR immunoreactivity (a measure of the expression of receptors) scores were transformed into standard units with a mean of 0 and a SD of 1 (ie, Z-scores). Positive scores represent greater than average α1-AR immunoreactivity (i.e. higher expression of α1-AR) compared with other samples in the run, and negative scores represent less than average α1-AR immunoreactivity. Normalized scores were averaged across multiple runs for each patient or control to obtain a mean α1-AR score. |
| Primary | Expression of Pain Association With Chronic Inflammation in Patients With Sympathetically Maintained Pain | Day 1 | Determine whether heightened expression of cutaneous 1-adrenoceptors is associated with signs of chronic inflammation in patients with sympathetically maintained pain |
| Primary | Decrease in Pain After Topical Adrenoceptor Blockade | 2 weeks after blockade |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Increased Adrenergic Sensitivity | Day 1 | Data on pain scores were not collected from 5 CRPS patients (not administered phenylephrine \[PE\] per physician decision) of the initial 90 patients. Thus, data from 85 patients were analyzed. Data on control arm not reported because the only purpose for enrolling them in the trial was so that their skin biopsies could be used in immunohistochemistry analyses (see Outcome Measure 2 description). We did not plan to collect pain scores from control arm participants and they weren't administered PE. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Expression of α1-adrenoceptors (α1-AR) in Dermal Nerve Bundles in the CRPS-affected Limb of Phenylephrine Responders and Non-responders | Day 2, after clonidine injection | After obtaining the mean α1-AR scores for all subjects at the affected/contralateral regions using the process described in the, Outcome Measure Description, we then compared the mean α1-AR score between the subgroup of patients who were classified as either phenylephrine responders or non-responders.Skin biopsies were collected for all patients but nerve bundles in reticular dermis could only be identified in 22 phenylephrine responders/non-responders. | z-score | MEAN |
| PRIMARY | Expression of Pain Association With Chronic Inflammation in Patients With Sympathetically Maintained Pain | Day 1 | Data on chronic inflammation was not collected | ||
| PRIMARY | Decrease in Pain After Topical Adrenoceptor Blockade | 2 weeks after blockade | Data were not collected--no patients were given a topical adrenoreceptor antagonist. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Increased Adrenergic Sensitivity | CRPS Patients | Phenylephrine responders | 32 | Participants | |
| Increased Adrenergic Sensitivity | CRPS Patients | Phenylephrine non-responders | 53 | Participants | |
| Expression of α1-adrenoceptors (α1-AR) in Dermal Nerve Bundles in the CRPS-affected Limb of Phenylephrine Responders and Non-responders | Phenylephrine Responders | Nerve bundles identified in reticular dermis | 1.146 | Standard Deviation 1.009 | z-score |
| Expression of α1-adrenoceptors (α1-AR) in Dermal Nerve Bundles in the CRPS-affected Limb of Phenylephrine Responders and Non-responders | Phenylephrine Non-responders | Nerve bundles identified in reticular dermis | 0.142 | Standard Deviation 0.617 | z-score |
| Expression of α1-adrenoceptors (α1-AR) in Dermal Nerve Bundles in the CRPS-affected Limb of Phenylephrine Responders and Non-responders | Phenylephrine Responders | Nerve bundle not identified in reticular dermis | NA | Standard Deviation NA | z-score |
| Expression of α1-adrenoceptors (α1-AR) in Dermal Nerve Bundles in the CRPS-affected Limb of Phenylephrine Responders and Non-responders | Phenylephrine Non-responders | Nerve bundle not identified in reticular dermis | NA | Standard Deviation NA | z-score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CRPS Patients | 90 | |
| Overall Study | STARTED | Control Participants | 38 | |
| Overall Study | COMPLETED | CRPS Patients | 90 | |
| Overall Study | COMPLETED | Control Participants | 38 | |
| Overall Study | NOT COMPLETED | CRPS Patients | 0 | |
| Overall Study | NOT COMPLETED | Control Participants | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenylephrine: CRPS Patients | 0 | 85 |
| Total, all-cause mortality | Clonidine: CRPS Patients | 0 | 85 |
| Total, all-cause mortality | CRPS Patients | 0 | 5 |
| Total, all-cause mortality | Control | 0 | 38 |
| Total, other adverse events | Phenylephrine: CRPS Patients | 0 | 85 |
| Total, other adverse events | Clonidine: CRPS Patients | 0 | 85 |
| Total, other adverse events | CRPS Patients | 0 | 5 |
| Total, other adverse events | Control | 0 | 38 |
| Total, serious adverse events | Phenylephrine: CRPS Patients | 0 | 85 |
| Total, serious adverse events | Clonidine: CRPS Patients | 0 | 85 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01813149
GET https://conductscience.org/api/trials/v1/NCT01813149/registered