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Prévia do material em texto

INTRODUCTION
Low back pain
Low back pain (LBP) is a very common condition
which poses significant problems to the health service.
The life-time incidence of LBP is 80%.1 It has been
suggested that 80–90% of patients will recover in 6
weeks without any intervention.2 In the year follow-
ing a first episode of LBP, the pain recurs in 60–86%
of patients.3 There appears to be a trend toward
chronic LBP with 40% of subjects reporting pain at 6
months and 33% still experiencing pain at 1–2 years.4,5
The human and financial cost of LBP is substantial.
There is not a complete understanding of the vul-
nerability to recurrence. Instability of the lumbar
motion segment is considered to be one important
cause.6 A model of spinal stability by Panjabi could
provide one explanation for these recurrences.7,8
Panjabi defined spinal instability in terms of a region
of laxity around the neutral position of a spinal seg-
ment called the ‘neutral zone’. This neutral zone is
shown to be increased with intersegmental injury,
intervertebral disc degeneration and muscular weak-
ness. The size of this neutral zone is influenced by the
interaction between what Panjabi described as the
passive, active and neural control systems: (i) the pas-
sive system constituting the vertebrae, intervertebral
discs, zygapophyseal joints and ligaments; (ii) the
active system constituting the muscles, and tendons
surrounding and acting on the spinal column; and (iii)
the neural system comprising the nerves and central ner-
vous system which direct and control the active system
in providing dynamic stability. Studies have shown that
muscles can provide segmental stabilisation by control-
ling motion in the neutral zone, and that the neutral
© W. S. Maney & Son Ltd 2007 DOI 10.1179/108331907X222949
SPECIFIC SPINAL STABILISATION EXERCISES IN
PATIENTS WITH LOW BACK PAIN 
– A SYSTEMATIC REVIEW
ANNIKA HAUGGAARD1 AND ANN L. PERSSON2
1City Rehab Physiotherapy Clinic, Helsingborg, Sweden
2Rehabilitation and Research Centre for Torture Victims, RCT, Copenhagen, Denmark
The aim of this review was to evaluate the effects of specific spinal stabilisation exercises in
patients with low back pain (LBP). PubMed and PEDro databases were searched. Ten relevant
randomised controlled trials (RCTs) with a study population of patients with acute, sub-acute
or chronic LBP were reviewed and quality assessed. The intervention method should have
included specific spinal stabilisation exercises including co-contraction of multifidus muscles
and transversus abdominis muscles. Seven RCTs were high quality and three were low quality.
The results indicate moderate evidence of improved disability and/or pain level, increased
multifidi cross-sectional area, and limited evidence for improved quality of life after treatment.
The outcome measures used showed extensive heterogeneity. Larger, randomised, controlled
trials of high quality, in different subgroups of LBP patients, with long-term follow-up are
warranted. A standardisation of outcome measures would be beneficial in order to facilitate
comparability among studies.
Keywords: Lumbar multifidus, physical therapy, quality assessment, rehabilitation, transversus
abdominis
Physical Therapy Reviews 2007; 12: 233–248
zone can be returned to within physiological limits by
effective muscle control.9–11
All muscles that traverse the lumbar region are
capable of contributing to the stabilisation and pro-
tection of the lumbar spine.12,13 There are studies sug-
gesting that the transversus abdominis muscles and
the lumbar multifidus muscles are particularly impor-
tant for lumbar segmental stability and for control of
motion in the neutral zone.9–11,14,15 The literature
reports varying disruptions in the pattern of recruit-
ment and co-contraction within and between differ-
ent muscle synergies in LBP populations.16 There is
evidence of ipsilateral atrophy of the multifidus mus-
cles in patients with acute and chronic LBP con-
firmed by ultrasound and computed tomography
(CT).17,18 In a magnetic resonance image (MRI) study,
multifidus muscle atrophy was present in 80% of
patients with LBP.19 Hides et al.17 showed that the
cross-sectional area of the multifidus muscles in
patients with acute LBP was reduced on the sympto-
matic side and isolated to one vertebral level (in most
cases the clinically determined level of symptoms).
The rapid onset and the localised distribution of mus-
cle wasting suggested that the mechanism of wasting
could not be generalised disuse atrophy or spinal
reflex inhibition. The explanation could be inhibition
due to perceived pain, via a long loop reflex, prevent-
ing movement to protect structures at the level of
pathology.17 Biopsies of multifidi in patients with LBP
also show abnormalities. Atrophy of type II fibres,
and internal structural changes of type I fibres, giving
them a ‘moth-eaten’ appearance, have been seen.20
The presence of dysfunction in the deep abdominal
muscles in subjects with chronic LBP has also been
reported.21,22
Specific stabilisation exercise and motor learning
Some authors claim that if there is a deficit of the sta-
bilising muscles, incorrect compensation of their
activity takes place from the movement muscles if
classic exercise techniques are used in rehabilita-
tion.23–25 Alterations of the appropriate muscle co-
ordination patterns could develop and increase the
risk of re-injury to the spine. Instead of using a gen-
eral exercise approach, focus should be on specific
training of local system muscles, i.e. transverses abdo-
minis muscles, diaphragm and multifidus muscles,
whose primary role is considered to be the provision
of dynamic stability and segmental control to the
spine.26,27 This approach is based on the principles of
motor learning and skill acquisition. The aim is to
train the skilled activation of the deep muscles, to
train the integration of the deep and superficial sys-
tems, and to progress through a programme of tai-
lored functional exercises in varying environments
and contexts to ensure transfer to normal activity.23
Motor learning occurs in three main phases – cog-
nitive, associative, and autonomous.28 The goal in the
initial phase of motor relearning for LBP is to con-
tract the deep muscles cognitively to increase the pre-
cision and skill of the contraction of the local muscles.
An isometric co-contraction of the deep abdominal
muscles and multifidus muscles with minimal co-acti-
vation of global system muscles should be obtained.
Contraction of the pelvic floor muscles will help to
inhibit global muscle substitution. It is critical to pro-
vide accurate feedback of contraction quality. This
may involve any of the senses including tactile (palpa-
tion), visual (ultrasound imaging), and auditory (elec-
tromyography [EMG] biofeedback) information.
Once mastered, the goal shifts to increased precision,
increased number of repetitions and holding time,
and decreased feedback of performance, success and
refinement. This phase involves performance of the
task in increasingly challenging positions (e.g. sitting,
and standing) and integration of deep and superficial
muscle function, for example using leg-loading tasks,
proprioceptive neuromuscular facilitation techniques,
and postural challenges. The final stage of motor
learning, the autonomous phase, is achieved after
considerable practice and experience. The task
becomes habitual or automatic, and the requirement
for conscious intervention is reduced.
