Today the GUARDIAN published an article promoting acupuncture on the NHS. The article is offensively misleading, I think, and therefore deserves a comment. I write these comments with a heavy heart, I should add, because the GUARDIAN is by far my favourite UK daily. In the following, I will cite key passages from the article in question and add my comments in bold.
Every woman needing pain relief while giving birth at University College London hospital (UCLH) is offered acupuncture, with around half of the hospital’s midwives specially trained to give the treatment. UCLH is far from typical in this respect, though: acupuncture is not standard throughout the UK and many health practitioners claim patients are often denied access to it through the NHS because of entrenched scepticism from sections of the medical establishment.
Entrenched scepticism? I would say that it could be perhaps be related to the evidence. The conclusions of the current Cochrane review on acupuncture for labour pain are cautious and do not seem strong enough to issue a general recommendation for general use in childbirth: “acupuncture and acupressure may have a role with reducing pain, increasing satisfaction with pain management and reduced use of pharmacological management. However, there is a need for further research.”
“There are conditions for which acupuncture works and others where it doesn’t. It is not a cure-all, and should be open to scrutiny. But the focus of my work is for acupuncture to become a standard part of midwifery training, and at the same time change perceptions among clinicians about its appropriate use for a whole range of other conditions.”
Open to scrutiny indeed! And if we scrutinise the evidence critically – rather than engaging in uncritical and arguably irresponsible promotion – we find that the evidence is not nearly as convincing as acupuncture fans try to make us believe.
The UK lags behind many other European countries in its support for acupuncture. Just 2,500 medical professionals here are qualified to practice it, compared with 45,000 in Germany. The National Institute for Clinical Excellence (Nice) recommends WMA specifically for the treatment of only two conditions – lower back pain (which costs the NHS £1bn a year) and headaches.
Yes, the UK also lags behind Germany in the use of leeches and other quackery. The ‘ad populum’ fallacy is certainly popular in alternative medicine – but surely, it is still a fallacy!
A growing body of healthcare practitioners believe it should be offered routinely for a variety of conditions, including pain in labour, cancer, musculoskeletal conditions and even irritable bowel syndrome (IBS).
Here we go, belief as a substitute for evidence and fallacies as a replacement of logical arguments. I had thought the GUARDIAN was better than this!
At a time of NHS cuts the use of needles at 8p per unit look attractive. In St Albans, where a group of nurse-led clinics have been using acupuncture since 2008 for patients with knee osteoarthritis, economics have been put under scrutiny. WMA was offered to 114 patients rather than a knee replacement costing £5,000, and 79% accepted. Two years later a third of them had not required a knee transplant, representing an annual saving of £100,000, as estimated by researchers to the St Albans local commissioning group.
This looks a bit like a ‘back of an envelope’ analysis. I would like to see this published in a reputable journal and see it scrutinised by a competent health economist.
So why is acupuncture not being used more widely? The difficulty of proving its efficacy is clearly one of the biggest stumbling blocks. An analysis of 29 studies of almost 18,000 patients found acupuncture effective in treating chronic pain compared with sham acupuncture.
This passage refers to an analysis by Vickers et al. It was severely and repeatedly criticised for being too optimistic and, more importantly, it is not nearly as positive as implied here. Its conclusions are in fact quite cautious: “acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.”
But even treatment proponents question whether a randomised controlled trial – the gold standard of medical research – works, given that faking treatment is nearly impossible.
What do you mean ‘even treatment proponents’? It is only proponents who question these sham needles! The reason: they frequently do not generate the results acupuncture fans had hoped for.
The article is clearly not the GUARDIAN’s finest hour. It lacks even a tinge of critical assessment. This is regrettable, I think, particularly as the truth about acupuncture is not that difficult to transmit to the public:
- Much of the research is of woefully poor quality.
- Its effectiveness is not proven beyond doubt for a single condition.
- Serious adverse effects have been reported.
- Because it requires substantial amounts of therapist time, it also is not cheap.
Much has been written on this blog and elsewhere about the risks of spinal manipulation. It relates almost exclusively to the risks of manipulating patients’ necks. There is far less on the safety of thrust joint manipulation (TJM) when applied to the thoracic spine. A new paper focusses on this specific topic.
The purpose of this review was to retrospectively analyse documented case reports in the literature describing patients who had experienced severe adverse events (AE) after receiving TJM to their thoracic spine.
