Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy
Topical clonidine significantly reduces pain associated with diabetic neuropathy in subjects with functional nociceptors in the affected skin, as revealed by testing with topical capsaicin. A length-dependent neuropathy with pain in the feet is a common complication of diabetes (painful diabetic neu...
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| Veröffentlicht in: | Pain (Amsterdam) 2012-09, Vol.153 (9), p.1815-1823 |
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| creator | Campbell, Claudia M. Kipnes, Mark S. Stouch, Bruce C. Brady, Kerrie L. Kelly, Margaret Schmidt, William K. Petersen, Karin L. Rowbotham, Michael C. Campbell, James N. |
| description | Topical clonidine significantly reduces pain associated with diabetic neuropathy in subjects with functional nociceptors in the affected skin, as revealed by testing with topical capsaicin.
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 α2-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 |
| doi_str_mv | 10.1016/j.pain.2012.04.014 |
| format | Article |
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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 α2-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.</description><identifier>ISSN: 0304-3959</identifier><identifier>EISSN: 1872-6623</identifier><identifier>DOI: 10.1016/j.pain.2012.04.014</identifier><identifier>PMID: 22683276</identifier><identifier>CODEN: PAINDB</identifier><language>eng</language><publisher>Philadelphia, PA: Elsevier B.V</publisher><subject>Administration, Cutaneous ; Aged ; Analgesics - therapeutic use ; Behavior therapy. Cognitive therapy ; Biological and medical sciences ; Capsaicin ; Clinical trial ; Clonidine - therapeutic use ; Diabetic Neuropathies - drug therapy ; Diabetic neuropathy ; Diseases of the nervous system ; Double-Blind Method ; Female ; Humans ; Male ; Medical sciences ; Middle Aged ; Nociceptive Pain - drug therapy ; Nociceptors - drug effects ; Pain ; Pain Measurement ; PDN ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Sensory System Agents ; Topical clonidine ; Treatment Outcome ; Treatments</subject><ispartof>Pain (Amsterdam), 2012-09, Vol.153 (9), p.1815-1823</ispartof><rights>2012 International Association for the Study of Pain</rights><rights>Lippincott Williams & Wilkins, Inc.</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.</rights><rights>2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5551-7b3cd53dac8f10d6c1308da71076ea8eedd008ad282995f48cfa8f271ce0bb5c3</citedby><cites>FETCH-LOGICAL-c5551-7b3cd53dac8f10d6c1308da71076ea8eedd008ad282995f48cfa8f271ce0bb5c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,27925,27926</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=26270035$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22683276$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Campbell, Claudia M.</creatorcontrib><creatorcontrib>Kipnes, Mark S.</creatorcontrib><creatorcontrib>Stouch, Bruce C.</creatorcontrib><creatorcontrib>Brady, Kerrie L.</creatorcontrib><creatorcontrib>Kelly, Margaret</creatorcontrib><creatorcontrib>Schmidt, William K.</creatorcontrib><creatorcontrib>Petersen, Karin L.</creatorcontrib><creatorcontrib>Rowbotham, Michael C.</creatorcontrib><creatorcontrib>Campbell, James N.</creatorcontrib><title>Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy</title><title>Pain (Amsterdam)</title><addtitle>Pain</addtitle><description>Topical clonidine significantly reduces pain associated with diabetic neuropathy in subjects with functional nociceptors in the affected skin, as revealed by testing with topical capsaicin.
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 α2-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.</description><subject>Administration, Cutaneous</subject><subject>Aged</subject><subject>Analgesics - therapeutic use</subject><subject>Behavior therapy. Cognitive therapy</subject><subject>Biological and medical sciences</subject><subject>Capsaicin</subject><subject>Clinical trial</subject><subject>Clonidine - therapeutic use</subject><subject>Diabetic Neuropathies - drug therapy</subject><subject>Diabetic neuropathy</subject><subject>Diseases of the nervous system</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Nociceptive Pain - drug therapy</subject><subject>Nociceptors - drug effects</subject><subject>Pain</subject><subject>Pain Measurement</subject><subject>PDN</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopathology. Psychiatry</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</subject><subject>Sensory System Agents</subject><subject>Topical clonidine</subject><subject>Treatment Outcome</subject><subject>Treatments</subject><issn>0304-3959</issn><issn>1872-6623</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kUuLFTEQhYMoznX0D7iQ3ghuuq0k_QQRhsEXDAiiGzchnVR7c00nbZKeYfz1prnXUTcuQhLqO1WHOoQ8pVBRoO3LQ7VI4yoGlFVQV0Dre2RH-46Vbcv4fbIDDnXJh2Y4I49iPAAAY2x4SM4Ya3vOunZHvn6STvvZ_ERdKO9S8LZIwUhb-KlIfjEqP5X1zmjjsJh8yGWUaUaXNmRzMK220EaOmIwqHK7BLzLtbx-TB5O0EZ-c7nPy5e2bz5fvy6uP7z5cXlyVqmkaWnYjV7rhWqp-oqBbRTn0WnYUuhZlj6g1QC8169kwNFPdq0n2E-uoQhjHRvFz8vrYd1nHGbXKzoK0YglmluFWeGnEvxVn9uKbvxa8przrIDd4cWoQ_I8VYxKziQqtlQ79GgWFvCveMT5klB1RFXyMAae7MRTEFoo4iG0lYgtFQC1yKFn07G-Dd5LfKWTg-QmQMe97CtIpE_9wLesAeJO5-sjdeJswxO92vcEg9iht2oscL7R8aMttNgz5V-ZDaZa9Osowp3BtsiIqg06hNgFVEtqb_9n_BfWvvTQ</recordid><startdate>20120901</startdate><enddate>20120901</enddate><creator>Campbell, Claudia M.