There are several types of core stability exercises
including Pilates exercise, Swiss ball programs,
McGill’s stability exercises, balance board training,
floor exercise programmes, etc. These programmes
aim to restore the capacity (strength and endurance)
of the trunk muscles to meet the demands of lum-
bopelvic control, whereas the motor learning model
describedabove aims to restore the co-ordination and
control of the trunk muscles to improve control of the
lumbar spine and pelvis.29 The programmes may be
used in a motor learning model as progressive train-
ing to rehabilitate the integration of the local and
global systems for higher-level activities.
Stabilisation training is widely used by physiothera-
pists in clinical practice, but the clinical evidence for
effectiveness of the intervention is not well docu-
mented in the literature.
Outcome measures
The importance of outcome measures in healthcare
policy, practice, and research have received wide-
spread recognition during the 1990s.30 Different out-
come measures are used in order to evaluate the
234 HAUGGAARD AND PERSSON
effects of treatment interventions. Seven major types
of instruments can be identified in the literature: dis-
ease/condition-specific; site-specific; dimension-spe-
cific; generic; summary item; individualised and
utility.31 Some outcome measures have elements of
more than one category. There are eight criteria that
investigators should apply to evaluate possible
patient-based outcome measures for any specific clin-
ical trial: appropriateness; reliability; validity; respon-
siveness; precision; interpretability; acceptability; and
feasibility.31
Recommendations for outcome measures to be
used in LBP research and to evaluate treatment in
spinal disorders have been presented.32,33 Five main
domains with a ‘core set’ of instruments have been
proposed: (i) back-related function measured with
Oswestry Disability Questionnaire (ODQ) or Roland
Morris Disability Questionnaire (RDQ); (ii) health-
related quality of life measured with Short-Form 36
(SF-36) or Short-Form 12 (SF-12); (iii) pain mea-
sured with the bodily pain subscale of SF-36 and the
number of days experiencing pain; (iv) work-related
disability could be measured with SF-36 role limita-
tion scales; and (v) patient satisfaction (no particular
outcome measure recommended). The World Health
Organization (WHO) has also recommended a cluster
of tests for use in research on individuals with LBP.34
Examples of these are: pain rating with the Visual
Analogue Scale (VAS); physical function with ODQ;
anxiety/depression with the Modified Zung and the
Modified Somatic Perception Questionnaire (MSPQ);
and Range of Motion (ROM) with the Modified
Schober.
Quality assessment
An important aim of reviewing the literature in
healthcare is to summarise the evidence on which
clinicians need to base their care and thus to provide
the empirical basis for clinical decision making.35
Quality assessment of studies is a way of establishing
the level of evidence and is an important part of con-
ducting reviews in evidence-based medicine. ‘Quality’
as a concept is not easy to define. Quality of randomised
controlled trials (RCTs) has been defined as ‘the likeli-
hood of the trial design to generate unbiased results’.36
This definition covers only the dimension of internal
validity. Most methodological guidelines measure at
least three dimensions that may encompass the concept
of quality in its broadest sense – internal validity, exter-
nal validity, and statistical analysis.35
The present study was performed in order to review
the literature for studies involving the treatment inter-
vention specific spinal stabilisation training, and
investigate what effect it has on patients with LBP. No
previous review of clinical trials performed in this field
was found from a literature search in PubMed and
PEDro. The aims of this review were to evaluate the
effects of specific spinal stabilisation training in patients
with LBP, and to assess the methodological quality and
level of evidence of the studies.
METHODOLOGY
Selection of studies
An extensive search was performed of the PubMed
and PEDro databases during October 2005 using the
following free text words: ‘specific spinal stabilisation
exercises’, ‘stabilisation training’, ‘transversus abdo-
minis’, ‘multifidus’, and ‘core strengthening’. The free
text words were first used separately and, thereafter,
in combination with AND ‘low back pain’, AND
‘rehabilitation’. Search in PubMed was also per-
formed using the following Medical Subject Headings
(MeSH): ‘Low Back Pain’, ‘Muscle Weakness’,
‘Rehabilitation’, ‘Exercise Therapy’, and ‘Exercise
Movement Techniques’. These MeSH terms were also
used in combination with the free text words men-
tioned above. The search did not give any new rele-
vant hits. The search in PubMed was limited to
studies published in English, German, French or
Swedish, published from January 1985 until October
2005. The search in PEDro was made as an advanced
search limited to studies published since 1985. In
January 2007, an identical search update was per-
formed for the time period 1 October 2005 to 31
December 2006.
Titles and abstracts of the identified articles were
reviewed to determine the potential relevance of the
articles for this review. In addition, references given in
the studies retrieved were further examined and
search of related articles performed. The study selec-
tion procedure is described in Figure 1.
Inclusion criteria
In order to be included in this review, the studies had
to meet the following inclusion criteria:
1. Randomised controlled trials (RCTs) in full text.
2. Studies with a study population consisting of
patients with acute, sub-acute or chronic LBP.
3. Studies with an intervention containing specific spinal
stabilisation exercises including co-contraction of
multifidus muscles and transversus abdominis
muscles.
SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 235
4. Studies using outcome measures including specific
functional questionnaires and/or generic
questionnaires and/or pain rating.
Exclusion criteria
Studies with the following criteria were excluded:
1. Studies with an intervention containing general
low back exercises and/or stabilising training
without emphasis on a co-contraction of
multifidus muscles and transversus abdominis
muscles were excluded from this review.
2. Reviews.
Quality assessment
The methodological quality of the studies was
assessed, using guidelines formed by the Cochrane
Collaboration Back Review Group (see Appendix).37
In accordance with these guidelines, the studies were
independently assessed by two reviewers (Annika
Hauggaard [author] and Anders Hauggaard [see
Acknowledgements]), and a consensus method was
used in order to resolve any disagreements. The
reviewers were not blinded to the title, authors, or
journal of the study. The conclusion on the effective-
ness of the therapeutic intervention was based on the
strength of the scientific level of evidence recom-
mended by Cochrane.37. The five levels are: (i) strong
236 HAUGGAARD AND PERSSON
Fig. 1. Flowchart of study selection procedure.
SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 237
Table 1. Summary data for RCTs evaluated
Study Cairns et al. (2006)38
Participants 97 patients, aged 18–60 years, who had had a minimum of one previous episode of LBP for which medical
care/intervention had been sought
Description of intervention The patients were randomised to one group receiving ‘conventional’ physiotherapy (n = 50) consisting of general
active exercise and manual therapy, or another group receiving ‘conventional’ physiotherapy plus specific spinal
stabilisation exercises (n = 47) with a maximum of 12 treatment sessions during 12 weeks. Both groups received ‘The
Back Book’ by Roland et al.
