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

The objective of this systematic review was to assess the effects and reliability of sham procedures in manual therapy (MT) trials in the treatment of back pain (BP) in order to provide methodological guidance for clinical trial development. Different databases were screened up to 20 August 2020. Randomised clinical trials involving adults affected by BP (cervical and lumbar), acute or chronic, were included. Hand contact sham treatment (ST) was compared with different MT (physiotherapy, chiropractic, osteopathy, massage, kinesiology, and reflexology) and to no treatment. Primary outcomes were BP improvement, the success of blinding, and adverse effect (AE). Secondary outcomes were the number of drop-outs. Dichotomous outcomes were analysed using risk ratio (RR), continuous using mean difference (MD), 95% CIs. The minimal clinically important difference was 30 mm changes in pain score.

A total of 24 trials were included involving 2019 participants. Different manual treatments were provided:

  • SM/chiropractic (7 studies, 567 participants).
  • Osteopathy (5 trials, 645 participants).
  • Kinesiology (1 trial, 58 participants).
  • Articular mobilisations (6 trials, 445 participants).
  • Muscular release (5 trials, 304 participants).

Very low evidence quality suggests clinically insignificant pain improvement in favour of MT compared with ST (MD 3.86, 95% CI 3.29 to 4.43) and no differences between ST and no treatment (MD -5.84, 95% CI -20.46 to 8.78).ST reliability shows a high percentage of correct detection by participants (ranged from 46.7% to 83.5%), spinal manipulation being the most recognised technique. Low quality of evidence suggests that AE and drop-out rates were similar between ST and MT (RR AE=0.84, 95% CI 0.55 to 1.28, RR drop-outs=0.98, 95% CI 0.77 to 1.25). A similar drop-out rate was reported for no treatment (RR=0.82, 95% 0.43 to 1.55).

Forest plot of comparison ST versus MT in back pain outcome at short term. MT, manual therapy; ST, sham treatment.

The authors concluded that MT does not seem to have clinically relevant effect compared with ST. Similar effects were found with no treatment. The heterogeneousness of sham MT studies and the very low quality of evidence render uncertain these review findings. Future trials should develop reliable kinds of ST, similar to active treatment, to ensure participant blinding and to guarantee a proper sample size for the reliable detection of clinically meaningful treatment effects.

Essentially these findings suggest that the effects patients experience after MT are not due to MT per see but to placebo effects. The review could be criticised because of the somewhat odd mix of MTs lumped together in one analysis. Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.

The authors of the review also provide this further comment:

Similar findings were found in other reviews conducted on LBP. Ruddock et al included studies where SM was compared with what authors called ‘an effective ST’, namely a credible sham manipulation that physically mimics the SM. Pooled data from four trials showed a very small and not clinically meaningful effect in favour of MT.

Rubinstein et al  compared SM and mobilisation techniques to recommended, non-recommended therapies and to ST. Their findings showed that 5/47 studies included attempted to blind patients to the assigned intervention by providing an ST. Of these five trials, two were judged at unclear risk of participants blinding. The authors also questioned the need for additional studies on this argument, as during the update of their review they found recent small pragmatic studies with high risk of bias. We agree with Rubinstein et al that recent studies included in this review did not show a higher quality of evidence. The development of RCT with similar characteristic will probably not add any proof of evidence on MT and ST effectiveness.

If we agree that chiropractic and osteopathy are placebo therapies, we might ask whether they should have a place in the management of BP. Considering the considerable risks associated with them, I feel that the answer is obvious and simple:

NO!

12 Responses to Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment

  • the paper (we can elaborate on its poor quality if you so wish) talks about comparing shat treatments to “physiotherapy, chiropractic, osteopathy, massage, kinesiology and reflexology” but somehow you manipulate it (pun intended) to your agenda…

    • what a moronic comment!
      I did point out that it is an odd mix
      I did point out that most trials are chiro or osteo!

