Evidence map›Paper›PMID 22683276›Full record

Trial reportPain2012

Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy.

Claudia M Campbell, Mark S Kipnes, Bruce C Stouch, Kerrie L Brady, Margaret Kelly, William K Schmidt, Karin L Petersen, Michael C Rowbotham, James N Campbell

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pain, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00695565 (A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy), which is not on this map. Cited by 62 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 5 pooled it
11.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00695565 phase2completednot on this map

A Multicenter, Randomized, Double-Blind, Parallel-Group Study Comparing the Efficacy and Safety of Clonidine Topical Gel, 0.1% With Placebo in the Management of Pain Associated With Painful Diabetic Neuropathy

TypeinterventionalSponsorArcion Therapeutics IncRan2008 to 2010Enrolled180ConditionsPainful Diabetic NeuropathyArmsPlacebo Gel, Clonidine Topical Gel (ARC-4558)
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 5 syntheses or guidelines pooled it, 159 citations in OpenAlex.

  1. Topical clonidine for neuropathic pain in adults.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Topical clonidine for neuropathic pain.The Cochrane database of systematic reviews · 2015
    Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Discovery of a peripherally restricted αCell reports. Medicine · 2026
    Article
  10. Review
  11. Diabetic neuropathy: cutting-edge research and future directions.Signal transduction and targeted therapy · 2025
    Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Painful Diabetic Peripheral Neuropathy: Practical Guidance and Challenges for Clinical Management.Diabetes, metabolic syndrome and obesity : targets and therapy · 2023
    Review
  17. Article
  18. Review
  19. Current Strategies for the Management of Painful Diabetic Neuropathy.Journal of diabetes science and technology · 2022
    Review
  20. Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Claudia M CampbellJohns Hopkins School of Medicine, Baltimore, MD 21224, USA Diabetes and Glandular Disease Clinic, San Antonio, TX 78229, USA BCS Consulting, Newtown Square, PA 19073, USA Arcion Therapeutics, Baltimore, MD 21224, USA University of California-San Francisco, San Francisco, CA 94143, USA California Pacific Medical Center Research Institute, San Francisco, CA 94107, USA.
Mark S Kipnes
Bruce C Stouch
Kerrie L Brady
Margaret Kelly
William K Schmidt
Karin L Petersen
Michael C Rowbotham
James N Campbell
California Pacific Medical Center · USABS Consulting (United States) · USDiabetes & Glandular Disease Clinic · USUniversity of California, San Francisco · US

Funding

Predicting Post-Operative Pain and Analgesic Use: The Role of Endogenous OpioidsK23NS070933 · NINDS · JOHNS HOPKINS UNIVERSITY · PI CAMPBELL, CLAUDIA MICHELLE · 2010 to 2014
$880k
NINDS NIH HHS K23 NS070933
6 · The paper itself

Abstract

A length-dependent neuropathy with pain in the feet is a common complication of diabetes (painful diabetic neuropathy). It was hypothesized that pain may arise from sensitized-hyperactive cutaneous nociceptors, and that this abnormal signaling may be reduced by topical administration of the α(2)-adrenergic agonist, clonidine, to the painful area. This was a randomized, double-blind, placebo-controlled, parallel-group, multicenter trial. Nociceptor function was measured by determining the painfulness of 0.1% topical capsaicin applied to the pretibial area of each subject for 30minutes during screening. Subjects were then randomized to receive 0.1% topical clonidine gel (n=89) or placebo gel (n=90) applied 3 times a day to their feet for 12weeks. The difference in foot pain at week 12 in relation to baseline, rated on a 0-10 numerical pain rating scale (NPRS), was compared between groups. Baseline NPRS was imputed for missing data for subjects who terminated the study early. The subjects treated with clonidine showed a trend toward decreased foot pain compared to the placebo-treated group (the primary endpoint; P=0.07). In subjects who felt any level of pain to capsaicin, clonidine was superior to placebo (P<0.05). In subjects with a capsaicin pain rating ⩾2 (0-10, NPRS), the mean decrease in foot pain was 2.6 for active compared to 1.4 for placebo (P=0.01). Topical clonidine gel significantly reduces the level of foot pain in painful diabetic neuropathy subjects with functional (and possibly sensitized) nociceptors in the affected skin as revealed by testing with topical capsaicin. Screening for cutaneous nociceptor function may help distinguish candidates for topical therapy for neuropathic pain.

Indexed as

Administration, CutaneousAgedAnalgesicsCapsaicinClonidineDiabetic NeuropathiesDouble-Blind MethodFemaleHumansMaleMiddle AgedNociceptive PainNociceptorsPain MeasurementSensory System AgentsTreatment OutcomeAnalgesicsCapsaicinClonidineSensory System Agents

Identifiers

PMID22683276
PMCPMC3413770
OpenAlexW1968607405

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.