MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

osteopathy

Manual therapy is considered a safe and less painful method and has been increasingly used to alleviate chronic neck pain. However, there is controversy about the effectiveness of manipulation therapy on chronic neck pain. Therefore, this systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to determine the effectiveness of manipulative therapy for chronic neck pain.

A search of the literature was conducted on seven databases (PubMed, Cochrane Center Register of Controlled Trials, Embase, Medline, CNKI, WanFang, and SinoMed) from the establishment of the databases to May 2022. The review included RCTs on chronic neck pain managed with manipulative therapy compared with sham, exercise, and other physical therapies. The retrieved records were independently reviewed by two researchers. Further, the methodological quality was evaluated using the PEDro scale. All statistical analyses were performed using RevMan V.5.3 software. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) assessment was used to evaluate the quality of the study results.

Seventeen RCTs, including 1190 participants, were included in this meta-analysis. Manipulative therapy showed better results regarding pain intensity and neck disability than the control group. Manipulative therapy was shown to relieve pain intensity (SMD = -0.83; 95% confidence interval [CI] = [-1.04 to -0.62]; p < 0.0001) and neck disability (MD = -3.65; 95% CI = [-5.67 to – 1.62]; p = 0.004). However, the studies had high heterogeneity, which could be explained by the type and control interventions. In addition, there were no significant differences in adverse events between the intervention and the control groups.

The authors concluded that manipulative therapy reduces the degree of chronic neck pain and neck disabilities.

Only a few days ago, we discussed another systematic review that drew quite a different conclusion: there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. Image result for systematic review, cartoon

How can this be?

Systematic reviews are supposed to generate reliable evidence!

How can we explain the contradiction?

There are several differences between the two papers:

  • One was published in a SCAM journal and the other one in a mainstream medical journal.
  • One was authored by Chinese researchers, the other one by an international team.
  • One included 17, the other one 23 RCTs.
  • One assessed ‘manual/manipulative therapies’, the other one spinal manipulation/mobilization.

The most profound difference is that the review by the Chinese authors is mostly on Chimese massage [tuina], while the other paper is on chiropractic or osteopathic spinal manipulation/mobilization. A look at the Chinese authors’ affiliation is revealing:

  • Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China.
  • Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].
  • Department of Tuina and Spinal Diseases Research, The Third School of Clinical Medicine (School of Rehabilitation Medicine), Zhejiang Chinese Medical University, Hangzhou, China; Department of Tuina, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China. Electronic address: [email protected].

What lesson can we learn from this confusion?

Perhaps that Tuina is effective for neck pain?

No!

What the abstract does not tell us is that the Tuina studies are of such poor quality that the conclusions drawn by the Chinese authors are not justified.

What we do learn – yet again – is that

  1. Chinese papers need to be taken with a large pintch of salt. In the present case, the searches underpinning the review and the evaluations of the included primary studies were clearly poorly conducted.
  2. Rubbish journals publish rubbish papers. How could the reviewers and the editors have missed the many flaws of this paper? The answer seems to be that they did not care. SCAM journals tend to publish any nonsense as long as the conclusion is positive.

 

This systematic review with meta-analysis of randomized clinical trials (RCTs) estimated the benefits and harms of cervical spinal manipulative therapy (SMT) for treating neck pain. The authors searched the MEDLINE, Cochrane CENTRAL, EMBASE, CINAHL, PEDro, Chiropractic Literature Index bibliographic databases, and grey literature sources, up to June 6, 2022.Image result for death by neck manipulation

RCTs evaluating SMT compared to guideline-recommended and non-recommended interventions, sham SMT, and no intervention for adults with neck pain were eligible. Pre-specified outcomes included pain, range of motion, disability, health-related quality of life.

A total of 28 RCTs could be included. There was very low to low certainty evidence that SMT was more effective than recommended interventions for improving pain at short-term (standardized mean difference [SMD] 0.66; confidence interval [CI] 0.35 to 0.97) and long-term (SMD 0.73; CI 0.31 to 1.16), and for reducing disability at short-term (SMD 0.95; CI 0.48 to 1.42) and long-term (SMD 0.65; CI 0.23 to 1.06). Only transient side effects were found (e.g., muscle soreness).