Outcomes measured Back-related disability (Roland Morris Disability Questionnaire), pain (Short-Form McGill Pain Questionnaire, 11-
point numeric rating scale), psychological distress (Modified Zung and Modified Somatic Perception Questionnaire),
generic health (Short-Form 36)
Follow-up periods At 6 and12 months
Results Both groups showed improved physical functioning, reduced pain intensity, and an improvement in the physical
component of quality of life. No statistically significant differences between the two groups were shown for any of the
outcomes measured, at any time
Authors’ conclusion Patients with LBP had improvement with both treatment packages to a similar degree. There was no additional
benefit adding specific spinal stabilisation exercises to a conventional physiotherapy package for patients with
recurrent LBP
Study Goldby et al. (2006)39
Participants 302 patients, aged 18–65 years, with chronic low back disorder, with the current episode lasting for a minimum
of 12 weeks
Description of intervention The patients were randomised to manual therapy (n = 121) with a maximum number of 10 interventions, a 10-week
spinal stabilisation rehabilitation programme (n = 121) with 1-h classes, or a minimal intervention control group (n =
60) receiving an educational booklet. All groups attended the Back School
Outcomes measured Pain intensity (0–100 numerical rating scale, pain diagram, indication of pain during the previous 2 days), disability
(Modified Oswestry Disability Index), handicap (Low-Back Outcome Score), impairment (range of lumbar flexion, a
timed walking test), quality of life (Nottingham Health Profile)
Follow-up periods At 3, 6, 12, 24 months
Results Results indicated a statistically significant improvement in favour of the spinal stabilisation group at the 6-month
stage in pain and dysfunction and at the 1-year stage in medication, dysfunction and disability
Authors’ conclusion As a component of musculoskeletal physiotherapy, the spinal stabilisation programme is more effective than manually
applied therapy or an education booklet in treating chronic low back disorder over time. Both manual therapy and the
spinal stabilisation programme are significantly effective in pain reduction in comparison to an active control
Study Hides et al. (1996)40
Participants 41 patients, aged 18–45 years, with acute LBP (experiencing their first episode of unilateral, mechanical LBP for less
than 3 weeks)
Description of intervention The patients were randomised to one intervention group (n = 21) receiving specific spinal stabilisation exercises twice
per week during 4 weeks, or a control group (n = 21) receiving medical management including advice on bed rest and
absence from work and prescription of medication
Outcomes measured Pain location, quality and intensity (McGill Pain Questionnaire, VAS, daily pain diaries), disability (Roland Morris
Disability Questionnaire), range of motion (oil-filled Rippstein goniometer), straight leg raise (oil-filled goniometer),
habitual activity levels (habitual activity questionnaire), multifidus cross-sectional area (ultrasound)
Follow-up periods 10 weeks
Results Multifidus muscle recovery was not spontaneous on remission of painful symptoms in patients in the control group.
Muscle recovery was more rapid and more complete in patients in the intervention group. Other outcome measures
were similar for the two groups at the 4-week examination. At the 10-week follow-up, the patients in the control
group still had decreased multifidus muscle size although they resumed normal levels of activity
Authors’ conclusion Multifidus muscle recovery is not spontaneous on remission of painful symptoms. Lack of localised, muscle support
may be one reason for the high recurrence rate of LBP following the initial episode
Study Hides et al. (2001)41
Participants 39 patients, aged 18–45 years with acute LBP
Description of intervention The patients were randomised to one intervention group (n = 20) receiving specific spinal stabilisation exercises twice
per week during 4 weeks, or a control group (n = 19) receiving medical management including advice on bed rest and
absence from work and prescription of medication
Outcomes measured Recurrence of LBP (telephone questionnaire)
Follow-up periods At 1 and 3 years
Results Patients from the intervention group experienced fewer recurrences of LBP than patients in the control group. One
year after treatment intervention group recurrence was 30% and control group recurrence 84% (P < 0.001). Two to
three years after treatment, intervention group recurrence was 35%, and control group recurrence was 75% (P < 0.01)
Authors’ conclusion Long-term results suggest that specific exercise therapy in addition to medical management and resumption of normal
activity may be more effective in reducing LBP recurrences than medical management and normal activity alone
238 HAUGGAARD AND PERSSON
Table 1. (continued) Summary data for RCTs evaluated
Study Kladny et al. (2003)42
Participants 99 patients, aged 18–55 years with chronic LBP
Description of intervention The patients were randomised to one intervention group (n = 50) receiving specific spinal stabilisation exercises, or
one control group (n = 49) receiving general strengthening exercises of abdominal and back muscles, and manual
therapy according to Maitland or McKenzie. Length of intervention or number of sessions was not stated
Outcomes measured Pain intensity (pain scale Self-Efficacy Scale, numerical rating scale), disability (Oswestry Low Back Pain Disability
Questionnaire, Hannover Functional Ability Questionnaire FFbH-R)
Follow-up periods At 3 months
Results There was a significant functional improvement in both groups measured with the Oswestry score and the FFbH-R.
