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We performed a single blind randomised controlled trial with three- and six-month follow-up. This
study was approved by local ethical committee and
participants signed informed consent. Fifty-one patients were enrolled and randomly inserted into
treatment group (TG, N.=29) or control group (CG,
N.=21) in a ratio of 3:2. We have chosen this ratio
because in the previous year we have treated around
60% of patients with chronic low back pain of those
assessed and resulted includable into a Back School
Program. The remaining 40% was excluded only for
the lack of financial resources. Hence, we decided
to maintain this proportion also into the design of
the present study. The concealed randomization was
performed by means of sealed envelopes extracted
every 15 patients: five patients were allocated in a
treatment group performing Back School Program,
other four patients in another similar treated group,
and the last six in the control group 25 (Figure 1). In
order to investigate the relationships between psychological features and rehabilitative outcomes, we
stratified patients in those with elevated scores in
one or more scales of MMPI-II (ES group) and those
with no elevations in anyone of the scores of MMPIII (NES), on the basis of the Italian standardization.26
Inclusion criteria were: age between 18 and 80
years and a diagnosis of chronic non-specific low
back pain. Exclusion criteria were: acute low back
pain, low back pain due to specific causes, presence
of reumathological, neurological or oncological concomitant diseases, previous back surgery, severe
cognitive impairments and pregnancy.
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Randomized
N=73
Subject assigned to
back school group
(BSG) N=44
Received 10 session in 1 month
(around 3 times/week N=44);
MMPI-II performed.
Excluded (N=15):
8 no sufficient answer to MMPI-II
4 refuse MMPI-II
3 lost to T-end evaluation:
unclear/no reasons (N=1);
No time (N=2)
Subject assigned to
control group
(CG) N=29
Received medical assistence
for one month;
MMPI-II performed.
Excluded (N=8):
5 no sufficient answer
to MMPI-II
3 refuse MMPI-II
Presence of
almost 1 MMPI-II
scale score
elevation (N=18)
No presence of
MMPI-II scale
score elevation
(N=11)
Presence of
almost 1 MMPI-II
scale score
elevation (N=10)
No presence of
MMPI-II scale
score elevation
(N=11)
Last 3 months
follow-up (N=0)
Last 3 months
follow-up (N=0)
Last 3 months
follow-up (N=0)
Last 3 months
follow-up (N=0)
Last 6 months
follow-up (N=0)
Last 6 months
follow-up (N=0)
Last 6 months
follow-up (N=0)
Last 6 months
follow-up (N=0)
Analyzed (N=18)
Excluded (N=0)
Analyzed (N=11)
Excluded (N=0)
Analyzed (N=10)
Excluded (N=0)
Analyzed (N=11)
Excluded (N=0)
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or other proprietary information of the Publisher.
Outcome measures
Socio-demographic and clinical data and MMPIII were collected at the baseline. Specific scales for
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quality of life (Short Form Health Status; SF-36), disability (Oswestry Disability Index, ODI, and Waddell
Index, WI), and pain perception (Visual Analogue
Scale, VAS) were assessed at the baseline (T0), at the
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means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
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Characteristics at baseline
Age
Gender
N. acute events
SF36-PCS
SF36-MCS
WI
ODI
VAS
Control group
NES
ES
NES
ES
58.013.1
6 m; 5 f
2.90.8
39.1 (10.3)
47.1 (14.6)
4 (2)
24 (42)
6 (4)
6015.7
7 m; 11 f
3.30.6
41.2 (9.2)
42.7 (15.3)
3 (3)
28 (18)
7 (2)
56.112.9
4 m; 7 f
3.40.5
46.1 (12.0)
50.3 (7.3)
1 (1)
12 (13)
7 (2)
58.414.9
2 m; 8 f
3.50.5
40.4 (6.2)
26.8 (18.9)
4 (1)
34 (10)
8 (1)
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Baseline characteristics for the four groups: mean standard deviation of age and median and interquartile range for the other characteristics. Number of
acute events in the last 12 months are also reported.
BSG
PCS
NES
Baseline
Analysis of Friedman
39.1 (10.3)
3 months
f-up
6 months
f-up
c2
p
MCS
ES
41.2
(9.2)
41.1
(9.0)
45.3 (4.5)
45.9 (11.6)
45.0 (8.8)
46.7 (13.1)
21.27
<0.001
13.80
0.003
NES
47.1
(14.6)
50.6
(17.0)
48.5
(19.9)
52.9
(7.7)
6.80
0.079
CG
PCS
ES
42.7 (15.3)
48.7
(8.8)
49.3 (10.9)
47.7 (11.4)
10.33
0.016
NES
46.1
(12.0)
46.6
(12.5)
42.8
(10.6)
46.3
(11.5)
0.41
0.938
ES
40.4
(6.2)
40.0
(5.1)
41.1
(7.4)
39.6
(6.8)
0.94
0.816
MCS
NES
50.3
(7.3)
52.1
(6.4)
50.5
(10.7)
48.9
(18.5)
2.24
0.525
ES
26.8
(18.9)
28.4
(19.6)
27.0
(17.1)
28.6
(23.7)
3.03
0.347
Medians and inter-quartile range for the Physical and Mental Composite Scores of SF-36 (PCS and MCS, respectively) for Back School Group (BSG) and
Control Group (CG) divided according to the presence (ES) or absence (NES) of elevation into MMPI-II scale scores. In the last two rows the results of
Friedmans analysis for each subgroup (in bold if P<0.05).
