Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain
Objective. – To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain. Patients and methods. – Multicenter, randomized, double-blinded, placebo-controlled trial. The stud...
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| Veröffentlicht in: | Joint, bone, spine : revue du rhumatisme bone, spine : revue du rhumatisme, 2003-09, Vol.70 (5), p.356-361 |
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| container_title | Joint, bone, spine : revue du rhumatisme |
| container_volume | 70 |
| creator | Tüzün, Fikret Ünalan, Halil Öner, Nazan Özgüzel, Hayri Kirazli, Yeşim İçağasioğlu, Afitap Kuran, Banu Tüzün, Şansın Başar, Günnur |
| description | Objective. –
To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain.
Patients and methods. –
Multicenter, randomized, double-blinded, placebo-controlled trial. The study was conducted between July 1998 and March 2000 in five centers. Hospitalized patients with acute low back pain were included. The primary evaluation criterion was spontaneous pain at rest assessed by visual analog scale (VAS). Hand-to-floor distance, muscle spasm intensity, patients’ global evaluation and analgesic tablet (paracetamol) consumption were used as secondary evaluation criteria.
Results. –
One hundred and forty nine patients were included. Both groups showed improvement on spontaneous pain assessed by VAS at the end of day 1; however, improvement was statistically significant in thiocolchicoside group on day 3 (
P < 0.001). Hand-to-floor distance and muscle spasm determined by palpation decreased significantly on day 5 in thiocolchicoside group (
P < 0.0005 for both). According to the patients’ global evaluation, 76.8% of patients in thiocolchicoside group evaluated the treatment as very good/good (
P < 0.0005). Also a significant difference was observed in favor of the thiocolchicoside group in the total paracetamol consumption (
P < 0.001). Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect.
Conclusion. –
Twice daily administration of 4 mg thiocolchicoside for 5 days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm. |
| doi_str_mv | 10.1016/S1297-319X(03)00075-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_71306922</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1297319X03000757</els_id><sourcerecordid>71306922</sourcerecordid><originalsourceid>FETCH-LOGICAL-c440t-5e86bfdf0543dfdb158faefed417d47b84eef5427ed680ecbc184739f04d4db23</originalsourceid><addsrcrecordid>eNqFkE9PHDEMxXMoKv_6EahyqlqJgWSSmcyeEFpBWwnEASpxi5LYEYHsZJtkWsGnZ5dd0WNPlu33_OQfIUecnXDG-9Nb3s5UI_js_isT3xhjqmvUB7L3Pt4l-6U8rhai7fqPZJfLrheyl3skXk-xBodjxXxMsxkhLcILwjGFNNmIjY1hhHW_jMahTY1LY80pRgRaczCRJk_rQ0guRfcQXCoBkIaRGjdVpDH9pda4J7o0YTwkO97Egp-29YD8ury4m_9orm6-_5yfXzVOSlabDofeevCskwI8WN4N3qBHkFyBVHaQiL6TrULoB4bOOj5IJWaeSZBgW3FAvmzuLnP6PWGpehGKwxjNiGkqWnHB-lm7FnYbocuplIxeL3NYmPysOdNrtPoNrV4z1EzoN7RarXyftwGTXSD8c225rgRnGwGu3vwTMOviAo4OIWR0VUMK_4l4BXq5jbc</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>71306922</pqid></control><display><type>article</type><title>Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain</title><source>MEDLINE</source><source>Access via ScienceDirect (Elsevier)</source><creator>Tüzün, Fikret ; Ünalan, Halil ; Öner, Nazan ; Özgüzel, Hayri ; Kirazli, Yeşim ; İçağasioğlu, Afitap ; Kuran, Banu ; Tüzün, Şansın ; Başar, Günnur</creator><creatorcontrib>Tüzün, Fikret ; Ünalan, Halil ; Öner, Nazan ; Özgüzel, Hayri ; Kirazli, Yeşim ; İçağasioğlu, Afitap ; Kuran, Banu ; Tüzün, Şansın ; Başar, Günnur</creatorcontrib><description>Objective. –
To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain.
Patients and methods. –
Multicenter, randomized, double-blinded, placebo-controlled trial. The study was conducted between July 1998 and March 2000 in five centers. Hospitalized patients with acute low back pain were included. The primary evaluation criterion was spontaneous pain at rest assessed by visual analog scale (VAS). Hand-to-floor distance, muscle spasm intensity, patients’ global evaluation and analgesic tablet (paracetamol) consumption were used as secondary evaluation criteria.
Results. –
One hundred and forty nine patients were included. Both groups showed improvement on spontaneous pain assessed by VAS at the end of day 1; however, improvement was statistically significant in thiocolchicoside group on day 3 (
P < 0.001). Hand-to-floor distance and muscle spasm determined by palpation decreased significantly on day 5 in thiocolchicoside group (
P < 0.0005 for both). According to the patients’ global evaluation, 76.8% of patients in thiocolchicoside group evaluated the treatment as very good/good (
P < 0.0005). Also a significant difference was observed in favor of the thiocolchicoside group in the total paracetamol consumption (
P < 0.001). Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect.
