The Impact of Electroacupuncture on Clinical Effect,Brain Structural and Functional Changes on Spinal Cord Injury
NCT ID: NCT03909958
Last Updated: 2020-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2019-11-26
2021-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Electroacupuncture+Routine rehabilitation training Group
42 patients will receive both electroacupuncture（HANS100A）therapy and routine rehabilitation training.
Electroacupuncture+Routine rehabilitation training Group
Electroacupuncture： Major acupoints: Jiaji points. With urinary and stool dysfunction:+Shenshu (BL23) ,Huiyang(BL35).
Localization:Jiaji points of the upper 1 and the lower 1 segment of the Spinal cord injury plane, a total of 4 points.
Operation: Insert Jiaji points By using Hwato-brand disposable acupuncture needles(0.30mm\*50mm), with 0.5 inch from the median line and a depth of 50 to 60mm with perpendicular insertion.Then, participants will receive electroacupuncture treatment by connecting Han's pain irritant instrument (HANS100A) for 30min with the stimulation frequency of 2 /100 Hz and intensity of 1-2mA. Once a day, 5 days a week and rest 2 days, a week is one course and the duration need 12 courses.
Routine rehabilitation training:
Same as Routine rehabilitation training Group.
Routine rehabilitation training Group
42 patients will receive simple routine rehabilitation training.
Routine rehabilitation training Group
Routine rehabilitation training:
Participants with good spinal stability will receive sitting training as early as possible, and will carry out standing training if participants had no adverse reactions (postural hypotension, etc.) after sitting training. Muscle strength training will be performed in recovery phase, and functional movement training will be selected according to participants' conditions. Functional movement training and transfer training will be performed for 20min each time and once a day;Standing and walking training, 2 times a day, 30min each time.
Interventions
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Electroacupuncture+Routine rehabilitation training Group
Electroacupuncture： Major acupoints: Jiaji points. With urinary and stool dysfunction:+Shenshu (BL23) ,Huiyang(BL35).
Localization:Jiaji points of the upper 1 and the lower 1 segment of the Spinal cord injury plane, a total of 4 points.
Operation: Insert Jiaji points By using Hwato-brand disposable acupuncture needles(0.30mm\*50mm), with 0.5 inch from the median line and a depth of 50 to 60mm with perpendicular insertion.Then, participants will receive electroacupuncture treatment by connecting Han's pain irritant instrument (HANS100A) for 30min with the stimulation frequency of 2 /100 Hz and intensity of 1-2mA. Once a day, 5 days a week and rest 2 days, a week is one course and the duration need 12 courses.
Routine rehabilitation training:
Same as Routine rehabilitation training Group.
Routine rehabilitation training Group
Routine rehabilitation training:
Participants with good spinal stability will receive sitting training as early as possible, and will carry out standing training if participants had no adverse reactions (postural hypotension, etc.) after sitting training. Muscle strength training will be performed in recovery phase, and functional movement training will be selected according to participants' conditions. Functional movement training and transfer training will be performed for 20min each time and once a day;Standing and walking training, 2 times a day, 30min each time.
Eligibility Criteria
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Exclusion Criteria
2. Severe structural asymmetry or lesions in the brain
3. Complications that may affect neurologic examination, such as severe peripheral nerve injury, limb fractures, and heterotopic ossification around the joints
4. With complex injury such as traumatic brain injury, organ injury, unstable vital signs or disturbance of consciousness
5. With severe primary diseases such as heart, liver, kidney and hematopoietic system
6. Patients with SCI due to myelitis, multiple sclerosis, vascular malformation caused spinal cord hemorrhage, intraspinal tumors, etc.
7. Pregnancy
18 Years
75 Years
ALL
No
Sponsors
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The Third Affiliated hospital of Zhejiang Chinese Medical University
OTHER
Responsible Party
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Ruijie Ma
Professor,Vice president of the Third Affiliated hospital of Zhejiang Chinese Medical University
Principal Investigators
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Ruijie Ma, Dr.
Role: PRINCIPAL_INVESTIGATOR
The Third Affiliated hospital of Zhejiang Chinese Medical University
Locations
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The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Kelin He, Master
Role: backup
References
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Hunter Revell SM. Symptom clusters in traumatic spinal cord injury: an exploratory literature review. J Neurosci Nurs. 2011 Apr;43(2):85-93. doi: 10.1097/jnn.0b013e31820c2533.
National Spinal Cord Injury Statistical Center. Spinal cord injury facts and figures at a glance. J Spinal Cord Med. 2013 Jan;36(1):1-2. doi: 10.1179/1079026813Z.000000000136. No abstract available.
Heo I, Shin BC, Kim YD, Hwang EH, Han CW, Heo KH. Acupuncture for spinal cord injury and its complications: a systematic review and meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2013;2013:364216. doi: 10.1155/2013/364216. Epub 2013 Feb 17.