The authors concluded that there was very low certainty evidence supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain.

Harms cannot be adequately investigated on the basis of RCT data. Firstly, because much larger sample sizes would be required for this purpose. Secondly, RCTs of spinal manipulation very often omit reporting adverse effects (as discussed repeatedly on this bolg). If we extend our searches beyond RCTs, we find many cases of serious harm caused by neck manipulations (also as discussed repeatedly on this bolg). Therefore, the conclusion of this review should be corrected:

Low certainty evidence exists supporting cervical SMT as an intervention to reduce pain and improve disability in people with neck pain. The evidence of harm is, however, substantial. It follows that the risk/benefit ratio is not positive. Cervical SMT should therefore be discouraged.

This systematic review and meta-analysis assessed the effectiveness of visceral osteopathy in improving pain intensity, disability and physical function in patients with low-back pain (LBP).

MEDLINE (Pubmed), PEDro, SCOPUS, Cochrane Library and Web of Science databases were searched from inception to February 2022. PICO search strategy was used to identify randomized clinical trials applying visceral techniques in patients with LBP. Eligible studies and data extraction were conducted independently by two reviewers. Quality of the studies was assessed with the Physiotherapy Evidence Database scale, and the risk of bias with Cochrane Collaboration tool. Meta-analyses were conducted using random effects models according to heterogeneity assessed with I2 coefficient. Data on outcomes of interest were extracted by a researcher using RevMan 5.4 software.

Five studies were included in the systematic review involving 268 patients with LBP. The methodological quality of the included ranged from high to low and the risk of bias was high. Visceral osteopathy techniques have shown no improvements in pain intensity (Standardized mean difference (SMD) = -0.53; 95% CI; -1.09, 0.03; I2: 78%), disability (SMD = -0.08; 95% CI; -0.44, 0.27; I2: 0%) and physical function (SMD = -0.26; 95% CI; -0.62, 0.10; I2: 0%) in patients with LBP.

The authors concluded that this systematic review and meta-analysis showed a lack of high-quality studies showing the effectiveness of visceral osteopathy in pain, disability, and physical function in patients with LBP.

Visceral osteopathy (or visceral manipulation) is an expansion of the general principles of osteopathy and involves the manual manipulation by a therapist of internal organs, blood vessels and nerves (the viscera) from outside the body.

Visceral osteopathy was developed by Jean-Piere Barral, a registered Osteopath and Physical Therapist who serves as Director (and faculty) of the Department of Osteopathic Manipulation in Paris, France. He stated that through his clinical work with thousands of patients, he created this modality based on organ-specific fascial mobilization. And through work in a dissection lab, he was able to experiment with visceral manipulation techniques and see the internal effects of the manipulations.[1]  According to its proponents, visceral manipulation is based on the specific placement of soft manual forces looking to encourage the normal mobility, tone and motion of the viscera and their connective tissues. These gentle manipulations may potentially improve the functioning of individual organs, the systems the organs function within, and the structural integrity of the entire body.[2] Visceral osteopathy comprises of several different manual techniques firstly for diagnosing a health problem and secondly for treating it.

Several studies have assessed the diagnostic reliability of the techniques involved. The totality of this evidence fails to show that they are sufficiently reliable to be od practical use.[3] Other studies have tested whether the therapeutic techniques used in visceral osteopathy are effective in curing disease or alleviating symptoms. The totality of this evidence fails to show that visceral osteopathy works for any condition.[4] 

The treatment itself seems to be safe, yet the risks of visceral osteopathy are nevertheless considerable: if a patient suffers from symptoms related to her inner organs, the therapist is likely to misdiagnose them and subsequently mistreat them. If the symptoms are due to a serious disease, this would amount to medical neglect and could, in extreme cases, cost the patient’s life.

