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Research and treatment bulletin
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International Journal of Osteopathic Medicine 11 (2008) 71e75 www.elsevier.com/locate/ijosm
RESEARCH AND TREATMENT BULLETIN Section Co-ordinator: Paul Blanchard British School of Osteopathy, London, UK
Adverse events round up Steven Vogel, Head of Research, The British School of Osteopathy, UK Side effects related to manual therapy have attracted increased concern in recent years. The distinction between inadvertent side effects, harm and benign treatment reactions is unclear. For example, it may be that some post-treatment pain and stiffness is associated with the process of osteopathic treatment for neck complaints; this is akin to pain and swelling associated with dental treatment. However, just as concern would be raised if there was an association between serious injuries and mortality after having a dental cavity treated, there has been concern about serious injury in the form of stroke related to dissection of the vertebral arteries after receiving manual therapies including highvelocity low-amplitude manipulation. In the UK, concerns from practitioners about what information to give patients and a desire from the UK regulator to provide patients and practitioners with helpful information has led to a series of research projects being commissioned by the National Council for Osteopathic Research and funded by the General Osteopathic Council. The medical press has to date focussed on the chiropractic profession, though debate is ongoing in all groups that use manual therapy. Three recent papers address risk of adverse events with respect to treatment of the cervical spine within the context of chiropractic care and these are reviewed here to assist readers in maintaining awareness of current literature pertaining to adverse events.
Chiropractors report on safety of neck manipulation Thiel and colleagues1 report the results of a prospective study conducted in the UK, which collected practitioner reports of 100 consecutive patients over a 6-week period. The focus of the study was on high-velocity low-amplitude thrust (HVLA), or mechanically assisted thrust, to the cervical spine. Details of the manipulations were recorded along with information about the area manipulated and whether the patient had experienced worsening of symptoms, new International Journal of Osteopathic Medicine
symptoms or any adverse event immediately following treatment. Significant serious adverse events were defined as ‘‘referred to a hospital accident and emergency department or resulted in persistent or significant disability/incapacity’’. The team went to great lengths to follow up on patients for whom data was missing, first contacting their chiropractor, then the patient themselves, and finally the patients’ general practitioner. Thirty-two percent (377 practitioners) of the British and Scottish Chiropractic Associations’ members were recruited via newsletters, conferences and personal contact. Data were recorded from 50,276 cervical manipulations generated by 28,109 treatment consultations. Four hundred and thirteen treatment consultations (1.4%) were lost to follow up. No significant adverse events were reported by the participating chiropractors. Although no hospital admissions or persistent disability was reported in this sample, there was an increase in neck pain symptoms in 1.7% of treatments. The most common onset of new symptoms was fainting/dizziness/light-headedness (1.5% of cases). Whilst this study undoubtedly contributes to knowledge in this area, there are some problems in applying these results to every day practice. There is still a debate about whether chiropractic and osteopathic manipulation are similar. Seemingly unique to chiropractic is the use of mechanical aids to manipulation e ‘activators’. Activators are used as alternatives to HVLA and are applied without gross movement of the cervical spine.2 It is unclear from this report whether there were differences in associated risks between hands on and mechanically aided manipulation. The most common concern, vertebral artery dissection, is a rare event and accounts for a small proportion of all strokes. As such, although a large number of individual consultations were reported, the precision of the risk estimates reported in the study would be improved by an even larger sample. This issue also pertains to the small percentage lost to follow up. It may be that significant adverse events were not recorded. In common with other studies in this area, it is difficult to judge what contribution patients’ existing pretreatment symptoms had on their report of additional symptoms. Finally, there are potential problems of reporter
bias when asking practitioners to collect and report this type of information. Those chiropractors who elected to participate may not be representative of chiropractors generally, and there was no check on whether participants recruited consecutive patients or might have been selective in their recruitment. Finally one might imagine that faceto-face report of perceived negative impacts of treatment may have been difficult for patients to offer to the person responsible for their treatment and future care. Overall, whilst this study offers some re-assurances about the safety of cervical manipulation, it is likely to underestimate the reported adverse events from cervical manipulation and makes no comment on the potential
benefit of treatment. Individual osteopaths are invited to obtain the paper and assess how relevant the findings are to their own practice. References 1. Thiel HW, Bolton JE, Docherty S, Portlock JC. Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine 2007;32: 2375e8. 2. Wood TG, Colloca CJ, Mathews R. A pilot randomized clinical trial on the relative effect of instrumental (MFMA) versus manual (HVLA) manipulation in the treatment of cervical spine dysfunction. J Manipulative Physiol Ther 2001;24: 260e71.
