Patient characteristics
132 patients were enrolled in this study,
28 (21%) received APLD/Ozone/Epidural and 104 (79%) received caudal epidural alone.
Patient characteristics are recorded in Table 1.
Certain data was unavailable.
10 patients were lost to follow up and were excluded from the study.
This included 3 (11%) in the APLD/Ozone/Epidural group and 7 (6.7%) in the caudal epidural group.
39 patients (32%) had documented lumbar disc herniation but not an MRI report or scan available for review.
Of these 39 patients,
34 (28%) also had no record of presence of single or multi-level disc herniation.
These patients with partially missing data were included in the overall analysis but excluded from analysis of the relevant subgroups.
Average patient age was 49.8 years (SD 16.55).
The APLD/Ozone/Epidural group was significantly younger (40.3,
SD 10.8) than the caudal epidural group (51.5,
SD17.3) when analysed using the two sample T-test.
The oldest patient was 84 and the youngest was 18.
73 males (59%) and 49 females (40 %) were included in this study.
Using the Pearson’s Chi squared test,
no significant difference in gender distribution was found between the APLD/Ozone/Epidural and caudal epidural treatment groups.
Symptoms of sciatica were a prerequisite for inclusion in this study.
91 patients (75%) reported symptoms of sciatica>LBP. 31 patients (25%) reported symptoms of LBP>sciatica.
Within the APLD/Ozone/Epidural treatment group,
20 patients (80%) reported symptoms of sciatica>LBP with 5 patients (20%) reporting symptoms of LBP>sciatica.
Within the caudal epidural treatment group 72 patients (73%) reported symptoms of Sciatica>LBP with 26 (27%) reporting symptoms of LBP>Sciatica.
There was no significant difference in type of symptoms between treatment groups.
94 patients (71%) reported symptoms ongoing for >1yr and 28 patients (21%) reported symptoms ongoing for <1yr.
Within the APLD/Ozone/Epidural treatment group 15 patients (60%) reported symptoms ongoing for >1yr with 5 patients (40%) reporting symptoms of <1yr.
Within the caudal epidural treatment group 80 patients (81%) reported symptoms ongoing for >1yr and 18 patients (19%) reported symptoms of <1yr.
There was no significant difference in the duration of symptoms between treatment groups.
Of the patients with available MRI scans or reports:
- 68 (88%) had contained disc herniation and 11 (12%) had non-contained disc herniation.
Within the APLD/Ozone/Epidural treatment group,
20 (83%) had contained disc herniations compared to 4 (17%) who had non-contained disc herniations.
Within the caudal epidural treatment group,
53 patients (88%) had contained herniations compared to 7 (12%) with uncontained herniations.
There was no significant difference in type of disc herniation between treatment groups.
- 36 (47%) had signs of nerve root compression on their MRI and 45 (53%) had no signs of nerve root compression.
In the APLD/Ozone/Epidural group 19 (79%) had signs of nerve root compression with 5 (21%) having no signs of nerve root compression.
In the caudal epidural group 20 (33%) had signs of nerve root compression whilst 40 (66%) had no signs of nerve root compression.
There were a significantly greater percentage of patients with signs of nerve root compression in the APLD/Ozone/Epidural treatment group than in the caudal epidural group (Pearson’s Chi squared test).
- 35 (43%) patients had single level disc disease whilst 47 (57%) had multi-level disease.
In the APLD/ozone/epidural group,
20 (71%) had single level disease whilst 8 (29%) had multi-level disease.
In the caudal epidural group,
20 (33%) had single level disease and 41 (67%) had multi-level disease. There were a significantly greater percentage of patients with single level disc disease in the APLD/Ozone/Epidural than in the caudal epidural group (Pearson’s Chi squared test).
Average follow up across all patients was 3.02 months (SD 1.3).
There was no significant difference in follow up between APLD/Ozone/Epidural and caudal epidural treatment groups.
Table 1.