</creator><creator>Kipnes, Mark S.</creator><creator>Stouch, Bruce C.</creator><creator>Brady, Kerrie L.</creator><creator>Kelly, Margaret</creator><creator>Schmidt, William K.</creator><creator>Petersen, Karin L.</creator><creator>Rowbotham, Michael C.</creator><creator>Campbell, James N.</creator><general>Elsevier B.V</general><general>Lippincott Williams & Wilkins, Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20120901</creationdate><title>Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy</title><author>Campbell, Claudia M. ; Kipnes, Mark S. ; Stouch, Bruce C. ; Brady, Kerrie L. ; Kelly, Margaret ; Schmidt, William K. ; Petersen, Karin L. ; Rowbotham, Michael C. ; Campbell, James N.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5551-7b3cd53dac8f10d6c1308da71076ea8eedd008ad282995f48cfa8f271ce0bb5c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Administration, Cutaneous</topic><topic>Aged</topic><topic>Analgesics - therapeutic use</topic><topic>Behavior therapy. Cognitive therapy</topic><topic>Biological and medical sciences</topic><topic>Capsaicin</topic><topic>Clinical trial</topic><topic>Clonidine - therapeutic use</topic><topic>Diabetic Neuropathies - drug therapy</topic><topic>Diabetic neuropathy</topic><topic>Diseases of the nervous system</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Nociceptive Pain - drug therapy</topic><topic>Nociceptors - drug effects</topic><topic>Pain</topic><topic>Pain Measurement</topic><topic>PDN</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopathology. Psychiatry</topic><topic>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)</topic><topic>Sensory System Agents</topic><topic>Topical clonidine</topic><topic>Treatment Outcome</topic><topic>Treatments</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Campbell, Claudia M.</creatorcontrib><creatorcontrib>Kipnes, Mark S.</creatorcontrib><creatorcontrib>Stouch, Bruce C.</creatorcontrib><creatorcontrib>Brady, Kerrie L.</creatorcontrib><creatorcontrib>Kelly, Margaret</creatorcontrib><creatorcontrib>Schmidt, William K.</creatorcontrib><creatorcontrib>Petersen, Karin L.</creatorcontrib><creatorcontrib>Rowbotham, Michael C.</creatorcontrib><creatorcontrib>Campbell, James N.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pain (Amsterdam)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Campbell, Claudia M.</au><au>Kipnes, Mark S.</au><au>Stouch, Bruce C.</au><au>Brady, Kerrie L.</au><au>Kelly, Margaret</au><au>Schmidt, William K.</au><au>Petersen, Karin L.</au><au>Rowbotham, Michael C.</au><au>Campbell, James N.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy</atitle><jtitle>Pain (Amsterdam)</jtitle><addtitle>Pain</addtitle><date>2012-09-01</date><risdate>2012</risdate><volume>153</volume><issue>9</issue><spage>1815</spage><epage>1823</epage><pages>1815-1823</pages><issn>0304-3959</issn><eissn>1872-6623</eissn><coden>PAINDB</coden><abstract>Topical clonidine significantly reduces pain associated with diabetic neuropathy in subjects with functional nociceptors in the affected skin, as revealed by testing with topical capsaicin.
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 α2-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.</abstract><cop>Philadelphia, PA</cop><pub>Elsevier B.V</pub><pmid>22683276</pmid><doi>10.1016/j.pain.2012.04.014</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Administration, Cutaneous Aged Analgesics - therapeutic use Behavior therapy. Cognitive therapy Biological and medical sciences Capsaicin Clinical trial Clonidine - therapeutic use Diabetic Neuropathies - drug therapy Diabetic neuropathy Diseases of the nervous system Double-Blind Method Female Humans Male Medical sciences Middle Aged Nociceptive Pain - drug therapy Nociceptors - drug effects Pain Pain Measurement PDN Psychology. Psychoanalysis. Psychiatry Psychopathology. Psychiatry Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) Sensory System Agents Topical clonidine Treatment Outcome Treatments |
| title | Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy |
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