Patients’ report on benefits and risks of chiropractic care for neck pain Rubinstein et al.1 describe the results from a large multicentre prospective study involving patients observed immediately after treatment, at 3 and then 12 months. The study, conducted in the Netherlands, focussed on describing positive and adverse events following treatment delivered by chiropractors on patients presenting with neck pain. Adverse events were defined as those relating to pain and stiffness local to the treated area and in another ‘‘treatment-related’’ area, as well as using a list of symptoms that have been previously reported as associated with manual therapy to the neck. These were: headache, tiredness, radiating pain in the arm of hand, nausea, ringing in the ears, confusion or disorientation, depression or fear, and other non specified reactions. The intensity of the adverse event was measured using an 11-point numerical rating scale (NRS). ‘‘Intense’’ adverse events were defined as those scoring 8 on the NRS and ‘‘serious’’ adverse events were defined as death or development of a life threatening condition, admittance to hospital, or disability that was temporary or permanent. In addition to measuring adverse events and patient demographics, the authors measured a number of other variables: pain, neck disability, perceived recovery, treatment satisfaction, intention to visit a chiropractor again, nature and severity of presenting complaint, history of previous manual and medical care, apprehension of treatment, treatment expectation, health status, and fear of movement or re-injury. Seventy-nine chiropractors were recruited from the Netherlands, Chiropractic Association (42%) by means of flyers, publicity at conferences, and personal contact. Participants were surveyed about their experience and common treatment approaches and were asked to recruit new patients between 18 and 65 with neck pain (including related cervicothoracic and periscapular symptoms) of any duration, who had not received manual therapy within the last three months. The chiropractors in the study were able to treat patients according to their normal practices. Patients taking part in the study and who failed to return questionnaires were followed up with a short telephone interview. Five hundred and seventy-nine patients were recruited for the study. Fifty subjects were excluded leaving the data from 529 patients available for analysis. Ninety percent of patients were followed up at 3 months, and 92% at 12 months. In terms of clinical outcomes there was a steady decrease in neck pain and related neck disability up to 3 months, but no further improvement at 12 months. Approximately two thirds of patients recovered at 3 and 12 months, although there were some who recovered at 3 months who were no longer recovered at 12 months. Conversely, there were some who had not recovered at 3 months who went on to recovery at 12 months. Rubinstein et al. suggest that some of those who initially recovered had a re-occurrence of symptoms affecting their status at 12 months. Very few patient participants reported being much worse (n ¼ 7) as measured on a six-point perceived recovery scale. Satisfaction levels were moderate to high for most patients. Close to 50% of patients returning for a second visit indicated a new, related or worsening of the presenting or existing complaint and 26% of those coming for a fourth visit indicated an adverse event following the second or third visit. Overall 56% indicated an adverse event in the process of their care. These, however, were rated largely as having nil or only a minor impact on patients’ daily activities. The most frequent events reported were musculoskeletal or pain related (72% and 75% of recorded events). Tiredness, dizziness, nausea or ringing in the ears were uncommon and made up 8% of all reported adverse events; although overall, 19% of the participants reported these. There were some reported intense adverse events (14% and 15%), but none of these patients were worse, or much worse at the end of the study. There were no serious adverse events reported in the study period. The results suggest that adverse events are most likely to occur in the early stages of treatment, and Rubinstein et al. suggest that practitioners might choose to modify treatment interventions at this stage, however, they do not provide an International Journal of Osteopathic Medicine
analysis of the association between particular interventions and adverse events so it is difficult to know what sort of changes should be made to treatment. Whilst this study offers new information about chiropractic interventions in neck pain, there are several limitations. There is the chance of a response and recall bias influencing the report of symptoms from patients and the likelihood that there is an over estimation of adverse events in the opposite direction to the study by Thiel et al.2 An observational study like this cannot account for the cause of any changes that were observed throughout the study, and it may be that rather than the treatment interventions, natural history or other factors were responsible. Further analysis from Rubinstein et al. will no doubt provide clearer insight into this field and lead to new studies that include a control group in the design. In order to control for selection bias, the investigators assessed the recruitment methods of participating chiropractors from a small number of practices and suggest that recruitment bias is likely to be a small factor. Rubinstein et al. conclude that the benefits of chiropractic for neck pain outweigh the potential risks. This conclusion is reasonable in the context of the paper, but further analyses and studies will need to be reported before practitioners have a clear enough picture to accurately inform their patients about the risk benefit profile of chiropractic treatment for neck pain. Readers interested in this topic are encouraged to obtain a full version of the paper. References 1. Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW. The benefits outweigh the risks for patients undergoing chiropractic care for neck pain: a prospective, multicenter, cohort study. J Manipulative Physiol Ther 2007;30: 408e18. 2. Thiel HW, Bolton JE, Docherty S, Portlock JC. Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine 2007;32: 2375e8.
