Sun2
The addition of hyperbaric oxygen to standard treatment for incomplete spinal injury at altitude reduced the grade of injury after treatment.
Clinical Bottom Line: 1. The addition of HBOT resulted in a higher proportion of patients with better ASIA grade of injury (normal or incomplete) than with standard treatment alone. |
Citation/s:1. Sun Q, Bao JF, An YL, Lei H, Ma J. Hyperbaric oxygen therapy and comprehensive orthopedic treatment for incomplete traumatic spinal cord injury on the qinghai-tibet plateau: Study protocol for an open-label randomized controlled clinical trial. Asia Pacific Journal of Clinical Trials: Nervous System Diseases. 2017 Apr 1;2(2):50.
Corresponding author: Jun Ma majunqh75@163.com
Three-part Clinical Question:For patients with incomplete spinal cord injury and living at high altitude, does the application of hyperbaric oxygen compared to air breathing, result in any improvement in recovery?
Search Terms: Spinal cord trauma; hypoxia; healing
The Study:Non-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: Adult patients with incomplete spinal cord injury and who had lived at altitude for at least two years.
Control group (N = 82; 82 analysed): Standard treatment with pedicle screw and laminectomy as indicated
Experimental group (N = 82; 82 analysed): As above plus forty daily sessions breathing 100% oxygen for 60 minutes at 2.0 ATA given in four sets of 10 treatments with 5 to 7 days intervals.
The Evidence:
Outcome |
Time to Outcome |
Control group |
Hyperbaric group |
Relative risk reduction |
Absolute risk reduction |
NNT |
American Spinal Injury Ass Grade D or E (best) |
At completion of treatment |
0.65 |
0.90 |
40% |
0.26 |
4 |
95% CIs: |
21% to 58% |
0.13 to 0.38 |
3 to 7 |
Measure |
Control Group |
Hyperbaric Group |
Difference |
95% CI | ||
Mean |
SD |
Mean |
SD | |||
Mod. Barthel Index (0 to 100). Higher is better. End of treatment |
75.4 |
12.3 |
89.9 |
11.6 |
14.5 |
-29.6 to 58.6 |
ASIA tactile score. End of treatment |
102.3 |
13.5 |
118.7* |
15.4 |
16.4 |
-48.3 to 81.1 |
ASIA motor score. End fo treatment |
86.3 |
12.3 |
99.2 |
17.0 |
12.9 |
-55.0 to 80.8 |
*Authors state max score is 112 ‘on each side’ in text. Meaning unclear.
Comments:
1. Recruitment completed 2016 and results published here in 2017. Further analysis reported for neuroinflammation in 2019 (See 'Sun' here).
2. Randomization method sounds reliable and concealed.
3. Sample size calculation suggested 188 patients needed but funds ran out.
Appraised by:Mike Bennett m.bennett@unsw.edu.au; Tuesday, 20 July 2021
Kill or Update By: July 2025