      • try and stay professional… critical thinking goes both ways you know… the paper is not “mainly” to do with chiropractic or osteopathy and vast majority of manual treatments are given by physio and most papers examined physiotherapy treatments … but why should you bother with the facts?

        • it is hard to be professional with moronic comments
          SM/chiropractic (7 studies, 567 participants).
          Osteopathy (5 trials, 645 participants).

  • Almost half of the studies:

    “Eleven trials used a single therapy session with a single technique performed in eight of those trials.”

    So a single therapy session didn’t reach MCID compared to sham or no treatment. Like duh, it’s not like it’s morphine.

    Of course the use of 30 mm as MCID across all studies could be questioned.

    “ From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values.”. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5317055/

    Of course one has to question any conclusions based upon very low to low quality research.

    BTW to purpose of the paper was to identify the status of finding a good sham in MT research…which apparently isn’t very good, at least based upon their inclusion/exclusion criteria.

  • “Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.” – Edzard Ernst.
    Edzard have you looked at the papers references?
    Lets go through them.
    Quite a few just discuss general placebo/nocebo effects, sham, guidelines etc. The remainder (with a running total for each profession):

    Acupuncture v Surgery. (1)
    Physio Manual Therapy v Physio v GP. (1)
    Anesthesia blinding in MT studies. Has potential – Chiro author. (1)
    Analgesia induced by touch. (1)
    Touch Therapy. (2)
    Validation of placebo in MT – Chiropractor. (2)
    Sham acupuncture v inert pill. (2)
    Osteo MT v Sham MT (1)
    Physio MT v Sham MT (2)
    Professional Kinesiology Practice. (Not chiro). (1)
    Physio rehab. (3)
    Dynamic back-muscle exercises, conventional physiotherapy, or placebo-control treatment – Physio (4)
    Chiro v muscle relaxants. (3)
    Physio spinal mobilization vs conventional physiotherapy (5)
    Osteo MT v sham MT v control (2)
    Physio MT (6)
    Physio mobilization. (7)
    Muscle energy technique – Physio. (8)
    Muscle inhibition technique – Physio. (9)
    Craniosacral therapy performed by………Physio’s. (10)
    Strain–counterstrain technique performed by German medical osteo’s. (3)
    Mixture of MT by osteo’s (Manip/mob/muscle). (4)
    Thrust Manip by Physio’s (11)
    Physio thoracic manip for neck pain. (12)
    Myoelectric activity of the right and left sternocleidomastoid muscles during isometric elevation of the shoulder girdle – Physio’s. (13)
    Osteo visceral manip for neck pain. (5)
    Physio pull move lumbar spine. (14)
    Arthrokinematic Approach-Hakata (AKA-H) method – Physio. (15)
    Mulligan bent leg raise technique – Physio. (16)
    Bilateral and multiple cavitation sounds during upper cervical thrust manipulation – James Dunning – Physio. (17)
    Spinal manipulation vs sham manipulation SR and MA by Osteo. (6)
    Benefits and harms of spinal manipulative therapy – Chiro and Physio. (4) (18)
    Therapeutic Touch – Nurse. (3)
    The risk of bias and sample size in MT – Chiro and Physio. (5) (19)
    Manual therapy: Exploiting the role of human touch – Physio. (20)
    Social touch. (4)

    Shall we not revisit your sweeping statement Edzard?
    “Yet, I think it is fair to point out that most of the studies were of chiropractic and osteopathy. Thus, this review implies that chiropractic and osteopathy are essentially placebo treatments.”
    To quote your own blog – “Bullshit”.

    Shall we examine the authors summary that you cite:
    “A total of 24 trials were included involving 2019 participants. Different manual treatments were provided:
    SM/chiropractic (7 studies, 567 participants).
    Osteopathy (5 trials, 645 participants).
    Kinesiology (1 trial, 58 participants).
    Articular mobilisations (6 trials, 445 participants).
    Muscular release (5 trials, 304 participants).”
    This is very poor science. But hay Edzard if it feeds your bias/agenda it must be worth citing.