Strokes and chiropractic care for neck pain Cassidy et al.1 have recently published a population based case control and case cross-over study investigating the purported association between patient consultation with a chiropractor or primary care physician and strokes secondary to vertebrobasilar artery pathology. This design aims to contrast patients’ experience in one setting with experiences in another. This involves retrospectively finding ‘cases’ from one setting and matching them with similar ‘cases’ from a different setting and then drawing conclusions from the contrast. Importantly, in this design subjects were matched with four controls to each case. In this study the investigators compare visits to chiropractors for neck pain and related areas of complaint with visits to primary care physicians for similar reasons. Subjects included as ‘cases’ were defined as those documented as having strokes secondary to vertebrobasilar occlusion or stenosis between 1993 and 2002 in Ontario, Canada, and covered by the public health insurance scheme. The cases were identified from two linked health record databases, and controls were obtained International Journal of Osteopathic Medicine
from a third database ‘‘Registered Persons database’’, which includes all health card numbers for Ontario. Controls excluded those who were in a long-term health care facility, or those who had suffered a stroke. The main findings were that patients suffering from vertebrobasilar stroke, and aged under 45 years, had three times greater likelihood of visiting a chiropractor before the stroke occurred in comparison to controls. The important and interesting finding of this study is that this likelihood was also found to be the same for those patients consulting a primary care physician. This increased likelihood of patients with vertebrobasilar stroke consulting a practitioner is not apparent in patients older than 45 years who consult with chiropractors, yet is maintained for those consulting primary care physicians. Cassidy et al. interpret this data as meaning that the increased likelihood of consulting a chiropractor or physician in those patients with vertebrobasilar stroke is related to patients presenting with a vertebrobasilar dissection in process, but before the development of a stroke. This study is important as it controls for confounding factors more effectively than previous attempts. However, although this study is based on a large
population of 109,020,875 personyears, only 818 vertebrobasilar strokes were identified. This type of stroke is extremely rare and the sample size of cases available in the study limits the potential for analysis of subgroups. The authors identify age stratification as a particular difficulty, meaning that a finer examination of the relationship between stroke, age and attendance for healthcare merits further examination. Whilst this design is stronger than previous attempts at answering the question about the association between chiropractic treatment and stroke, the ideal design is still a prospective case control study; however, the logistics and costs associated with such an endeavour and the rarity of the event, make such a study unlikely to ever take place. As the authors identify, this study does not conclude that cervical manipulation does not cause stroke, but it does suggest that it is unlikely to be a major cause of this type of stroke. Reference ^te P, He Y, 1. Cassidy JD, Boyle E, Co Hogg-Johnson S, Silver FL, et al. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case control and case-crossover study. Spine 2008;33(Suppl.): S176e83.
Osteopathy, physiotherapy and exercise for chronic back pain e which works best? Brett Vaughan, Lecturer, School of Biomedical and Clinical Sciences, Victoria University, Australia In a recent study conducted in the UK, Chown et al.1 report the results of a prospective randomised trial of interventions for chronic low back pain. The researchers aimed to determine the effectiveness of (1) group exercise versus one-on-one physiotherapy and (2) one-on-one physiotherapy versus one-on-one osteopathic treatment. Outcome measures employed were the Oswestry Disability Index (ODI), the EuroQoL (EQ-5D) (quality-of-life) and the shuttle walk test (functional capacity) with the outcomes assessed at baseline, at 6 weeks follow-up and at 12 months. Life satisfaction, and satisfaction with the intervention received, were also measured. Four physiotherapists provided the one-on-one treatment, one osteopath provided the oneon-one osteopathic treatment, and the group exercise therapy was lead by a physiotherapist. Practitioners in the manual treatment groups were permitted to access other interventions or treatment techniques. Participants were required to attend five sessions of their allocated intervention within a three-month period. Two hundred and thirty-nine people with chronic low back pain of greater than 3 months duration entered the study with 98 participants completing their allocated intervention and were available to 6-week follow-up. Only 65 participants completed the follow-up at 12 months. There were a large number of participants who did not complete their allocated intervention (group exercise, n ¼ 48; physiotherapy, n ¼ 21; osteopathy, n ¼ 16).
Mean reductions in disability scores at 6 weeks were 6.1 points (group exercise), 4.0 points (physiotherapy) and 5.0 points (osteopathy) with changes between 6 weeks and 12 months being 1.2 points (group exercise), 0.3 (physiotherapy) and þ1.5 (osteopathy). Patient satisfaction at 6 weeks follow-up was good with 63% (group exercise), 79% (physiotherapy) and 87% (osteopathy) of participants indicating that they were ‘somewhat/very satisfied’ with their treatment. The small sample size at follow-up is disappointing and limits the ability to draw conclusions about the effectiveness of one intervention over another. External validity is limited given the number of practitioners involved, particularly with only one osteopath being used. The large standard deviations for each of the outcomes assessed is also problematic. Given a larger sample size and possibly greater response rate at follow-up, more promising results could have been obtained given that the effect sizes for disability were 0.43 (group exercise), 0.42 (physiotherapy) and 0.68 (osteopathy). It would also be interesting to see a comparison of the cost effectiveness of each intervention. This is an interesting study and although it is pleasing to see studies like this being performed, the complexities and organisation of such trials need adequate resourcing to enable follow-up assessments to be pursued more vigorously, thereby allowing conclusions to be drawn more firmly. Reference 1. Chown M, Whittamore L, Rush M, Allan S, Stott D, Archer M. A prospective study of patients with chronic back pain randomised to group exercise, physiotherapy or osteopathy. Physiother 2008; 94: 21e8.
