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Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau

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ClinicalTrials.gov Identifier: NCT03112941
Recruitment Status : Completed
First Posted : April 13, 2017
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Ma, Qinghai University

Tracking Information
First Submitted Date  ICMJE April 8, 2017
First Posted Date  ICMJE April 13, 2017
Last Update Posted Date February 9, 2018
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2017)
Modified Barthel index [ Time Frame: 40 days after treatment ]
To assess the difference before and after treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2017)
American Spinal Injury Association impairment scale grading [ Time Frame: 40 days after treatment ]
To assess the recovery of spine nerve function before and after treatment. American Spinal Injury Association(ASIA) is a spinal cord injury (SCI) neurological assessment criteria developed by the American Spinal Injury Association in 1982, contains grades A-E.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau
Official Title  ICMJE Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau: an Open-label Randomized Controlled Clinical Trial
Brief Summary To observe modified Barthel index, American Spinal Injury Association (ASIA) impairment scale grading, sensory score and motor score in patients with incomplete SCI in the plateau using 0.2 MPa HBO combined with pedicle screw fixation and decompressive laminectomy so as to investigate the effect of HBO therapy on incomplete SCI in the plateau.
Detailed Description

History and current related studies Spinal cord injury (SCI) is a kind of serious disabling disease caused by various factors (such as trauma, infection), and can lead to paralysis. At present, 16-40 people/million suffer from SCI in developed countries every year; 34.3-60 people affect SCI in China every year. SCI is often caused by physical trauma, such as rotation, compression and hyperextension. This type of SCI is also known as traumatic spinal cord injury (TSCI). At present, there are many treatments for TSCI, but the prognosis is poor.

Hyperbaric oxygen (HBO) therapy is the medical use of oxygen at a level higher than atmospheric pressure for treating hypoxic disease (Hu et al., 2016). Secondary injuries, such as edema, neuronal necrosis, blood and spinal cord barrier disorders, have been shown to be strongly associated with a large number of inflammatory factors. HBO can effectively inhibit the generation of inflammatory factors, and promote repair and regeneration of neurons. Moreover, HBO can relieve hypoxia, protect the surrounding tissue, reduce the mitochondrial dysfunction in injury area, reduce bleeding area and reduce edema. HBO has been used to treat TSCI for a long time. Holbach et al. first found that HBO therapy improved postoperative dysfunction in TSCI patients. In recent years, a number of clinical studies have focused on HBO therapy for TSCI, and the patients recovered well. Atmospheric pressure is very low in the plateau, and oxygen content in plateau environment is less than that in plain area. Secondary apoptosis induced by ischemia and hypoxia after SCI is the main cause of spinal cord dysfunction. HBO therapy can increase the dissolved oxygen, which is helpful for the recovery of incomplete spinal nerve function. Therefore, HBO therapy has higher therapeutic value in plateau than in plain.

Data management The observation forms were filled out accurately, completely and timely by researchers. Data were recorded electronically by data managers using a double-data entry strategy. The electronic database was collated and locked only by the project manager. The locked electronic database could not be altered. All data regarding this trial were preserved by the Affiliated Hospital of Qinghai University, China. The electronic database was statistically analyzed by a professional statistician. Anonymized trial data will be published at www.figshare.com.

Statistical analysis Statistical analysis was performed using SPSS 22.0 software (IBM, Armonk, NY, USA). Measurement data were expressed as mean ± SD. Normality test and variance homogeneity test were conducted. Normally distributed data with homogeneity were compared using one-way analysis of variance. Non-normally distributed data were compared using Wilcoxon two-sample rank sum test. Ranked data were analyzed using rank sum test. A value of P < 0.05 was considered statistically significant. Results followed the intention-to-treat principle.

Confidentiality Identifying information, such as observation forms and informed consent, was password-protected and not altered for future reference. No person, other than an authorized researcher, may be in contact with it.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
164 patients with traumatic incomplete spinal cord injury (SCI) were recruited in the plateau from June 2012 to February 2016.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • Procedure: control group
    Patients with traumatic incomplete spinal cord injury (SCI) in the control group are treated with pedicle screw fixation and decompressive laminectomy.
  • Other: hyperbaric oxygen group
    Patients with traumatic incomplete spinal cord injury (SCI) in the hyperbaric oxygen group are treated with pedicle screw fixation and decompressive laminectomy, and are given 0.2 MPa hyperbaric oxygen (HBO), once a day, 10 times as a course, with 5-7 days of resting between two courses, totally four courses.
Study Arms  ICMJE
  • Experimental: control group
    Patients with traumatic incomplete spinal cord injury (SCI) in the control group are treated with pedicle screw fixation and decompressive laminectomy.
    Intervention: Procedure: control group
  • Experimental: hyperbaric oxygen group
    Patients with traumatic incomplete spinal cord injury (SCI) in the hyperbaric oxygen group are treated with pedicle screw fixation and decompressive laminectomy, and are given 0.2 MPa hyperbaric oxygen (HBO), once a day, 10 times as a course, with 5-7 days of resting between two courses, totally four courses.
    Intervention: Other: hyperbaric oxygen group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 8, 2017)
164
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Incomplete spinal cord injury (SCI) (contusion) assessed by rectal examination in accordance with International standards for neurological classification of spinal cord injury (Revised 2011);
  • SCI revealed by CT, X-ray or MRI scan;
  • Clear trauma in the spine;
  • Different degrees of movement, sensation and sphincter dysfunction below spine injury segment;
  • Living in the plateau for at least 2 years;
  • Age of ≥18 years, irrespective of sex.

Exclusion Criteria:

  • Brain trauma, combined injury of chest and abdominal organs, instable vital signs or disturbance of consciousness;
  • Coagulation dysfunction;
  • Hypertension, heart disease, diabetes, stroke, brain damage and neurological disease;
  • Lumbar surgery, trauma history, lumbar fracture, infection, tumor, severe osteoporosis;
  • Nerve pain, limb cramps, periarticular heterotopic ossification;
  • Other diseases that may impact neurological examination;
  • Participating in other clinical trials.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03112941
Other Study ID Numbers  ICMJE QinghaiUH_JM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jun Ma, Qinghai University
Study Sponsor  ICMJE Qinghai University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jun Ma, Ph.D Affiliated Hospital of Qinghai University
PRS Account Qinghai University
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP