Manual Therapy (2003) 8(2), 80–91 r 2003 Elsevier Science Ltd. All rights reserved.

Manual Therapy (2003) 8(2), 80–91
r 2003 Elsevier Science Ltd. All rights reserved.
1356-689X/03/$ - see front matter
doi:10.1016/S1356-689X(02)00066-8
Systematic review
A systematic review of physiotherapy for spondylolysis and spondylolisthesis
Margaret L. McNeely, G. Torrance, D. J. Magee
Department of Physical Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Canada
SUMMARY. The purpose of this systematic review was to assess the evidence concerning the effectiveness of
physiotherapy intervention in the treatment of low back pain related to spondylolysis and spondylolisthesis. A
literature search of published and unpublished articles resulted in the retrieval of 71 potential studies on the subject
area. Fifty-two of the 71 articles were studies, and these studies were reviewed using preset relevance criteria. Given
the inclusion and exclusion criteria chosen for this systematic review, there were very few acceptable studies and
only two studies met the relevance criteria for the critical appraisal. Both studies provide evidence to suggest that
specific exercise interventions, alone or in combination with other treatments, have a positive effect on low-back
pain due to spondylolysis and spondylolisthesis; however, the type of exercise used was different in the two studies.
In this review, very few prospective studies were found that examined the efficacy of physiotherapy on the topic
area; therefore, few conclusions can be made, and further research is warranted.
r 2003 Elsevier Science Ltd. All rights reserved.
When doing a systematic literature review, large
randomized controlled trials (RCTs) are sought, as
they provide the strongest evidence (Stein & Cutler
1996; Magee 1998). Internal validity of the study,
with an RCT, is enhanced as extraneous factors are
controlled, and as randomization of subjects reduces
selection bias (Portney & Watkins 2000, p 167). Valid
and reliable measures, as well as valid, reliable, and
sensitive measurements and instruments insure that
data are accurate and meaningful (Warren 1994). In
addition, having outcomes measured by independent
(blinded) observers, or by the patients themselves,
further enhance the validity of the study. To control
for confounders and to assess the external validity of
the study, inclusion and exclusion criteria should be
clearly stated and details provided on the study
population. Among these details, such things as
agreement to participate, attrition and the reasons
for subjects being lost to follow-up must be included.
In treatment studies, pretreatment clinical signs and
symptoms have to be documented, and treatment
interventions explained in enough detail to allow for
replication of the study (Magee 1998).
The purpose of the present systematic review
was to examine research studies assessing the efficacy
of physiotherapy interventions in the treatment of
low-back pain related to spondylolysis and spondylolisthesis.
INTRODUCTION
A systematic review is an evaluation of existing
literature using a research format. As such it
constitutes research; it poses a question, identifies a
population and draws a sample (Magee 1998).
Published and unpublished studies are assembled
using explicit searching methods, and a predetermined protocol of evaluation is used with inclusion
and exclusion criteria (Jefferson & Deeks 1999, p
225). Research papers are read selectively and
critically, measurements are analysed, and conclusions are drawn based on the scientific merit of the
research findings. It is hoped that the findings of a
systematic review will help guide practitioners in
prescribing effective interventions for their patients
(de Vet et al. 1997) and provide insight into future
research directions.
Received: 30 October 2001
Revised: 17 June 2002
Accepted: 2 July 2002
Margaret L. McNeely, MSc, PT, Graduate Student, Grace
Torrance BSc PT, Graduate Student, Dr David J. Magee PhD,
BPT, Professor, Department of Physical Therapy, Faculty of
Rehabilitation Medicine, University of Alberta, Canada
Correspondence to: MM, Department of Physical Therapy,
Faculty of Rehabilitation Medicine, University of Alberta, 250
Corbett Hall, Alberta, Canada T6G 2G4. Fax: +1 780 492 1626;
E-mail: [email protected]
80
Spondylolysis and spondylolisthesis 81
THE PROBLEM
Low-back pain has become a significant health
problem and continues to be a major expense to the
healthcare system (Linton et al. 1989; Cherkin et al.
1998). Segmental instability of the lumbar spine is
a potential cause of low-back pain, and particularly,
in children and adolescents, may be the result
of spondylolysis and/or spondylolisthesis (Fritz et al.
1998). Spondylolysis is a defect or break in the
narrow portion of the vertebral bone, lying between
the superior and inferior articular facets of the
vertebral arch (Johnson 1993), called the pars
interarticularis. Spondylolisthesis, on the other hand,
is the ‘slipping’, or forward displacement, of one
vertebra over another (Magee 1997). Though the two
conditions are distinct radiographically, spondylolysis in the lumbar spine is found in 50–81% of cases
of spondylolisthesis (Szapalski et al. 1999), with
spondylolytic spondylolisthesis the consequence of
spondylolysis progressing to spondylolisthesis. Thus
the two conditions are often reviewed and studied
together (Lonstein 1999).