Case reports published in peer reviewed journals were searched in Medline (using Ovid Technologies, Inc.), Science Direct, Web of Science, PEDro (Physiotherapy Evidence Database), Index of Chiropractic literature, AMED (Allied and Alternative Medicine Database), PubMed and the Cumulative Index to Nursing and Allied Health (CINHAL) from January 1950 to February 2015.
Case reports were included if they: (1) were peer-reviewed; (2) were published between 1950 and 2015; (3) provided case reports or case series; and (4) had TJM as an intervention. The authors only looked at serious complications, not at the much more frequent transient AEs after spinal manipulations. Articles were excluded if: (1) the AE occurred without TJM (e.g. spontaneous); (2) the article was a systematic or literature review; or (3) it was written in a language other than English or Spanish. Data extracted from each case report included: gender; age; who performed the TJM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the TJM; as well as type of severe AE that resulted.
Ten cases, reported in 7 articles, were reviewed. Cases involved females (8) more than males (2), with mean age being 43.5 years. The most frequent AE reported was injury (mechanical or vascular) to the spinal cord (7/10); pneumothorax and hematothorax (2/10) and CSF leak secondary to dural sleeve injury (1/10) were also reported.
The authors point out that there were only a small number of case reports published in the literature and there may have been discrepancies between what was reported and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the TJM, published the cases.
The authors concluded that serious AE do occur in the thoracic spine, most commonly, trauma to the spinal cord, followed by pneumothorax. This suggests that excessive peak forces may have been applied to thoracic spine, and it should serve as a cautionary note for clinicians to decrease these peak forces.
These are odd conclusions, in my view, and I think I ought to add a few points:
- As I stated above, the actual rate of experiencing AEs after having chiropractic spinal manipulations is much larger; it is around 50%.
- Most complications on record occur with chiropractors, while other professions are far less frequently implicated.
- The authors’ statement about ‘excessive peak force’ is purely speculative and is therefore not a legitimate conclusion.
- As the authors mention, it is hardly ever the chiropractor who reports a serious complication when it occurs.
- In fact, there is no functioning reporting scheme where the public might inform themselves about such complications.
- Therefore their true rate is anyone’s guess.
- As there is no good evidence that thoracic spinal manipulations are effective for any condition, the risk/benefit balance for this intervention fails to be positive.
- Many consumers believe that a chiropractor will only manipulate in the region where they feel pain; this is not necessarily true – they will manipulate where they believe to diagnose ‘SUBLUXATIONS’, and that can be anywhere.
- Finally, I would not call a review that excludes all languages other than English and Spanish ‘systematic’.
And my conclusion from all this? THORACIC SPINAL MANIPULATIONS CAN CAUSE CONSIDERABLE HARM AND SHOULD BE AVOIDED.
Being constantly on the look-out for new, good quality articles on alternative therapy which suggest that a treatment might actually work, I was excited to find not just one or two but four recent publications on an old favourite of mine: massage therapy.
The first paper described a study aimed to investigate the effect of whole body massage on the vital signs, Glasgow Coma Scale (GCS) scores and arterial blood gases (ABG) in trauma ICU patients.
In a randomized, double-blind trial, 108 trauma ICU patients received whole body massage or routine care only. The patients vital signs; systolic blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR), pulse rate (PR), Temperature (T), GCS score and ABG parameters were measured in both groups before the intervention and 1 hour and 3 hours after the intervention. The patient in experimental group received full body massage in 45 minute by a family member.
Significant differences were observed between experimental and control groups in SBP 1 hour and 3 hours after intervention, DBP, RR and PR 1 hour after intervention, and GCS 1 hour and 3 hours after intervention. Significant differences were also observed between experimental and control groups in O2 saturation, PH and pO2. No significant differences between experimental and control groups were noted in Temperature, pCO2 and HCO3.
The authors concluded that massage therapy is a safe and effective treatment in intensive care units to reduce patient’s physical and psychological problems. Therefore the use of massage therapy is recommended to clinical practice as a routine method.
The second paper reported a clinical trial on 66 male and female nurses working in intensive care units of Isfahan University of Medical Sciences, Iran.
Patients were randomly divided into experimental and control groups. The Occupational Stress Inventory (OSI) (Osipow and Spokane, 1987) was completed by participants of the two groups before, immediately after, and 2 weeks after the intervention. Swedish massage was performed on participants of the experimental group for 25 min in each session, twice a week for 4 weeks.