Characteristics of patients included in study
|
|
All patients
(n=122)
|
APLD/Ozone/Epidural treatment group
(n=25)
|
Caudal epidural treatment group
(n=97)
|
|
Average age
(years)
|
49.7
(SD 16.557)
|
40.3*
(SD 11.108)
|
52.2*
(16.898)
|
|
Age
|
Patients <50yrs
|
65
(53.3)
|
21
(84)
|
44
(45)
|
|
Patients >50yrs
|
57
(46.7)
|
4
(16)
|
53
(54.6)
|
|
Gender
|
Male
|
73
(59.8)
|
18
(72)
|
55
(56.7)
|
|
Female
|
49
(40.2)
|
7
(28)
|
42
(43.3)
|
|
Pre-procedure symptoms
|
Sciatica>LBP
|
9
(74.6)
|
5
(20)
|
26
(26.8)
|
|
LBP>Sciatica
|
31
(25.4)
|
20
(80)
|
71
(73.2)
|
|
Duration of symptoms
|
<1year
|
28
(22.9)
|
10
(40)
|
18
(18.6)
|
|
>1year
|
94
(77.1)
|
15
(60)
|
79
(81.4)
|
|
Type of disc herniation**
|
Contained
|
68
(88.3)
|
18
(85.7)
|
50
(89.3)
|
|
Non-contained
|
9
(11.7)
|
3
(14.3)
|
6
(10.7)
|
|
Degree of nerve root compression
**
|
Nerve root compression
|
36
(46.8)
|
17
(80.9)
|
19
(33.9)
|
|
No nerve root compression
|
41
(53.2)
|
4
(19.1)
|
37
(66.1)
|
|
Single or multi level disc disease
**
|
Single level
|
35
(42.7)
|
17
(68)
|
18
(31.6)
|
|
Multi level
|
47
(57.3)
|
8
(32)
|
39
(68.4)
|
|
Average duration of final follow up
|
3.02
(SD 1.307)
|
2.64#
(SD 1.113)
|
3.12#
(1.341)
|
Legend:
- Numbers outside brackets = actual figures
- Numbers inside brackets = percentages unless stated otherwise
- = Statistically significant difference in age between treatment groups
- # = No statistically significant difference between duration of final follow up
- **=this data not available on all patients in study
Overall Results
Table 2.
Summary of results for all patients
|
|
Treatment Group
|
|
|
Outcome Score
|
APLD/Ozone/Epidural
|
Caudal Epidural
|
P-value
|
|
Mean improvement VAS back pain at 1 month
|
1.98 (1.9336)
|
1.79 (1.6962)
|
0.6320
|
|
Mean improvement VAS back pain at final follow up
|
2.1 (2.2126)
|
1.35 (1.5575)
|
0.0544
|
|
Mean improvement VAS sciatica at 1 month
|
3.48 (2.6750)
|
2.38 (2.3124)
|
0.0417
|
|
Mean improvement VAS sciatica at final follow up
|
3.36 (2.8814)
|
1.66 (2.1468)
|
0.0015
|
|
Mean McNab score at 1 month
|
3.4 (1.1547)
|
2.97 (0.8833)
|
0.0440
|
|
Mean McNab score at final follow up
|
3.28 (1.1733)
|
2.62 (0.8077)
|
0.0015
|
Numbers in brackets = standard deviation (SD)
Numbers in red indicate p-value of statistical significance
- 1. McNab clinical outcome score
This was the primary outcome measure which was recorded one month after treatment and at final follow up.
- a. One month McNab score
The overall mean one month McNab score (Table 1) was higher in the APLD/Ozone/Epidural treatment group than the caudal epidural treatment group although this did not reach statistical significance.
Patients treated with APLD/Ozone/Epidural had higher final McNab scores than those treated with caudal epidural except in patients with non-contained disc herniations and those with multi-level disc disease.
However this difference did not reach statistical significance in any of the subgroups (Appendix: Supplementary Tables 1-7)
Graph 1 demonstrates the McNab score received by patients at one month after treatment.
A McNab score of 4-5 is considered a good-excellent outcome.
A McNab score of 3 and above is considered a successful outcome.
Table 2 demonstrates the percentage of patients whose treatment outcome was successful according to their one month McNab score.
Overall 72% of patients had a successful outcome one month after APLD/Ozone/Epidural treatment compared to 62.8% of patients who had a successful outcome with caudal epidural treatment.
The APLD/Ozone/Epidural treatment produces higher rates of success in all subgroups except patients with multi-level disc disease and patients with no signs of nerve root compression on MRI.
However,
no statistically significant differences were noted.
