Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial
Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect. To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain. Prospective, randomized, double-blind, pla...
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| Veröffentlicht in: | Journal of postgraduate medicine 2011-10, Vol.57 (4), p.278-285 |
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| creator | Chandanwale, A S Chopra, A Goregaonkar, A Medhi, B Shah, V Gaikwad, S Langade, D G Maroli, S Mehta, S C Naikwadi, A Pawar, D R |
| description | Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect.
To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain.
Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India.
It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability.
Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test.
Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P |
| doi_str_mv | 10.4103/0022-3859.90076 |
| format | Article |
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To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain.
Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India.
It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability.
Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test.
Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients.
Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP.</description><identifier>ISSN: 0022-3859</identifier><identifier>EISSN: 0972-2823</identifier><identifier>DOI: 10.4103/0022-3859.90076</identifier><identifier>PMID: 22120855</identifier><language>eng</language><publisher>India: Medknow Publications and Media Pvt. Ltd</publisher><subject>Acute Disease ; Adult ; Analgesics ; Back pain ; Backache ; Care and treatment ; Clinical outcomes ; Double-Blind Method ; Drug therapy ; Female ; Health aspects ; Humans ; Low Back Pain - complications ; Male ; Middle Aged ; Muscle Relaxants, Central - adverse effects ; Muscle Relaxants, Central - therapeutic use ; Muscle, Skeletal ; Pharmacology ; Propiophenones - adverse effects ; Propiophenones - therapeutic use ; Risk factors ; Spasm - complications ; Spasm - drug therapy ; Spasms</subject><ispartof>Journal of postgraduate medicine, 2011-10, Vol.57 (4), p.278-285</ispartof><rights>COPYRIGHT 2011 Medknow Publications and Media Pvt. Ltd.</rights><rights>Copyright Medknow Publications & Media Pvt Ltd Oct-Dec 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c423t-fdeb0b12fc42f2bb668280f11866e0242a9b4c4bf7b5cd337293d549ca1fa2033</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22120855$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chandanwale, A S</creatorcontrib><creatorcontrib>Chopra, A</creatorcontrib><creatorcontrib>Goregaonkar, A</creatorcontrib><creatorcontrib>Medhi, B</creatorcontrib><creatorcontrib>Shah, V</creatorcontrib><creatorcontrib>Gaikwad, S</creatorcontrib><creatorcontrib>Langade, D G</creatorcontrib><creatorcontrib>Maroli, S</creatorcontrib><creatorcontrib>Mehta, S C</creatorcontrib><creatorcontrib>Naikwadi, A</creatorcontrib><creatorcontrib>Pawar, D R</creatorcontrib><title>Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial</title><title>Journal of postgraduate medicine</title><addtitle>J Postgrad Med</addtitle><description>Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect.
To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain.
Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India.
It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability.
Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test.
Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients.
Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP.</description><subject>Acute Disease</subject><subject>Adult</subject><subject>Analgesics</subject><subject>Back pain</subject><subject>Backache</subject><subject>Care and treatment</subject><subject>Clinical outcomes</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Low Back Pain - complications</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Muscle Relaxants, Central - adverse effects</subject><subject>Muscle Relaxants, Central - therapeutic use</subject><subject>Muscle, Skeletal</subject><subject>Pharmacology</subject><subject>Propiophenones - adverse effects</subject><subject>Propiophenones - therapeutic use</subject><subject>Risk factors</subject><subject>Spasm - complications</subject><subject>Spasm - drug