Maintenance Care is an approach whereby patients have chiropractic manipulations even when symptom-free. Thus, it is an ideal method to keep chiropractors in clover. Previous reviews concluded that evidence behind this strategy is lacking. Since then, more data have emerged. It was therefore timely to review the evidence.
Fourteen original research articles were included in the review. Maintenance Care was defined as a secondary or tertiary preventive approach, recommended to patients with previous pain episodes, who respond well to chiropractic care. Maintenance Care is applied to approximately 30% of Scandinavian chiropractic patients. Both chiropractors and patients believe in the efficacy of Maintenance Care. Four studies investigating the effect of chiropractic Maintenance Care were identified, with disparate results on pain and disability of neck and back pain. However, only one of these studies utilized all the existing evidence when selecting study subjects and found that Maintenance Care patients experienced fewer days with low back pain compared to patients invited to contact their chiropractor ‘when needed’. No studies were found on the cost-effectiveness of Maintenance Care.
The authors concluded that knowledge of chiropractic Maintenance Care has advanced. There is reasonable consensus among chiropractors on what Maintenance Care is, how it should be used, and its indications. Presently, Maintenance Care can be considered an evidence-based method to perform secondary or tertiary prevention in patients with previous episodes of low back pain, who report a good outcome from the initial treatments. However, these results should not be interpreted as an indication for Maintenance Care on all patients, who receive chiropractic treatment.
I have to admit, I have problems with these conclusions.
- Maintenance Care is not normally defined as secondary or tertitary prevention. It also includes primary prevention, which means that chiropractors recommend it for just about anyone. By definition it is long term care, that is not therapeutically necessary, but performed at regular intervals to help prevent injury and enhance quality of life. This form of care is provided after maximal therapeutic benefit is achieved, without a trial of treatment withdrawal, to prevent symptoms from returning or for those without symptoms to promote health or prevent future problems.
- I am not convinced that the evidence would be positive, even if we confined it to secondary and tertiary prevention.
To explain my last point, let’s have a look at the 4 RCT and check whether they really warrant such a relatively positive conclusion.
FIRST STUDY For individuals with recurrent or persistent non-specific low back pain (LBP), exercise and exercise combined with education have been shown to be effective in preventing new episodes or in reducing the impact of the condition. Chiropractors have traditionally used Maintenance Care (MC), as secondary and tertiary prevention strategies. The aim of this trial was to investigate the effectiveness of MC on pain trajectories for patients with recurrent or persistent LBP.
This pragmatic, investigator-blinded, two arm randomized controlled trial included consecutive patients (18–65 years old) with non-specific LBP, who had an early favorable response to chiropractic care. After an initial course of treatment, eligible subjects were randomized to either MC or control (symptom-guided treatment). The primary outcome was total number of days with bothersome LBP during 52 weeks collected weekly with text-messages (SMS) and estimated by a GEE model.
Three hundred and twenty-eight subjects were randomly allocated to one of the two treatment groups. MC resulted in a reduction in the total number of days per week with bothersome LBP compared with symptom-guided treatment. During the 12 month study period, the MC group (n = 163, 3 dropouts) reported 12.8 (95% CI = 10.1, 15.5; p = <0.001) fewer days in total with bothersome LBP compared to the control group (n = 158, 4 dropouts) and received 1.7 (95% CI = 1.8, 2.1; p = <0.001) more treatments. Numbers presented are means. No serious adverse events were recorded.
MC was more effective than symptom-guided treatment in reducing the total number of days over 52 weeks with bothersome non-specific LBP but it resulted in a higher number of treatments. For selected patients with recurrent or persistent non-specific LBP who respond well to an initial course of chiropractic care, MC should be considered an option for tertiary prevention.
SECOND STUDY Back and neck pain are associated with disability and loss of independence in older adults. Whether long‐term management using commonly recommended treatments is superior to shorter‐term treatment is unknown. This randomized clinical trial compared short‐term treatment (12 weeks) versus long‐term management (36 weeks) of back‐ and neck‐related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Eligible participants were ages ≥65 years with back and neck disability for ≥12 weeks. Coprimary outcomes were changes in Oswestry Disability Index (ODI) and Neck Disability Index (NDI) scores after 36 weeks. An intent‐to‐treat approach used linear mixed‐model analysis to detect between‐group differences. Secondary analyses included other self‐reported outcomes, adverse events, and objective functional measures.
THIRD STUDY A prospective single blinded placebo controlled study was conducted. To assess the effectiveness of spinal manipulation therapy (SMT) for the management of chronic nonspecific low back pain (LBP) and to determine the effectiveness of maintenance SMT in long-term reduction of pain and disability levels associated with chronic low back conditions after an initial phase of treatments. SMT is a common treatment option for LBP. Numerous clinical trials have attempted to evaluate its effectiveness for different subgroups of acute and chronic LBP but the efficacy of maintenance SMT in chronic nonspecific LBP has not been studied. Sixty patients, with chronic, nonspecific LBP lasting at least 6 months, were randomized to receive either (1) 12 treatments of sham SMT over a 1-month period, (2) 12 treatments, consisting of SMT over a 1-month period, but no treatments for the subsequent 9 months, or (3) 12 treatments over a 1-month period, along with “maintenance spinal manipulation” every 2 weeks for the following 9 months. To determine any difference among therapies, we measured pain and disability scores, generic health status, and back-specific patient satisfaction at baseline and at 1-, 4-, 7-, and 10-month intervals. Patients in second and third groups experienced significantly lower pain and disability scores than first group at the end of 1-month period (P = 0.0027 and 0.0029, respectively). However, only the third group that was given spinal manipulations (SM) during the follow-up period showed more improvement in pain and disability scores at the 10-month evaluation. In the nonmaintained SMT group, however, the mean pain and disability scores returned back near to their pretreatment level.SMT is effective for the treatment of chronic nonspecific LBP. To obtain long-term benefit, this study suggests maintenance SM after the initial intensive manipulative therapy.
FORTH STUDY Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program.Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP.
I honestly do not think that the findings from these 4 small trials justify the far-reaching conclusion that Maintenance Care can be considered an evidence-based method… For that statement to be evidence-based, one would need to see more and better studies. Therefore, the honest conclusion, I think, is that maintenance care is not supported by sound evidence for effectiveness; as chiropractic manipulations are costly and not risk-free, its risk/benefit balance fails to be positive. Therefore, this approach cannot be recommended.
Spinal epidural haematoma is a potentially serious condition that can occur due to trauma, such as spinal manipulation, particularly in the presence of a blood clotting abnormality. A case has been published of a patient who, after performing self-neck manipulation, suffered spinal epidural haematoma and subsequent paralysis of all 4 limbs.
A 63-year-old man presented to the emergency department with worsening inter-scapular pain radiating to his neck one day after performing self-manipulation of his cervical spine. He was anti-coagulated with warfarin therapy for the management of his atrial fibrillation. Approximately 48 h after the manipulation, the patient became acutely quadriparetic and hypotensive. Urgent magnetic resonance imaging revealed a multilevel spinal epidural haematoma from the lower cervical to thoracic spine.
a Pre-operative sagittal T2-weighted MRI of the cervical spine demonstrates an epidural hematoma (arrows) with the cranial extent at the C6/7 level. The hematoma is mixed signal intensity, consistent with various stages of bleeding. Severe spinal cord (asterisk) compression is present at the C7 level. b Pre-operative axial T2-weighted MRI at the C7 level demonstrates a loculated epidural hematoma (arrow) compressing the spinal cord (asterisk). Due to the urgent nature of the MRI, image quality is degraded
With identification of an active bleed and an INR remaining close to 7.0, the patient’s hypercoaguable state was reversed prior to emergency surgery. The patient underwent partial C7, complete T1 and T2, and partial T3 bilateral laminectomy for evacuation of haematoma. Placement of an epidural drainage catheter was also performed.
During the first 6 days following surgery, the patient recovered some function of the upper and lower extremities while undergoing hospital-based physical therapy. Post-operative MRI showed resolution of the haematoma and cord compression without resultant cord damage.
The patient completed a 2-week course of acute interdisciplinary rehabilitation. The epidural drainage catheter remained in place for most of his post-operative stay. His neurogenic bladder with urinary retention resolved. At hospital discharge, the patient’s greatest deficits remained his fine motor skills to his right hand along with residual paraesthesia in his lower extremities. He also exhibited mild dyspraxia with finger-to-nose testing on the right and heel-to-shin testing bilaterally. The patient regained full manual muscle strength of all 4 extremities and ultimately returned to his baseline functional status, which included ambulating independently with a cane and independence with activities of daily living.
The authors concluded that partial C7, complete T1 and T2, and partial T3 bilateral laminectomy was performed for evacuation of the spinal epidural hematoma. Following a 2-week course of acute inpatient rehabilitation, the patient returned to his baseline functional status. This case highlights the risks of self-manipulation of the neck and potentially other activities that significantly stretch or apply torque to the cervical spine. It also presents a clinical scenario in which practitioners of spinal manipulation therapy should be aware of patients undergoing anticoagulation therapy.
In the present case, the spinal manipulation was self-inflicted. Usually it is performed by a chiropractor, and there are published case reports where chiropractic spinal manipulations have caused epidural haematoma. No matter who does this treatment, it is, I think, wise to consider the fact that the risks of spinal manipulations do not demonstrably outweigh its benefits.
This systematic review was aimed at investigating the current evidence to determine whether there is an association between chiropractic use and opioid receipt.
Controlled studies, cohort studies, and case-control studies including adults with noncancer pain were eligible for inclusion. Studies reporting opioid receipt for both subjects who used chiropractic care and nonusers were included. Data extraction and risk of bias assessment were completed independently by pairs of reviewers. Meta-analysis was performed and presented as an odds ratio with 95% confidence interval.
In all, 874 articles were identified. After detailed selection, 26 articles were reviewed in full, and 6 met the inclusion criteria. Five studies focused on back pain and one on neck pain. The prevalence of chiropractic care among patients with spinal pain varied between 11.3% and 51.3%. The proportion of patients receiving an opioid prescription was lower for chiropractic users (range = 12.3-57.6%) than nonusers (range = 31.2-65.9%). In a random-effects analysis, chiropractic users had a 64% lower odds of receiving an opioid prescription than nonusers (odds ratio = 0.36, 95% confidence interval = 0.30-0.43, P < 0.001, I2 = 92.8%).
The authors concluded that this review demonstrated an inverse association between chiropractic use and opioid receipt among patients with spinal pain. Further research is warranted to assess this association and the implications it may have for case management strategies to decrease opioid use.
These results are in line with a previous study showing that among New Hampshire adults with office visits for noncancer low-back pain, the likelihood of filling a prescription for an opioid analgesic was significantly lower for recipients of services delivered by doctors of chiropractic compared with nonrecipients. The underlying cause of this correlation remains unknown, indicating the need for further investigation.
The question is: what do such findings tell us?
I have no doubt that chiropractors will claim that using their services will reduce the opioid problem. But this is, of course, wishful thinking. The thing that will reduce it is not more chiro use but quite simply less opioid use!
The important thing to remember here is CORRELATION IS NOT CAUSATION!
People who drive a VW car are less likely to buy a Mercedes.
People who have ordered fish in a restaurant are unlikely to also order a steak.
People who use physiotherapy for back pain will probably use less opioids than those who don’t consult physios.
People who treat their back pain with massage therapy are less likely to also use opioids.
This is all very obvious, self-evident and perhaps even boring.
The most interesting finding here is in my view the fact that 31.2-65.9% of patients using chiropractic for their neck/back pain also took opioids. This seems to confirm what we often have discussed before:
CHIROPRACTIC TREATMENT IS NOT NEARLY AS EFFECTIVE AS CHIROS WANT US TO BELIEVE.
Japanese neurosurgeons reported the case of A 55-year-old man who presented with progressive pain and expanding swelling in his right neck. He had no history of trauma or infectious disease. The patient had undergone chiropractic manipulations once in a month and the last manipulation was done one day before the admission to hospital.
On examination by laryngeal endoscopy, a swelling was found on the posterior wall of the pharynx on the right side. The right piriform fossa was invisible. CT revealed hematoma in the posterior wall of the right oropharynx compressing the airway tract. Aneurysm-like enhanced lesion was also seen near the right common carotid artery. Ultrasound imaging revealed a fistula of approximately 1.2 mm at the posterior wall of the external carotid artery and inflow image of blood to the aneurysm of a diameter of approximately 12 mm. No dissection or stenosis of the artery was found. Jet inflow of blood into the aneurysm was confirmed by angiography. T1-weighted MR imaging revealed presence of hematoma on the posterior wall of the pharynx and the aneurysm was recognized by gadolinium-enhancement.
The neurosurgeons performed an emergency operation to remove the aneurysm while preserving the patency of the external carotid artery. The pin-hole fistula was sutured and the wall of the aneurysm was removed. Histopathological assessment of the tissue revealed a pseudoaneurysm (also called a false aneurism), a collection of blood that forms between the two outer layers of an artery.
The patient was discharged after 12 days without a neurological deficit. Progressively growing aneurysm of the external carotid artery is caused by various factors and early intervention is recommended. Although, currently, intravascular surgery is commonly indicated, direct surgery is also feasible and has advantages with regard to pathological diagnosis and complete repair of the parent artery.
The relationship between the pseudoaneurysm and the chiropractic manipulations seems unclear. The way I see it, there are the following three possibilities:
- The manipulations have causally contributed to the pseudo-aneurysm.
- They have exacerbated the condition and/or its symptoms.
- They are unrelated to the condition.
If someone is able to read the Japanese full text of this paper, please let us know what the neurosurgeons thought about this.
Osteopathy is a tricky subject:
- Osteopathic manipulations/mobilisations are advocated mainly for spinal complaints.
- Yet many osteopaths use them also for a myriad of non-spinal conditions.
- Osteopathy comprises two entirely different professions; in the US, osteopaths are very similar to medically trained doctors, and many hardly ever employ osteopathic manual techniques; outside the US, osteopaths are alternative practitioners who use mainly osteopathic techniques and believe in the obsolete gospel of their guru Andrew Taylor Still (this post relates to the latter type of osteopathy).
- The question whether osteopathic manual therapies are effective is still open – even for the indication that osteopaths treat most, spinal complaints.
- Like chiropractors, osteopaths now insist that osteopathy is not a treatment but a profession; the transparent reason for this argument is to gain more wriggle-room when faced with negative evidence regarding they hallmark treatment of osteopathic manipulation/mobilisation.
A new paper authored by osteopaths is an attempt to shed more light on the effectiveness of osteopathy. The aim of this systematic review evaluated the impact of osteopathic care for spinal complaints. Only randomized controlled trials conducted in high-income Western countries were considered. Two authors independently screened the titles and abstracts. Primary outcomes included ‘pain’ and ‘functional status’, while secondary outcomes included ‘medication use’ and ‘health status’.
Nineteen studies were included and qualitatively synthesized. Nine studies were from the US, followed by Germany with 7 studies. The majority of studies (n = 13) focused on low back pain.
In general, mixed findings related to the impact of osteopathic care on primary and secondary outcomes were observed. For the primary outcomes, a clear distinction between US and European studies was found, where the latter RCTs reported positive results more frequently. Studies were characterized by substantial methodological differences in sample sizes, number of treatments, control groups, and follow-up.
The authors concluded that “the findings of the current literature review suggested that osteopathic care may improve pain and functional status in patients suffering from spinal complaints. A clear distinction was observed between studies conducted in the US and those in Europe, in favor of the latter. Today, no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn. Further studies with larger study samples also assessing the long-term impact of osteopathic care for spinal complaints are required to further strengthen the body of evidence.”
Some of the most obvious weaknesses of this review include the following:
- In none of the studies employed blinding of patients, care provider or outcome assessor occurred, or it was unclear. Blinding of outcome assessors is easily implemented and should be standard in any RCT.
- In three studies, the study groups differed to some extent at baseline indicating that randomisation was not successful..
- Five studies were derived from the ‘grey literature’ and were therefore not peer-reviewed.
- One study (the UK BEAM trial) employed not just osteopaths but also chiropractors and physiotherapists for administering the spinal manipulations. It is therefore hardly an adequate test of osteopathy.
- The study was funded by an unrestricted grant from the GNRPO, the umbrella organization of the ‘Belgian Professional Associations for Osteopaths’.
Considering this last point, the authors’ honesty in admitting that no clear conclusions of the impact of osteopathic care for spinal complaints can be drawn is remarkable and deserves praise.
Considering that the evidence for osteopathy is even far worse for non-spinal conditions (numerous trials exist for all sorts of other conditions, but they tend to be flimsy and usually lack independent replications), it is fair to conclude that osteopathy is NOT an evidence-based therapy.
Osteopathic visceral manipulation (OVM) have been our subject several times before. The method has been developed by the French Osteopath and Physical Therapist Jean-Pierre Barral. According to uncounted Internet-sites, books and other promotional literature, OVM is a miracle cure for just about every disease imaginable. Most of us hearing such claims hear alarm bells ringing – rightly so, I think. The evidence for OVM is thin, to put it mildly. But now, there is a new study to consider.
Brazilian researchers designed a placebo-controlled study using placebo visceral manipulation as the control to evaluate the effect of OVM of the stomach and liver on pain, cervical mobility, and electromyographic activity of the upper trapezius (UT) muscle in individuals with nonspecific neck pain (NS-NP) and functional dyspepsia. Twenty-eight NS-NP patients were randomly assigned into two groups: treated with OVM (OVMG; n = 14) and treated with placebo visceral manipulation (PVMG; n = 14). The effects were evaluated immediately and 7 days after treatment through pain, cervical range, and electromyographic activity of the UT muscle.
Significant effects were confirmed immediately after treatment (OVMG and PVMG) for numeric rating scale scores and pain area. Significant increases in EMG amplitude were identified immediately and 7 days after treatment for the OVMG. No differences were identified between the OVMG and the PVMG for cervical range of motion.
The authors concluded that the results of this pilot study indicate that a single session of osteopathic visceral manipulation for the stomach and liver reduces cervical pain and increases the amplitude of the upper trapezius muscle EMG signal immediately and 7 days after treatment in patients with nonspecific neck pain and functional dyspepsia. Patients treated with placebo visceral mobilisation reported a significant decrease in pain immediately after treatment. The effect of this intervention on the cervical range of motion was inconclusive. The results of this study suggest that further investigation is necessary.
There are numerous problems with this study:
- The authors call it a pilot study. Such a trial is for exploring the feasibility of a proper study. With the introduction of a placebo-OVM, this would make sense. The relevant question would then be: is the placebo valid and indistinguishable from the real thing? Sadly, this issue is not even addressed in the trial.
- A pilot study certainly is not for evaluating the effectiveness of an intervention. Sadly, this is precisely what the authors used it for. The label ‘pilot’, it seems, was merely given to excuse the many methodological flaws of their trial.
- For an evaluation of treatment effects, the study was far too small. This means the reported results can be discarded as meaningless.
- If we nevertheless took them seriously, we would want to explain how the findings were generated. The authors believe that they were caused by OVM. I find this most unlikely.
- The more plausible explanation would be that patient-blinding was unsuccessful. In other words, the placebo is not indistinguishable from the real OVM. Looking at the pictures above, one can easily see that the patients were able to tell to which group they had been allocated.
- The failure to blind patients (and, of course, the therapists), in turn, would mean that the verum group were better motivated to out-perform the placebo group in the outcome measures.
- Finally, I disagree with the authors’ view that the results of this study suggest that further investigation is necessary. On the contrary, I think that any further investment into OVM is ill-advised.
My conclusion: OVM is an implausible, non-evidence-based SCAM, and dodgy science is not going to make it look any more convincing.
In 1995, Dabbs and Lauretti reviewed the risks of cervical manipulation and compared them to those of non-steroidal, anti-inflammatory drugs (NSAIDs). They concluded that the best evidence indicates that cervical manipulation for neck pain is much safer than the use of NSAIDs, by as much as a factor of several hundred times. This article must be amongst the most-quoted paper by chiropractors, and its conclusion has become somewhat of a chiropractic mantra which is being repeated ad nauseam. For instance, the American Chiropractic Association states that the risks associated with some of the most common treatments for musculoskeletal pain—over-the-counter or prescription nonsteroidal anti-inflammatory drugs (NSAIDS) and prescription painkillers—are significantly greater than those of chiropractic manipulation.
As far as I can see, no further comparative safety-analyses between cervical manipulation and NSAIDs have become available since this 1995 article. It would therefore be time, I think, to conduct new comparative safety and risk/benefit analyses aimed at updating our knowledge in this important area.
Meanwhile, I will attempt a quick assessment of the much-quoted paper by Dabbs and Lauretti with a view of checking how reliable its conclusions truly are.
The most obvious criticism of this article has already been mentioned: it is now 23 years old, and today we know much more about the risks and benefits of these two therapeutic approaches. This point alone should make responsible healthcare professionals think twice before promoting its conclusions.
Equally important is the fact that we still have no surveillance system to monitor the adverse events of spinal manipulation. Consequently, our data on this issue are woefully incomplete, and we have to rely mostly on case reports. Yet, most adverse events remain unpublished and under-reporting is therefore huge. We have shown that, in our UK survey, it amounted to exactly 100%.
To make matters worse, case reports were excluded from the analysis of Dabbs and Lauretti. In fact, they included only articles providing numerical estimates of risk (even reports that reported no adverse effects at all), the opinion of exerts, and a 1993 statistic from a malpractice insurer. None of these sources would lead to reliable incidence figures; they are thus no adequate basis for a comparative analysis.
In contrast, NSAIDs have long been subject to proper post-marketing surveillance systems generating realistic incidence figures of adverse effects which Dabbs and Lauretti were able to use. It is, however, important to note that the figures they did employ were not from patients using NSAIDs for neck pain. Instead they were from patients using NSAIDs for arthritis. Equally important is the fact that they refer to long-term use of NSAIDs, while cervical manipulation is rarely applied long-term. Therefore, the comparison of risks of these two approaches seems not valid.
Moreover, when comparing the risks between cervical manipulation and NSAIDs, Dabbs and Lauretti seemed to have used incidence per manipulation, while for NSAIDs the incidence figures were bases on events per patient using these drugs (the paper is not well-constructed and does not have a methods section; thus, it is often unclear what exactly the authors did investigate and how). Similarly, it remains unclear whether the NSAID-risk refers only to patients who had used the prescribed dose, or whether over-dosing (a phenomenon that surely is not uncommon with patients suffering from chronic arthritis pain) was included in the incidence figures.
It is worth mentioning that the article by Dabbs and Lauretti refers to neck pain only. Many chiropractors have in the past broadened its conclusions to mean that spinal manipulations or chiropractic care are safer than drugs. This is clearly not permissible without sound data to support such claims. As far as I can see, such data do not exist (if anyone knows of such evidence, I would be most thankful to let me see it).
To obtain a fair picture of the risks in a real life situation, one should perhaps also mention that chiropractors often fail to warn patients of the possibility of adverse effects. With NSAIDs, by contrast, patients have, at the very minimum, the drug information leaflets that do warn them of potential harm in full detail.
Finally, one could argue that the effectiveness and costs of the two therapies need careful consideration. The costs for most NSAIDs per day are certainly much lower than those for repeated sessions of manipulations. As to the effectiveness of the treatments, it is clear that NSAIDs do effectively alleviate pain, while the evidence seems far from being conclusively positive in the case of cervical manipulation.
In conclusion, the much-cited paper by Dabbs and Lauretti is out-dated, poor quality, and heavily biased. It provides no sound basis for an evidence-based judgement on the relative risks of cervical manipulation and NSAIDs. The notion that cervical manipulations are safer than NSAIDs is therefore not based on reliable data. Thus, it is misleading and irresponsible to repeat this claim.
The most frequent of all potentially serious adverse events of acupuncture is pneumothorax. It happens when an acupuncture needle penetrates the lungs which subsequently deflate. The pulmonary collapse can be partial or complete as well as one or two sided. This new case-report shows just how serious a pneumothorax can be.
A 52-year-old man underwent acupuncture and cupping treatment at an illegal Chinese medicine clinic for neck and back discomfort. Multiple 0.25 mm × 75 mm needles were utilized and the acupuncture points were located in the middle and on both sides of the upper back and the middle of the lower back. He was admitted to hospital with severe dyspnoea about 30 hours later. On admission, the patient was lucid, was gasping, had apnoea and low respiratory murmur, accompanied by some wheeze in both sides of the lungs. Because of the respiratory difficulty, the patient could hardly speak. After primary physical examination, he was suspected of having a foreign body airway obstruction. Around 30 minutes after admission, the patient suddenly became unconscious and died despite attempts of cardiopulmonary resuscitation.
Whole-body post-mortem computed tomography of the victim revealed the collapse of the both lungs and mediastinal compression, which were also confirmed by autopsy. More than 20 pinprick injuries were found on the skin of the upper and lower back in which multiple pinpricks were located on the body surface projection of the lungs. The cause of death was determined as acute respiratory and circulatory failure due to acupuncture-induced bilateral tension pneumothorax.
The authors caution that acupuncture-induced tension pneumothorax is rare and should be recognized by forensic pathologists. Postmortem computed tomography can be used to detect and accurately evaluate the severity of pneumothorax before autopsy and can play a supporting role in determining the cause of death.
The authors mention that pneumothorax is the most frequent but by no means the only serious complication of acupuncture. Other adverse events include:
- central nervous system injury,
- epidural haematoma,
- subarachnoid haemorrhage,
- cardiac tamponade,
- gallbladder perforation,
No other possible lung diseases that may lead to bilateral spontaneous pneumothorax were found. The needles used in the case left tiny perforations in the victim’s lungs. A small amount of air continued to slowly enter the chest cavities over a long period. The victim possibly tolerated the mild discomfort and did not pay attention when early symptoms appeared. It took 30 hours to develop into symptoms of a severe pneumothorax, and then the victim was sent to the hospital. There he was misdiagnosed, not adequately treated and thus died. I applaud the authors for nevertheless publishing this case-report.
This case occurred in China. Acupuncturists might argue that such things would not happen in Western countries where acupuncturists are fully trained and aware of the danger. They would be mistaken – and alarmingly, there is no surveillance system that could tell us how often serious complications occur.
A pain in the neck is just that: A PAIN IN THE NECK! Unfortunately, this symptom is both common and often difficult to treat. Chiropractors pride themselves of treating neck pain effectively. Yet, the evidence is at best thin, the costs are high and, as often-discussed, the risks might be considerable. Thus, any inexpensive, effective and safe alternative would be welcome.
This RCT tested two hypotheses:
1) that denneroll cervical traction (a very simple device for the rehabilitation of sagittal cervical alignment) will improve the sagittal alignment of the cervical spine.
2) that restoration of normal cervical sagittal alignment will improve both short and long-term outcomes in cervical myofascial pain syndrome patients.
The study included 120 (76 males) patients with chronic myofascial cervical pain syndrome (CMCPS) and defined cervical sagittal posture abnormalities. They were randomly assigned to the control or an intervention group. Both groups received the Integrated neuromuscular inhibition technique (INIT); additionally, the intervention group received the denneroll cervical traction device. Alignment outcomes included two measures of sagittal posture: cervical angle (CV), and shoulder angle (SH). Patient relevant outcome measures included: neck pain intensity (NRS), neck disability (NDI), pressure pain thresholds (PPT), cervical range of motion using the CROM. Measures were assessed at three intervals: baseline, 10 weeks, and 1 year after the 10 week follow up.
After 10 weeks of treatment, between group statistical analysis, showed equal improvements for both the intervention and control groups in NRS and NDI. However, at 10 weeks, there were significant differences between groups favouring the intervention group for PPT and all measures of CROM. Additionally, at 10 weeks the sagittal alignment variables showed significant differences favouring the intervention group for CV and SH indicating improved CSA. Importantly, at the 1-year follow-up, between group analysis identified a regression back to baseline values for the control group for the non-significant group differences (NRS and NDI) at the 10-week mark. Thus, all variables were significantly different between groups favouring the intervention group at 1-year follow up.
The authors concluded that the addition of the denneroll cervical orthotic to a multimodal program positively affected CMCPS outcomes at long term follow up. We speculate the improved sagittal cervical posture alignment outcomes contributed to our findings.
Yes, I know, this study is far from rigorous or conclusive. And the evidence for traction is largely negative. But the device has one huge advantage over chiropractic: it cannot cause much harm. The harm to the wallet is less than that of endless sessions chiropractors or other manual therapists (conceivably, a self-made cushion will have similar effects without any expense); and the chances that patients suffer a stroke are close to zero.
On this blog, I have repeatedly discussed chiropractic research that, on closer examination, turns out to be some deplorable caricature of science. Today, I have another example of what I would call pseudo-research.
This RCT compared short-term treatment (12 weeks) versus long-term management (36 weeks) of back and neck related disability in older adults using spinal manipulative therapy (SMT) combined with supervised rehabilitative exercises (SRE).
Eligible participants were aged 65 and older with back and neck disability for more than 12 weeks. Co-primary outcomes were changes in Oswestry and Neck Disability Index after 36 weeks. An intention to treat approach used linear mixed-model analysis to detect between group differences. Secondary analyses included other self-reported outcomes, adverse events and objective functional measures.
A total of 182 participants were randomized. The short-term and long-term groups demonstrated significant improvements in back and neck disability after 36 weeks, with no difference between groups. The long-term management group experienced greater improvement in neck pain at week 36, self-efficacy at week 36 and 52, functional ability and balance.
The authors concluded that for older adults with chronic back and neck disability, extending management with SMT and SRE from 12 to 36 weeks did not result in any additional important reduction in disability.
What renders this paper particularly fascinating is the fact that its authors include some of the foremost researchers in (and most prominent proponents of) chiropractic today. I therefore find it interesting to critically consider the hypothesis on which this seemingly rigorous study is based.
As far as I can see, it essentially is this:
36 weeks of chiropractic therapy plus exercise leads to better results than 12 weeks of the same treatment.
I find this a most remarkable hypothesis.
Imagine any other form of treatment that is, like SMT, not solidly based on evidence of efficacy. Let’s use a new drug as an example, more precisely a drug for which there is no solid evidence for efficacy or safety. Now let’s assume that the company marketing this drug publishes a trial based on the hypothesis that:
36 weeks of therapy with the new drug plus exercise leads to better results than 12 weeks of the same treatment.
Now let’s assume the authors affiliated with the drug manufacturer concluded from their findings that for patients with chronic back and neck disability, extending drug therapy plus exercise from 12 to 36 weeks did not result in any additional important reduction in disability.
WHAT DO YOU THINK SUCH A TRIAL CAN TELL US?
My answer is ‘next to nothing’.
I think, it merely tells us that
- daft hypotheses lead to daft research,
- even ‘top’ chiropractors have problems with critical thinking,
- SMT might not be the solution to neck and back related disability.
I REST MY CASE.