Over the years there has been considerable interest
in, and controversy over, both the aetiology and
treatment of these conditions. This is because, to
date, the correlation between radiographic evidence
and clinical symptoms has been poor (Osterman et al.
1993). As well, many individuals with radiographic
evidence of lumbar instability, spondylolysis and
spondylolisthesis are asymptomatic (Magora 1976).
Though the significance of lumbar instability in
low-back pain remains unclear (Fritz et al. 1998),
treatment, which may include surgery, is routinely
prescribed (Spratt et al. 1993).
Incidence
Spondylolysis occurs in approximately 6% of the
population (Hensinger 1989). While defects in the
pars interarticularis have not been found in newborns, the prevalence is approximately 5% by the age
of 7 years (Hensinger 1989), and 6% by adulthood.
These defects are twice as common in boys as in girls
(Hensinger 1989). Interestingly, a high incidence of
spondyloysis is found in certain subgroups of the
population. A prevalence rate of 26% is found in the
Inuit population (Lonstein 1999), for example, and a
higher incidence is also found in those with a family
history of spondylolysis (Johnson 1993). Of particular concern is that damage to the pars interarticularis
is observed in 25–39% of sports-related low-back
pain (Johnson 1993). This damage is especially
common in young athletes in certain competitive
sports, including power and weight lifting, skiing,
racquet sports, football, gymnastics, diving, wresting
and rowing (Johnson 1993).
Manual Therapy (2003) 8(2), 80–91
The reported incidence of spondylolisthesis is
estimated to be between 2% and 6% (Magora 1976;
Osterman et al. 1993). An increased prevalence
of spondylolisthesis is found between the ages of
10 and 15 years, and the forward displacement,
or ‘slip’, is believed to occur during the adolescent
growth spurt. Though spondylolisthesis is reported
to rarely progress after skeletal maturity (Lonstein
1999), a recent study by Floman reported documented slip progression ranging from 9% to 30%
in adults in the third decade of life (Floman 2000).
The increased slip was associated with disc degeneration (spondylosis) and, as a result, previously
asymptomatic lesions became symptomatic. Spondylolisthesis is normally divided into five categories:
dysplastic or congenital, isthmic or spondylolytic,
degenerative, traumatic and pathologic (Lonstein
1999).
Aetiology
Though the exact cause of spondylolysis is unknown,
theories have evolved implicating both congenital
and developmental causes (Hensinger 1989). The
basis of the ‘congenital theory’ is that there is a
genetically predisposed weakness in the pars interarticularis (Motley et al. 1998), and evidence for the
theory is found in the increased incidence of both
spondylolysis and spondylolisthesis in first-degree
relatives of children with these conditions (Lonstein
1999). Genetic predisposition alone, however, is
unlikely to be the sole cause, as lesions are not
present in infants or pre-ambulatory children, and
are also not found in those who have never walked
(Newell 1995).
The basis of the ‘developmental theory’ is that
a fatigue fracture develops as a gradual response
to mechanical usage (Newell 1995). It is believed
that microtrauma or microstress causes this fracture
of the pars interarticularis (Lonstein 1999)
and though an episode of minor trauma often
initiates symptoms, there is seldom a history of
severe injury to the low back (Hensinger 1989).
Supporting this hypothesis further, pars defects
can be reproduced by fatigue loading in vitro (Newell
1995). However, these reproduced defects have
been bilateral, and, thus, the presence of unilateral
defects may suggest a congenital association (Newell
1995).
Mechanically, the interarticular area, particularly
that of the fifth lumbar vertebra, is in a position of
special vulnerability, absorbing the force of weight
due to the lumbo-sacral alignment and the normal
lumbar lordosis of the spine (Newell 1995). The
normal flexion contractures of the hip seen in
childhood (Hensinger 1989) and/or poor posture
result in an accentuated lumbar lordosis, and further
increase the impact forces in this region. The pars
r 2003 Elsevier Science Ltd. All rights reserved.
82 Manual Therapy
interarticularis is especially susceptible to damage in
the growing child, due to incomplete ossification of
the neural arches (Johnson 1993). In young athletes,
it is believed that repetitive motions and/or overuse,
on an already compromised region of the vertebra,
cause fracture or elongation of the pars interarticularis (Johnson 1993). In summary, though genetic
factors may predispose to spondylolysis, it is likely
that mechanical forces related to normal weight
bearing, posture, repetitive activities and mild trauma, especially on an immature spine, combine to
produce the initial defect (Hensinger 1989; Lonstein
1999).
Spondylolisthesis, as stated previously, usually
results from spondylolysis. The normal resistance to
forward displacement of the vertebra is provided by
the posterior facets, ligaments and the intervertebral
disc (Magee 1982). With fracture or elongation of the
pars interarticularis, however, the posterior elements
are compromised (Lonstein 1999) and the vertebral
body is allowed to slip forward, resulting in
instability (Magee 1982). Narrowing of the spinal
canal will occur if posterior elements also slide
forward (Magee 1982) and, as a result, symptoms
may develop.
Treatment
In the majority of symptomatic cases of spondylolysis
and spondylolisthesis non-operative treatment is
recommended. Physiotherapy is the most common
method used to apply non-operative treatment and
may include the use of modalities for pain relief,
bracing, exercise, electrical stimulation and activity
modification (Fellander-Tsai & Micheli 1998; Szapalski 1999). Physiotherapy treatment is recommended to reduce pain, to restore range of motion
and function, and to strengthen and stabilize the
spine (Fritz et al. 1998; Hall & Brody 1999). Though
non-operative treatment is reported as being effective
in relieving the symptoms of back pain due to
spondylolysis and spondylolisthesis (Szapalski
1999), few studies have been done examining the
efficacy of the various treatment interventions.
Operative treatment is indicated to alleviate pain in
patients not responding to conservative treatment,
and to prevent progression of the slip in those with
severe slip (>40%) of the vertebrae (Fritz et al. 1998;
Szapalski 1999). As costs and complications due to
surgery are high and long-term benefits uncertain
(Fritz 1998), further study into the efficacy of nonoperative treatment is warranted.
Signs and symptoms
The presenting signs and symptoms normally include
pain, restricted range of motion, paraspinal muscle
spasm, flattening of the sacrum and a peculiar gait
(Magee 1982; Johnson 1993; Osterman et al. 1993.
Pain is usually reported as mild to moderate, and is
initially a dull ache that gradually increases in
intensity (Motley 1998). Pain is commonly localized
to the paraspinal region, gluteals (Hall & Brody 1999)
and posterior aspect of the thighs (Barash et al. 1970).
Initially pain may be associated with a very mobile
spine, with symptoms appearing at extremes of
lumbar range of motion only. In the adolescent
athlete, extension- and rotation-type movements,
specific to the individual’s sport, are reported to
exacerbate symptoms (Johnson 1993). Progression
results in hamstring tightness (Osterman et al. 1993),
posterior tilting of the pelvis, and a flexed hip and
knee posture (Barash et al. 1970). The individual may
walk with a stiff legged, short-stride gait (Barash et al.
1970; Hensinger 1989) and a characteristic pelvic
‘waddle’ (pelvic rotation with stepping) may be
observed (Hensinger 1989).
On examination, pain is reproduced with the onelegged standing lumbar extension test, and with
spondylolisthesis, a step deformity in the lumbar
spine may be observed or palpated (Magee 1997). In
moderate to severe cases, marked limitation of trunk
flexion range of motion is often seen (Barash et al.
1970) and a limited straight leg raise found (Barash
et al. 1970; Magee 1982).
r 2003 Elsevier Science Ltd. All rights reserved.
METHODS AND MATERIALS
The process of systematic reviewing involves thorough detective work aimed at identifying all studies
on a specific topic. Studies are chosen based on preset
criteria that may include, for example, study design,
type of experimental intervention and specific outcome measures. For this review, the literature was
searched for published studies and unpublished
studies on physiotherapy interventions in treating
spondylolysis and spondylolisthesis. Two independent investigators screened the titles of articles found
on the databases, and if available, the abstract of the
article as well. If either or both investigator felt that
the article potentially met the inclusion criteria, or if
there was inadequate information to make a decision,
copies of the article were obtained.
Search strategy
A literature search was conducted to identify appropriate studies using numerous databases including
MEDLINE and CINAHL (Table 1). Keywords and
medical subject headings related to the condition and
potential treatment were identified prior to initiating
the search. If any of the searches resulted in less than
300 titles, then all articles found in the particular
database were assessed for potential inclusion; otherwise, terms related to treatment such as ‘exercise(s)’,
‘physiotherapy’ and ‘rehabilitation’ were used to
Manual Therapy (2003) 8(2), 80–91
Spondylolysis and spondylolisthesis 83
Table 1. Search strategy
Search for published studies
Keywords (medical subject headings are in italics):
*
*
Terms related to the condition: Spondylolysis, Spondylolisthesis, Pars interarticularis, Lumbar instability, Low-back pain, Spinal vertebra
(lumbar vertebra)
Terms related to the intervention: Physical therapy (physiotherapy), Rehabilitation, Exercise(s) (Therapeutic exercise, Stabilization
exercise(s), Pilates, McKenzie, Feldenkrais).
The Medical Librarian provided assistance on appropriate use of truncation, query and set operators (use of OR/AND) for combining
terms. To allow for a broad search of the literature, limits for publication types were not used
Databasen
Medline: 1966–February 2001
CINAHL: 1982–February 2001
ERIC: 1986–2000
EMBASE (Excerpta Medica) (1982–March 2000)
Sport Discus: 1975–l999
Best Evidence: 1991–1999
Dissertation Abstracts: 1999
Biological Abstracts: 1997–1999
Library of Congress
Cochrane Collaboration: Database of RCT and systematic reviews
Expanded search/search for unpublished studies
1. Hand-searching reference lists of all retrieved articles (including review articles)
2. Hand-search of the journal SPINE: 1994–2000
3. Citation searching: key authors—Rossi F, Davis IS, Farfan HF, Jackson DW, Magora A, Batts M, King AB, Verbostad A, Meyerding
HW, Szapalski M, Gunzburg R, Pope M, Grieve GP
4. Local experts were contacted for additional information:
*
*
*
ISSL (International Society for the Study of the Lumbar Spine) abstracts were provided
Management of Low Back Pain: Beyond Rhetoric Toward Outcomes (September 1999): conference abstracts were provided
Dr David Magee: permission to access personal orthopaedic research database
5. Research: Federal Research in Progress
University of Iowa, USA
Curtin University of Technology, Australia
University of Alberta, Canada
n
For some of the databases, slight modification in search strategy was required.
narrow the search. For the purposes of this review,
the literature search was conducted from January
2000 to February 2001.
The next phase of the search strategy involved
searching for studies potentially overlooked or absent
from the databases and for unpublished studies. This
involved hand-searching the references of all retrieved articles for potential studies and handsearching the journal Spine. Citation indexing was
used to track referencing of key authors in the field,
conference abstracts were reviewed, and local experts
were contacted for further information.
Criteria development
Criteria were developed at the beginning of the study
to determine keywords to use in the search strategy,
and to help determine whether the studies found were
relevant to the topic area of this systematic review.
The inclusion and exclusion criteria were deemed
important for ensuring internal validity of the study.
The base criterion required that the study include
activities that could be classed as physiotherapy
interventions within the scope of practice of physioManual Therapy (2003) 8(2), 80–91
therapists in Canada. This requirement meant that a
researcher from any discipline could undertake
the study, as long as one or more of the interventions
was within the scope of practice of Canadian physiotherapists.
Although randomized controlled studies were
sought, because of the clinical nature of the topic
and the paucity of research in the physiotherapy field
in general, other research methods were considered
eligible for the review. The investigators felt that
other research methods might demonstrate differences and suggest important research hypotheses.
However, to ensure that some degree of scientific
rigour was maintained it was determined that only
prospective studies would be included and that
quantitative studies were required to have a control
group (Lohr & Carey, 1999).
Further inclusion criteria used to determine
whether the study was relevant for this overview
were: (a) male and female humans; (b) symptomatic
low-back pain; (c) within the age of 10–60 years; (d)
lumbar spine involvement and (e) radiographic
evidence of spondylolysis or spondylolisthesis in the
lumbar spine. The exclusion criteria were developed
r 2003 Elsevier Science Ltd. All rights reserved.
84 Manual Therapy
to limit the influence that extraneous factors might
have on the results of the treatment intervention
(confounding variables), and in an attempt to limit
the study to true symptomatic spondylolysis and
spondylolisthesis. Exclusion criteria for this overview
were: (a) no neurological or autonomic deficits; (b) no
other fracture or bony abnormalities; (c) no rheumatic disease and (d) no other spinal problems. For
outcome measurements, the study had to include one
or more of the following: range of motion, pain,
functional outcome measure or patient satisfaction.
The information was developed into a relevance
tool (Table 2) that was used by the investigators to
independently evaluate the retrieved papers. Each
criterion was graded on a yes/no basis—that is, the
published study had to provide enough information
to adequately meet the criterion. All criteria on the
rating form had to be met for the study to be
evaluated at the next level, the Critical Appraisal.
Once the criteria were developed, a group of 10
studies were gathered. Interrater reliability of independent initial grading of these papers using the
relevance tool was 100%.
The next level of the systematic review, the Critical
Appraisal, involved rating the accepted studies to
determine internal and external validity (Table 3).