Conclusion. –
Twice daily administration of 4 mg thiocolchicoside for 5 days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm.</description><identifier>ISSN: 1297-319X</identifier><identifier>DOI: 10.1016/S1297-319X(03)00075-7</identifier><identifier>PMID: 14563464</identifier><language>eng</language><publisher>France: Elsevier SAS</publisher><subject>Acute Disease ; Adult ; Colchicine - administration & dosage ; Colchicine - analogs & derivatives ; Double-Blind Method ; Female ; Humans ; Injections, Intramuscular ; Low back pain ; Low Back Pain - drug therapy ; Male ; Middle Aged ; Muscle relaxant ; Neuromuscular Agents - administration & dosage ; Pain Measurement ; Prospective Studies ; Spasm - drug therapy ; Thiocolchicoside ; Treatment Outcome</subject><ispartof>Joint, bone, spine : revue du rhumatisme, 2003-09, Vol.70 (5), p.356-361</ispartof><rights>2003 Éditions scientifiques et médicales Elsevier SAS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-5e86bfdf0543dfdb158faefed417d47b84eef5427ed680ecbc184739f04d4db23</citedby><cites>FETCH-LOGICAL-c440t-5e86bfdf0543dfdb158faefed417d47b84eef5427ed680ecbc184739f04d4db23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S1297-319X(03)00075-7$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,781,785,3551,27929,27930,46000</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14563464$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tüzün, Fikret</creatorcontrib><creatorcontrib>Ünalan, Halil</creatorcontrib><creatorcontrib>Öner, Nazan</creatorcontrib><creatorcontrib>Özgüzel, Hayri</creatorcontrib><creatorcontrib>Kirazli, Yeşim</creatorcontrib><creatorcontrib>İçağasioğlu, Afitap</creatorcontrib><creatorcontrib>Kuran, Banu</creatorcontrib><creatorcontrib>Tüzün, Şansın</creatorcontrib><creatorcontrib>Başar, Günnur</creatorcontrib><title>Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain</title><title>Joint, bone, spine : revue du rhumatisme</title><addtitle>Joint Bone Spine</addtitle><description>Objective. –
To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain.
Patients and methods. –
Multicenter, randomized, double-blinded, placebo-controlled trial. The study was conducted between July 1998 and March 2000 in five centers. Hospitalized patients with acute low back pain were included. The primary evaluation criterion was spontaneous pain at rest assessed by visual analog scale (VAS). Hand-to-floor distance, muscle spasm intensity, patients’ global evaluation and analgesic tablet (paracetamol) consumption were used as secondary evaluation criteria.
Results. –
One hundred and forty nine patients were included. Both groups showed improvement on spontaneous pain assessed by VAS at the end of day 1; however, improvement was statistically significant in thiocolchicoside group on day 3 (
P < 0.001). Hand-to-floor distance and muscle spasm determined by palpation decreased significantly on day 5 in thiocolchicoside group (
P < 0.0005 for both). According to the patients’ global evaluation, 76.8% of patients in thiocolchicoside group evaluated the treatment as very good/good (
P < 0.0005). Also a significant difference was observed in favor of the thiocolchicoside group in the total paracetamol consumption (
P < 0.001). Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect.
Conclusion. –
Twice daily administration of 4 mg thiocolchicoside for 5 days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm.</description><subject>Acute Disease</subject><subject>Adult</subject><subject>Colchicine - administration & dosage</subject><subject>Colchicine - analogs & derivatives</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Injections, Intramuscular</subject><subject>Low back pain</subject><subject>Low Back Pain - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Muscle relaxant</subject><subject>Neuromuscular Agents - administration & dosage</subject><subject>Pain Measurement</subject><subject>Prospective Studies</subject><subject>Spasm - drug therapy</subject><subject>Thiocolchicoside</subject><subject>Treatment Outcome</subject><issn>1297-319X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2003</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkE9PHDEMxXMoKv_6EahyqlqJgWSSmcyeEFpBWwnEASpxi5LYEYHsZJtkWsGnZ5dd0WNPlu33_OQfIUecnXDG-9Nb3s5UI_js_isT3xhjqmvUB7L3Pt4l-6U8rhai7fqPZJfLrheyl3skXk-xBodjxXxMsxkhLcILwjGFNNmIjY1hhHW_jMahTY1LY80pRgRaczCRJk_rQ0guRfcQXCoBkIaRGjdVpDH9pda4J7o0YTwkO97Egp-29YD8ury4m_9orm6-_5yfXzVOSlabDofeevCskwI8WN4N3qBHkFyBVHaQiL6TrULoB4bOOj5IJWaeSZBgW3FAvmzuLnP6PWGpehGKwxjNiGkqWnHB-lm7FnYbocuplIxeL3NYmPysOdNrtPoNrV4z1EzoN7RarXyftwGTXSD8c225rgRnGwGu3vwTMOviAo4OIWR0VUMK_4l4BXq5jbc</recordid><startdate>20030901</startdate><enddate>20030901</enddate><creator>Tüzün, Fikret</creator><creator>Ünalan, Halil</creator><creator>Öner, Nazan</creator><creator>Özgüzel, Hayri</creator><creator>Kirazli, Yeşim</creator><creator>İçağasioğlu, Afitap</creator><creator>Kuran, Banu</creator><creator>Tüzün, Şansın</creator><creator>Başar, Günnur</creator><general>Elsevier