Table 3 demonstrates the percentage of patients whose treatment outcome was good–excellent according to their one month McNab score.
Overall 56% of patients had good-excellent outcomes with APLD/Ozone/Epidural treatment compared to only 30.9% of patients with the caudal epidural treatment.
This difference was close to significance.
The APLD/Ozone/Epidural treatment produced higher rates of success in all subgroups except patients with multi-level disc disease and patients with non-contained disc herniation.
None of the subgroups produced significant differences.
Fig 1.
All patients: McNab score at one month follow up
Table 3.
McNab score at 1 month follow up,
% of patients with successful outcome
|
|
% of successful treatments based on 1 month McNab score
|
|
|
Patient group
|
APLD/Ozone/Epidural treatment group
|
Caudal epidural treatment group
|
P-value
|
|
All Patients
|
72%
|
62.8%
|
0.39
|
|
Female
|
71.4%
|
64.3%
|
0.71
|
|
Male
|
72.3%
|
61.8%
|
0.42
|
|
<50years
|
71.5%
|
65.9%
|
0.65
|
|
>50years
|
75%
|
60.4%
|
0.56
|
|
LBP>Sciatica
|
60%
|
50%
|
0.68
|
|
Sciatica>LBP
|
75%
|
67.6%
|
0.53
|
|
Symptoms ongoing <1yr
|
80%
|
72.2%
|
0.65
|
|
Symptoms ongoing >1yr
|
66.7%
|
60.8%
|
0.67
|
|
Contained disc herniation
|
66.7%
|
62%
|
0.73
|
|
Non-contained disc herniation
|
66.7%
|
66.6%
|
1
|
|
Nerve root compression
|
70.6%
|
68.4%
|
0.08
|
|
No nerve root compression
|
50%
|
59%
|
0.72
|
|
Single level disc disease
|
82.2%
|
55.6%
|
0.089
|
|
Multi level disc disease
|
50%
|
66.5%
|
0.32
|
Table 4.
McNab score at 1 month follow up,
% with good–excellent outcome
|
|
% of good-excellent outcomes at final follow up based on 1 month McNab score
|
|
|
Patient group
|
APLD/Ozone/Epidural treatment group
|
Caudal epidural treatment group
|
P-Value
|
|
All Patients
|
56%
|
30.9%
|
0.02
|
|
Female
|
57.1%
|
31%
|
0.17
|
|
Male
|
55.6%
|
30.9%
|
0.66
|
|
<50years
|
52.4%
|
40.9%
|
0.38
|
|
>50years
|
75%
|
22.7%
|
0.022
|
|
LBP>Sciatica
|
60%
|
15.4%
|
0.029
|
|
Sciatica>LBP
|
55%
|
36.6%
|
0.14
|
|
Symptoms ongoing <1yr
|
60%
|
38.9%
|
0.28
|
|
Symptoms ongoing >1yr
|
53.4%
|
29.1%
|
0.67
|
|
Contained disc herniation
|
50%
|
32%
|
0.17
|
|
Non-contained disc herniation
|
33.4%
|
66.6%
|
0.34
|
|
Nerve root compression
|
47.1%
|
42.1%
|
0.76
|
|
No nerve root compression
|
50%
|
32%
|
0.48
|
|
Single level disc disease
|
70.5%
|
38.9%
|
0.06
|
|
Multi level disc disease
|
25%
|
35.8%
|
0.55
|
- b. Final McNab Score
The overall mean final McNab score was significantly higher in the APLD/Ozone/Epidural treatment group compared to the caudal epidural treatment group (Table 1).
Patients treated with APLD/Ozone/Epidural had higher final McNab scores than those treated caudal epidural in all subgroups (appendix Table ???).
McNab scores were significantly higher in the APLD/Ozone/Epidural treatment group in patients older than 50,
those with symptoms ongoing for >1yr and those with single level disc herniation.
Graph 2 demonstrates the McNab score of patients at final follow up.
Table 4 demonstrates the percentage of patients with a successful outcome according to the final McNab score.
Overall 68% of patients had a successful outcome at final follow up after receiving the APLD/Ozone/Epidural treatment compared to 51% of patients who had a successful outcome with caudal epidural treatment although this difference was not significant.
The APLD/Ozone/Epidural treatment produced higher rates of success in all subgroups at final follow up with significant almost being reached in patients with single level disc disease.
Table 5 demonstrates the percentage of patients with good– excellent outcomes based on final McNab score.
Overall 48% of patients who received APLD/Ozone/Epidural treatment had good-excellent outcome.
This compares to only 13% of patients in the caudal epidural treatment group with good-excellent outcome. This difference was statistically significant.
Patients treated with APLD/Ozone/Epidural had significantly higher rates of good-excellent outcome in; both female and male patients,
all age groups,
both symptom subgroups,
patients with symptoms ongoing for >1year,
patients with contained disc herniation and patients with single level disc disease.
Fig 2.
All patients: McNab score at final follow up
Table 5.
McNab score at final follow up,
% of successful outcome
|
|
% of successful treatments based on final McNab score
|
|
|
Patient group
|
APLD/Ozone/Epidural treatment group
|
Caudal epidural treatment group
|
P-value
|
|
All Patients
|
68%
|
51%
|
0.12
|
|
Female
|
57.2%
|
45.2%
|
0.56
|
|
Male
|
72.2%
|
54.5%
|
0.18
|
|
<50years
|
66.6%
|
45.4%
|
0.11
|
|
>50years
|
75%
|
54.7%
|
0.43
|
|
LBP>Sciatica
|
60%
|
42.3%
|
0.47
|
|
Sciatica>LBP
|
70%
|
53.5%
|
0.19
|
|
Symptoms ongoing <1yr
|
80%
|
66.7%
|
0.45
|
|
Symptoms ongoing >1yr
|
60%
|
46.8%
|
0.35
|
|
Contained disc herniation
|
61.1%
|
50%
|
0.42
|
|
Non-contained disc herniation
|
66%
|
66%
|
1
|
|
Nerve root compression
|
64.7%
|
63.2%
|
0.92
|
|
No nerve root compression
|
50%
|
45.9%
|
0.87
|
|
Single level disc disease
|
76.6%
|
44.1%
|
0.05
|
|
Multi level disc disease
|
50%
|
35.9%
|
0.84
|
Table 6.
McNab score at final follow up,
% with good–excellent outcome
|
|
% of good-excellent outcomes at final follow up based on final McNab score
|
|
|
Patient group
|
APLD/Ozone/Epidural treatment group
|
Caudal epidural treatment group
|
P-value
|
|
All Patients
|
48%
|
13%
|
0
|
|
Female
|
42.3%
|
11.9%
|
0.04
|
|
Male
|
50%
|
14.5
|
0.002
|
|
<50years
|
42.8%
|
13.6%
|
0.009
|
|
>50years
|
75%
|
13.2%
|
0.002
|
|
LBP>Sciatica
|
0%
|
7.69%
|
0.004
|
|
Sciatica>LBP
|
45%
|
15.5%
|
0.005
|
|
Symptoms ongoing <1yr
|
50%
|
33%
|
0.38
|
|
Symptoms ongoing >1yr
|
46.7%
|
8.9%
|
0
|
|
Contained disc herniation
|
50%
|
14%
|
0.002
|
|
Non-contained disc herniation
|
33%
|
16%
|
0.57
|
|
Nerve root compression
|
47%
|
15.8%
|
0.042
|
|
No nerve root compression
|
50%
|
13.5%
|
0.065
|
|
Single level disc disease
|
58.9%
|
5.5%
|
0.001
|
|
Multi level disc disease
|
25%
|
0%
|
0.644
|
- 2. Improvement in VAS LBP and sciatica scores
This was the study’s secondary outcome measure.
No significant differences existed between baseline LBP and sciatica scores between the two treatment groups,
overall and within patient subgroups (Appendix: Supplementary Tables 1-7).
There were improvements in LBP and sciatica scores one month after treatment and at final follow up in both treatment groups with the largest improvements found after treatment with APLD/Ozone/Epidural.
However there was only a significant difference between treatment groups regarding the improvement in sciatica at final follow up (Table 1).
Graph 3 shows the overall final follow up results for each treatment group.
Sciatica tends to improve more than LBP independent of treatment received and there was a greater improvement within the APLD/Ozone/Epidural treatment group than the caudal epidural treatment group.
Fig 3.
Overall results: improvement in VAS LBP/Sciatica and McNab score at final follow up