Orthopaedic tests of the shoulder e are they accurate? Paul Blanchard, Research Fellow and Senior Clinical Tutor, The British School of Osteopathy, London, UK Special diagnostic tests of the shoulder are widely used during physical examination to differentially diagnose tissues and pathologies contributing to the presenting symptoms. Despite increasing numbers of studies examining the diagnostic accuracy of such tests it remains unclear if these tests have any utility in clinical practice. Hegedus and colleagues1 performed an exhaustive literature search and subsequent systematic review of 45 identified studies that investigated a variety of physical examination tests. Unfortunately only half of these were deemed of sufficient quality to offer results worthy of inclusion in the systematic review. Reporting of raw data in a number of studies allowed the authors to perform a meta-analysis for three commonly used diagnostic tests: (1) the Neer and (2) Hawkinse Kennedy tests for impingement, and (3) the Speed test for pathology of the glenoid labrum or ‘Superior Labrum Anterior Posterior’ (or ‘SLAP’ lesion). Results reported for the remaining orthopaedic tests where meta-analysis was not possible revealed only a small number where both specificity and sensitivity were high enough for the test to be clinically useful. In all, recommendations for use in clinical practice were given for 12 special tests. Where meta-analysis was performed the results for sensitivity (Sn) and specificity (Sp) were disappointing; for the Neer test these were reported as 0.79 and 0.53, respectively, and for the HawkinseKennedy test as 0.79 and 0.59, respectively. Diagnostic odds ratios were also calculated for both tests
International Journal of Osteopathic Medicine
leading to the conclusion that neither test has diagnostic utility for the diagnosis of impingement. Similarly the meta-analysis of the Speed test revealed the Sn ¼ 0.32 and Sp ¼ 0.61. Diagnostic odds ratios again revealed that the Speed test has no diagnostic utility for a SLAP lesion and that its ability to diagnose such a lesion was no better than chance alone. The shoulder complex is widely acknowledged by clinicians as a notoriously difficult region to differentially diagnose. Perhaps some of the difficulties may be due to the over reliance on some special tests that, based on the accuracy data, have much lower diagnostic usefulness than is commonly believed. To date, this systematic review is the largest of its kind and contains clinically useful information both for the tests which it cautiously recommends and for those it suggests should be regarded with caution. The authors conclude by quoting the conclusion of a similar review performed eight years prior to this one, ‘‘clearly we need large methodologically robust studies on history and physical examination!’’ Reference 1. Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, et al. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med 2008;42: 80e92.
Referred and nerve root pain arising from the low back e are they two distinct entities? Paul Blanchard, Research Fellow and Senior Clinical Tutor, The British School of Osteopathy, London, UK An attempt is often made clinically to divide pain radiating distally into the extremities from the low back into two distinct syndromes e (i) radicular or nerve root pain and (ii) pseudoradicular or referred pain. A commonly used criterion for such differentiation is that nerve root pain may extend below the knee whereas referred pain does not. A pathoanatomic rationale is also used to separate these two phenomena with the irritation of a lumbar nerve root being the source of ‘true’ radicular pain while pseudoradicular pain may be generated by a variety of other structures such as facet joints, muscle and ligaments. Various examinations and special tests have traditionally been used in an attempt to differentiate between the two including such procedures as the Straight Leg Raise, tendon reflexes, and examination of sensory and motor function. In certain circumstances imaging and neurophysiological testing may be called upon to provide clarification. Such distinction is important to clinicians as it is often used as
International Journal of Osteopathic Medicine
a guide to subsequent treatment modalities and prognosis for the application of manual therapy. Indeed, the presence of radicular pain is used by many practitioners as a contraindication to certain techniques such as high velocity thrust techniques in the lumbar spine. Freynhagen and colleagues1 set out to investigate if such a distinction between radicular and pseudo-radicular pain is justified and likely to be clinically relevant using the technique of Quantitative Sensory Testing (QST) to examine nerve function in subjects with radicular and pseudo-radicular pain as well as in normal volunteers. Unlike normal bedside neurological examination, QST uses a battery of tests which interrogate both large and small nerve fibre function. As pain conduction predominantly involves the small afferent C-fibres this is of particular relevance to these syndromes. Bedside tests will usually interrogate the larger fibre function only. Quantitative Sensory Testing is also used to differentiate the so-called ‘neuropathic’ components of pain from those of nociceptive or inflammatory origin. A total of 30 patients with low back pain extending into one leg were evaluated. Four experienced practitioners independently examined all patients with the task of determining the predominant pain type as being either radicular or pseudo-radicular. Diagnostic criteria for each were those in common use.
Ninety percent (27 patients) had their pain type independently classified similarly by all four practitioners and these 27 went forward for QST. Overall the results of the QST testing confirmed that there were two separate groups of patients with sensory deficits, and in particular vibration perception, being more affected in the group designated as having radicular pain. The interesting finding, however, was that although the deficits were more pronounced in the radicular pain group they were also present in the pseudo-radicular pain group, and on statistical testing the two groups showed no significant difference. The investigators conclude that ‘‘ .the symptoms and signs of either pseudoradiculopathy or radiculopathy patients reflects more of a disease continuum rather than different disease entities’’. A thorough discussion of the neurophysiological and anatomical basis for this continuum is given as well as the implications for the presence of neuropathic components in back pain. Reference €lle 1. Freynhagen R, Rolke R, Baron R, To TR, Rutjes AK, Schu S, et al. Pseudoradicular and radicular low-back pain e a disease continuum rather than different entities? Answers from quantitative sensory testing. Pain 2008;135: 65e74.
