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Lumbar fusion rehabilitation
Title page
Rehabilitation following lumbar fusion surgery: a systematic review
and meta-analysis.
Corresponding author, James Greenwood, BSc(hons), MRes, Internal Box
8, Victor Horsely Dept of Neurosurgery, National Hospital of Neurology and
Neurosurgery, Queen Square, London WC1 3BG. Tel;02034483568 Fax;
02034483340 email; [email protected]
Address for reprints via corresponding author.
Professor Alison McGregor, PhD, Biodynamics Lab, Imperial College London,
Charing Cross Hospital, Charing Cross Campus, London, W6 8RP.
Professor Fiona Jones, PhD, St Georges University of London, Faculty of Health
and Social Care Sciences, 2nd Floor Grosvenor Wing, Cranmer Terrace, London
SW17 0RE.
Jacqueline Mullane, BSc (hons), MSc, Internal Box 8, Victor Horsely Dept of
Neurosurgery, National Hospital of Neurology and Neurosurgery, Queen Square,
London WC1 3BG.
Professor Michael Hurley, PhD, St Georges University of London, Faculty of
Health and Social Care Sciences, 2nd Floor Grosvenor Wing, St Georges
Hospital, Cranmer Terrace, London, SW17 0RE.
Support and Funding; Funding for this protocol and subsequent trial was
provided by the NIHR. This paper presents independent research funded by the
National Institute for Health Research (NIHR). The views expressed are those of
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the author(s) and not necessarily those of the NHS, the NIHR or the Department
of Health.
Acknowledgements; KB- Kate Brunskill, Librarian, UCL (for her invaluable
professional advice and support in developing and utilising the search
strategy).
Abstract
Study design; Systematic review with meta-analysis.
Objective; To conduct a systematic review and meta-analysis of current
evidence evaluating the effectiveness of rehabilitation following lumbar
fusion surgery (LFS).
Summary of background data; LFS for the management of lower back
pain, with(out) neurogenic leg pain, is increasing as the population ages.
Clinical outcomes commonly lag behind surgical outcomes and 40% of
patients experience significant back related disability 12 months after LFS.
Identifying rehabilitation strategies to improve function and quality of life
following LFS is important.
Methods; A systematic review of databases were searched, including
MEDLINE, CINAHL and grey literature. Studies identified were screened for
inclusion by title and abstract. Full text of eligible/potentially eligible
studies were evaluated against predetermined eligibility criteria. Included
studies were subjected to critical appraisal and risk of bias evaluation. The
GRADE approach to quality of evidence was utilised. A meta-analysis
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comparing usual care with ‘complex rehabilitation’, comprising exercise and
cognitive behavioural therapy, for outcomes relating to pain, disability, fear
of movement and mental health was conducted at short and longer term (<3
and >12 months post-surgery) time points.
Results; Three studies were identified for the systematic review and two
included in the meta-analysis (n=237, female=62%, mean age=55). Low
quality evidence suggests ‘complex rehabilitation’ provides short term
improvement in disability (effect size,-0.85, 95% CI, -1.41, -0.29) and fear
avoidance behaviour (-1.07, 95% CI -1.33, -0.80), compared with usual care.
Low quality evidence exists favouring ‘complex rehabilitation’ over usual
care for longer term disability (-0.84, 95% CI -1.11, -0.58) and fear
avoidance behaviour (-1.40, 95% CI –1.69 to -1.12).
Conclusions; A small number of low quality studies suggest ‘complex
rehabilitation’ reduces short and long term disability and fear avoidance
behaviour following LFS. More, high quality research is required to confirm the
effectiveness of ‘complex rehabilitation’ programmes.
Key words; systematic review, meta-analysis, lumbar fusion, spinal
surgery, rehabilitation, physiotherapy, cognitive behavioural therapy.
OCEBM; Level 1
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Key Points
1. Currently there are high levels of patient dissatisfaction following LFS.
2. ‘Complex rehabilitation’ reduces disability and fear avoidance behaviour in both
short and longer term following LFS.
3. There is a need for high quality, mixed methods studies with economic
evaluation, to better understand patient needs and optimum rehabilitation
strategies following LFS.
Mini abstract
Following lumbar fusion surgery many patients suffer back related disability. We
report a systematic review of evidence evaluating rehabilitation following
lumbar fusion. A meta-analysis comparing ‘complex rehabilitation’, combining
exercise with cognitive behavioural therapy, improved short and long-term
disability and fear avoidance behaviour. High quality research is needed to
confirm this.