Statistical analysis
Baseline characteristics and scale scores were reported in Table I. Median values and inter-quartile
range (i.e., the difference between third and first
quartile) were computed and reported in Table II
for the primary outcome measures. In the Figures,
mean and standard error (because of the high intersubjects variability) were reported. Kruskal-Wallis
analysis was used for main comparisons among the
four groups (BSG-NES, BSG-ES, CG-NES, CG-ES).
Mann-Whitney U test was performed for comparisons between main groups at baseline (BSG vs. CG).
Friedmans analysis were used to assess the significance of differences recorded along time. Repeated
measures analysis of variance was performed on
SF36-PCS and SF36-MCS to take into account the
effects of time (within factor), treatment (BSG vs.
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means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
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50
45
40
NES
ES
Baseline
End of
treatment
3 months
follow-up
6 months
follow-up
45
40
NES
ES
35
Baseline
End of
treatment
3 months
follow-up
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35
50
Physical composite score
6 months
follow-up
Figure 2.Primary outcome measures. On the top panel the Physical Composite Score and on the below panel the Mental Composite Score
of SF-36 recorded for subjects with NES (black) and ES (grey).
At baseline, 29 out of the 50 participants (58%) resulted with an elevation in at least one scale of MMPI-II. One elevation was noted in 13 subjects (26%,
9 of them with hypochondria), and two or more elevations in 16 subjects (32%, with hypochondria, depression, hysteria, paranoia as the most commonly
noted). Nineteen patients out of these 29 ones were
included into BSG and 10 into CG.
The mean ages standard deviations, gender,
baseline values of primary and secondary outcome
measures and number of acute pain events reported
in the last year were reported in Table I for the four
subgroups of patients. There were no statistical differences for age among the four subgroups (2=1.23,
P=0.746).
At baseline, also the scores recorded for participants included into BS-treatment were not significantly different from those recorded for control
group (CG) in terms of SF36-PCS (P=0.191), SF36MCS (p=0.852), WI (p=0.185), OSW (p=0.113), and
VAS (p=0.195). Conversely, some differences were
recorded in terms of OSW (p=0.014) and SF36-MCS
(p=0.016) between ES and NES. However, these
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differences were not significant when the two BSsubgroups were compared (OSW: P=910; SF36MCS: P=0.445), but only due to differences between
untreated subgroups (OSW: P=0.001, SF36-MCS:
P=0.024). No other differences resulted significant
between groups at baseline.
Primary outcome measure: quality of life
Baseline assessment
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means which may allow access to the Article. The use of all or any part of the Article for any Commercial Use is not permitted. The creation of derivative works from the Article is not permitted. The production of reprints for personal or commercial use is
not permitted. It is not permitted to remove, cover, overlay, obscure, block, or change any copyright notices or terms of use which the Publisher may post on the Article. It is not permitted to frame or use framing techniques to enclose any trademark, logo,
or other proprietary information of the Publisher.
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Table III.Improvement in domains of quality of life and reduction in disability and pain.
BSG-NES
BSG-ES
CG-NES
CG-ES
17.81
<0.001
5.12
0.163
17.42
0.001
12.17
0.007
10.47
0.015
0.75
0.861
5.87
0.118
4.81
0.186
20.4
<0.001
15.64
0.001
23.17
<0.001
9.16
0.027
9.53
0.023
22.21
<0.001
9.96
0.019
21.98
<0.001
4.40
0.222
14.43
0.002
9.06
0.029
12.32
0.006
18.28
<0.001
23.40
<0.001
0.81
0.846
0.79
0.852
5.83
0.120
5.07
0.166
5.08
0.166
4.20
0.241
2.50
0.475
1.03
0.794
0.69
0.875
2.28
0.516
1.35
0.716
3.72
0.293
1.50
0.682
1.47
0.689
5.85
0.119
2.04
0.564
4.05
0.256
4.45
0.216
0.71
0.871
1.32
0.724
3.07
0.381
3.17
0.366
PF
RP
BP
GH
Waddel Index
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6.82
0.01
0.50
6.59
0.74
1.21
0.77
<0.001
0.943
0.484
<0.001
0.394
0.309
0.513
1.70
2.73
6.49
4.20
5.04
1.05
0.94
0.170
0.105
0.014
0.007
0.030
0.374
0.426
ME
MCS
Results of repeated measures analysis of variance (in bold if P<0.05) performed on Physical (PCS) and Mental Composite Scores (MCS) of SF-36 of
all the participants, using as factors between subjects the treatment (Back
School vs. Control group), the elevations on MMPI-II scale scores (presence
vs absence) and using time as factor within subjects.
NES
ES
3
2
1
0
RE
Time
Treatment
Elevations on scale
Time*Treatment
Treatment*Elevations
Time* Elevations
Time*Treatment*Elevations
45
40
35
30
25
20
15
10
5
0
NES
ES
SF
PCS
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VT
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or other proprietary information of the Publisher.
NES
ES
4
2
0
Baseline
End
of treatment
3 months
follow-up
6 months
follow-up
Figure 3.Secondary outcome measures. From top to below: Oswestry Disability Index, Waddel Disability Index, Pain Visual Analogue Scale for subjects with NES (black) and ES (grey).
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Discussion
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