On this blog, we have repeatedly discussed the serious adverse effects of Spinal Manipulative Therapies (SMT) as frequently administered by chiropractors, osteopaths and physiotherapists. These events mostly relate to vascular accidents involving vertebral or carotid arterial dissections after SMT of the upper spine. Lower down, the spine is anatomically far less vulnerable which, however, does not mean that injuries in this region after SMT are impossible. They have been reported repeatedly but, to the best of my knowledge, there is no up-to-date review of such events – that is until recently.
Australian researchers have just filled this gap by publishing a systematic review aimed at systematically reviewing all reports of serious adverse events following lumbo-pelvic SMT. They conducted electronic searches in MEDLINE, EMBASE, CINAHL, and The Cochrane Library up to January 12, 2012. Article-selection was performed by two independent reviewers using predefined criteria. Cases were included involving individuals 18 years or older who experienced a serious adverse event following SMT applied to the lumbar spine or pelvis by any type of provider (chiropractic, medical, physical therapy, osteopathic, layperson). A serious adverse event was defined as an untoward occurrence that resulted in death or was life threatening, required hospital admission, or resulted in significant or permanent disability. Reports published in English, German, Dutch, and Swedish were included.
The searches identified a total of 2046 papers, and 41 articles reporting a total of 77 cases were included in the review. Important case details were frequently missing in these reports, such as descriptions of SMT technique, the pre-SMT presentation of the patient, the specific details of the adverse event, time from SMT to the adverse event, factors contributing to the adverse event, and clinical outcome.
The 77 adverse events consisted of cauda equina syndrome (29 cases); lumbar disk herniation (23 cases); fracture (7 cases); haematoma or haemorrhagic cyst (6 cases); and12 cases of neurologic or vascular compromise, soft tissue trauma, muscle abscess formation, disrupted fracture healing, and oesophageal rupture.
The authors’ conclusion was that this systematic review describes case details from published articles that describe serious adverse events that have been reported to occur following SMT of the lumbo-pelvic region. The anecdotal nature of these cases does not allow for causal inferences between SMT and the events identified in this review.
This review is timely and sound. Yet several factors need consideration:
1) The search strategy was thorough but it is unlikely that all relevant articles were retrieved because these papers are often well-hidden in obscure and not electronically listed journals.
2) It is laudable that the authors included languages other than English but it would have been preferable to impose no language restrictions at all.
3) Under-reporting of adverse events is a huge problem, and it is anyone’s guess how large it really is [we have shown that, in our research it was precisely 100%]
4) This means that the 77 cases, which seem like a minute number, could in reality be 770 or 7700 or 77000; nobody can tell.
Cauda equina (horse tail) syndrome was the most frequent and most serious adverse event reported. This condition is caused by nerve injury at the lower end of the spinal canal. Symptoms can include leg pain along the sciatic nerve, severe back pain, altered or loss of sensation over the area around the genitals, anus and inner thighs as well as urine retention or incontinence and faecal incontinence. The condition must be treated as an emergency and usually requires surgical decompression of the injured nerves.
Disk herniation, the second most frequent adverse event, is an interesting complication of SMT. Most therapists using SMT would probably claim (no, I have no reference for that speculation!) that they can effectively treat herniated disks with SMT. The evidence for this claim is, as far as I know, non-existent. In view of the fact that SMT can actually cause a disk to herniate, I wonder whether SMT should not be contra-indicated for this condition. I am sure there will be some discussion about this question following this post.
The authors make a strong point about the fact that case reports never allow causal inference. One can only agree with this notion. However, the precautionary principle in medicine also means that, if case reports provide reasonable suspicion that an intervention might led to adverse-effects, we need to be careful and should warn patients of this possibility. It also means that it is up to the users of SMT to demonstrate beyond reasonable doubt that SMT is safe.
Tai Chi, as we know it in the West, is said to promote the smooth flow of “energy” throughout the body by performing postures, slow meditative movements and controlled breathing. Tai Chi is also supposed to help increasing flexibility, suppleness, balance and coordination. According to enthusiasts, the smooth, gentle movements of Tai Chi aid relaxation and help to keep the mind calm and focused.
Tai Chi has become popular in Western countries and is being considered for a surprisingly wide range of conditions. The patient/consumer is taught to perform postures, slow meditative movements and controlled breathing. The concepts underlying Tai Chi are strange, but that does not necessarily mean that the treatment is not effective for certain illnesses or symptoms.
There has been a surprising amount of research in this area, and some studies have generated encouraging results. A recent study which is unfortunately not available electronically ( Wu, WF; Muheremu, A; Chen, CH; Liu, WG; Sun, L. Effectiveness of Tai Chi Practice for Non-Specific Chronic Low Back Pain on Retired Athletes: A Randomized Controlled Study. JOURNAL OF MUSCULOSKELETAL PAIN 2013, 21:1, p.37-45) tested the effectiveness of Tai Chi for chronic back pain. Specifically, the researchers wanted to determine whether regular Tai Chi practice is superior to other means of sports rehabilitation in relieving non-specific chronic low back pain [LBP] in a younger population. They randomized 320 former athletes suffering from chronic LBP into a treatment [tai chi practice] and several control groups [regular sessions with swimming, backward walking or jogging, or no such interventions]. At the beginning, middle, and end of a six-month intervention, patients from all groups completed questionnaires assessing the intensity of LBP; in addition, a physical examination was conducted.