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Rehabilitation following lumbar fusion surgery: a systematic review
and meta-analysis.
Introduction;
Lumbar fusion surgery (LFS) is undertaken to rigidly stabilise adjacent
vertebral motion segments. This is commonly undertaken with
simultaneous surgical decompression of affected neural tissue, to relieve
back and/or associated neurogenic leg symptoms [1-3]. Common surgical
indications include spondylolisthesis, disc disease and stenosis [4-6].
In the UK the rate of LFS is increasing, in 2009/10 4036 were performed
increasing by over 60% to 6547 by 2012/13 [7]. A similar trend of
escalating LFS is reported in the USA, particularly in patients over 60 years
[8]. It is suggested that as 30% of the UK population is predicted to be over
60 by 2037 [9] rates of LFS will continue rising.
Following LFS many patients have residual problems. Data from the
Swedish National Spine Register reports that 25% of patients experience
static/worsening pain and 40% are unsure/dissatisfied with outcomes 12
months after LFS [10]. It is timely, therefore, to evaluate mechanisms to
improve post-surgical clinical outcomes.
A recent Cochrane Back Review Group (CBRG) report suggests
rehabilitation (supervised active exercise) following laminectomy surgery
for lumbar stenosis, reduces pain and improves functional status [11]. It is
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not clear if this applies to LFS, with no clear consensus regarding the
efficacy of rehabilitation following LFS [12].
A previous systematic review and meta-analysis found inconclusive, very
low quality evidence for the effectiveness of physiotherapy (exercise,
manual therapy, electrotherapy, cognitive behavioural therapy (CBT))
following LFS, further research was an ‘urgent consideration’ [13].
Objectives
This review was undertaken to appraise the evidence evaluating
rehabilitation strategies, in adults, having undergone LFS for degenerative
conditions. Eligible trials included randomised design, suitable comparator
(eg; usual care) and validated outcome measures related to pain and/or
disability in the short and longer term (<6/>12 months respectively).
Materials and Methods
Protocol and registration
A protocol based on methods described by the CBRG and Cochrane
Handbook [14, 15] was utilised. Reporting was in accordance with the
PRISMA statement [16] and registered with the International Prospective
Register of Systematic Reviews (POSPERO).
Eligibility criteria
Studies describing rehabilitation following LFS, fulfilling the criteria below,
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were included in the review.
Study inclusion criteria.
Design; Randomised Controlled Trial (RCT).
Participants; >16 years, LFS for degenerative conditions.
Intervention; Rehabilitation (physical, psychological or combined).
Comparator; Suitable comparator, eg usual care.
Date; 1974 onwards.
Reporting; Short and long-term (<6 months, >12 months).
Outcome measures; One or more validated measure of pain/physical
function.
Language; any, translation arranged as necessary.
Information sources
The following databases were utilised.
CINAHL, EMBASE, MEDLINE, PEDro, PsycINFO, databases.
Cochrane library; Health Technology Assessment Database, NHS Economic
Evaluation database.
National Research Register, Current Controlled Trial website (York).
Cochrane Back Review Group.
Grey literature.
Hand searches key journals.
Search strategy
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The search strategy employed a 3-phase approach. A scoping search of
MEDLINE, AMED and CINAHL utilising combinations of keywords, lumbar,
fusion and rehabilitation was undertaken. Titles and abstracts of the results
identified specific keywords to develop a comprehensive search strategy,
trialed and modified with librarian assistance (KB). The final phase included
hand searching of key journals and grey literature.
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Table 1; Example search strategy employed for MEDLINE
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Study selection
Two review authors (JG, JM) independently searched the databases. Results
were saved, pooled, duplicates removed and combined with those from grey
literature and hand searches.
Titles were reviewed by one author (JG), rejecting those unrelated to the
topic of interest. Abstracts of the remaining articles (n=34) were obtained,
reviewed by two authors (JG, JM) and graded; eligible, ineligible or
potentially eligible according to the inclusion criteria. Disagreements
between authors were measured (Cohen’s k) and mediated via a third party
(AM, subject and methodological expert) to achieve consensus.
Full text of eligible and potentially eligible abstracts were retrieved and
evaluated independently, by two authors (JG, JM), to determine eligibility
for inclusion in the review. Inter-reviewer agreement was measured
(Cohen’s k). Disagreements between authors were resolved via a 3rd party
mediator (AM) to achieve consensus.