The intervention group showed better values at the end of the treatment. There was also a significant improvement in
pain score in both groups but no difference between the groups (P = 0.05)
Authors’ conclusion Out-patient rehabilitation improved functional capacity and pain in both groups. Advantages could be seen in the
intervention group concerning functional status. The specific stabilisation exercise approach appears to be effective in
conservative treatment programs of LBP and lumbar disc disease
Study Koumantakis et al. (2005)43
Participants 55 patients (mean age 39.2 years) with recurrent, non-specific LBP and no clinical signs suggesting spinal instability
Description of intervention The patients were randomised to a stabilisation-enhanced exercise group (n = 29), or a general exercise-only group (n
= 29). Both groups were treated twice a week during 8 weeks
Outcomes measured Pain perception (Short-form McGill Pain Questionnaire, pain intensity (VAS), disability (Roland Morris Disability
Questionnaire), pain beliefs (Tampa Scale of Kinesiophobia), pain self-efficacy beliefs (Pain Self-Efficacy
Questionnaire), pain locus of control (Pain Locus of Control Scale)
Follow-up periods At 3 months
Results Both groups showed improvements in all outcome measures except the Pain Locus of Control Scale after intervention
and at 3-month follow-up. There was a significant difference in the Roland Morris Disability Questionnaire score in
favour of the control group after intervention but not at the 3-month follow-up (P =0.05)
Authors’ conclusion A general exercise programme reduced disability in the short term to a greater extent than a stabilisation-enhanced
exercise approach in patients with recurrent LBP. Stabilisation exercises do not appear to provide additional benefit to
patients with sub acute or chronic LBP who have no clinical signs suggesting presence of spinal instability
Study Lewis et al. (2005)44
Participants 80 patients, aged 18–75 years, with mechanical LBP (of a non-radicular nature) for more than 3 months
Description of intervention The patients were randomised to a 10-station exercise class (n = 40), involving aerobic exercises, stabilisation exercises,
manual therapy (~5 min.) for eight 1-h sessions during 8 weeks, or a one-to-one treatment (n = 40), involving eight 30-
min sessions of manual therapy and stabilisation exercises during 8 weeksOutcomes measured Disability (Quebec Back Pain Disability Scale), lumbar range of motion, pain intensity (VAS), straight leg raise
(inclinometer)
Follow-up periods At 6 and 12 months
Results Both groups showed significant reduction in the disability questionnaire score and significant increases in range of
motion (P =0.05)
Authors’ conclusion Both forms of intervention were associated with significant improvement. On-going clinical research is necessary to
provide guidance as to the clinical efficacy of various forms of intervention
Study Niemistö et al. (2003)45
Participants 204 patients with chronic low back pain aged 24–46 years
Description of intervention The patients were randomised to an intervention group receiving manipulation, stabilisation exercises and stretching
(n = 102) or a control group receiving no treatment (n = 102). Both groups received an educational booklet,
information about LBP, individual instructions regarding posture and ergonomics and 3–4 home exercises
Outcomes measured Pain intensity (VAS and frequency of LBP), back-specific disability (Oswestry Low Back Pain Disability
Questionnaire)
Follow-up periods At 5 and 12 months
Results At 5- and 12-month follow-up, the intervention group showed more significant reductions in pain intensity (P <
0.001) and self-rated disability (P = 0.002) than the control group. There was no significant difference between the
groups in health-related quality of life
Authors’ conclusion The manipulative treatment with stabilisation exercises was more effective in reducing pain intensity and disability
than the physician’s consultation alone (control group). Short, specific, treatment programmes with proper patient
information may alter the course of chronic LBP
Study O’Sullivan et al. (1997)46
Participants 44 patients, aged 16–49 years, with recurrent LBP pain (with or without radiating pain to lower limbs) where
symptoms had persisted more than 3 months. The patients should have the radiological diagnosis of spondylolysis or
spondylolisthesis
Description of intervention The patients were randomised to a specific exercise group (n = 22) treated with stabilisation exercises during 10 sessions
over a 10-week period plus daily home exercises, or a control group (n = 22) where the 10-week treatment consisted of
general exercises such as swimming, walking and gym work directed by each patient’s medical practitioner
Outcomes measured Pain (Short-Form McGill Pain Questionnaire), disability (Oswestry Disability Questionnaire), lumbar spine and hip
sagittal range of movement in standing (Cybex Electronic digital inclinometer)
evidence – consistent findings among multiple, high-
quality RCTs; (ii) moderate evidence – consistent
findings among multiple, low-quality RCTs and/or
one high-quality RCT; (iii) limited evidence – one
low-quality RCT; (iv) conflicting evidence – inconsis-
tent findings among multiple trials (RCTs); and (v) no
evidence – no RCTs.
RESULTS
Study selection
The original search in the PubMed and PEDro data-
bases gave a total of 977 references, of which 872 were
excluded immediately from reading the abstract because
they were considered irrelevant to this review. The num-
ber of relevant references from the first screening process
was 105. Of these, 63 were excluded since they were
duplicates, and another 34 were excluded because they
did not fulfil the selection criteria (Fig. 1). In the original
selection, eight RCTs were found that met the inclusion
criteria. In the search update made in January 2007, two
additional RCTs met the inclusion criteria giving a total
of ten RCTs38–47 that were included in the current sys-
tematic review. All articles found were published in
English except for one article that was published in
German.42 Two of the studies were related, since one was
a long-term follow-up from the same study group.40,41
Interventions
The stabilisation exercise programme used in all the
selected studies was based on the principle of a co-
contraction of multifidus muscles and transversus
abdominis muscles following the motor learning
model.26 A summary of the reviewed studies is pre-
sented in Table 1.
In three of the studies,38,44,45 the intervention group
received other treatments such as manipulation,
stretching, manual therapy and/or general exercises in
addition to stabilisation exercises. Lewis et al.44 used a
10-station exercise class in the control group involving
aerobic exercises, manual therapy, and stabilisation
exercises. Koumantakis et al.43 combined the stabili-
sation exercises with general exercises in the interven-
tion group. The general exercises were similar in both
the intervention group and the control group, but
were introduced in the intervention group at a later
stage when the patients were able to perform the sta-
bilisation exercises properly.
There was no intervention at all in the control
group in one study.47 In the study by Niemistö et al.,45
both groups received an educational booklet, infor-
mation about LBP, individual instructions regarding
posture and ergonomics and home exercises. In the
study of Goldby et al.,39 there were three groups, one
group given stabilisation exercises, one group treated
with manual therapy and a third group given an edu-
cational booklet. In the other studies, the intervention
for the control group was medication, bed rest and
absence from work,40,41 general exercise pro-
grammes,38,42–44,46 and in three studies additional manual
therapy.38,42,44
The duration of the intervention period varied.
Three studies had a 4-week intervention period.40,41,45
Two studies had an 8-week intervention period,43,44
three studies a 10-week intervention period39,46,47 and
one study a 12-week intervention period.38 Kladny et
al.42 did not specify the number of treatment sessions
or the length of the intervention period. The follow-up
SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 239
Table 1. (continued) Summary data for RCTs evaluated
Follow-up periods At 3, 6 and 30 months
Results The specific exercise group showed significant reduction in pain intensity and functional disability levels which was
maintained at the 30-month follow-up. The control group showed no significant change in these parameters (P < 0.05)
Authors’ conclusion An approach with specific spinal stabilisation exercises appears more effective than other commonly prescribed
conservative treatment programmes in patients with chronically symptomatic spondylolysis or spondylolisthesis
Study Shaughnessy & Caulfield (2004)47
Participants 41 patients, aged 20–60 years, with complaints of LBP for a minimum of 3 months
Description of intervention The patients were randomised to a treatment group (n = 20) which underwent 10 sessions of spinal stabilisation
exercises during 10 weeks plus daily home exercises, or a control group (n = 21) receiving no intervention
Outcomes measured Disability (Oswestry Disability Questionnaire, Roland Morris Disability Questionnaire), perceived quality of life
(Short-Form 36)
Follow-up periods None
Results Significant improvements were seen in all measures in the treatment group whereas control subjects demonstrated
either no change or a significant worsening (P < 0.05)
Authors’ conclusion The results suggest that a programme of lumbar stabilisation exercises is effective in improving quality of life and
functional outcome in patients with chronic LBP
period varied from 4 weeks to 3 years. The study pop-
ulation in the included studies varied in size (mean n
= 100, median n = 68, and range 39–302; see Table 1).