International Journal of Osteopathic Medicine 11 (2008) 71e75 www.elsevier.com/locate/ijosm
RESEARCH AND TREATMENT BULLETIN Section Co-ordinator: Paul Blanchard British School of Osteopathy, London, UK
Adverse events round up Steven Vogel, Head of Research, The British School of Osteopathy, UK Side effects related to manual therapy have attracted increased concern in recent years. The distinction between inadvertent side effects, harm and benign treatment reactions is unclear. For example, it may be that some post-treatment pain and stiffness is associated with the process of osteopathic treatment for neck complaints; this is akin to pain and swelling associated with dental treatment. However, just as concern would be raised if there was an association between serious injuries and mortality after having a dental cavity treated, there has been concern about serious injury in the form of stroke related to dissection of the vertebral arteries after receiving manual therapies including highvelocity low-amplitude manipulation. In the UK, concerns from practitioners about what information to give patients and a desire from the UK regulator to provide patients and practitioners with helpful information has led to a series of research projects being commissioned by the National Council for Osteopathic Research and funded by the General Osteopathic Council. The medical press has to date focussed on the chiropractic profession, though debate is ongoing in all groups that use manual therapy. Three recent papers address risk of adverse events with respect to treatment of the cervical spine within the context of chiropractic care and these are reviewed here to assist readers in maintaining awareness of current literature pertaining to adverse events.
Chiropractors report on safety of neck manipulation Thiel and colleagues1 report the results of a prospective study conducted in the UK, which collected practitioner reports of 100 consecutive patients over a 6-week period. The focus of the study was on high-velocity low-amplitude thrust (HVLA), or mechanically assisted thrust, to the cervical spine. Details of the manipulations were recorded along with information about the area manipulated and whether the patient had experienced worsening of symptoms, new International Journal of Osteopathic Medicine
symptoms or any adverse event immediately following treatment. Significant serious adverse events were defined as ‘‘referred to a hospital accident and emergency department or resulted in persistent or significant disability/incapacity’’. The team went to great lengths to follow up on patients for whom data was missing, first contacting their chiropractor, then the patient themselves, and finally the patients’ general practitioner. Thirty-two percent (377 practitioners) of the British and Scottish Chiropractic Associations’ members were recruited via newsletters, conferences and personal contact. Data were recorded from 50,276 cervical manipulations generated by 28,109 treatment consultations. Four hundred and thirteen treatment consultations (1.4%) were lost to follow up. No significant adverse events were reported by the participating chiropractors. Although no hospital admissions or persistent disability was reported in this sample, there was an increase in neck pain symptoms in 1.7% of treatments. The most common onset of new symptoms was fainting/dizziness/light-headedness (1.5% of cases). Whilst this study undoubtedly contributes to knowledge in this area, there are some problems in applying these results to every day practice. There is still a debate about whether chiropractic and osteopathic manipulation are similar. Seemingly unique to chiropractic is the use of mechanical aids to manipulation e ‘activators’. Activators are used as alternatives to HVLA and are applied without gross movement of the cervical spine.2 It is unclear from this report whether there were differences in associated risks between hands on and mechanically aided manipulation. The most common concern, vertebral artery dissection, is a rare event and accounts for a small proportion of all strokes. As such, although a large number of individual consultations were reported, the precision of the risk estimates reported in the study would be improved by an even larger sample. This issue also pertains to the small percentage lost to follow up. It may be that significant adverse events were not recorded. In common with other studies in this area, it is difficult to judge what contribution patients’ existing pretreatment symptoms had on their report of additional symptoms. Finally, there are potential problems of reporter
bias when asking practitioners to collect and report this type of information. Those chiropractors who elected to participate may not be representative of chiropractors generally, and there was no check on whether participants recruited consecutive patients or might have been selective in their recruitment. Finally one might imagine that faceto-face report of perceived negative impacts of treatment may have been difficult for patients to offer to the person responsible for their treatment and future care. Overall, whilst this study offers some re-assurances about the safety of cervical manipulation, it is likely to underestimate the reported adverse events from cervical manipulation and makes no comment on the potential
benefit of treatment. Individual osteopaths are invited to obtain the paper and assess how relevant the findings are to their own practice. References 1. Thiel HW, Bolton JE, Docherty S, Portlock JC. Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine 2007;32: 2375e8. 2. Wood TG, Colloca CJ, Mathews R. A pilot randomized clinical trial on the relative effect of instrumental (MFMA) versus manual (HVLA) manipulation in the treatment of cervical spine dysfunction. J Manipulative Physiol Ther 2001;24: 260e71.