Data extraction
A data extraction form, based on the ‘characteristics of included studies’
table from the Cochrane Handbook, [15] was piloted in parallel with the
development of the search strategy and modified to match the needs of this
review. Data extraction was undertaken independently by two reviewers
(JG, JM). A third reviewer (MH) checked the form against selected studies
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for accuracy of data imputation. Authors of studies included in the review
were contacted for raw data. This was received from one study [17].
Extracted data items
Study design, participants (including surgical indications), interventions,
comparators, primary and secondary outcome measures (short/longer term
time points) and results, including disability, pain, mental health and fear
avoidance behaviour. No simplifications or assumptions were made.
Risk of bias within individual studies
The Cochrane risk of bias assessment tool was used to assess internal
validity and potential sources of systematic error.
Summary measures and synthesis of results
The protocol only allowed inclusion of studies with similar participants,
interventions, comparators and outcomes. The review authors identified
short and longer term outcomes for disability, pain, mental health and fear
avoidance behaviour as suitable for pooled analyses across studies.
Meta-analysis using RevMan [18] software, utilising the inverse variance
model for continuous data (change in mean values from baseline), was
employed. The DerSimonian Laird [19] random effects model was utilised
to accommodate the assumption that the studies were reporting different,
yet related, intervention effects. Confidence intervals (CI) were set at 95%
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and mean change from baseline scores analysed using the standardised
mean difference [15].
The standard deviation (SD) for mean change from baseline was available
for one study [20], raw data provided by the corresponding author was
utilised to calculate this for the other [17].
Risk of bias across studies
Formal risk of bias across studies was not indicated due to the paucity of
studies. Funnel plots were not warranted. The quality of evidence using the
GRADE criteria [21] was reported.
Additional analyses
The lack of studies precluded additional analysis.
Results
Study selection process
Identified databases were searched (JG, JM, 13th/20th October, 2014
respectively). This yielded 1006 results, screened by title, (JG) removing
972 irrelevant papers/duplicates. Abstracts for the 34 remaining articles
were retrieved and reviewed (JG, JM), leaving 13 papers considered
eligible/potentially eligible for full text review. Inter-reviewer reliability
was good (Cohen’s k 0.78).
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Five papers, reporting data from 3 original studies, were selected for
inclusion in the review with very good agreement between authors
(Cohen’s k 0.88).
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Fig 1; Flow chart of study selection process with reasons for rejection
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Study characteristics
Intro
Three papers met the eligibility criteria for inclusion in this review [12] [22]
[17]. All three studies compared usual care with innovative form(s) of
rehabilitation. Christensen et al compared usual care with a ‘back café’
group and a physical training group [12], Abbott et al with ‘psychomotor
therapy’ [22] and Monticone et al with exercise and CBT [17].
Detail of studies
In the study by Christensen et al, [12] participants (n=90, mean age 45)
were randomised to 3 intervention arms. They compared usual care (video
demonstration and single physiotherapy session for explanation of
exercises) with two innovative intervention groups (‘back café’ and physical
training groups). Rehabilitation commenced 3 months after LFS.
The physical training group was offered twice-weekly physiotherapy
appointments (90 minutes each) for supervised exercises over 8 weeks. The
‘back café’ group received usual care (video and advice) and in addition,
was invited to attend a ‘back café’. This consisted of 3 meetings (90 minutes
each) with other LFS patients and a physiotherapist modulator. The
purpose was to exchange experiences related to pain, disability, concerns
regarding rehabilitation and coping strategies.
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A primary outcome measure was not identified but evaluation with the low
back pain rating (LBPR) scale [23] was reported at 3, 6, 12 and 24 months
post LFS.
Abbott et al [22] randomised participants (n=107, mean age 51 years) to
either usual care or ‘psychomotor therapy’. The usual care group (n=54)
received a single session of exercise advice (20 minutes) delivered in
Hospital by a physiotherapist. The ‘psychomotor therapy’ group (n=53)
received usual care and three 90-minute Hospital outpatient appointments
(post-operative weeks 3, 6 and 9). These outpatient visits consisted of
physiotherapist-supervised core stability exercises, education, training in
cognitive coping strategies, relaxation, motivational goal setting and help
managing blocks to recovery/relapses. This combined physical
rehabilitation based on the work of Richardson et al [24] and CBT based on
the work of Linton [25] was coined ‘psychomotor therapy’ by the authors.
Rehabilitation was commenced within 3 weeks of discharge following LFS.