After 3 and 6 months, no statistically significant difference in the intensity of LBP was demonstrated between the Tai Chi and swimming. However, significant differences were demonstrated between the Tai Chi and backward walking, jogging, and no exercise groups.
The authors’ concluded that “Tai chi has better efficacy than certain other sports on the treatment of non-specific chronic LBP.”
This is only the second RCT of Tai chi for back pain. The first such study consisted of 160 volunteers between ages 18 and 70 years with persistent nonspecific low back pain. The experimental group (n = 80) had 18 Tai Chi sessions over a 10-week period. The waitlist control group continued with their usual health care. Bothersomeness of symptoms was the primary outcome, and secondary outcomes included pain intensity and pain-related disability. Tai Chi reduced bothersomeness of back symptoms by 1.7 points on a 0-10 scale, reduced pain intensity by 1.3 points on a 0-10 scale, and improved self-report disability by 2.6 points on the 0-24 Roland-Morris Disability Questionnaire scale. The authors of this RCT concluded that a 10-week Tai Chi program improved pain and disability outcomes and can be considered a safe and effective intervention for those experiencing long-term low back pain symptoms.
My own team have conducted their fair share of Tai Chi research. Specifically,we have published several systematic reviews of Tai Chi as an adjunctive or supportive treatment of various conditions, and the conclusions (in italics) have been mixed.
DIABETES: The existing evidence does not suggest that tai chi is an effective therapy for type 2 diabetes.
HYPERTENSION: The evidence for tai chi in reducing blood pressure in the elderly individuals is limited.
BREAST CANCER: the existing trial evidence does not show convincingly that tai chi is effective for supportive breast cancer care.
IMPROVEMENT OF AEROBIC EXCERCISE CAPACITY: the existing evidence does not suggest that regular tai chi is an effective way of increasing aerobic capacity.
PARKINSON’S DISEASE: the evidence is insufficient to suggest tai chi is an effective intervention for Parkinson’s Disease.
OSTEOPOROSIS: The evidence for tai chi in the prevention or treatment of osteoporosis is not convincing.
OSTEOARTHRITIS: there is some encouraging evidence suggesting that tai chi may be effective for pain control in patients with knee OA.
RHEUMATOID ARTHRITIS: Collectively this evidence is not convincing enough to suggest that tai chi is an effective treatment for RA.
Finally, an overview over all systematic reviews of Tai Chi suggested that the only area where the evidence is convincing is the prevention of falls in the elderly.
I think, this indicates that we should not pin our hopes too high as to the therapeutic value of Tai Chi. In particular, for back pain, the evidence might be optimistically judged as encouraging, but it is by no means convincing; the effect size seems to be small and two studies are not enough to issue general recommendations. On the other hand, considering that there is so little to offer to back pain patients, I concede that this is an area that should be studied further. Meanwhile, one could argue that Tai Chi can be fun and is devoid of risks – so, why not give it a try?
Some national and international guidelines advise physicians to use spinal manipulation for patients suffering from acute (and chronic) low back pain. Many experts have been concerned about the validity of this advice. Now an up-date of the Cochrane review on this subject seems to provide clarity on this rather important matter.
Its aim was to assess the effectiveness of spinal manipulative therapy (SMT) as a treatment of acute low back pain. Randomized controlled trials (RCTs) testing manipulation/mobilization in adults with low back pain of less than 6-weeks duration were included. The primary outcome measures were pain, functional status and perceived recovery. Secondary endpoints were return-to-work and quality of life. Two authors independently conducted the study selection, risk of bias assessment and data extraction. The effects were examined for SMT versus inert interventions, sham SMT, other interventions, and for SMT as an adjunct to other forms of treatment.
The researchers identified 20 RCTs with a total number of 2674 participants, 12 (60%) RCTs had not been included in the previous version of this review. Only 6 of the 20 studies had a low risk of bias. For pain and functional status, there was low- to very low-quality evidence suggesting no difference in effectiveness of SMT compared with inert interventions, sham SMT or as adjunct therapy. There was varying quality of evidence suggesting no difference in effectiveness of SMT compared with other interventions. Data were sparse for recovery, return-to-work, quality of life, and costs of care.
The authors draw the following conclusion: “SMT is no more effective for acute low back pain than inert interventions, sham SMT or as adjunct therapy. SMT also seems to be no better than other recommended therapies. Our evaluation is limited by the few numbers of studies; therefore, future research is likely to have an important impact on these estimates. Future RCTs should examine specific subgroups and include an economic evaluation.”
In other words, guidelines that recommend SMT for acute low back pain are not based on the current best evidence. But perhaps the situation is different for chronic low back pain? The current Cochrane review of 26 RCTs is equally negative: “High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.”
This clearly begs the question why many of the current guidelines seem to mislead us. I am not sure I know the answer to this one; however I suspect that the panels writing the guidelines might have been dominated by chiropractors and osteopaths or their supporters who have not exactly made a name for themselves for being impartial. Whatever the reason, I think it is time for a re-think and for up-dating guidelines which are out of date and misleading.
Similarly, it might be time to question for what conditions chiropractors and osteopaths, the two professions who use spinal manipulation/mobilisation most, do actually offer anything of real value at all. Back pain and SMT are clearly their domains; if it turns out that SMT is not evidence-based for back pain, what is left? There is no good evidence for anything else, as far as I can see. To make matters worse, there are quite undeniable risks associated with SMT. The conclusion of such considerations is, I fear, obvious: the value of and need for these two professions should be re-assessed.