Rekand T, Hagen EM, Gronning M. Chronic pain following spinal cord injury. Tidsskr Nor Laegeforen. 2012 Apr 30;132(8):974-9. doi: 10.4045/tidsskr.11.0794. English, Norwegian.
Shin BC, Lee MS, Kong JC, Jang I, Park JJ. Acupuncture for spinal cord injury survivors in Chinese literature: a systematic review. Complement Ther Med. 2009 Oct-Dec;17(5-6):316-27. doi: 10.1016/j.ctim.2009.09.001. Epub 2009 Oct 21.
Buss A, Brook GA, Kakulas B, Martin D, Franzen R, Schoenen J, Noth J, Schmitt AB. Gradual loss of myelin and formation of an astrocytic scar during Wallerian degeneration in the human spinal cord. Brain. 2004 Jan;127(Pt 1):34-44. doi: 10.1093/brain/awh001. Epub 2003 Oct 8.
Hains BC, Black JA, Waxman SG. Primary cortical motor neurons undergo apoptosis after axotomizing spinal cord injury. J Comp Neurol. 2003 Jun 9;462(3):328-41. doi: 10.1002/cne.10733.
Kim BG, Dai HN, McAtee M, Vicini S, Bregman BS. Remodeling of synaptic structures in the motor cortex following spinal cord injury. Exp Neurol. 2006 Apr;198(2):401-15. doi: 10.1016/j.expneurol.2005.12.010. Epub 2006 Jan 26.
Wu J, Zhao Z, Sabirzhanov B, Stoica BA, Kumar A, Luo T, Skovira J, Faden AI. Spinal cord injury causes brain inflammation associated with cognitive and affective changes: role of cell cycle pathways. J Neurosci. 2014 Aug 13;34(33):10989-1006. doi: 10.1523/JNEUROSCI.5110-13.2014.
Altamura AC, Maggioni E, Dhanoa T, Ciappolino V, Paoli RA, Cremaschi L, Prunas C, Orsenigo G, Caletti E, Cinnante CM, Triulzi FM, Dell'Osso B, Yatham L, Brambilla P. The impact of psychosis on brain anatomy in bipolar disorder: A structural MRI study. J Affect Disord. 2018 Jun;233:100-109. doi: 10.1016/j.jad.2017.11.092. Epub 2017 Nov 29.
Saricicek A, Yalin N, Hidiroglu C, Cavusoglu B, Tas C, Ceylan D, Zorlu N, Ada E, Tunca Z, Ozerdem A. Neuroanatomical correlates of genetic risk for bipolar disorder: A voxel-based morphometry study in bipolar type I patients and healthy first degree relatives. J Affect Disord. 2015 Nov 1;186:110-8. doi: 10.1016/j.jad.2015.06.055. Epub 2015 Jul 26.
Hutton C, De Vita E, Ashburner J, Deichmann R, Turner R. Voxel-based cortical thickness measurements in MRI. Neuroimage. 2008 May 1;40(4):1701-10. doi: 10.1016/j.neuroimage.2008.01.027. Epub 2008 Feb 1.
Benetti S, Pettersson-Yeo W, Hutton C, Catani M, Williams SC, Allen P, Kambeitz-Ilankovic LM, McGuire P, Mechelli A. Elucidating neuroanatomical alterations in the at risk mental state and first episode psychosis: a combined voxel-based morphometry and voxel-based cortical thickness study. Schizophr Res. 2013 Nov;150(2-3):505-11. doi: 10.1016/j.schres.2013.08.030. Epub 2013 Sep 29.
Freund P, Weiskopf N, Ward NS, Hutton C, Gall A, Ciccarelli O, Craggs M, Friston K, Thompson AJ. Disability, atrophy and cortical reorganization following spinal cord injury. Brain. 2011 Jun;134(Pt 6):1610-22. doi: 10.1093/brain/awr093. Epub 2011 May 17.
Jurkiewicz MT, Crawley AP, Verrier MC, Fehlings MG, Mikulis DJ. Somatosensory cortical atrophy after spinal cord injury: a voxel-based morphometry study. Neurology. 2006 Mar 14;66(5):762-4. doi: 10.1212/01.wnl.0000201276.28141.40.
Ma R, Liu X, Clark J, Williams GM, Doi SA. The Impact of Acupuncture on Neurological Recovery in Spinal Cord Injury: A Systematic Review and Meta-Analysis. J Neurotrauma. 2015 Dec 15;32(24):1943-57. doi: 10.1089/neu.2014.3866. Epub 2015 Aug 28.
Other Identifiers
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2019ZZ013
Identifier Type: -
Identifier Source: org_study_id
NCT03909087
Identifier Type: -
Identifier Source: nct_alias
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