Effect of ultrasound-guided injection of botulinum toxin type A into shoulder joint cavity on shoulder pain in poststroke patients: study protocol for a randomized controlled trial.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
Read More Add to Saved list
  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Shoulder Pain*/drug therapy ; Shoulder Pain*/etiology ; Ultrasonography, Interventional* ; Stroke*/complications ; Stroke*/drug therapy ; Botulinum Toxins, Type A*/administration & dosage ; Randomized Controlled Trials as Topic* ; Pain Measurement* ; Shoulder Joint*/physiopathology ; Shoulder Joint*/diagnostic imaging; Humans ; Injections, Intra-Articular ; Treatment Outcome ; Time Factors ; Hemiplegia/etiology ; Hemiplegia/drug therapy ; Recovery of Function ; Range of Motion, Articular ; China ; Neuromuscular Agents/administration & dosage ; Double-Blind Method ; Biomechanical Phenomena
    • Abstract:
      Background: Hemiplegic shoulder pain (HSP) is a common complication after stroke. It severely affects the recovery of upper limb motor function. Early shoulder pain in hemiplegic patients is mainly neuropathic caused by central nerve injury or neuroplasticity. Commonly used corticosteroid injections in the shoulder joint can reduce shoulder pain; however, the side effects also include soft tissue degeneration or increased tendon fragility, and the long-term effects remain controversial. Botulinum toxin injections are relatively new and are thought to block the transmission of pain receptors in the shoulder joint cavity and inhibit the production of neuropathogenic substances to reduce neurogenic inflammation. Some studies suggest that the shoulder pain of hemiplegia after stroke is caused by changes in the central system related to shoulder joint pain, and persistent pain may induce the reorganization of the cortical sensory center or motor center. However, there is no conclusive evidence as to whether or not the amelioration of pain by botulinum toxin affects brain function. In previous studies of botulinum toxin versus glucocorticoids (triamcinolone acetonide injection) in the treatment of shoulder pain, there is a lack of observation of differences in changes in brain function. As the content of previous assessments of pain improvement was predominantly subjective, objective quantitative assessment indicators were lacking. Functional near-infrared imaging (fNIRS) can remedy this problem.
      Methods: This study protocol is designed for a double-blind, randomized controlled clinical trial of patients with post-stroke HSP without biceps longus tenosynovitis or acromion bursitis. Seventy-eight patients will be randomly assigned to either the botulinum toxin type A or glucocorticoid group. At baseline, patients in each group will receive shoulder cavity injections of either botulinum toxin or glucocorticoids and will be followed for 1 and 4 weeks. The primary outcome is change in shoulder pain on the visual analog scale (VAS). The secondary outcome is the assessment of changes in oxyhemoglobin levels in the corresponding brain regions by fNIRS imaging, shoulder flexion, external rotation range of motion, upper extremity Fugl-Meyer, and modified Ashworth score.
      Discussion: Ultrasound-guided botulinum toxin type A shoulder joint cavity injections may provide evidence of pain improvement in patients with HSP. The results of this trial are also help to analyze the correlation between changes in shoulder pain and changes in cerebral hemodynamics and shoulder joint motor function.
      Trial Registration: Chinese clinical Trial Registry, ChiCTR2300070132. Registered 03 April 2023, https://www.chictr.org.cn/showproj.html?proj=193722 .
      (© 2024. The Author(s).)