The primary outcome measure was the Oswestry Disability Index (ODI)
reported 3, 6, 12 and 24-36 months post-LFS. Secondary outcomes included
measures of pain, visual analogue scale (VAS), quality of life (QoL),
European Quality of Life Questionnaire (EQ-5D), mental health, the mental
health sub-scale of the Short Form Health Survey (SF-36) and fear
avoidance behaviour, Tampa Scale of Kinesiophobia (TSK).
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Monticone et al [17] randomised participants (n=130, mean age 57) to usual
care or an ‘experimental group’. Usual care consisted of supervised exercise
sessions (90 minutes), 5 times per week, for 4 weeks. The ‘experimental
group’ received usual care and additionally CBT (60 minutes) twice-weekly
for 4 weeks. Rehabilitation commenced after LFS, the exact time is not well
described.
The primary outcome was post-rehabilitation change in ODI score.
Secondary outcomes included TSK, pain, Numerical Rating Scale (NRS) and
QoL, including mental health (SF-36). Outcomes were recorded pre-
treatment, immediately post rehabilitation and at 12 months following LFS.
Summary data for included studies is given in Table 2.
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Table 2; Summary data from included studies evaluating rehabilitation following LFS.
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Table 2; Summary data from included studies evaluating rehabilitation following LFS (cont).
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Table 2; Summary data from included studies evaluating rehabilitation following LFS (cont).
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Risk of bias
The paper by Christensen et al, [12] had a mixture of high and unclear risk
of bias domains. Subsequent publications describing the long term primary
health care demands [26] and economic analysis [27], did not change the
overall risk of bias. Papers by Abbott et al [22] and Moticone et al, [17] had a
lower overall risk of bias, with one unclear and one high risk domain, the
remaining domains being low risk (Fig 2). Agreement between study
authors was good (Cohen’s k 0.72).
The nature of the interventions made blinding participants problematic to
adequately achieve, all three studies had this high-risk domain in common.
This is unlikely to have significantly affected results.
Fig 2; Risk of Bias Summary Table
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Synthesis of results
The reporting of median and range (non-parametric) data in the study by
Christensen et al, [12] precludes its inclusion in the meta-analysis. Abbott et
al [22] and Monticone et al [17] both describe a usual care (exercise) arm
and an experimental (exercise plus CBT) arm. For the purposes of this
review the combined, exercise plus CBT, approach was referred to as
‘complex rehabilitation’. Data were pooled to compare ‘complex
rehabilitation’ versus usual care across comparable outcomes. The
consensus amongst review authors was to pool data for disability (ODI),
back pain (VAS and NRS), mental health (SF-36, mental health sub-scale)
and fear avoidance behaviour (TSK).
The results of 2 individual studies [17, 22] with an unclear risk of bias were
pooled, (n=237, females=62%, mean age=55) to compare mean change from
baseline, at short and longer-term time points, for participants undergoing
usual care versus ‘complex rehabilitation’. Short term follow up in both
studies was immediately post rehabilitation, Abbott reports this as 3
months post LFS [22], Monticone et al reports this as immediately following
the 4 week rehabilitation regime [17]. Pooled data evaluating longer term
follow up was one year following entry into both studies.
In the short term one study showed evidence of significant improvements in
disability, back pain and fear avoidance behaviour [22]. The other study
reported significant improvements in disability, pain (low back and leg),
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fear avoidance behaviour, and mental health [17]. In both cases these
results favoured ‘complex rehabilitation’ over usual care.
Pooled analysis of the two studies suggests a significant short-term effect
for disability (effect size, -0.85, 95% CI -1.41, -0.29, Fig 3a) and fear
avoidance behaviour, (-1.07, 95% CI -1.33, -0.80, Fig 3b) favouring ‘complex
rehabilitation’. Pooled analysis for short-term low back pain (LBP) narrowly
failed to reach levels of significance (-0.71, 95% CI -1.44, 0.01, Fig 3c).
Fig 3a; meta-analysis results, short term disability
Fig 3b; meta-analysis results, short term fear avoidance behaviour
Fig 3c; meta-analysis results, short term low back pain
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Heterogeneity (I2) was high in the pooled analysis for disability (77%, Fig
3a) and LBP (87%, Fig 3c) perhaps contributing to the lack of effect.
Heterogeneity for fear avoidance behaviour was lower (0%, Fig 3b).
In the longer term, (12 months) one study reported significant
improvements in disability and fear avoidance behaviour [22], the other
reported significant improvements in disability, pain (back and leg), fear
avoidance behaviour and mental health [17]. In all cases this favoured
‘complex rehabilitation’.