therapy</subject><subject>Spasms</subject><issn>0022-3859</issn><issn>0972-2823</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNptksluFDEQhlsIRBY4c0MWXNMTL71yi6KwSJG4wLlVtssZJ267sd1E4Y14SzxMgoQ08sEu1_dXqUp_Vb1hdNMwKs4p5bwWQztuRkr77ll1TMee13zg4nl5P2WPqpOUbillXdeIl9UR54zToW2Pq99XP8GtkG3wJBiCC0abgkeyfdAxqK0L0Wok1pO8RZIjQp7R5x0Las1I5jWp1YV0hw4zOJIWSDOBlIKykFGTe5u3xIV7IkHdkQWs_0CARPA6zPYX6jOiwyod1tJZX6LFgUIZahV8jsG5UiJHC-5V9cKAS_j68T6tvn-8-nb5ub7--unL5cV1rRoucm00SioZNyU0XMquG_hADWND1yHlDYdRNqqRppet0kL0fBS6bUYFzACnQpxW7_Z1lxh-rJjydBvW6EvLaWR8aNnA2wK930M34HCy3oQcQc02qemC923Pd20LVR-gbtBjBFeWbGz5_o_fHODL0ThbdVBwvheoGFKKaKYl2hniw8TotDPItLPAtLPA9NcgRfH2cbpVzqj_8U-OEH8AH6K3TA</recordid><startdate>20111001</startdate><enddate>20111001</enddate><creator>Chandanwale, A S</creator><creator>Chopra, A</creator><creator>Goregaonkar, A</creator><creator>Medhi, B</creator><creator>Shah, V</creator><creator>Gaikwad, S</creator><creator>Langade, D G</creator><creator>Maroli, S</creator><creator>Mehta, S C</creator><creator>Naikwadi, A</creator><creator>Pawar, D R</creator><general>Medknow Publications and Media Pvt. 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Chopra, A ; Goregaonkar, A ; Medhi, B ; Shah, V ; Gaikwad, S ; Langade, D G ; Maroli, S ; Mehta, S C ; Naikwadi, A ; Pawar, D R</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c423t-fdeb0b12fc42f2bb668280f11866e0242a9b4c4bf7b5cd337293d549ca1fa2033</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Acute Disease</topic><topic>Adult</topic><topic>Analgesics</topic><topic>Back pain</topic><topic>Backache</topic><topic>Care and treatment</topic><topic>Clinical outcomes</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Health aspects</topic><topic>Humans</topic><topic>Low Back Pain - complications</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Muscle Relaxants, Central - adverse effects</topic><topic>Muscle Relaxants, Central - therapeutic use</topic><topic>Muscle, Skeletal</topic><topic>Pharmacology</topic><topic>Propiophenones - adverse effects</topic><topic>Propiophenones - therapeutic use</topic><topic>Risk factors</topic><topic>Spasm - complications</topic><topic>Spasm - drug therapy</topic><topic>Spasms</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chandanwale, A S</creatorcontrib><creatorcontrib>Chopra, A</creatorcontrib><creatorcontrib>Goregaonkar, A</creatorcontrib><creatorcontrib>Medhi, B</creatorcontrib><creatorcontrib>Shah, V</creatorcontrib><creatorcontrib>Gaikwad, S</creatorcontrib><creatorcontrib>Langade, D G</creatorcontrib><creatorcontrib>Maroli, S</creatorcontrib><creatorcontrib>Mehta, S C</creatorcontrib><creatorcontrib>Naikwadi, A</creatorcontrib><creatorcontrib>Pawar, D R</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><jtitle>Journal of postgraduate medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chandanwale, A S</au><au>Chopra, A</au><au>Goregaonkar, A</au><au>Medhi, B</au><au>Shah, V</au><au>Gaikwad, S</au><au>Langade, D G</au><au>Maroli, S</au><au>Mehta, S C</au><au>Naikwadi, A</au><au>Pawar, D R</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial</atitle><jtitle>Journal of postgraduate medicine</jtitle><addtitle>J Postgrad Med</addtitle><date>2011-10-01</date><risdate>2011</risdate><volume>57</volume><issue>4</issue><spage>278</spage><epage>285</epage><pages>278-285</pages><issn>0022-3859</issn><eissn>0972-2823</eissn><abstract>Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect.
To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain.
Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India.
It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability.
Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test.
Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients.
Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP.</abstract><cop>India</cop><pub>Medknow Publications and Media Pvt. Ltd</pub><pmid>22120855</pmid><doi>10.4103/0022-3859.90076</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of postgraduate medicine, 2011-10, Vol.57 (4), p.278-285 |
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| source | MEDLINE; Bioline International; EZB-FREE-00999 freely available EZB journals |
| subjects | Acute Disease Adult Analgesics Back pain Backache Care and treatment Clinical outcomes Double-Blind Method Drug therapy Female Health aspects Humans Low Back Pain - complications Male Middle Aged Muscle Relaxants, Central - adverse effects Muscle Relaxants, Central - therapeutic use Muscle, Skeletal Pharmacology Propiophenones - adverse effects Propiophenones - therapeutic use Risk factors Spasm - complications Spasm - drug therapy Spasms |
| title | Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial |
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