    Now lets look at the title of this blog:
    “Manual therapy (mainly chiropractic and osteopathy) does not have clinically relevant effects on back pain compared with sham treatment” – “Bullshit” – Edzard Ernst.

    Now lets examine your reply to Guy Almog’s comment:
    “I did point out that most trials are chiro or osteo!”
    Your own comment is an appropriate reply to that statement “what a moronic comment!”.
    Perhaps you should read the papers before making sweeping comments.

  • Never mind the ad hominem – can those with relevant qualifications please explain why they studied and trained in osteopathy rather than chiropractic?

    Or in osteopathy or chiropractic rather than physiotherapy?

    Or in osteopathy/chiropractic/physiotherapy rather than in medicine?

    • I do not have a relevant qualification, yet I see three possibilities:
      1) They subscribe to the special ‘philosophy’ of chiro/osteo
      2) They expected to earn better money
      3) They were not bright enough to do medicine or physio

      • To be in a profession that does not tend to rely on pharmaceuticals for nonspecific back pain does appeal to some people who wish to focus on that population.

        Some prefer a more “natural” approach. Example:

        “Spinal manipulation provides modest short- and long-term relief of back pain, improves psychological well-being, and increases functioning.2,30” https://www.aafp.org/afp/2009/0615/p1067.html

      • @Richard Rawlins
        In my family is an head and neck oncologist, neurosurgeon, GP, general surgeon, O&G, PhD, Chiro’s and RN. My oldest son who is completing engineering contemplated doing medicine. Every doctor in the family advised him that they would not go into medicine if starting today. The GP’s who I work with in a medical centre all advised him “don’t do medicine”. Not one medico he talked to was positive about a career in medicine.
        I personally know 4 physio’s who have then studied chiropractic, 3 chiro’s who have studied physio, 2 physio’s who have studied medicine, 3 chiro’s who have studied medicine and one orthopedic surgeon who is currently at uni studying chiropractic. I was referred to a chiro by my father who is a surgeon after injuring my low back playing rugby.

        “I do not have a relevant qualification, yet I see three possibilities:
        1) They subscribe to the special ‘philosophy’ of chiro/osteo
        2) They expected to earn better money
        3) They were not bright enough to do medicine or physio”
        Cynical carpet bombing statements yet again Edzard.

        Your relevant qualification is Retired Professor of Complimentary Medicine at Exeter University. This should indicate that you read the paper before making sweeping generalizations. In the past I held out hope that you would evaluate the evidence as it presents itself and be prepared to change. Your blog on Charlotte Leboeuf-Yde demonstrated otherwise. See here:
        https://edzardernst.com/2017/04/we-have-an-ethical-legal-and-moral-duty-to-discourage-chiropractic-neck-manipulations/
        Here is a researcher doing research on cervical adverse events who you “have always thought highly of Charlotte’s work” yet you ignored her research until you could take exception on two sentences written in a “blog” then wrote your own hatchet blog. You harp on about this topic yet fail to support or write about Charlotte’s work. This speaks volumes about cherry picking and ignoring papers you have read that challenge your beliefs.

        Many people commenting on this blog look exclusively for the BS in chiropractic and equate it to the whole profession with arguments that mirror statements from vitalistic chiropractors who are defending their sacred beliefs/trust. The irony seems to escape both. You as a former professor are across the research, have the skills to assess a paper, yet you write this blog citing a very poorly written paper.

  • Your comments are very childish, as if you spend an inordinate amount of time trolling about picking fights using ad hominem attacks and poor logic. Every, single new comment section, there you are like a rash that never clears up. Do you not have loved ones or other objects of more vital focus? I don’t mind seeing a well argued debate, not at all, but you just seem bent on petulance on here. You wreck it in your own way like a wildfire scorches the earth.

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