My bottom line: if you see visceral osteopathy being employed anywhere, turn araound and seek proper healthcare whatever your illness might be.

References

[1]  https://www.barralinstitute.com/about/jean-pierre-barral.php .

[2]  http://www.barralinstitute.co.uk/ .

[3] Guillaud A, Darbois N, Monvoisin R, Pinsault N (2018) Reliability of diagnosis and clinical efficacy of visceral osteopathy: a systematic review. BMC Complement Altern Med 18:65

[4]  http://www.barralinstitute.co.uk/ .

This short news report appeared on X [formerly Twitter]:Short-haired blonde woman on a stage speaking into a headset microphone, wearing an animal stripe jacket with a bare lightbulb and draped cloth behind her

The Ohio State Medical Board just approved the indefinite suspension Dr. Sherri Tenpenny’s medical license, an osteopathic physician and longtime figure in the anti-vaccine movement. The board got around 350 complaints into her behavior, but that’s not why she’s being suspended.

As this could easily be unreliable, I looked for confirmations … and found several, for instance, this one:

An Ohio physician who sparked widespread ridicule in 2021 after spreading bizarre COVID-19 vaccine conspiracies to the House Health Committee by claiming the jabs magnetize their hosts and “interface” with cell towers had her medical license indefinitely suspended Wednesday. Anti-vaccine spreader Sherri Tenpenny sparked a firestorm in June, 2021 after making the comments, which saw 350 complaints sent to the State Medical Board. According to Cleveland.com, the board’s decision was not based on the comments, rather on procedural grounds, citing Tenpenny’s refusal to cooperate with investigators during the inquiry. “Dr. Tenpenny, neither you nor any doctor licensed by this board is above the law, and you must comply with the investigation,” said Dr. Jonathan Feibel, an orthopedic surgeon and medical board member, according to the outlet. “You have not done so, and therefore, until you do, your license will be suspended.” A lawyer for Tenpenny, Tom Renz, described the investigation as a form of “harassment” on her “free speech rights.” Tenpenny did not speak after the announcement, however Renz declared, “This appears very much like a lynch mob.”

Who is Sherry Tenpenny? Here is what Wiki tells us about her:

Sherri J. Tenpenny is an American anti-vaccination activist and conspiracy theorist who promulgates the disproven hypothesis that vaccines cause autism.[1] An osteopathic physician, she is the author of four books opposing vaccination. A 2015 lecture tour of Australia was canceled due to a public outcry over her views on vaccination, which oppose established scientific consensus. A 2021 Center for Countering Digital Hate analysis concluded that Tenpenny is among the top twelve people spreading COVID-19 misinformation and pseudoscientific anti-vaccine misinformation on social media platforms. She has falsely asserted that the vaccines magnetize people and connect them with cellphone towers…

The story is puzzling, in my view. The biggest question for me is this:

Why only now?

She should have been suspended years ago!

Massage is frequently used for recovery and increased performance. This review, aimed to search and systemize current literature findings relating to massages’ effects on sports and exercise performance concerning its effects on motor abilities and neurophysiological and psychological mechanisms.

One hundred and fourteen articles were included. The data revealed that massages, in general, do not affect motor abilities, except flexibility. However, several studies demonstrated that positive muscle force and strength changed 48 h after the massage was given. Concerning neurophysiological parameters, massage did not change blood lactate clearance, muscle blood flow, muscle temperature, or activation. However, many studies indicated a reduction of pain and delayed onset muscle soreness, which are probably correlated with the reduction of the level of creatine kinase enzyme and psychological mechanisms. In addition, massage treatment led to a decrease in depression, stress, anxiety, and the perception of fatigue and an increase in mood, relaxation, and the perception of recovery.

The authors concluded that the direct usage of massages just for gaining results in sport and exercise performance seems questionable. However, it is indirectly connected to performance as an important tool when an athlete should stay focused and relaxed during competition or training and recover after them.