The two investigators independently reviewed the
studies. Each study was analysed based on specific
predetermined criteria. These criteria were then rated
as pass (P), moderate (M) and fail (F). The rating
system was based on a similar rating system developed by de Vet et al. (1997). The Critical Appraisal
was then taken to the final stage for an overall
assessment of the study (Table 4). At this point, the
study was graded as weak, moderate or strong,
depending on how well it met each of the critical
appraisal criteria. All criteria were weighted equally.
Results
A total of 71 articles were obtained through the
literature search; 52 articles were studied and were
reviewed using the relevance tool (Table 2). Out of
the 52 studies reviewed, only two studies met all
selection criteria (Spratt et al. 1993; O’Sullivan et al.
1997). Clarification was required by one author
(Spratt et al. 1993) to verify that one specific criterion
was met and this was done by e-mail communication.
None of the other studies came close to meeting all
Table 2. Physiotherapy effectiveness project relevance tool—primary studies (Study: Physiotherapy intervention for low-back pain related
to spondylolisthesis and spondylolysis)
Instructions for completion
1. Circle Y or N for each relevance criterion
2. Record inclusion decision: article must satisfy all relevant criteria
3. Ensure that no exclusion criteria are included
4. Record if additional references are to be retrieved
5. Complete validity form for articles to be included
Relevance criteria
1. Does this article evaluate a physiotherapy intervention or program?
2. Is the intervention within the scope of physiotherapy practice in Canada?
3. Are the subject inclusion criteria covered?
a. male/female humans
b. low back pain
c. age 10–60
d. lumbar spine involvement
e. radiographic evidence of spondylolisthesis and spondylolysis
4. Are patient exclusion criteria included?
a. no neurological/autonomic deficits
b. no other fracture/bony deformities
c. no rheumatic disease
d. no other spinal problems
5. Is one or more appropriate outcomes (ROM, Pain, outcome measure, patient satisfaction) measured?
6. Is the article a prospective study?
(allocation, exposure to intervention occurs during research period and prior to measurement of outcome)
7. If a quantitative study, is there a control group?
Y
Y
N
N
Y
Y
Y
Y
Y
N
N
N
N
N
Y
Y
Y
Y
Y
N
N
N
N
N
Y
Y
N
N
Y
N
Y
N
If discreepancy inclusion decision
Reason for discrepancy
Oversight
Differences in interpretation of criteria
Differences in interpretation of study
Y
Y
Y
N
N
Y
Final decision: include in study
Y
N
Reviewer decision
1. Include in critical appraisal (Yes = Y to all relevance criteria)
If yes, please complete validity form
2. Additional references
If yes, mark items on reference list of article
r 2003 Elsevier Science Ltd. All rights reserved.
Manual Therapy (2003) 8(2), 80–91
Spondylolysis and spondylolisthesis 85
Table 3. Critical appraisal—included studies (Study: Physical therapy intervention for low-back pain related to spondylolisthesis and
spondylolysis (included studies))
1. Type of study
i. random/quasirandom
ii. cohort/before-after
iii. case control/cross-sectional
iv. descriptive
2. Confounders controlled
i. age
ii. sex
iii. classification
iv. medication
3.
4.
5.
6.
(I)
(II)
(III)
(IV)
(P)
(M)
(F)
(F)
Y
Y
Y
Y
N
N
N
N
Differences between groups not
statistically controlled
P=all
M=2–3
F=0–1
Agreement to participate
i. >80%
ii. 60–80%
iii. o60%
iv. cannot tell
Intervention
i. acupuncture
ii. mobilization
iii. manipulation
iv. massage
v. superficial heat
vi. bracing
vii. deep heat
viii. ice
ix. ultrasound
x. traction
xi. exercise
xii. education
xiii. TNS/IFC/HVG
xiv. Other, pls. specify
Physiotherapy treatment
i. well described
Y
ii. specific to tested groups
Y
P=2
M=1
F=O
(well described: dosage, time, placement)
Sample size
i. large
>100
ii. medium
20–100
iii. small o20 o20
(P)
(M)
(F)
(F)
Outcome: 6 or all=P, validity +(3–4)=M, validity + (0–2)=F
N/A is not a fail for this category
N
N
(P)
(M)
(F)
criteria. There was 100% agreement between reviewers about the rating of all papers.
The two studies that were evaluated at the
Critical Appraisal level were initially rated as ‘weak’.
However, after e-mail communication with one
of the authors, one study (O’Sullivan et al. 1997)
was re-rated as strong. The results of the Critical
Appraisal for each of the two studies are provided
in Table 5.
DISCUSSION
In this systematic review, few prospective studies
were found that addressed the question of the efficacy
of physiotherapy interventions in the treatment of
low-back pain related to spondylolysis and spondylolisthesis. The strict criteria established for inclusion
and exclusion criteria, as well as the requirement for a
Manual Therapy (2003) 8(2), 80–91
7. Data collection methods
i. self-reported (pain, functional outcome)
inter-rater reliability
Y
N
N/A
intra-rater reliability
Y
N
N/A
reliable test inst.
