Table 1: Summary of each of the
studies meeting the inclusion criteria and the related level of evidence for
each study according to Oxford CEBM.
Authors |
Study name |
Study design |
Patient population |
No. of patients |
Treatment groups |
Outcomes |
Level of evidence** |
Cao et al.
2011 [13] |
Intradiscal
injection therapy for degenerative chronic discogenic low back pain with end
plate Modic changes |
RCT |
Discogenic LBP
and end plate |
120 |
Intradiscal
injection of saline, diprospan, and diprospan+songmeile. |
No significant
pain relief within the groups receiving intradiscal saline. The groups that
received either diprospan or diprospan + songmeile injections significantly
improved their VAS and ODI scores. |
1b |
Peng et al. 2010 [6] |
A randomized placebo-controlled trial of intradiscal
methylene blue injection for the treatment of chronic discogenic low back
pain |
RCT |
Discogenic LBP longer than 6 months with no previous
lumbar surgery |
72 |
Intradiscal injection of methylene blue and isotonic
saline |
Mean reduction in NRS-101 of 52.50, and ODI of
35.58. As well as 91.6% patient satisfaction in the MB group vs 0.70%, 1.68%,
and 14.3% in the placebo group. |
1b |
Khot et al.
2004 [8] |
The Use of
Intradiscal Steroid Therapy for Lumbar |
RCT |
Chronic
discogenic LBP |
120 |
Intradiscal
injection of methylprednisolone and saline |
No difference
in outcomes measures (disability and pain scores) at 12 months |
1b |
Beall et al. 2020 [9] |
VAST Clinical Trial: Safely Supplementing Tissue
Lost to Degenerative Disc Disease |
RCT |
Disc degeneration at 1 or 2 vertebral levels from L1
to S1 with chronic low back pain for a minimum of 6 months |
220 |
Allograft, saline or continue nonsurgical management
(NSM) |
VAS improved at 6 months from 54.81 to 16.0 on the
allograft group and from 55.25 to 41 in the saline group. At 12 months the
allograft decreased to 12.27 and in the saline group decreased to 19.67. ODI
from 53.73 and 49.25 in the allograft and saline respectively to 18.47 at 6
months and 28.75 at 12 months in the allograft group. Saline group: 15.67 and
9.33 at 6 and 12 months, respectively. |
1b |
Kallewaard et
al. 2019 [7] |
A multicenter
randomized controlled trial on the efficacy of intradiscal methylene blue injection
for chronic discogenic low back pain: the IMBI study |
Double-blinded
RCT |
Chronic
discogenic low back pain for at least 6 months with poor response to
conservative therapy |
84 |
Intradiscal
injection of methylene blue and isotonic saline |
NRS between the
groups was statistically insignificant after 6 months with no change in the
PGIC |
1b |
Nguyen et al. 2017 [26] |
Intradiscal glucocorticoid injection for patients
with chronic low back pain (LBP) associated with active discopathy |
Double-blinded RCT |
Chronic lower back pain for at least 3 months with
discopathy on MRI |
135 |
glucocorticoids and iodixanol contrast vs iodixanol
contrast alone |
At 1 month 11-point NRS was higher in the GC IDI
(55.4%) vs control (33.3%), the improvement of LBP-related limitation
improved in the GC IDI group (84.6% VS 54.0%). At 3 months pain scores in the
GC IDI were higher than in the control and by 12 months, there were not
differences between the 2 groups |
1b |
Schwetschenau et al. 1976 [10] |
Double-blinded
evaluation of intradiscal chymopapain for herniated lumbar disc |
Double-blinded
RCT |
LBP with
radiculopathy and no improvement after 3 months of conservative treatment |
66 |
Chymopapain vs
placebo |
The successful
rate for the chymopapain group was 58% and for the placebo group was 49%,
with a p value of 0.14 |
1b |
Bae et al. 2014 [12] |
Is there clinical improvement associated with saline
injection for discogenic low back pain: comparison of RCTs |
Post-hoc comparison of RCT |
N/A |
N/A |
Intervertebral disc injection of saline vs
investigational drug |
At 12 months: saline patients had a 58.5% decreased
in VAS vs 36.6% decreased for the investigational group |
1a |
** level of evidence key.
According to Oxford Centre for Evidence-Based
Medicine (CEBM).