The evidence about the value of massage therapy is limited through the mostly poor quality of the primary studies. Unfortunately, the review authors did not bother to address this issue. Another recent and in my opinion more rigorous review identified 29 eligible studies recruiting 1012 participants, representing the largest examination of the effects of massage. Its authors found no evidence that massage improves measures of strength, jump, sprint, endurance, or fatigue, but massage was associated with small but statistically significant improvements in flexibility and DOMS. Massage therapy has the additional advantage that it is agreeable and nearly free of adverse effects. So, on balance, I think massage therapy might be worth considering for athletes.

Cervical artery dissection (CeAD), which includes both vertebral artery dissection (VAD) and carotid artery dissection (CAD), is the most serious safety concern associated with cervical spinal manipulation (CSM). This study evaluated the association between CSM and CeAD among US adults.“As soon as the chiropractor manipulated my neck, everything went black”

Through analysis of health claims data, the researchers employed a case-control study with matched controls, a case-control design in which controls were diagnosed with ischemic stroke, and a case-crossover design in which recent exposures were compared to exposures in the same case that occurred 6-7 months earlier. The researchers evaluated the association between CeAD and the 3-level exposure, CSM versus office visit for medical evaluation and management (E&M) versus neither, with E&M set as the referent group.

2337 VAD cases and 2916 CAD cases were identified. Compared to population controls, VAD cases were 0.17 (95% CI 0.09 to 0.32) times as likely to have received CSM in the previous week as compared to E&M. In other words, E&M was about 5 times more likely than CSM in the previous week in cases, relative to controls. CSM was 2.53 (95% CI 1.71 to 3.68) times as likely as E&M in the previous week among individuals with VAD than among individuals experiencing a stroke without CeAD. In the case-crossover study, CSM was 0.38 (95% CI 0.15 to 0.91) times as likely as E&M in the week before a VAD, relative to 6 months earlier. In other words, E&M was approximately 3 times more likely than CSM in the previous week in cases, relative to controls. Results for the 14-day and 30-day timeframes were similar to those at one week.

The authors concluded that, among privately insured US adults, the overall risk of CeAD is very low. Prior receipt of CSM was more likely than E&M among VAD patients as compared to stroke patients. However, for CAD patients as compared to stroke patients, as well as for both VAD and CAD patients in comparison with population controls and in case-crossover analysis, prior receipt of E&M was more likely than CSM.

What seems fairly clear from this and a previous similar analysis by the same authors is, I think, this: retrospective studies of this type can unfortunately not provide us with much reliable information about the risks of spinal manipulation. The reasons for this are manyfold, e.g.: less than exact classifications in patients’ records, or the fact that multiple types of spinal manipulations exist of which only some might be dangerous.

There is widespread agreement amongst clinicians that people with non-specific low back pain (NSLBP) comprise a heterogeneous group and that their management should be individually tailored. One treatment known by its tailored design is the McKenzie method (e.g. an individualized program of exercises based on clinical clues observed during assessment) used mostly but not exclusively by physiotherapists.

A recent Cochrane review evaluated the effectiveness of the McKenzie method in people with (sub)acute non-specific low back pain. Randomized clinical trials (RCTs) investigating the effectiveness of the McKenzie method in adults with (sub)acute (less than 12 weeks) NSLBP.

Five RCTs were included with a total of 563 participants recruited from primary or tertiary care. Three trials were conducted in the USA, one in Australia, and one in Scotland. Three trials received financial support from non-commercial funders and two did not provide information on funding sources. All trials were at high risk of performance and detection bias. None of the included trials measured adverse events.

McKenzie method versus minimal intervention (educational booklet; McKenzie method as a supplement to other intervention – main comparison) There is low-certainty evidence that the McKenzie method may result in a slight reduction in pain in the short term (MD -7.3, 95% CI -12.0 to -2.56; 2 trials, 377 participants) but not in the intermediate term (MD -5.0, 95% CI -14.3 to 4.3; 1 trial, 180 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -2.5, 95% CI -7.5 to 2.0; 2 trials, 328 participants) nor in the intermediate term (MD -0.9, 95% CI -7.3 to 5.6; 1 trial, 180 participants).