Patients’ report on benefits and risks of chiropractic care for neck pain Rubinstein et al.1 describe the results from a large multicentre prospective study involving patients observed immediately after treatment, at 3 and then 12 months. The study, conducted in the Netherlands, focussed on describing positive and adverse events following treatment delivered by chiropractors on patients presenting with neck pain. Adverse events were defined as those relating to pain and stiffness local to the treated area and in another ‘‘treatment-related’’ area, as well as using a list of symptoms that have been previously reported as associated with manual therapy to the neck. These were: headache, tiredness, radiating pain in the arm of hand, nausea, ringing in the ears, confusion or disorientation, depression or fear, and other non specified reactions. The intensity of the adverse event was measured using an 11-point numerical rating scale (NRS). ‘‘Intense’’ adverse events were defined as those scoring 8 on the NRS and ‘‘serious’’ adverse events were defined as death or development of a life threatening condition, admittance to hospital, or disability that was temporary or permanent. In addition to measuring adverse events and patient demographics, the authors measured a number of other variables: pain, neck disability, perceived recovery, treatment satisfaction, intention to visit a chiropractor again, nature and severity of presenting complaint, history of previous manual and medical care, apprehension of treatment, treatment expectation, health status, and fear of movement or re-injury. Seventy-nine chiropractors were recruited from the Netherlands, Chiropractic Association (42%) by means of flyers, publicity at conferences, and personal contact. Participants were surveyed about their experience and common treatment approaches and were asked to recruit new patients between 18 and 65 with neck pain (including related cervicothoracic and periscapular symptoms) of any duration, who had not received manual therapy within the last three months. The chiropractors in the study were able to treat patients according to their normal practices. Patients taking part in the study and who failed to return questionnaires were followed up with a short telephone interview. Five hundred and seventy-nine patients were recruited for the study. Fifty subjects were excluded leaving the data from 529 patients available for analysis. Ninety percent of patients were followed up at 3 months, and 92% at 12 months. In terms of clinical outcomes there was a steady decrease in neck pain and related neck disability up to 3 months, but no further improvement at 12 months. Approximately two thirds of patients recovered at 3 and 12 months, although there were some who recovered at 3 months who were no longer recovered at 12 months. Conversely, there were some who had not recovered at 3 months who went on to recovery at 12 months. Rubinstein et al. suggest that some of those who initially recovered had a re-occurrence of symptoms affecting their status at 12 months. Very few patient participants reported being much worse (n ¼ 7) as measured on a six-point perceived recovery scale. Satisfaction levels were moderate to high for most patients. Close to 50% of patients returning for a second visit indicated a new, related or worsening of the presenting or existing complaint and 26% of those coming for a fourth visit indicated an adverse event following the second or third visit. Overall 56% indicated an adverse event in the process of their care. These, however, were rated largely as having nil or only a minor impact on patients’ daily activities. The most frequent events reported were musculoskeletal or pain related (72% and 75% of recorded events). Tiredness, dizziness, nausea or ringing in the ears were uncommon and made up 8% of all reported adverse events; although overall, 19% of the participants reported these. There were some reported intense adverse events (14% and 15%), but none of these patients were worse, or much worse at the end of the study. There were no serious adverse events reported in the study period. The results suggest that adverse events are most likely to occur in the early stages of treatment, and Rubinstein et al. suggest that practitioners might choose to modify treatment interventions at this stage, however, they do not provide an International Journal of Osteopathic Medicine
analysis of the association between particular interventions and adverse events so it is difficult to know what sort of changes should be made to treatment. Whilst this study offers new information about chiropractic interventions in neck pain, there are several limitations. There is the chance of a response and recall bias influencing the report of symptoms from patients and the likelihood that there is an over estimation of adverse events in the opposite direction to the study by Thiel et al.2 An observational study like this cannot account for the cause of any changes that were observed throughout the study, and it may be that rather than the treatment interventions, natural history or other factors were responsible. Further analysis from Rubinstein et al. will no doubt provide clearer insight into this field and lead to new studies that include a control group in the design. In order to control for selection bias, the investigators assessed the recruitment methods of participating chiropractors from a small number of practices and suggest that recruitment bias is likely to be a small factor. Rubinstein et al. conclude that the benefits of chiropractic for neck pain outweigh the potential risks. This conclusion is reasonable in the context of the paper, but further analyses and studies will need to be reported before practitioners have a clear enough picture to accurately inform their patients about the risk benefit profile of chiropractic treatment for neck pain. Readers interested in this topic are encouraged to obtain a full version of the paper. References 1. Rubinstein SM, Leboeuf-Yde C, Knol DL, de Koekkoek TE, Pfeifle CE, van Tulder MW. The benefits outweigh the risks for patients undergoing chiropractic care for neck pain: a prospective, multicenter, cohort study. J Manipulative Physiol Ther 2007;30: 408e18. 2. Thiel HW, Bolton JE, Docherty S, Portlock JC. Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine 2007;32: 2375e8.