Results showed a significant difference in favour of the massage therapy in overall mean occupation stress scores between experimental and control groups two weeks after the intervention.
The authors concluded that it is recommended that massage, as a valuable noninvasive method, be used for nurses in intensive care units to reduce their stress, promote mental health, and prevent the decrease in quality of nursing work life.
The third paper described a randomized controlled trial evaluating the effects of post-operative massage in patients undergoing abdominal colorectal surgery.
One hundred twenty-seven patients were randomized to receive a 20-min massage or social visit and relaxation session on postoperative days 2 and 3. Vital signs and psychological well-being (pain, tension, anxiety, satisfaction with care, relaxation) were assessed before and after each intervention.
Post-operative massage significantly improved the patients’ perception of pain, tension, and anxiety, but overall satisfaction was unchanged.
The authors concluded that massage may be beneficial during postoperative recovery for patients undergoing abdominal colorectal surgery. Further studies are warranted to optimize timing and duration and to determine other benefits in this clinical setting.
The fourth paper reported a systematic review was to evaluate the effectiveness of massage on the short- and long-term outcomes of pre-term infants.
Literature searches were conducted using the PRISMA framework. Validity of included studies was assessed using criteria defined by the Cochrane Collaboration. Assessments were carried out independently by two reviewers with a third reviewer to resolve differences.
Thirty-four studies met the inclusion criteria, 3 were quasi-experimental, 1 was a pilot study, and the remaining 30 were RCTs. The outcomes that could be used in the meta-analysis and found in more than three studies suggested that massage improved daily weight gain by 0.53 g, and resulted in a significant improvement in mental scores by 7.89 points. There were no significant effects on length of hospital stay, caloric intake, or weight at discharge. Other outcomes were not analyzed either because the units of measurement varied between studies, or because means and standard deviations were not provided by the authors. The quality of the studies was variable with methods of randomization and blinding of assessment unclear in 18 of the 34 trials.
The authors concluded that massage therapy could be a comforting measure for infants in the NICU to improve weight gain and enhance mental development. However, the high heterogeneity, the weak quality in some studies, and the lack of a scientific association between massage and developmental outcomes preclude making definite recommendations and highlight the need for further RCTs to contribute to the existing body of knowledge.
I am not saying that these articles are flawless, nor that I agree with all of their conclusion. What I am trying to indicate is that we finally have here an alternative therapy that is promising.
When I worked in Germany and later in Austria, massage was considered to be entirely mainstream. It was only after I had moved to the UK when I realised that, in English-speaking countries, it is mostly considered to be alternative. Perhaps this classification is wrong?
Perhaps we should differentiate according to what type of massage we are talking about. In the realm of alternative medicine – and not just there, I suppose – this seems good advice indeed.
The above papers are about classical massage therapy, but there are some types pf massage which are less than conventional: aura-massage, Marma massage, Indian head massage, shiatsu etc. etc. the list seems endless. These are alternative in more than one sense, and they have one thing in common: there is, as far as I can see, no good evidence to show that they do anything to human health.
My conclusion therefore is that, even with something as common as massage therapy, we need to be careful not to be roped in by the charlatans.
On this blog, we have discussed many different alternative treatments. As it turns out, hardly any of them fulfil the criteria for being used routinely in clinical practice. But here I present one that might be the exception.
The Feldenkrais Method (FM) aims to reduce pain or limitations in movement, to improve physical function, and to promote general wellbeing by increasing the patient’s awareness of herself and by expanding her movement repertoire. The FM is an educational method similar to the Alexander Technique.
The practitioner directs his attention to the patient’s habitual movement patterns which are inefficient or strained, and teaches new patterns using gentle, slow, repeated movements. Slow repetition is believed to be necessary to impart a new habit and allow it to begin to feel normal. These movements may be passive (performed by the practitioner on the recipient’s body) or active (performed by the patient).
At this point, we should ask: but does FM really and demonstrably work?
Ten years ago, we published a systematic review of all RCTs available at the time testing the effectiveness of FM. Six studies met our inclusion criteria. They were all burdened with significant methodological weaknesses. The indications included multiple sclerosis, neck/shoulder problems and chronic back pain. All but one trial reported positive results. We concluded that the evidence for the FM is encouraging but, due to the paucity and low quality of studies, by no means compelling.
Since then, more research has become available, and an update of our research seemed necessary. This new review aimed to update the evidence for the benefits of FM. Included studies were appraised using the Cochrane risk of bias approach and trial findings analysed individually and collectively where possible. Twenty RCTs were included (an additional 14 to our earlier systematic review). The population, outcome, and findings were highly heterogeneous. Meta-analyses were performed with 7 studies, finding in favour of the FM for improving balance in ageing populations. Single studies reported significant positive effects for reduced perceived effort and increased comfort, body image perception, and dexterity. Risk of bias was high in all studies, thus tempering some results. The effects seemed to be generic, supporting the proposal that FM works on a learning paradigm rather than disease-based mechanisms.
The authors concluded that further research is required; however, in the meantime, clinicians and professionals may promote the use of FM in populations interested in efficient physical performance and self-efficacy.
One might discuss whether or not FM is truly an alternative therapy; it has many characteristics of a physiotherapy, and physiotherapists often employ FM. On the other hand, it is considered to be alternative by some practitioners. So, for the purpose of this article, I will call it alternative.
The evidence for FM has become substantially more promising since we last looked at it systematically. The indication for which the evidence is most convincing is the improvement of elderly people’s balance. Considering that FM is virtually risk-free and inexpensive, I feel that it is one of the rare alternative therapy that could be integrated into clinical routine (for this particular indication).
Reflexology? Isn’t that an alternative therapy? And as such, a physiotherapist would not normally use it, most of us might think.
Well, think again! Here is what the UK Chartered Society of Physiotherapists writes about reflexology:
Developed centuries ago in countries such as China, Egypt and India, reflexology is often referred to as a ‘gentle’ and ‘holistic’ therapy that benefits both mind and body. It centres on the feet because these are said by practitioners to be a mirror, or topographical map, for the rest of the body. Manipulation of certain pressure, or reflex, points is claimed to have an effect on corresponding zones in the body. The impact, say reflexologists, extends throughout – to bones, muscles, organs, glands, circulatory and neural pathways. The head and hands can also be massaged in some cases. The treatment is perhaps best known for use in connection with relaxation and relief from stress, anxiety, pain, sleep disorders, headaches, migraine, menstrual and digestive problems. But advocates say it can be used to great effect far more widely, often in conjunction with other treatments.
Reflexology, or Reflex Therapy (RT) as some physiotherapists prefer to call it, clearly is approved by the UK Chartered Society of Physiotherapists. And what evidence do they have for it?
One hundred members of the Association of Chartered Physiotherapists in Reflex Therapy (ACPIRT) participated in an audit to establish a baseline of practice. Findings indicate that experienced therapists use RT in conjunction with their professional skills to induce relaxation (95%) and reduce pain (86%) for patients with conditions including whiplash injury and chronic pain. According to 68% of respondents, RT is “very good,” “good” or “as good as” orthodox physiotherapy practices. Requiring minimal equipment, RT may be as cost effective as orthodox physiotherapy with regards to duration and frequency of treatment.
But that’s not evidence!!! I hear you grumble. No, it isn’t, I agree.
Is there good evidence to show that RT is effective?
I am afraid not!
My own systematic review concluded that the best evidence available to date does not demonstrate convincingly that reflexology is an effective treatment for any medical condition.
Does that mean that the Chartered Society of Physiotherapists promotes quackery?
I let my readers answer that question.
Kinesiology tape is all the rage. Its proponents claim that it increases cutaneous stimulation, which facilitates motor unit firing, and consequently improves functional performance. But is this just clever marketing, wishful thinking or is it true? To find out, we need reliable data.
The current trial results are sparse, confusing and contradictory. A recent systematic review indicated that kinesiology tape may have limited potential to reduce pain in individuals with musculoskeletal injury; however, depending on the conditions, the reduction in pain may not be clinically meaningful. Kinesiology tape application did not reduce specific pain measures related to musculoskeletal injury above and beyond other modalities compared in the context of included articles.
The authors concluded that kinesiology tape may be used in conjunction with or in place of more traditional therapies, and further research that employs controlled measures compared with kinesiology tape is needed to evaluate efficacy.
This need for further research has just been met by Korean investigators who conducted a study testing the true effects of KinTape by a deceptive, randomized, clinical trial.
Thirty healthy participants performed isokinetic testing of three taping conditions: true facilitative KinTape, sham KinTape, and no KinTape. The participants were blindfolded during the evaluation. Under the pretense of applying adhesive muscle sensors, KinTape was applied to their quadriceps in the first two conditions. Normalized peak torque, normalized total work, and time to peak torque were measured at two angular speeds (60°/s and 180°/s) and analyzed with one-way repeated measures ANOVA.
Participants were successfully deceived and they were ignorant about KinTape. No significant differences were found between normalized peak torque, normalized total work, and time to peak torque at 60°/s or 180°/s (p = 0.31-0.99) between three taping conditions. The results showed that KinTape did not facilitate muscle performance in generating higher peak torque, yielding a greater total work, or inducing an earlier onset of peak torque.
The authors concluded that previously reported muscle facilitatory effects using KinTape may be attributed to placebo effects.
The claims that are being made for kinesiology taping are truly extraordinary; just consider what this website is trying to tell us:
Kinesiology tape is a breakthrough new method for treating athletic sprains, strains and sports injuries. You may have seen Olympic and celebrity athletes wearing multicolored tape on their arms, legs, shoulders and back. This type of athletic tape is a revolutionary therapeutic elastic style of support that works in multiple ways to improve health and circulation in ways that traditional athletic tapes can’t compare. Not only does this new type of athletic tape help support and heal muscles, but it also provides faster, more thorough healing by aiding with blood circulation throughout the body.
Many athletes who have switched to using this new type of athletic tape report a wide variety of benefits including improved neuromuscular movement and circulation, pain relief and more. In addition to its many medical uses, Kinesiology tape is also used to help prevent injuries and manage pain and swelling, such as from edema. Unlike regular athletic taping, using elastic tape allows you the freedom of motion without restricting muscles or blood flow. By allowing the muscles a larger degree of movement, the body is able to heal itself more quickly and fully than before.
Whenever I read such over-enthusiastic promotion that is not based on evidence but on keen salesmanship, my alarm-bells start ringing and I see parallels to the worst type of alternative medicine hype. In fact, kinesiology tapes have all the hallmarks of alternative medicine and its promoters have, as far as I can see, all the characteristics of quacks. The motto seems to be: LET’S EARN SOME MONEY FAST AND IGNORE THE SCIENCE WHILE WE CAN.
Chiropractors, like other alternative practitioners, use their own unique diagnostic tools for identifying the health problems of their patients. One such test is the Kemp’s test, a manual test used by most chiropractors to diagnose problems with lumbar facet joints. The chiropractor rotates the torso of the patient, while her pelvis is fixed; if manual counter-rotative resistance on one side of the pelvis by the chiropractor causes lumbar pain for the patient, it is interpreted as a sign of lumbar facet joint dysfunction which, in turn would be treated with spinal manipulation.
All diagnostic tests have to fulfil certain criteria in order to be useful. It is therefore interesting to ask whether the Kemp’s test meets these criteria. This is precisely the question addressed in a recent paper. Its objective was to evaluate the existing literature regarding the accuracy of the Kemp’s test in the diagnosis of facet joint pain compared to a reference standard.
All diagnostic accuracy studies comparing the Kemp’s test with an acceptable reference standard were located and included in the review. Subsequently, all studies were scored for quality and internal validity.
Five articles met the inclusion criteria. Only two studies had a low risk of bias, and three had a low concern regarding applicability. Pooling of data from studies using similar methods revealed that the test’s negative predictive value was the only diagnostic accuracy measure above 50% (56.8%, 59.9%).
The authors concluded that currently, the literature supporting the use of the Kemp’s test is limited and indicates that it has poor diagnostic accuracy. It is debatable whether clinicians should continue to use this test to diagnose facet joint pain.
The problem with chiropractic diagnostic methods is not confined to the Kemp’s test, but extends to most tests employed by chiropractors. Why should this matter?
If diagnostic methods are not reliable, they produce either false-positive or false-negative findings. When a false-negative diagnosis is made, the chiropractor might not treat a condition that needs attention. Much more common in chiropractic routine, I guess, are false-positive diagnoses. This means chiropractors frequently treat conditions which the patient does not have. This, in turn, is not just a waste of money and time but also, if the ensuing treatment is associated with risks, an unnecessary exposure of patients to getting harmed.
The authors of this review, chiropractors from Canada, should be praised for tackling this subject. However, their conclusion that “it is debatable whether clinicians should continue to use this test to diagnose facet joint pain” is in itself highly debatable: the use of nonsensical diagnostic tools can only result in nonsense and should therefore be disallowed.
The mechanisms thorough which spinal manipulative therapy (SMT) exerts its alleged clinical effects are not well established. A new study investigated the effects of subject expectation on clinical outcomes.
Sixty healthy subjects underwent quantitative sensory testing to their legs and low backs. They were randomly assigned to receive a positive, negative, or neutral expectation instructional set regarding the effects of a spe cific SMT technique on pain perception. Following the instructional set, all subjects received SMT and underwent repeat sensory tests.
No inter-group differences in pain response were present in the lower extremity following SMT. However, a main effect for hypoalgesia was present. A significant interaction was present between change in pain perception and group assignment in the low back with participants receiving a negative expectation instructional set demonstrating significant hyperalgesia.
The authors concluded that this study provides preliminary evidence for the influence of a non- specific effect (expectation) on the hypoalgesia associated with a single session of SMT in normal subjects. We replicated our previous findings of hypoalgesia in the lower extremity associated with SMT to the low back. Additionally, the resultant hypoalgesia in the lower extremity was independent of an expectation instructional set directed at the low back. Conversely, participants receiving a negative expectation instructional set demonstrated hyperalgesia in the low back following SMT which was not observed in those receiving a positive or neutral instructional set.
More than 10 years ago, we addressed a similar issue by conducting a systematic review of all sham-controlled trials of SMT. Specifically, we wanted to summarize the evidence from sham-controlled clinical trials of SMT. Eight studies fulfilled our inclusion/exclusion criteria. Three trials (two on back pain and one on enuresis) were judged to be burdened with serious methodological flaws. The results of the three most rigorous studies (two on asthma and one on primary dysmenorrhea) did not suggest that SMT leads to therapeutic responses which differ from an inactive sham-treatment. We concluded that sham-controlled trials of SMT are sparse but feasible. The most rigorous of these studies suggest that SMT is not associated with clinically relevant specific therapeutic effects.
Taken together, these two articles provide intriguing evidence to suggest that SMT is little more than a theatrical placebo. Given the facts that SMT is neither cheap nor devoid of risks, the onus is now on those who promote SMT, e.g. chiropractors, osteopaths and physiotherapists, to show that this is not true.
Mohamed Khalifa is a therapist who works in Austria and has been practicing manual therapy for more than 30 years. His treatment, the so-called “Khalifa therapy”, is based on rhythmically applying manual pressure on parts of the body. Khalifa claims to be able to speed the self-healing processes of the human body. He has treated many top-athletes from all over the world; however, his method has never been investigated in detail within interdisciplinary scientific studies.
Now the first RCT of Khalifa therapy has become available.
Rupture of the anterior cruciate ligament (ACL) is an injury which usually needs to be treated surgically. It does not heal spontaneously, although some claim this commonly accepted knowledge to be not true. This randomized, controlled, observer-blinded, multicentre study was performed to test the effectiveness of Khalifa therapy for ACL. Thirty patients with complete ACL rupture, magnetic resonance imaging (MRI) verified, were included. Study examinations (e.g., international knee documentation committee (IKDC) score) were performed at inclusion (t 0). Patients were randomized to receive either standardised physiotherapy (ST) or additionally 1 hour of Khalifa therapy at the first session (STK). Twenty-four hours later, study examinations were performed again (t 1). Three months later control MRI and follow-up examinations were performed (t 2).
Initial status was comparable between both groups. There was a highly significant difference of mean IKDC score results at t 1 and t 2. After 3 months, 47% of the STK patients, but no ST patient, demonstrated an end-to-end homogeneous ACL in MRI. Clinical and physical examinations were significantly different in t 1 and t 2. ACL healing can be improved with manual therapy. Physical activity could be performed without pain and nearly normal range of motion after one treatment of specific pressure.
The authors of this study concluded that spontaneous healing of ACL rupture is possible within 3 months after lesion, enhanced by Khalifa therapy. The effect sizes of 1.6 and 2.0 standard deviations after treatment and after 3 months are considerable and prompt further work. Further progress in understanding the underlying mechanisms including placebo will be possible when more experience with the manual pressure therapy has been gathered by other therapists.
The authors of this RCT state that according to common knowledge, it (ACL) does not heal spontaneously. Other authors disagree with this notion:
Observations on 14 patients with ACL, for instance, indicated an acutely injured ACL may eventually spontaneously heal without using an extension brace, allowing return to athletic activity. Another study suggested that an acutely injured ACL has healing capability. It also suggests that conservative management of the acute ACL injury can yield satisfactory results in a group of individuals who have low athletic demands and continuous ACL on MRI, provided the patients are willing to accept the slight risk of late ACL reconstruction and meniscal injury.
So yes, the authors of the new RCT are correct in stating: spontaneous healing of ACL rupture is possible within 3 months … but the healing might indeed be SPONTANEOUS, i.e. unrelated to the Khalifa therapy. Before we can accept that Khalifa therapy is anything but a theatrical placebo, this RCT needs independent replication. Generally speaking, it seems a bad idea to make exaggerated claims on the basis of one single trial, particularly for treatments that are as implausible as this one.
The safety of the manual treatments such as spinal manipulation is a frequent subject on this blog. Few experts would disagree with the argument that more good data are needed – and what could be better data than that coming from a randomised clinical trial (RCT)?
The aim of this RCT was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists (i.e. chiropractors, naprapaths, osteopaths, physicians and physiotherapists) for patients seeking care for back and/or neck pain.
Participants were recruited among patients seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm. 767 patients were randomized to one of three treatment arms:
- manual therapy (i.e. spinal manipulation, spinal mobilization, stretching and massage) (n = 249),
- manual therapy excluding spinal manipulation (n = 258)
- manual therapy excluding stretching (n = 260).
Treatments were provided by students in the seventh semester (of total 8). Adverse events were monitored via a questionnaire after each return visit and categorized in to five levels:
- short minor,
- long minor,
- short moderate,
- long moderate,
This was based on the duration and/or severity of the event.
The most common adverse events were soreness in muscles, increased pain and stiffness. No differences were found between the treatment arms concerning the occurrence of these adverse event. Fifty-one percent of patients, who received at least three treatments, experienced at least one adverse event after one or more visits. Women more often had short moderate adverse events, and long moderate adverse events than men.
The authors conclude that adverse events after manual therapy are common and transient. Excluding spinal manipulation or stretching do not affect the occurrence of adverse events. The most common adverse event is soreness in the muscles. Women reports more adverse events than men.
What on earth is naprapathy? I hear you ask. Here is a full explanation from a naprapathy website:
Naprapathy is a form of bodywork that is focused on the manual manipulation of the spine and connective tissue. Based on the fundamental principles of osteopathy and chiropractic techniques, naprapathy is a holistic and integrative approach to restoring whole health. In fact, naprapathy often incorporates multiple, complimentary therapies, such as massage, nutritional counseling, electrical muscle stimulation and low-level laser therapy.
Naprapathy also targets vertebral subluxations, or physical abnormalities present that suggest a misalignment or injury of the spinal vertebrae. This analysis is made by a physical inspection of the musculoskeletal system, as well as visual observation. The practitioner will also conduct a lengthy interview with the client to help determine stress level and nutritional status as well. An imbalance along one or more of these lines may signal trouble within the musculoskeletal structure.
The naprapathy practitioner is particularly skilled in identifying restricted or stressed components of the fascial system, or connective tissue. It is believed that where constriction of muscles, ligaments, and tendons exists, there is impaired blood flow and nerve functioning. Naprapathy attempts to correct these blockages through hands-on manipulation and stretching of connective tissue. However, since this discipline embodies a holistic approach, the naprapathy practitioner is also concerned with their client’s emotional health. To that end, many practitioners are also trained in psychotherapy and even hypnotherapy.
So, now we know!
We also know that the manual therapies tested here cause adverse effects in about half of all patients. This figure ties in nicely with the ones we had regarding chiropractic: ~ 50% of all patients suffer mild to moderate adverse effects after chiropractic spinal manipulation which usually last 2-3 days and can be strong enough to affect their quality of life. In addition very serious complications have been noted which luckily seem to be much rarer events.
In my view, this raises the question: DO THESE TREATMENTS GENERATE MORE GOOD THAN HARM? I fail to see any good evidence to suggest that they do – but, of course, I would be more than happy to revise this verdict, provided someone shows me the evidence.