Outcome measures
The outcome measures used in the reviewed studies
showed an extensive heterogeneity. A summary of the
outcome measures is presented in Table 2. In total,
there were 26 outcome measures and, of these, 18
were used in single studies. All studiesincluded an
outcome measure for assessment of functional dis-
ability. The ODQ was used in four studies,42,45–47 the
Modified Oswestry Disability Questionnaire
(MODQ) in one study,39 and the RDQ, which is
regarded to have similar qualities as the ODQ,48 was
used in four of the studies.38,40,43,47 The Baecke
Questionnaire of Habitual Physical Activity was used
in one study,40 and the Quebec Back Pain Disability
Scale (QBPDS) in one study.44
Pain intensity was assessed in all of the studies. The
VAS was used in four studies.40,43–45 The Numeric Pain
Rating Scale (NRS), which has similar features as
VAS, was used in three studies.38,39,42 The McGill Pain
Questionnaire (MPQ) or the shorter version Short-
Form McGill Pain Questionnaire (SF-MPQ) were
used in four of the studies.38,40,43,46
Four studies used ROM as an outcome mea-
sure.39,40,44,46 Four studies used a generic health status
measure, the SF-36,38,47 the Nottingham Health Profile
(NHP),39 and the 15D-measure.45 Two studies used out-
come measures for psychological distress.38,45 Cairns et
al.38 combined the Modified Zung and the MSPQ
according to the Distress and Risk Assessment
Method (DRAM),49 and Niemistö et al.45 used the
240 HAUGGAARD AND PERSSON
Table 2. Domains and outcome measures used in the 10 reviewed RCTs
Domain Outcome measure Type Used in study
Pain perception
VAS Summary item 40,43,44,45
NRS Summary item 38,39,42
SES Dimension specific 42
MPQ Dimension specific 40
SF-MPQ Dimension specific 38,43,46
Pain diary Dimension specific 40
Pain beliefs TSK Dimension specific 43
PSEQ Dimension specific 43
PLC Dimension specific 43
Psychological distress Modified Zung Dimension specific 38
MSPQ Dimension specific 38
DEPS Dimension specific 45
Functional status RDQ Disease/condition specific 38,40,43,47
ODQ Disease/condition specific 42,45,46,47
MODQ Disease/condition specific 39
QBPDS Disease/condition specific 44
FFbH-R Dimension specific 44
Baecke Questionnaire Dimension specific 40
Health status SF-36 Generic 38,47
NHP Generic 39
15D-measure Generic 45
Physical examination ROM Not applicable 40,44,46
SLR Not applicable 40,44
Timed walking test Not applicable 39
Other CSA Not applicable 40
Phone questionnaire Disease/condition specific 41
VAS, Visual Analog Scale; NRS, Numeric Pain Rating Scale; SES, Pain Experience Scale; MPQ, McGill Pain Questionnaire; SF-MPQ,
Short-Form McGill Pain Questionnaire; TSK, Tampa Scale of Kinesiophobia; PSEQ, Pain Self-Efficacy Questionnaire; PLC, Pain
Locus of Control Scale; MSPQ, Modified Somatic Perception Questionnaire; DEPS, Finnish Depression Questionnaire; RDQ,
Roland-Morris Disability Questionnaire; ODQ, Oswestry Disability Questionnaire; MODQ, Modified Oswestry Disability
Questionnaire; QBPDS, Quebec Back Pain Disability Scale; FFbH-R, Hannover Functional Ability Questionnaire; SF-36, Short-Form
36; NHP, Nottingham Health Profile; ROM, range of motion; SLR, straight leg raise; CSA, cross-sectional area.
Finnish Depression Questionnaire (DEPS).
Koumantakis et al.43 were the only authors using out-
come measures in order to evaluate pain beliefs and
anxiety using the Tampa Scale of Kinesiophobia
(TSK), the Pain Self-Efficacy Questionnaire (PSEQ),
and the Pain Locus of Control Scale (PLC). Work-
related disability and patient satisfaction were not
reported in any of the studies.
Studies with positive outcome
Positive outcome was defined as statistically signifi-
cantly better outcome after treatment intervention com-
pared to other treatments or placebo. In three of the
studies,39,45,46 the intervention group showed significant
reduction in pain intensity and self-rated disability com-
pared to the control group, which was maintained at the
follow-up periods (Table 1). In Shaughnessy and
Caulfield’s study,47 a significant improvement in all out-
come measures, ODQ, RDQ, SF-36, was seen in the
intervention group after 10 weeks compared to no
change or a significant worsening in the control group.
In the study by Hides et al.,40 the multifidus muscles
cross sectional area was increased in the intervention
group at both 4- and 10-week follow-up but not in the
control group. A second, long-term follow-up study
by the same authors41 showed that the patients in the
intervention group had fewer recurrences of LBP at
both 1-year follow-up and at 3-year follow-up. The
percentage of recurrences was for the intervention
group 30% and 35%, and for the control group 84%
and 75%, respectively.
Studies with indifferent outcome
Indifferent outcome was defined as no statistically sig-
nificant difference in outcome after treatment interven-
tion compared to other treatments or placebo.
Cairns et al.38 reported improved physical function-
ing measured with the RDQ for both intervention
group and control group. No statistically significant
differences between the two groups were shown for
any of the outcomes measured at any time.
Hides et al.,40 who examined patients with acute
LBP, reported similar outcome results for both inter-
vention group and control group at 4- and 10-weeks
follow-up regarding reduced levels of pain and dis-
ability and increased ROM (Table 1).
Kladny et al.42 reported improved functional capac-
ity in both intervention group and control group, but
more in the intervention group. There was also a sig-
nificant improvement in pain scores with similar
results in both groups.
Koumantakis et al.43 stated that both intervention
group and control group showed improvements in all
outcome measures except the PLC after the interven-
tion and at 3-month follow-up. There was a signifi-
cant difference in RDQ in favour of the control group
after intervention but not at the 3-month follow-up.
Lewis et al.44 reported significant reduction in dis-
ability and significant increase in ROM in both inter-
vention group and control group.
Niemistö et al.45 concluded that there was no significant
difference between the groups regarding quality of life.
Studies with negative outcome
Negative outcome was defined as statistically signifi-
cant worse outcome after treatment intervention
compared to other treatments or placebo. None of
the reviewed studies presented a negative outcome
stated as above.