Strokes and chiropractic care for neck pain Cassidy et al.1 have recently published a population based case control and case cross-over study investigating the purported association between patient consultation with a chiropractor or primary care physician and strokes secondary to vertebrobasilar artery pathology. This design aims to contrast patients’ experience in one setting with experiences in another. This involves retrospectively finding ‘cases’ from one setting and matching them with similar ‘cases’ from a different setting and then drawing conclusions from the contrast. Importantly, in this design subjects were matched with four controls to each case. In this study the investigators compare visits to chiropractors for neck pain and related areas of complaint with visits to primary care physicians for similar reasons. Subjects included as ‘cases’ were defined as those documented as having strokes secondary to vertebrobasilar occlusion or stenosis between 1993 and 2002 in Ontario, Canada, and covered by the public health insurance scheme. The cases were identified from two linked health record databases, and controls were obtained International Journal of Osteopathic Medicine
from a third database ‘‘Registered Persons database’’, which includes all health card numbers for Ontario. Controls excluded those who were in a long-term health care facility, or those who had suffered a stroke. The main findings were that patients suffering from vertebrobasilar stroke, and aged under 45 years, had three times greater likelihood of visiting a chiropractor before the stroke occurred in comparison to controls. The important and interesting finding of this study is that this likelihood was also found to be the same for those patients consulting a primary care physician. This increased likelihood of patients with vertebrobasilar stroke consulting a practitioner is not apparent in patients older than 45 years who consult with chiropractors, yet is maintained for those consulting primary care physicians. Cassidy et al. interpret this data as meaning that the increased likelihood of consulting a chiropractor or physician in those patients with vertebrobasilar stroke is related to patients presenting with a vertebrobasilar dissection in process, but before the development of a stroke. This study is important as it controls for confounding factors more effectively than previous attempts. However, although this study is based on a large
population of 109,020,875 personyears, only 818 vertebrobasilar strokes were identified. This type of stroke is extremely rare and the sample size of cases available in the study limits the potential for analysis of subgroups. The authors identify age stratification as a particular difficulty, meaning that a finer examination of the relationship between stroke, age and attendance for healthcare merits further examination. Whilst this design is stronger than previous attempts at answering the question about the association between chiropractic treatment and stroke, the ideal design is still a prospective case control study; however, the logistics and costs associated with such an endeavour and the rarity of the event, make such a study unlikely to ever take place. As the authors identify, this study does not conclude that cervical manipulation does not cause stroke, but it does suggest that it is unlikely to be a major cause of this type of stroke. Reference ^te P, He Y, 1. Cassidy JD, Boyle E, Co Hogg-Johnson S, Silver FL, et al. Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case control and case-crossover study. Spine 2008;33(Suppl.): S176e83.
Osteopathy, physiotherapy and exercise for chronic back pain e which works best? Brett Vaughan, Lecturer, School of Biomedical and Clinical Sciences, Victoria University, Australia In a recent study conducted in the UK, Chown et al.1 report the results of a prospective randomised trial of interventions for chronic low back pain. The researchers aimed to determine the effectiveness of (1) group exercise versus one-on-one physiotherapy and (2) one-on-one physiotherapy versus one-on-one osteopathic treatment. Outcome measures employed were the Oswestry Disability Index (ODI), the EuroQoL (EQ-5D) (quality-of-life) and the shuttle walk test (functional capacity) with the outcomes assessed at baseline, at 6 weeks follow-up and at 12 months. Life satisfaction, and satisfaction with the intervention received, were also measured. Four physiotherapists provided the one-on-one treatment, one osteopath provided the oneon-one osteopathic treatment, and the group exercise therapy was lead by a physiotherapist. Practitioners in the manual treatment groups were permitted to access other interventions or treatment techniques. Participants were required to attend five sessions of their allocated intervention within a three-month period. Two hundred and thirty-nine people with chronic low back pain of greater than 3 months duration entered the study with 98 participants completing their allocated intervention and were available to 6-week follow-up. Only 65 participants completed the follow-up at 12 months. There were a large number of participants who did not complete their allocated intervention (group exercise, n ¼ 48; physiotherapy, n ¼ 21; osteopathy, n ¼ 16).
Mean reductions in disability scores at 6 weeks were 6.1 points (group exercise), 4.0 points (physiotherapy) and 5.0 points (osteopathy) with changes between 6 weeks and 12 months being 1.2 points (group exercise), 0.3 (physiotherapy) and þ1.5 (osteopathy). Patient satisfaction at 6 weeks follow-up was good with 63% (group exercise), 79% (physiotherapy) and 87% (osteopathy) of participants indicating that they were ‘somewhat/very satisfied’ with their treatment. The small sample size at follow-up is disappointing and limits the ability to draw conclusions about the effectiveness of one intervention over another. External validity is limited given the number of practitioners involved, particularly with only one osteopath being used. The large standard deviations for each of the outcomes assessed is also problematic. Given a larger sample size and possibly greater response rate at follow-up, more promising results could have been obtained given that the effect sizes for disability were 0.43 (group exercise), 0.42 (physiotherapy) and 0.68 (osteopathy). It would also be interesting to see a comparison of the cost effectiveness of each intervention. This is an interesting study and although it is pleasing to see studies like this being performed, the complexities and organisation of such trials need adequate resourcing to enable follow-up assessments to be pursued more vigorously, thereby allowing conclusions to be drawn more firmly. Reference 1. Chown M, Whittamore L, Rush M, Allan S, Stott D, Archer M. A prospective study of patients with chronic back pain randomised to group exercise, physiotherapy or osteopathy. Physiother 2008; 94: 21e8.
