Hyperbaric Oxygen and Orthopedic Comprehensive Treatment for Traumatic Incomplete Spinal Cord Injury in the Plateau: an Open-label Randomized Controlled Clinical Trial
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.
Condition:
Spinal Cord Injuries
Treatment:
control group
Start Date:
January 2012
Sponsor:
Qinghai University
For More Information:
https://clinicaltrials.gov/show/NCT03112941