    • References:
      Pain Manag. 2020 Nov;10(6):411-420. (PMID: 33073703)
      Pain. 2008 Jul;137(1):7-15. (PMID: 18410991)
      Neuroimage. 2008 Jun;41(2):252-9. (PMID: 18394924)
      Neuroimage. 2014 Jan 15;85 Pt 1:6-27. (PMID: 23684868)
      J Rehabil Med. 2007 Jul;39(6):440-7. (PMID: 17624477)
      Toxicon. 2003 Oct;42(5):461-9. (PMID: 14529727)
      Stroke. 2013 May;44(5):1238-43. (PMID: 23559265)
      Cereb Cortex. 2015 Jul;25(7):1906-19. (PMID: 24464941)
      Toxins (Basel). 2015 Jun 30;7(7):2454-80. (PMID: 26134256)
      Phys Med Rehabil Clin N Am. 2015 Nov;26(4):641-55. (PMID: 26522903)
      Diagn Interv Imaging. 2015 Jan;96(1):37-43. (PMID: 24703886)
      Neuroscience. 2021 Mar 15;458:256-270. (PMID: 33465410)
      J Headache Pain. 2016 Dec;17(1):63. (PMID: 27377706)
      J Neuroimaging. 2020 Nov;30(6):808-814. (PMID: 32896933)
      Medicine (Baltimore). 2019 Nov;98(45):e17933. (PMID: 31702679)
      Ann Rehabil Med. 2013 Apr;37(2):208-14. (PMID: 23705115)
      Ann Phys Rehabil Med. 2022 Sep;65(5):101602. (PMID: 34757009)
      Int J Mol Sci. 2020 May 13;21(10):. (PMID: 32414089)
      Arch Phys Med Rehabil. 2012 Jun;93(6):949-56. (PMID: 22483593)
      Toxicon. 2019 Jul;165:69-77. (PMID: 30995453)
      Neuroimage. 2004 Jan;21(1):99-111. (PMID: 14741647)
      Toxins (Basel). 2019 Aug 05;11(8):. (PMID: 31387301)
      J Neurol Neurosurg Psychiatry. 2007 Aug;78(8):845-8. (PMID: 17088333)
      Clin J Pain. 2013 Oct;29(10):857-64. (PMID: 23370074)
      Ann Rehabil Med. 2016 Aug;40(4):592-9. (PMID: 27606265)
      PLoS One. 2013 Oct 03;8(10):e75360. (PMID: 24098378)
      Knee Surg Sports Traumatol Arthrosc. 2012 Oct;20(10):1947-52. (PMID: 22113218)
      J Clin Neurosci. 2021 Aug;90:144-151. (PMID: 34275540)
      Sci Rep. 2015 Mar 30;5:9469. (PMID: 25820289)
      Aesthetic Plast Surg. 2022 Feb;46(1):406-418. (PMID: 34341856)
      Neurotox Res. 2006 Apr;9(2-3):179-88. (PMID: 16785116)
      Am J Phys Med Rehabil. 2016 Oct;95(10):758-63. (PMID: 27003204)
      Prog Neurobiol. 2014 Aug-Sep;119-120:39-59. (PMID: 24915026)
      Stroke. 2021 Dec;52(12):3759-3767. (PMID: 34470492)
      Ann Neurol. 2014 Apr;75(4):591-6. (PMID: 24550077)
      Int J Gen Med. 2020 Dec 07;13:1411-1426. (PMID: 33324087)
      Clin J Pain. 2002 Nov-Dec;18(6 Suppl):S177-81. (PMID: 12569966)
      Neurol Sci. 2017 Sep;38(9):1697-1701. (PMID: 28699104)
      Arch Phys Med Rehabil. 2011 Jul;92(7):1034-7. (PMID: 21704782)
      Am J Phys Med Rehabil. 2011 Sep;90(9):768-80. (PMID: 21430513)
      PLoS One. 2021 Aug 23;16(8):e0256626. (PMID: 34424921)
    • Grant Information:
      52105305 National Natural Science Foundation of China; 2020A1515011292 Natural Science Foundation of Guangdong Province; 2020B1212060077 Foundation of Guangdong Provincial Key Laboratory of Sensor Technology and Biomedical Instrument
    • Contributed Indexing:
      Keywords: Botulinum toxin type A; Hemiplegic shoulder pain; Protocol; Randomized controlled trial; Stroke
    • Accession Number:
      EC 3.4.24.69 (Botulinum Toxins, Type A)
      0 (Neuromuscular Agents)
    • Publication Date:
      Date Created: 20240627 Date Completed: 20240628 Latest Revision: 20240828
    • Publication Date:
      20240830
    • Accession Number:
      PMC11212400
    • Accession Number:
      10.1186/s13063-024-08258-8
    • Accession Number:
      38937804