McKenzie method versus manual therapy There is low-certainty evidence that the McKenzie method may not reduce pain in the short term (MD -8.7, 95% CI -27.4 to 10.0; 3 trials, 298 participants) and may result in a slight increase in pain in the intermediate term (MD 7.0, 95% CI 0.7 to 13.3; 1 trial, 235 participants). There is low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD -5.0, 95% CI -15.0 to 5.0; 3 trials, 298 participants) nor in the intermediate term (MD 4.3, 95% CI -0.7 to 9.3; 1 trial, 235 participants).

McKenzie method versus other interventions (massage and advice) There is very low-certainty evidence that the McKenzie method may not reduce disability in the short term (MD 4.0, 95% CI -15.4 to 23.4; 1 trial, 30 participants) nor in the intermediate term (MD 10.0, 95% CI -8.9 to 28.9; 1 trial, 30 participants).

The authors concluded that, based on low- to very low-certainty evidence, the treatment effects for pain and disability found in our review were not clinically important. Thus, we can conclude that the McKenzie method is not an effective treatment for (sub)acute NSLBP.

 The hallmark of the McKenzie method for back pain involves the identification and classification of nonspecific spinal pain into homogenous subgroups. These subgroups are based on the similar responses of a patient’s symptoms when subjected to mechanical forces. The subgroups include postural syndrome, dysfunction syndrome, derangement syndrome, or “other,” with treatment plans directed to each subgroup. The McKenzie method emphasizes the centralization phenomenon in the assessment and treatment of spinal pain, in which pain originating from the spine refers distally, and through targeted repetitive movements the pain migrates back toward the spine. The clinician will then use the information obtained from this assessment to prescribe specific exercises and advise on which postures to adopt or avoid. Through an individualized treatment program, the patient will perform specific exercises at home approximately ten times per day, as opposed to 1 or 2 physical therapy visits per week. According to the McKenzie method, if there is no restoration of normal function, tissue healing will not occur, and the problem will persist.

Classification:

The postural syndrome is pain caused by mechanical deformation of soft tissue or vasculature arising from prolonged postural stresses. These may affect the joint surfaces, muscles, or tendons, and can occur in sitting, standing, or lying. Pain may be reproducible when such individuals maintain positions or postures for sustained periods. Repeated movements should not affect symptoms, and relief of pain typically occurs immediately following the correction of abnormal posture.

The dysfunction syndrome is pain caused by the mechanical deformation of structurally impaired soft tissue; this may be due to traumatic, inflammatory, or degenerative processes, causing tissue contraction, scarring, adhesion, or adaptive shortening. The hallmark is a loss of movement and pain at the end range of motion. Dysfunction has subsyndromes based upon the end-range direction that elicits this pain: flexion, extension, side-glide, multidirectional, adherent nerve root, and nerve root entrapment subsyndromes. Successful treatment focuses on patient education and mobilization exercises that focus on the direction of the dysfunction/direction of pain. The goal is on tissue remodeling which can be a prolonged process.

The derangement syndrome is the most commonly encountered pain syndrome, reported in one study to have a prevalence as high as 78% of patients classified by the McKenzie method. It is caused by an internal dislocation of articular tissue, causing a disturbance in the normal position of affected joint surfaces, deforming the capsule, and periarticular supportive ligaments. This derangement will both generate pain and obstruct movement in the direction of the displacement. There are seven different subsyndromes which are classified by the location of pain and the presence, or absence, of deformities. Pain is typically elicited by provocative assessment movements, such as flexion or extension of the spine. The centralization and peripheralization of symptoms can only occur in the derangement syndrome. Thus the treatment for derangement syndrome focuses on repeated movement in a single direction that causes a gradual reduction in pain. Studies have shown approximately anywhere between 58% to 91% prevalence of centralization of lower back pain. Studies have also shown that between 67% to 85% of centralizers displayed the directional preference for a spinal extension. This preference may partially explain why the McKenzie method has become synonymous with spinal extension exercises. However, care must be taken to accurately diagnose the direction of pain, as one randomized controlled study has shown that giving the ‘wrong’ direction of exercises can actually lead to poorer outcomes.

