Renan Fernandes, Patrick Thornley, Jennifer Urquhart, Abdulmajeed Alahmari, Nasser Alenezi, Sean Kelly, Parham Rasoulinejad, Supriya Singh, Fawaz Siddiqi, Kevin Gurr, Chris Bailey
{"title":"颈椎矫形器不能改善颈椎后路融合术后疼痛:随机对照试验。","authors":"Renan Fernandes, Patrick Thornley, Jennifer Urquhart, Abdulmajeed Alahmari, Nasser Alenezi, Sean Kelly, Parham Rasoulinejad, Supriya Singh, Fawaz Siddiqi, Kevin Gurr, Chris Bailey","doi":"10.1007/s00586-024-08456-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis.</p><p><strong>Methods: </strong>Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data.</p><p><strong>Results: </strong>Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks.</p><p><strong>Conclusion: </strong>Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.</p>","PeriodicalId":12323,"journal":{"name":"European Spine Journal","volume":null,"pages":null},"PeriodicalIF":2.6000,"publicationDate":"2024-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.\",\"authors\":\"Renan Fernandes, Patrick Thornley, Jennifer Urquhart, Abdulmajeed Alahmari, Nasser Alenezi, Sean Kelly, Parham Rasoulinejad, Supriya Singh, Fawaz Siddiqi, Kevin Gurr, Chris Bailey\",\"doi\":\"10.1007/s00586-024-08456-7\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis.</p><p><strong>Methods: </strong>Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data.</p><p><strong>Results: </strong>Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks.</p><p><strong>Conclusion: </strong>Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.</p>\",\"PeriodicalId\":12323,\"journal\":{\"name\":\"European Spine Journal\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2024-08-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Spine Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s00586-024-08456-7\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Spine Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s00586-024-08456-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.
Purpose: To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis.
Methods: Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data.
Results: Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks.
Conclusion: Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.
期刊介绍:
"European Spine Journal" is a publication founded in response to the increasing trend toward specialization in spinal surgery and spinal pathology in general. The Journal is devoted to all spine related disciplines, including functional and surgical anatomy of the spine, biomechanics and pathophysiology, diagnostic procedures, and neurology, surgery and outcomes. The aim of "European Spine Journal" is to support the further development of highly innovative spine treatments including but not restricted to surgery and to provide an integrated and balanced view of diagnostic, research and treatment procedures as well as outcomes that will enhance effective collaboration among specialists worldwide. The “European Spine Journal” also participates in education by means of videos, interactive meetings and the endorsement of educative efforts.
Official publication of EUROSPINE, The Spine Society of Europe