Y
N
validity test inst.
Y
N
sensitivity
Y
N
well described
Y
N
ii. single blind assessor (pain, ROM, functional outcome)
inter-rater reliability
Y
N
N/A
intra-rater reliability
Y
N
reliable test inst.
Y
N
validity test inst.
Y
N
sensitivity
Y
N
well described
Y
N
iii. clinician performed (ROM, functional outcome)
inter-rater reliability
Y
N
N/A
intra-rater reliability
Y
N
reliable test inst.
Y
N
validity test inst.
Y
N
sensitivity
Y
N
well described
Y
N
8. Subjects starting and finishing study
i. immediate
>80%
(P)
60–80%
(M)
>60%
(F)
ii. post-treatment >80%
(P)
60–80%
(F)
o60%
(M)
iii. follow-up
>80%
(P)
60–80%
(M)
>60%
(F)
9. External validity
Y
N
10. Limitations
i. Major
ii. Minor
11. Was there statistical test(s) of the intervention effects?
Y
N
prospective study, eliminated many potential studies
for review.
The two studies that did meet our criteria were
both randomized controlled trials and each study
provided evidence of improvement in outcome
measures from the physiotherapy intervention. A
descriptive review of the two studies is provided in
Table 6.
O’Sullivan and colleagues provided evidence supporting the use of very specific exercise treatment
regime for subjects with spondylolysis and spondylolisthesis. The treatment group (TG) demonstrated
statistically significant decreases in pain (both in
intensity and in description) and functional disability
when compared to the control group (CG). The
results were effective in the short term (3 months)
as well as the long term (30 months). A statistically
significant difference was found within the CG
following the treatment period for pain descriptors
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86 Manual Therapy
Table 4. Critical appraisal—final decision (Study: Physiotherapy
intervention for low back pain related to spondylolisthesis and
spondylolysis (final decision))
Overall assessment of the study
1. Type of study
2. Confounders controlled
3. Agreement to participate
4. Intervention
5. Physiotherapy treatment
6. Sample size
7. Data collection methods
i. Pain
ii. ROM
iii. Patient satisfaction/outcome
8. Subjects starting and finishing study
i. Immediate
ii. At end of treatment
intervention
iii. At follow-up (6 month)
Review rating
Weak
(any F)
P
P
P
P
P
P
M
M
M
M
M
M
F
F
F
F
F
F
P
P
P
M
M
M
F
F
F
P
P
M
M
F
F
P
M
F
Moderate
(No F;
o4 P)
Strong
(No F;
4+P)
If discrepancy in validity decision between reviewers
Reason for discrepancy
i. Oversight
ii. Differences in interpretation of criteria
iii. Differences in interpretation of study
Final decision
Weak
Moderate
Strong
only. No significant change was found in the CG for
the follow-up period.
Spratt et al. (1993) examined the efficacy of flexion
and extension treatments, incorporating braces for
low-back pain, in patients with retrodisplacement,
spondylolisthesis and normal sagittal translation. The
study used a mixed-model repeated measures design
with the three classification categories, three treatment groups (flexion, extension and control) and pretest/post-test measures (3 3 2 design). The most
important finding in this study was the reduction in
pain in the extension treatment group. This finding
occurred across all translation types and was
significant.
The primary concerns of the two studies identified
by this review were as follows: (a) interventions/
control group activities were not well described; (b)
the chosen outcome measure was not well described
especially in terms of validity and reliability; (c)
inadequate information was provided in regard to
training of the individuals responsible for administering the outcome measures and (d) sample size
The exercise description in the O’Sullivan study
was well described and could be reproduced based on
the published description; however, the control group
activities were not clearly outlined or standardized.
As the control group received many different,
uncontrolled treatments, it is difficult to determine
the actual effect of ‘conservative treatment’ on
outcome.
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The exact treatment provided to the groups in
the Spratt study was also not explained in detail.
For example, though the flexion group received a
flexion brace, flexion exercises and education on
avoiding lordotic postures, detail was not provided
on the type, intensity, frequency and duration of
the exercise programme, nor on instructions for
expected brace wearing-time. The control group was
provided with a ‘sham’ brace and subjects were
assigned to a physiotherapist. It is not clear if the
control group received alternate forms of physiotherapy or if monitoring of control group activities was
done.
The outcome measures utilized in the O’Sullivan
study were: the McGill pain questionnaire, the
Oswestry disability questionnaire, lumbar spine
and hip sagittal range of motion (using a Cybex
electronic digital inclinometer) and surface electromyography of abdominal muscle recruitment patterns. An independent assessor administered the
outcome measures. The same assessor was used at
the pre- and post-10-week treatment period and selfrated mail-out questionnaires were used during the
follow-up period of the study. The chosen outcome
measures were not well described in terms of
reliability, and of concern was the validity of the
Oswestry. However, in communication with the
author, testing for reliability and validity of measures
was done and intra-rater reliability of the independent assessor was reported as ‘good’ (O’Sullivan,
personal communication, 2000).
In the Spratt study, outcome measures included
range of motion, trunk strength, compliance to
treatment, patient perception of treatment effectiveness and pain assessment using a visual analogue
scale. The primary outcome measure was pain. A
visual analogue scale was used, which is a valid and
sensitive measure, and was well described in this
study. The subject’s assigned physiotherapist (who
also provided the treatment) was responsible for
measurement of range of motion and trunk strength.
Information was not provided on the measurement
methods or on the intra- and inter-rater reliability of
the physiotherapists performing these measures.
Independent assessors were not used but would have
strengthened the study. As well, inadequate information was provided with respect to the questionnaire
used to evaluate subject perception of treatment
effect.
The review findings also suggest that in future
more attention should be given to the size of the
study populations. In the two studies reviewed,
information was not provided on how the sample
size was predetermined. Specifically in the Spratt
study, the final sample size of 56 subjects was
inadequate for the study design. As well, there were
only 19 subjects in total with spondylolisthesis and
this classification included both degenerative and
Manual Therapy (2003) 8(2), 80–91
Spondylolysis and spondylolisthesis 87
Table 5. Results of critical appraisal
O’Sullivan et al.
Rating:
O’Sullivan
Spratt et al.
Rating:
Spratt
Type of study
Confounders
controlled age, sex,
classification,
medicine
Randomized controlled trial
Age: 16–49, sex: males >females
Classification: limited to isthmic
spondylolysis and spondylolisthesis
(degree of slip: 0–2)
Medication: monitored
n
No significant differences between
groups
P
P
P
F
Agreement to
participare
Physiotherapy
Intervention
Intervention
described in enough
detail to allow for
replication
100%
P
Randomized controlled trial
Age 18–60 years: age and gender
not equal across groups
Classification: both spondylolytic
(isthmic) and degenerative
spondylolisthesis included
n
Stringent inclusion criteria to
control for age-related conditions
Medication: no information
provided
100%
Stabilization exercises
Yes
Yes
Treatment group: well described and
could be reproduced based on
description
Control group: not clearly outlined or
standardized
44 subjects
McGill Pain Questionnaire: selfreported, valid measure, reliable,
sensitive
M
Bracing
Exercise
Insufficient details on intervention
to allow for replication
Sample size
Primary outcome
measure
M
P
Additional outcome
measure
Oswestry Disability Questionnaire:
self-reported, concurrent validity:
unclear, reliable, sensitive
P
Additional outcome
measure
Range of motion: single independent
assessor (blinded), valid measure,
reliable, sensitive, intra-rater reliability
reported as ‘good’
44 subjects randomized: immediate
42 subjects completed the treatment
period (21 SEG and 21 CG)=95%
41 subjects completed 3-months
follow-up (21 SEG and 20 CG)=93%
40 subjects completed 6-month followup (21 SEG and 19 CG)=90%
34 subjects completed full protocol (30
months) (19 SEG and 15 CG)=77%
* Generalizability of results to those
with isthmic spondylolysis and
spondylolisthesis from 0 to 2nd
degree ‘slip’
* Reasons provided for loss to
follow-up
* Control group treatments not
standardized
TG showed a significant improvement
at 30 months when compared to the
CG
M
Subjects starting and
finishing
External validity/
limitations
Statistical tests
Overall rating:
Weak (any F)
Moderate (No F;
o4 P)
Strong (No F; 4+P)
P
P
65 subjects
VAS:
Self-reported
Valid measure: yes, reliable: yes,
sensitive: yes
ROM:
* Independent (blinded) assessors
not used
ROM: validity, reliability,
sensitivity: unclear, not
described
* No information on inter-rater
and intra-rater reliability
testing
Patient perception of treatment
effect: Self-administered: yes
Validity, reliability, sensitivity of
measure: unclear
65 subjects randomized: immediate
56 finished treatment=86%
M
P
F
F
P
P
P
(M)
Yes
Reason not provided for loss
for loss to follow-up
Authors acknowledge
limitations: small sample size
No
Significant improvement in pain in
the extension treatment group (all
translation categories)
Yes
*
Yes
Minor
Yes
Strong
Weak
F=3
M=3
P=8
P=4
Manual Therapy (2003) 8(2), 80–91
M
P
F=0
M=3
spondylolytic types. As there is limited knowledge of
the aetiology of low-back pain related to spondylolysis and spondylolisthesis, a potential difficulty
would be to obtain a homogeneous study population
P
(Koes 1992). A larger sample size would provide
more confidence that randomization of subjects had
adequately controlled for known and unknown
confounding factors (Koes 1992).
r 2003 Elsevier Science Ltd. All rights reserved.
r 2003 Elsevier Science Ltd. All rights reserved.