Pooled analysis revealed levels of statistical significance for disability (effect
size -0.84, 95% CI, -1.11, -0.58, Fig 4a) and fear avoidance behaviour (-1.40,
95% CI -1.69, -1.12, Fig 4b) in favour of ‘complex rehabilitation’.
Fig 4a; meta-analysis results, long term disability
Fig 4b; meta-analysis results long term fear avoidance behaviour
Heterogeneity was acceptable in both meta-analyses.
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The long-term meta-analysis for LBP (Fig 5) did not support any positive
effect of ‘complex rehabilitation’ over usual care.
Figure 5; meta-analysis results, long-term low back pain
Risk of bias across studies
Two studies were included in the meta-analysis [17, 22]. Both studies had
one high risk domain (blinding participants), and one also had an unclear
risk of bias (blinding outcome assessment) [22]. The summary risk of bias
assessment has the majority of information coming from studies with a
low/unclear risk of bias and the overall risk of bias across studies is
therefore unclear (Fig 2).
Discussion
Summary of evidence
Results from this systematic review and meta-analysis suggests patients
undergoing ‘complex rehabilitation’ have lower levels of self reported
disability and reduced fear avoidance behavior compared to patients
receiving usual care for up to 12 months following LFS. Therefore usual
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care as currently provided may contribute to the reported dissatisfaction
with LFS amongst some patients [10].
The results from this review contrast with a previous review which showed
no effect of physiotherapy following LFS [13]. This is most likely due to the
exclusion of the Christensen study [12], and the inclusion of the recent
study by Monticone et al [17]. This enabled a wider comparison between
studies and increased the number of participants in the pooled analyses.
It is proposed that 12.4% represents the minimally important clinical
difference in the Oswestry Disability Index [28]. The studies of Abbott et al
[22] and Monticone et al [17] showed that ‘complex rehabilitation’ could
produce a clinically meaningful reduction in disability in the short and
longer term.
Monticone et al [17] showed the largest reduction in disability (ODI). This is
possibly related to the greater content of the ‘experimental group’
intervention, however dose response relationships in pain rehabilitation
programs for chronic low back pain are contentious [29] . The setting, a
specialised, multi-professional, rehabilitation centre, may also have
contributed to the greater effect size.
Limitations
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The main factor limiting this review is the lack of available studies for
inclusion in the meta-analyses. The strength of evidence, using the GRADE
assessment [21], was low so further research is very likely to have an
important impact on the estimated effect sizes.
The meta-analysis should be interpreted within the context of potential
risks of bias (unclear) across the two included studies. Service
users/providers and commissioners alike should be mindful of this.
There are limitations related to the varied composition of both usual care
and ‘complex rehabilitation’ groups in each study. Both provide a CBT
component as an adjunct to exercise therapy, however the volume of the
‘complex rehabilitation’ intervention is markedly different between studies.
Monticone et al [17] reported a maximum of 38 hours of ‘complex
rehabilitation’ compared with 4.8 hours in the study by Abbott et al [22].
The composition of usual care also varied between studies, Abbott et al [22]
and Christensen et al [12] utilised largely self directed home exercise
regimes following a single session of advice from a physiotherapist.
Monticone et al [17] describe a maximum of 30 hours of supervised exercise
over a period of one month. This variation will have contributed to the
heterogeneity observed and the overall lack of effect in some comparisons.
Conclusions
‘Complex rehabilitation’, comprising exercise and CBT, offers short and
longer term functional benefits to patients following LFS. A lack of high
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quality research in this area remains. If commissioners and surgical teams
are to continue providing LFS, more research needs to be undertaken to
better understand patients post-operative requirements and the optimal
rehabilitation regimens that are best designed to meet these needs.
Further research needs to be of a higher methodological quality, with
clearer reporting, including compliance, which has been shown to be
problematic in comparable works [30]. Mixed methods of evaluation,
proposed as the new gold standard’ of clinical research [31], should be
employed with robust economic evaluation to assess affordability. Recent
guidelines on the process evaluation of complex interventions should be
considered [32].
Studies will need to consider the possible mechanistic underpinning of
interventions and highlight the ‘active’ components of rehabilitation
strategies. The current review demonstrates a significant and meaningful
improvement in physical function and fear avoidance behavoiur,
independent of pain. It is difficult to currently discern whether reported
gains are due to improvements in physical conditioning, psychological
functioning, or both. Further work in this area is needed and there is at least
one protocol [33] and one study published since this review was
undertaken [34] expanding the evidence base.
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