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 A literature search of published and unpublished articles resulted in the retrieval of 71 potential studies on the subject area.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 r 2003 Elsevier Science Ltd. All rights reserved. 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. r 2003 Elsevier Science Ltd. All rights reserved. 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. References CONCLUSION Systematic reviews in physiotherapy are used to assess the literature to determine the efﬁcacy of treatment. In this review, very few prospective studies were found that examined the efﬁcacy of physiotherapy on the topic area. The two studies undergoing critical appraisal were both initially rated as weak. Despite this, there is evidence suggesting that special trunk stabilizing exercises have a positive effect on low-back pain related to spondylolysis and spondylolisthesis. There was also evidence indicating that combined extension exercise, extension bracing and education are beneﬁcial, though it is not possible to separate the individual effects of this combined programme. Future research is needed in examining the aetiology of the two conditions and the relationship between instability and presenting symptoms. This will hopefully allow for prevention, early detection and appropriate treatment. Speciﬁcally, in physiotherapy, randomized controlled trials are needed and should extend to examining the efﬁcacy of treatment modalities. As well, to effectively study these conditions, treatment response should be evaluated with subjects of different ages and in different stages of ‘slip’ and therefore may necessitate multicentre trials. Increased exposure time and sports participation, among children and adolescents, have been correlated with an increase in reported low-back pain (Motley 1998). In present-day society, rising numbers are participating in the new acrobatic variations of snowboarding, cycling, skate boarding and roller Manual Therapy (2003) 8(2), 80–91 Barash HL, Galante JO, Lambert CN, Ray RD 1970 Spondylolisthesis and tight hamstrings. 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