RCT
65 subjects
Subacute and chronic
low-back pain: 4 weeks
to under 5 years
3 3 2 design
* 3 instability
categories
* 3 treatments
* pre-post-test
measures
Three categories of
instability
1. Retrodisplacement
2. Spondylolisthesis
3. Normal translation
Spratt et al.
(1993)
Location:
United States
All groups received education on low-back care.
RCT
44 subjects >3 months
history of low-back pain
10-week intervention
pre-post-test design with
follow-up at 3, 6, 30
months
Single independent
assessor (blinded)
O’Sullivan et al.
(1997)
Location:
Australia
n
Key features
Reference
TG showed a
significant
improvement at 30
months when
compared to the CG
Pain intensity:
F=14.4, Po0.0006
Pain descriptors:
F=6.1, P=0.0187
Oswestry disability:
F=4.2, Po0.0481
Pain: extension
group showed
improvement over
time: F=11.61,
Po0.03
Patient perception:
flexion group
reported low benefit
from treatment,
whereas extension
group reported large
benefit from brace
and education
components:
F=3.65, Po0.04
Pain:
modified VAS
ROM:
Strength:
Compliance
monitored Patient
perception of
treatment effect
Randomized to one
of:
1. Flexion exercises
and flexion
bracen
2. Extension
excercises and
extension bracen
3. Control (sham
treatment
group)n
Statistics
Pain: VAS
Function: Oswestry
ROM: cybex digital
inclinometer
Abdominal muscle
recruitment: surface
electromyography
Outcome measures
Randomized to one
of:
1. Treatment group:
Strengtheing of
deep abdominal
muscles with
coactivation of
lumbar
multifidus
2. Control group:
Treatment as
recommended by
medical
practitioner
Intervention
Table 6. Comparative summary of studies meeting relevance criteria
Significant
improvement in pain
in the extension
treatment group (all
translation
categories)
Authors suggest that
improvement found
with extension
treatment may
indicate advanced
disease of the disc as
underlying
pathology
Specific exercise to
train trunk stabilizer
musculature is
effective to decrease
pain, functional
disability, reduce use
of pain medication
Exercise effective in
long term: to 30
months
Authors conclusions
Both spondylolytic and
degenerative
spondylolisthesis studied
(one classification)
Poor compliance with
the flexion treatment
especially in those with
spondylolisthesis
Inadequate sample for
study design: low power
Study rated as weak
initially until further
information obtained
from the author
Exercise program lends
itself to reproducibility
within clinic setting
Control group activities
not standarized
Comments
88 Manual Therapy
Manual Therapy (2003) 8(2), 80–91
Spondylolysis and spondylolisthesis 89
Limitations
The findings of this review are specific to low-back
pain due to spondylolysis and spondylolisthesis and
to the field of physiotherapy. As time and resources
were limited, the focus of the search was on studies
written in the English language. Attempts were made
to identify unpublished studies; however, no such
studies were found. Therefore, the studies identified
in this review may not represent all existing research
in the area but a representative sample. As it was
anticipated that very few acceptable studies would
be found, this systematic review was open to the
inclusion of any prospective study. As a result,
the Critical Appraisal focused more on the methodological criteria related to clinical significance
(subjects, description of treatments, and the validity
and reliability of the chosen outcome measures).
Therefore, an additional limitation of this review is
that it did not consider criteria that have been shown
to discriminate between biased and unbiased randomized controlled trials such as the random allocation
procedure and method of concealment of allocation.
blading. As the current sporting trend is likely to
result in an increased number of individuals presenting with spondylolysis and spondylolisthesis, further
study is needed specifically within the young athletic
population. It is also apparent from this review that
authors of clinical trials need to publish study
methods and results in enough detail to allow for
analysis of scientific rigour. In conclusion, as the
results of this systematic review are very limited, the
field is wide open for further research in this area.
Acknowledgements
The authors would like to acknowledge the assistance of librarian
Sandra Shores, BA, MLS, Reference Librarian, John W. Scott
Health Sciences Library at the University of Alberta. Her
assistance in the search component of this systematic review was
invaluable. The authors would also like to thank Trevor McNeely,
MA, English Professor, Brandon University for his review of the
manuscript.
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`