SAS</general><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></search><sort><creationdate>20030901</creationdate><title>Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain</title><author>Tüzün, Fikret ; Ünalan, Halil ; Öner, Nazan ; Özgüzel, Hayri ; Kirazli, Yeşim ; İçağasioğlu, Afitap ; Kuran, Banu ; Tüzün, Şansın ; Başar, Günnur</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c440t-5e86bfdf0543dfdb158faefed417d47b84eef5427ed680ecbc184739f04d4db23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2003</creationdate><topic>Acute Disease</topic><topic>Adult</topic><topic>Colchicine - administration & dosage</topic><topic>Colchicine - analogs & derivatives</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Injections, Intramuscular</topic><topic>Low back pain</topic><topic>Low Back Pain - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Muscle relaxant</topic><topic>Neuromuscular Agents - administration & dosage</topic><topic>Pain Measurement</topic><topic>Prospective Studies</topic><topic>Spasm - drug therapy</topic><topic>Thiocolchicoside</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tüzün, Fikret</creatorcontrib><creatorcontrib>Ünalan, Halil</creatorcontrib><creatorcontrib>Öner, Nazan</creatorcontrib><creatorcontrib>Özgüzel, Hayri</creatorcontrib><creatorcontrib>Kirazli, Yeşim</creatorcontrib><creatorcontrib>İçağasioğlu, Afitap</creatorcontrib><creatorcontrib>Kuran, Banu</creatorcontrib><creatorcontrib>Tüzün, Şansın</creatorcontrib><creatorcontrib>Başar, Günnur</creatorcontrib><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><jtitle>Joint, bone, spine : revue du rhumatisme</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tüzün, Fikret</au><au>Ünalan, Halil</au><au>Öner, Nazan</au><au>Özgüzel, Hayri</au><au>Kirazli, Yeşim</au><au>İçağasioğlu, Afitap</au><au>Kuran, Banu</au><au>Tüzün, Şansın</au><au>Başar, Günnur</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain</atitle><jtitle>Joint, bone, spine : revue du rhumatisme</jtitle><addtitle>Joint Bone Spine</addtitle><date>2003-09-01</date><risdate>2003</risdate><volume>70</volume><issue>5</issue><spage>356</spage><epage>361</epage><pages>356-361</pages><issn>1297-319X</issn><abstract>Objective. –
To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain.
Patients and methods. –
Multicenter, randomized, double-blinded, placebo-controlled trial. The study was conducted between July 1998 and March 2000 in five centers. Hospitalized patients with acute low back pain were included. The primary evaluation criterion was spontaneous pain at rest assessed by visual analog scale (VAS). Hand-to-floor distance, muscle spasm intensity, patients’ global evaluation and analgesic tablet (paracetamol) consumption were used as secondary evaluation criteria.
Results. –
One hundred and forty nine patients were included. Both groups showed improvement on spontaneous pain assessed by VAS at the end of day 1; however, improvement was statistically significant in thiocolchicoside group on day 3 (
P < 0.001). Hand-to-floor distance and muscle spasm determined by palpation decreased significantly on day 5 in thiocolchicoside group (
P < 0.0005 for both). According to the patients’ global evaluation, 76.8% of patients in thiocolchicoside group evaluated the treatment as very good/good (
P < 0.0005). Also a significant difference was observed in favor of the thiocolchicoside group in the total paracetamol consumption (
P < 0.001). Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect.
Conclusion. –
Twice daily administration of 4 mg thiocolchicoside for 5 days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm.</abstract><cop>France</cop><pub>Elsevier SAS</pub><pmid>14563464</pmid><doi>10.1016/S1297-319X(03)00075-7</doi><tpages>6</tpages></addata></record> |
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| identifier | ISSN: 1297-319X |
| ispartof | Joint, bone, spine : revue du rhumatisme, 2003-09, Vol.70 (5), p.356-361 |
| issn | 1297-319X |
| language | eng |
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| source | MEDLINE; Access via ScienceDirect (Elsevier) |
| subjects | Acute Disease Adult Colchicine - administration & dosage Colchicine - analogs & derivatives Double-Blind Method Female Humans Injections, Intramuscular Low back pain Low Back Pain - drug therapy Male Middle Aged Muscle relaxant Neuromuscular Agents - administration & dosage Pain Measurement Prospective Studies Spasm - drug therapy Thiocolchicoside Treatment Outcome |
| title | Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain |
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