Methodological quality
The methodological quality of the 10 RCTs according
to the Method Guidelines from the Cochrane
Collaboration Back Review Group is described in
Table 3. Assessed by this guideline, seven of the studies
were of high quality with scores of at least 6 out of
11,38,40,41,43–46 and three studies were of low quality.39,42,47
The mean quality score was 6.8, and the median score
was 6, ranging from 5 to 10 points out of a total of a pos-
sible 11 points (Table 3). Not all the methodological cri-
teria were met in the studies reviewed. For example, the
criteria ‘blinding of subjects’ was difficult to obtain due
to study design. Some studies did not clearly specify if a
criterion was met, and consequently the criterion was
scored as ‘don’t know’.
Evidence of outcome
Significant improvement in pain and disability levels
for the group treated with specific stabilisation exer-
cises was reported in two studies of high methodolog-
ical quality,45,46 and two studies of low quality.39,47 The
level of evidence for reduced pain and disability must,
therefore, be considered as moderate.
Other effects seen from specific stabilisation train-
ing were improved multifidus muscle recovery40
resulting in fewer recurrences during a follow-up
period of 3 years;41 however, since there was only one
study of high quality confirming these outcomes, the
level of evidence must be considered as moderate.
One study showed a positive outcome measuring
SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 241
quality of life.47 Since this study was of low quality,
the level of evidence mustbe considered as limited.
In conclusion, this review suggests moderate evi-
dence for improved pain and disability levels and
increased multifidus muscle cross-sectional area, and
limited evidence for improved quality of life after the
use of specific spinal stabilisation exercises as a treat-
ment intervention for patients with LBP.
DISCUSSION
Although LBP is a wide-spread and disabling condi-
tion, there is a lack of evidence-based medicine with
respect to its treatment and rehabilitation. There is a
general consensus in the literature supporting the
need for active exercise therapy in the treatment of
LBP.50 Unfortunately, there is little agreement on
which exercise regimens that are most effective. In a
review regarding exercise therapy for LBP made by
the Cochrane Collaboration Back Review Group,51
the authors concluded that exercise therapy does not
seem to be effective for acute LBP, but that exercises
may be helpful for patients with chronic LBP. The
types of exercise programmes for chronic LBP vary
widely from land-based exercise versus exercise in
water, to isolated trunk exercise versus a walking pro-
gramme. Therefore, exercise can not be regarded as a
single class of treatment and reviewers summarising
trials need to take this variety into consideration. In
recent times, specific spinal stabilisation programmes
aimed at enhancing strength and re-education of the
local stabilisers in the lumbar region have increased in
popularity in the treatment of LBP.52 The current
review was conducted in order to investigate the
effects reported from clinical trials using this specific
treatment intervention.
Study design and populations
In order to analyse and summarise the data from the
included studies, a qualitative review was undertaken.
This in line with the recommendations from the
Editorial Board of the Cochrane Back Review Group
who state that a meta-analysis should be avoided if
relevant, valid data are lacking, (e.g. data are too sparse
or of too low quality), or if data are statistically and
clinically too heterogeneous.53 A grading system for lev-
els of evidence was used for this purpose.
The study population and outcome measures dif-
fered in the studies (Table 1). All patients suffered
from LBP, but in the Hides et al. study40 the patients
had acute LBP, in the O’Sullivan et al. study46 the
patients had a radiological diagnosis of spondylolysis
or spondylolisthesis, whereas in the rest of the studies
the study population had sub-acute LBP or chronic
LBP. In two studies, co-interventions were used,42,44
and in two other studies it was unclear if co-interven-
tions were used.45,46 In the Lewis et al. study,44 stabili-
sation exercises were part of the treatment intervention
in both the groups studied. In group 1 (exercise class) it
was used in combination with other exercises, and in
group 2 (individual treatment) in combination with
242 HAUGGAARD AND PERSSON
Table 3. Methodological quality assessment of the 10 reviewed RCT studies
Cairns et al. Goldby et al. Hides et al. Hides et al. Kladny et al. Koumantakis Lewis et al. Niemistö O’Sullivan Shaughnessy & 
Criteria (2006)38 (2006)39 (1996)40 (2001)41 (2003)42 et al. (2005)43 (2005)44 et al. (2003)45 et al. (1997)46 Caulfield (2004)47
1. + + + + + + + + + ?
2. + + ? ? ? + + + + ?
3. + – + + + + – + + +
4. + – – – – + – – – –
5. – – – – – – – – – –
6. + + + + + + + + + +
7. + + + + – + – ? ? +
8. + – + + ? + – + ? ?
9. + – ? + + + + + + +
10. + + + + + + + + + +
11. + – – – – + + + – –
Quality High Low High High Low High High High High Low
(points) (10/11) (5/11) (6/11) (7/11) (5/11) (10/11) (6/11) (8/11) (6/11) (5/11)
The Cochrane Method Guidelines criteria list37 (Yes, +; No, –; and Don’t know, ?).
Criteria: 1. Was the method of randomisation adequate?; 2. Was the treatment allocation concealed?; 3. Were the groups similar at
baseline regarding to the most important prognostic indicators?; 4. Was the patient blinded to the intervention?; 5. Was the care
provider blinded to the intervention?; 6. Was the outcome assessor blinded to the intervention?; 7. Were co-interventions avoided or
similar?; 8. Was the compliance acceptable in all groups?; 9. Was the drop-our rate described and acceptable?; 10. Was the timing of the
outcome assessments in all groups similar?; 11. Did the analysis include an intention-to-treat analysis?; Result: 6/11 points or more are
defined as high quality.
manual therapy techniques. A significant disability
reduction was found in both groups (Table 1). Due to
the fact that stabilisation exercises were used in both
groups, it can be argued that the study should have
been excluded from this review, since the effect of sta-
bilisation training alone can not be distinguished. In
another study, the treatment group was compared to
a control group which received no intervention.47
The hands-on effect in certain trials, where the par-
ticipants in the control group had a limited number
of appointments with the physiotherapist or no
intervention at all, should not be neglected. There
may be a positive association between the number of
contacts with the healthcare providers and improve-
ment of back-related symptoms.54
Considering that the basic stabilising exercises with
the co-contraction of transversus abdominis muscles
and multifidus muscles take some time to master, the
4-week intervention period in some of the stud-
ies40,41,45 is relatively short. O’Sullivan et al.46 reported
that several subjects in their trial took as long as 4 or
5 weeks of specific training before an accurate pattern
of co-contraction could be achieved. The feed-back
given by the physiotherapist regarding the perfor-
mance of the exercises is also important, since the
patients otherwise might not complete the co-con-
traction successfully. This feed-back was not given in
all studies. Not all studies measured the patient com-
pliance with the treatment intervention. Since the aim
of the method is that the co-contraction of transver-
sus abdominis muscles and multifidus muscles should
be used in daily tasks, and the stabilisation exercises
performed on a daily basis, it is important to measure
compliance in order to evaluate the patients’ activity
during the intervention period.