Orthopaedic tests of the shoulder e are they accurate? Paul Blanchard, Research Fellow and Senior Clinical Tutor, The British School of Osteopathy, London, UK Special diagnostic tests of the shoulder are widely used during physical examination to differentially diagnose tissues and pathologies contributing to the presenting symptoms. Despite increasing numbers of studies examining the diagnostic accuracy of such tests it remains unclear if these tests have any utility in clinical practice. Hegedus and colleagues1 performed an exhaustive literature search and subsequent systematic review of 45 identified studies that investigated a variety of physical examination tests. Unfortunately only half of these were deemed of sufficient quality to offer results worthy of inclusion in the systematic review. Reporting of raw data in a number of studies allowed the authors to perform a meta-analysis for three commonly used diagnostic tests: (1) the Neer and (2) Hawkinse Kennedy tests for impingement, and (3) the Speed test for pathology of the glenoid labrum or ‘Superior Labrum Anterior Posterior’ (or ‘SLAP’ lesion). Results reported for the remaining orthopaedic tests where meta-analysis was not possible revealed only a small number where both specificity and sensitivity were high enough for the test to be clinically useful. In all, recommendations for use in clinical practice were given for 12 special tests. Where meta-analysis was performed the results for sensitivity (Sn) and specificity (Sp) were disappointing; for the Neer test these were reported as 0.79 and 0.53, respectively, and for the HawkinseKennedy test as 0.79 and 0.59, respectively. Diagnostic odds ratios were also calculated for both tests
International Journal of Osteopathic Medicine
leading to the conclusion that neither test has diagnostic utility for the diagnosis of impingement. Similarly the meta-analysis of the Speed test revealed the Sn ¼ 0.32 and Sp ¼ 0.61. Diagnostic odds ratios again revealed that the Speed test has no diagnostic utility for a SLAP lesion and that its ability to diagnose such a lesion was no better than chance alone. The shoulder complex is widely acknowledged by clinicians as a notoriously difficult region to differentially diagnose. Perhaps some of the difficulties may be due to the over reliance on some special tests that, based on the accuracy data, have much lower diagnostic usefulness than is commonly believed. To date, this systematic review is the largest of its kind and contains clinically useful information both for the tests which it cautiously recommends and for those it suggests should be regarded with caution. The authors conclude by quoting the conclusion of a similar review performed eight years prior to this one, ‘‘clearly we need large methodologically robust studies on history and physical examination!’’ Reference 1. Hegedus EJ, Goode A, Campbell S, Morin A, Tamaddoni M, Moorman CT 3rd, et al. Physical examination tests of the shoulder: a systematic review with meta-analysis of individual tests. Br J Sports Med 2008;42: 80e92.
Referred and nerve root pain arising from the low back e are they two distinct entities? Paul Blanchard, Research Fellow and Senior Clinical Tutor, The British School of Osteopathy, London, UK An attempt is often made clinically to divide pain radiating distally into the extremities from the low back into two distinct syndromes e (i) radicular or nerve root pain and (ii) pseudoradicular or referred pain. A commonly used criterion for such differentiation is that nerve root pain may extend below the knee whereas referred pain does not. A pathoanatomic rationale is also used to separate these two phenomena with the irritation of a lumbar nerve root being the source of ‘true’ radicular pain while pseudoradicular pain may be generated by a variety of other structures such as facet joints, muscle and ligaments. Various examinations and special tests have traditionally been used in an attempt to differentiate between the two including such procedures as the Straight Leg Raise, tendon reflexes, and examination of sensory and motor function. In certain circumstances imaging and neurophysiological testing may be called upon to provide clarification. Such distinction is important to clinicians as it is often used as
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a guide to subsequent treatment modalities and prognosis for the application of manual therapy. Indeed, the presence of radicular pain is used by many practitioners as a contraindication to certain techniques such as high velocity thrust techniques in the lumbar spine. Freynhagen and colleagues1 set out to investigate if such a distinction between radicular and pseudo-radicular pain is justified and likely to be clinically relevant using the technique of Quantitative Sensory Testing (QST) to examine nerve function in subjects with radicular and pseudo-radicular pain as well as in normal volunteers. Unlike normal bedside neurological examination, QST uses a battery of tests which interrogate both large and small nerve fibre function. As pain conduction predominantly involves the small afferent C-fibres this is of particular relevance to these syndromes. Bedside tests will usually interrogate the larger fibre function only. Quantitative Sensory Testing is also used to differentiate the so-called ‘neuropathic’ components of pain from those of nociceptive or inflammatory origin. A total of 30 patients with low back pain extending into one leg were evaluated. Four experienced practitioners independently examined all patients with the task of determining the predominant pain type as being either radicular or pseudo-radicular. Diagnostic criteria for each were those in common use.
Ninety percent (27 patients) had their pain type independently classified similarly by all four practitioners and these 27 went forward for QST. Overall the results of the QST testing confirmed that there were two separate groups of patients with sensory deficits, and in particular vibration perception, being more affected in the group designated as having radicular pain. The interesting finding, however, was that although the deficits were more pronounced in the radicular pain group they were also present in the pseudo-radicular pain group, and on statistical testing the two groups showed no significant difference. The investigators conclude that ‘‘ .the symptoms and signs of either pseudoradiculopathy or radiculopathy patients reflects more of a disease continuum rather than different disease entities’’. A thorough discussion of the neurophysiological and anatomical basis for this continuum is given as well as the implications for the presence of neuropathic components in back pain. Reference €lle 1. Freynhagen R, Rolke R, Baron R, To TR, Rutjes AK, Schu S, et al. Pseudoradicular and radicular low-back pain e a disease continuum rather than different entities? Answers from quantitative sensory testing. Pain 2008;135: 65e74.