Other or Nonmechanical syndrome refers to any symptom that does not fit in with the other mechanical syndromes, but exhibits signs and symptoms of other known pathology; Some of these examples include spinal stenosis, sacroiliac disorders, hip disorders, zygapophyseal disorders, post-surgical complications, low back pain secondary to pregnancy, spondylolysis, and spondylolisthesis.

CONCLUSION:

“Internationally researched” and found to be ineffective!

This study allegedly evaluated the efficacy of osteopathic manipulative therapy (OMT) compared to that of the Kaltenborn-Evjenth Orthopedic Manipulative Therapy (KEOMT) for patients with chronic LBP.

It included 68 participants of both genders, aged 30 to 60, with chronic LBP. Participants were randomly assigned to one of two parallel groups, each with 34 members. The OMT group received, as a direct technique, a high-velocity/low-amplitude (HVLA) impulse, and as indirect techniques, strain counterstrain (SCS), myofascial release (MFR), and visceral mobilization therapy (VMT). The KEOMT group received lumbar segmental traction and lumbar segmental mobilization-flexion and gliding therapy grade 3. The participants in both groups received 10 treatments, two per week for five weeks. The primary outcome was pain severity, using a numeric pain rating scale (NPRS). The secondary outcome was the measurement of functional disability, using the Oswestry Disability Index (ODI).

The OMT and KEOMT both decreased pain and disability; however, the changes on the NPRS and ODI postintervention were statistically greater for the OMT group compared to the KEOMT group (P < .05).

The authors concluded that the OMT was better at reducing pain and improving quality of life. It reduced functional disability more than KEOMT in patients with chronic LBP.

The Kaltenborn-Evjenth Orthopedic Manipulative Therapy (KEOMT) concept is a treatment and training system based upon a comprehensive biomechanical evaluation of the arthro-neuro-muscular system and an individual’s functional abilities. This system of diagnosis and patient management applies to both patients with acute, subacute and chronic conditions of the spine and extremities and to athletes seeking to improve performance. It offers a reliable and practical approach that focuses on optimal physical health and function.

Has the KEOMT concept been tested and shown to be effective for LBP?

No!

So, what we have here is an equivalence trial of two manual techniques. As such it is FAR too small to yield a meaningful result. If the findings were meaningful, would they show that OMT is effective?

No!

As we have no proof that KEOMT does not impede recovery from LBP, the result could merely be due to the fact that OMT does not influence the natural history of LBP, while KEOMT has a detrimental effect.

Last question: which journal publishes such rubbish?

Ahh, it’s the remarkable Alternative therapies in health and medicine. That explains a lot!

 

This trial investigated the effect of osteopathic visceral manipulation (OVM) on disability and pain intensity in individuals with functional constipation and chronic nonspecific low back pain. It was designed as a randomized controlled trial with a blinded assessor. Seventy-six volunteers with functional constipation and chronic nonspecific low back pain were randomized to two groups: OVM and sham OVM. The primary clinical outcome was pain intensity measured using a numeric rating scale (NRS) and disability measured using the Oswestry Disability Index (ODI). The secondary outcomes were electromyographic signals measured during the flexion-extension cycle, the finger-to-floor distance during complete flexion of the trunk, and the Fear-Avoidance Beliefs Questionnaire (FABQ). All outcomes were determined after six weeks of treatment as well as three months after randomization.

The OVM group reported a reduction in pain intensity after six weeks of treatment and at the three-month evaluation (p < .0002) and the sham group reported a reduction in pain intensity after three-month evaluation (p < .007). For the ODI was also found in the OVM group six weeks after the end of treatment (treatment effect = -6.59, 95% CI: -12.01 to -1.17, p = .01) and at the three-month evaluation (treatment effect = -6.02, 95% CI: -11.55 to -0.49, p = .03). Significant differences were also found for paravertebral muscle activity during the dynamic phases (flexion and extension) six-week evaluations.

The authors concluded that the OVM group demonstrated a reduction in pain intensity and improvement in disability after six-weeks and three-month follow-up while the sham group reduction in pain three-month follow-up.

I have no access to the full paper (if someone can send me the paper, I would update my post accordingly), but from reading the abstract, it seems the reported findings are based on within-group changes. The whole point of having a control group is to compare verum and control. The other point of importance is that it would have been crucial to verify whether patients were able to tell the verum from the sham intervention. If patients were able to tell, they would no longer be blinded and the placebo effect would have not been accounted for. A third point of relevance might be that the study seems tiny and far too small for drawing general conclusions about the value of OVM.

_________________________

I have now seen the protocol of the paper – thanks for making it available – and might add the following points to the discussion:

  • The sham treatment consisted of  “light touches over the different parts of the abdomen, without any deep mobilization or movement. The osteopath applied her hands over the same points with the
    same duration as in OVM to give the patient the perception of being treated.” It is likely that patients in the control group could have guessed that they were sham-treated.
  • The stats issue cannot be resolved on the basis of just the protocol.
  • “To assess patients’ blinding to treatment allocation, patients are asked post treatment (six weeks after
    the start of treatment) to report which study treatment they think that they received (OVM/SOVM). The effect of their reports on outcome will be examined in explorative analysis.” As I have no

access to the results, I still do not know whether blinding was successful.

Lumbosacral Radicular Syndrome (LSRS) is a condition characterized by pain radiating in one or more dermatomes (Radicular Pain) and/or the presence of neurological impairments (Radiculopathy). So far, different reviews have investigated the effect of HVLA (high-velocity low-amplitude) spinal manipulations in LSRS. However, these studies included ‘mixed’ population samples (LBP patients with or without LSRS) and treatments other than HVLA spinal manipulations (e.g., mobilisation, soft tissue treatment, etc.). Hence, the efficacy of HVLAT in LSRS is yet to be fully understood.

This review investigated the effect and safety of HVLATs on pain, levels of disability, and health-related quality of life in LSRS, as well as any possible adverse events.

Randomized clinical trials (RCTs) published in English in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (PubMed), EMBASE, PEDro, and Web of Science were identified. RCTs on an adult population (18-65 years) with LSRS that compared HVLATs with other non-surgical treatments, sham spinal manipulation, or no intervention were considered. Two authors selected the studies, extracted the data, and assessed the methodological quality through the ‘Risk of Bias (RoB) Tool 2.0’ and the certainty of the evidence through the ‘GRADE tool’. A meta-analysis was performed to quantify the effect of HVLA on pain levels.

A total of 308 records were retrieved from the search strings. Only two studies met the inclusion criteria. Both studies were at high RoB. Two meta-analyses were performed for low back and leg pain levels. HVLA seemed to reduce the levels of low back (MD = -1.48; 95% CI = -2.45, -0.50) and lower limb (MD = -2.36; 95% CI = -3.28, -1.44) pain compared to other conservative treatments, at three months after treatment. However, high heterogeneity was found (I² = 0.0%, p = 0.735). Besides, their certainty of the evidence was ‘very low’. No adverse events were reported.

The authors stated that they cannot conclude whether HVLA spinal manipulations can be helpful for the treatment of LSRS or not. Future high-quality RCTs are needed to establish the actual effect of HVLA manipulation in this disease with adequate sample size and LSRS definition.

Chiropractors earn their living by applying HVLA thrusts to patients suffering from LSRS. One would therefore have assumed that the question of efficacy has been extensively researched and conclusively answered. It seems that one would have assumed wrongly!

Now that this is (yet again) in the open, I wonder whether chiropractors will, in the future, tell their patients while obtaining informed consent: “I plan to give you a treatment for which sound evidence is not available; it can also cause harm; and, of course, it will cost you – I hope you don’t mind.”

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