Outcome measures
The outcome measures used in the studies showed
extensive heterogeneity (Table 2). The most common
outcome measures were pain and back specific func-
tion. The fact that similar functional outcome mea-
sures were used in eight of the studies, RDQ, ODQ
and MODQ,38–40,42,43,45–47 facilitates comparison
between results for disability. The RDQ and ODQ are
widely used questionnaires with similar structure.48
With reference to the outcome measures recom-
mended in back pain studies,32–34 there was a lack of
instruments measuring health-related quality of life,
work-related disability, patient satisfaction, and
depression.
It is important to keep in mind that pain and dis-
ability in patients with chronic LBP are complicated
phenomena that cannot be explained by physical factors
alone.55,56 However, biomechanics still play a major
role in the spinal pathology and LBP. Waddell57 sug-
gested that sometimes illness behaviour can become as
disabling as the original physical problem and may even
become the major management problem.
Psychological factors (distress, depressive mood,
and somatisation) are implicated in the transition to
chronic LBP.58 Early identification of these risk fac-
tors (for example, by use of a screening questionnaire
for psychosocial risk factors) may lead to more effec-
tive treatment by identifying which patients are likely
to benefit from behavioural treatment.59 The psycho-
social component involved in LBP is also important
to assess with health-related outcome measures like
the SF-36. This type of outcome measure was only
used in four ofthe studies.38,39,45,47 Fear-avoidance and
self-efficacy beliefs are also considered important fea-
tures for development of chronic LBP,60 and were
only examined by Koumantakis et al.43 The WHO
recommends the use of outcome measures for anxiety/
depression with the Modified Zung and the MSPQ.34.
These measures were only used in one trial;38 the
DEPS, another outcome measure for depression, was
used in one trial.45
Methodological quality
Despite some differences in methodological score,
there were no disagreements between the two review-
ers on which study was of low or high quality. The
level of disagreement between the reviewers was only
4.5%. Seven out of the 10 RCTs were assessed as hav-
ing a high quality (6–10 points of 11 possible; Table
3). It should, however, be noted that three of the stud-
ies40,44,46 achieved a score of 6, the minimum score to
be defined as a high-quality study.
In several studies there was lack of data needed for
the methodological assessment and when important
data are missing the result of the methodological
assessment can be questioned. Many methodological
criteria were not fulfilled. Randomisation, blinding of
patients and outcome assessors, tracking of co-inter-
ventions and compliance were not properly con-
ducted in some of the studies. Blinding of the care
providers in this type of trial is difficult, if not impos-
sible. Blinding of patients is also difficult. In two of
the trials, the treatment credibility was evaluated and
the treatments were equally credible and acceptable to
patients.38,43 The criteria regarding patient blinding
were, therefore, in these trials scored as a ‘yes’.
Blinding of the outcome assessor should, however, be
possible. In some of the trials this was not stated
clearly but it was mentioned that the follow-up con-
sisted of patient-completed outcome measures only.
SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 243
In these cases, the question about outcome assessor
blinding was scored as a ‘yes’.
Evidence of outcome
In this review there were two trials of high method-
ological quality,45,46 and two of low quality,39,47 where
the results confirmed reduced levels of pain and dis-
ability. The consensus among the Editorial Board of
the Cochrane Back Review Group is that strong evi-
dence can only be provided by multiple, high-quality
trials that replicate findings of other researchers in
other settings.37 Consequently, the level of evidence
for reduced pain and disability was judged as moder-
ate. One of these studies45 used additional treatment
interventions apart from stabilisation exercises in the
intervention group. For that reason, a separate analy-
sis of the effectiveness of stabilisation exercises only
can not be made. Moreover, the other study46 had a
study population of patients with spondylolysis or
spondylolisthesis; therefore, conclusions can only be
drawn regarding these two diagnoses.46 Hence, it
might be a limitation that studies with sub-groups
and additional treatment interventions apart from
stabilisation exercises were included in the present
review. Nevertheless, it can be of value to discover
that certain sub-groups with LBP might benefit more
from this specific treatment. The conclusion by
Goldby et al.39 needs careful consideration due to the
high drop-out rate in the trial. Only 66% of the ran-
domised subjects completed treatment, only 62% were
followed up at 3 months, and even fewer at the 6-, 12-,
and 24-month follow-ups. The data analysis in the
study was not based on the intention-to-treat approach.
Only one study of high methodological quality
(6/11 points) investigated the effect of stabilisation
exercises on the multifidus cross sectional area.40
Thus, based on the results from this single trial only, it
can be questioned if it is adequate to consider the
level of evidence as moderate. Regarding quality of
life, only one low-quality study showed positive out-
come,47 so the level of evidence must here be consid-
ered as limited.
Other studies and reviews
There has been a recent, well-conducted RCT with a
2-year follow-up on patients with pelvic girdle pain
after pregnancy.61,62 Eighty-one women were ran-
domly assigned to two treatment groups for 20 weeks.
One group performed stabilisation exercises and the
other group received individualised physical therapy
without stabilisation exercises. Outcome measures
used were VAS, MODQ and the SF-36. There were no
drop-outs in the study. The results showed significant
lower pain intensity, lower disability and higher qual-
ity of life in the intervention group compared with the
control group, after the intervention period, and at 1
and 2 years post partum. The results from this trial
and the result of O’Sullivan et al.46 (studying patients
with the diagnosis spondylolysis or spondylolisthesis)
indicate that stabilisation exercises might be specifi-
cally effective for patients with low back instability
and sacro-iliac joint laxity. This is in line with recent
research showing that contraction of the transversus
abdominis significantly decreases the laxity of the
sacroiliac joints.63
Two cohort studies within this field have been pub-
lished.64,65 One was conducted on 54 patients with
subacute LBP64 who received stabilisation exercises
twice weekly during 8 weeks and were requested to
perform daily home exercises. Disability was mea-
sured with MODQ and served as the reference stan-
dard to determine success of the treatment
programme. Eighteen subjects were categorised as
treatment success (≥ 50% change in MODQ score), 15
as treatment failures and 21 as somewhat improved.
The other cohort study65 was conducted on 16
patients with chronic LBP who performed five differ-
ent stabilisation exercises and were supervised 3 times
weekly for 4 weeks. ODQ scores showed a significant
improvement of the functional status after 4 weeks.
These trials had no control group but both results
indicate that specific stabilisation exercises seem to
have a positive effect on disability.
Five reviews regarding stabilisation exercise train-
ing were retrieved,25,29,52,66,67 but not included in the
present review (Fig. 1). These reviews focus mainly on
the concepts behind lumbar stabilisation and core
strengthening and do not compare the quality and
results from clinical trials as is done in this review.
The proven decreased multifidus muscle size in
patients with LBP appears to be similar to the reflex
inhibition of muscles surrounding the knee resulting
in hypotrophy of the vastus medialis muscle, and can
occur in the absence of pain.40,68 The positive natural
history of acute LBP in the short term, might lead to
an underestimation of the importance of early inter-
ventions, which aim to prevent recurrences. The con-
trol group at the long-term follow-up in the study by
Hides et al.41 showed that the recurrence rate was high
during the first year (84%) after the original episode.
Restored symmetry of muscle size in the multifidus
muscles at the segmental level after the specific exer-
cise programme was shown in the specific exercise
group, but was not found in the control group. The
implication may be that such a specific programme is
necessary during the first stage of rehabilitation before
244 HAUGGAARD AND PERSSON
introduction of more generalised stabilisation training, so
that muscle control at the segmental level might be
assured.40 Hides et al.41 did not measure the cross-sec-
tional area in the long-term follow-up, which would be of
interest to do in future studies in order to see if the
increase in cross-sectional area persists over time.
Future research
Clinical research concerning intervention outcome in
LBP treatment is often difficult. Many of the muscles
tested are deeply situated and require invasive instru-
ments to determine muscular activity accurately.It is
often difficult to judge what different degrees of
strength, flexibility, and movement patterns should be
considered ‘normal’ or clinically significant. Long-term
change that occurs because of exercise depends on the
subject’s motivation, effort, and compliance with the
programme. It may be difficult to design adequate
placebo controls. The natural history of back pain fur-
ther complicates this research. Each episode of back
pain generally has a good prognosis,2 and studies that
look at recurrences need to have frequent, long-term fol-
low-up to capture differences between groups. If only
patients with persistent back pain are studied, central
and peripheral pain processing problems may have a
major contribution to the persistence of the pain, and
symptoms may not change as muscle function improves.
We agree with authors of other studies and reviews
that, in order to establish stronger evidence for the
therapeutic intervention, well-designed studies with
larger study groups and long-term follow-up need to
be conducted. There is also a challenge to identify if
there are certain sub-groups of LBP patients that are
more likely to benefit from this treatment approach
than others. An on-going RCT is now performed by
an Australian research group who are also completing
a systematic review.69
It would be beneficial if the research community
could agree to standardise outcome measures in order
to facilitate comparability among studies. Preferably
there should, apart from pain rating and functional
outcome measures, be some outcome measures
included for assessment of fear-avoidance behaviour,
self-efficacy beliefs and health-related quality of life.
The use of valid and reliable outcome measures as
described by an international group of experts in the
LBP field is advocated for future studies.32,33
CONCLUSIONS
Ten RCTs using specific spinal stabilisation exercises
in the treatment of patients with LBP were reviewed.
The majority of the studies were of high quality when
assessed according to the Cochrane Method Guidelines.
Results suggest moderate evidence of improved disabil-
ity level, reduced pain level and increased multifidi cross
sectional area, and limited evidence for improved qual-
ity of life. The outcome measures used in the studies
showed extensive heterogeneity. Future research with
RCTs of high quality and with long-term follow-up is
needed in order to evaluate the treatment intervention
properly. Studies using the treatment intervention on
different sub-groups of LBP patients are also warranted.
ACKNOWLEDGEMENTS
We wish to thank Jörgen Kristensen MD PhD and
Anders Hauggaard MD for contributing with helpful
suggestions and constructive discussions, and specifi-
cally Anders Hauggaard for participating as reviewer
in the method quality assessments.
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SPINAL STABILISATION EXERCISES IN PATIENTS WITH LOW BACK PAIN 247
ANNIKA HAUGGAARD PT (for correspondence)
City Rehab Sjukgymnastik, Norra Strandgatan 13, SE-252 20 Helsingborg, Sweden
Fax +971 3 7670051; E-mail: moresand@emirates.net.ae
ANN L. PERSSON PT PhD
Rehabilitation and Research Centre for Torture Victims, RCT, Postbox 2107, DK-1014 Copenhagen K, Denmark
Tel: +45 33 760000; Fax: +45 33 760510; E-mail: ap@rct.dk
APPENDIX see next page
Was the method of randomisation adequate?
A random (unpredictable) assignment sequence.
Examples of adequate methods are computer-gener-
ated random-number table and use of sealed
envelopes. Methods of allocation using date of birth,
data admission, hospital number, or alternation
should not be regarded as appropriate
Was the treatment allocation concealed?
Assignment generated by an independent person not
responsible for determining the eligibility of the
patients. The person has no information about the
persons included in the trial and has no influence on
the assignment sequence or on the decision about eli-
gibility of the patient
Were the groups similar at baseline regarding to the
most important prognostic indicators?
In order to receive a ‘yes’, groups have to be similar at
baseline regarding to demographic factors, duration,
and severity of complaints, percentage of patients
with neurological symptoms, and value of main out-
come measure(s)
Was the patient blinded to the intervention?The reviewer determines if enough information about
the blinding is given in order to score a ‘yes’
Was the care provider blinded to the intervention?
The reviewer determines if enough information about
the blinding is given in order to score a ‘yes’
Was the outcome assessor blinded to the intervention?
The reviewer determines if enough information about
the blinding is given in order to score a ‘yes’
Were co-interventions avoided or similar?
Co-interventions should either be avoided in the trial
design or similar between the index and control group
Was the compliance acceptable in all groups?
The reviewer determines if the compliance to the inter-
vention is acceptable based on the report intensity,
duration, number and frequency of sessions for both
the index intervention and control intervention(s)
Was the drop-out rate described and acceptable?
The number of participants who were included in the
study but did not complete the observation period or
were not included in the analysis must be described
and reasons given. If the percentage of withdrawals
and drop-outs does not exceed 20% for short-term
follow-up and 30% for long-term follow-up and does
not lead to substantial bias. a ‘yes’ is scored. (NB
these percentages are arbitrary, not supported by the
literature)
Was the timing of the outcome assessments in all
groups similar?
Timing of outcome assessment should be identical for
all intervention groups and for all important outcome
assessments
Did the analysis include an intention-to-treat analysis?
All randomisation patients are reported/analysed in
the group they were allocated to by randomisation for
the most important moments of effect measurement
(minus missing values) irrespective of non-compli-
ance and co-interventions
Result
6/11 or more are defined as high quality
248 HAUGGAARD AND PERSSON
APPENDIX
THE COCHRANE METHOD GUIDELINES37

Outros materiais