Lumbar spinal stenosis (LSS) is a common reason for spine surgery. Several non-surgical LSS treatment options are also available, but their effectiveness remains unproven. The objective of this study was to explore the comparative clinical effectiveness of three non-surgical interventions for patients with LSS:
- medical care,
- group exercise,
- individualised exercise plus manual therapy.
All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat.
Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. The primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes).
A total of 259 participants were allocated to medical care (n = 88), group exercise (n = 84), or manual therapy/individualized exercise (n = 87). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care or group exercise. Manual therapy/individualized exercise had a greater proportion of responders (≥30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates.
The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity.
In many ways, this is a fairly rigorous study; in one important way, however, it is odd. One can easily see why one group received the usual standard care (except perhaps for the fact that standard medical care should also include exercise). I also understand why one group attended group exercise. Yet, I fail to see the logic in the third intervention, individualised exercise plus manual therapy.
Individualised exercise is likely to be superior to group exercise. If the researchers wanted to test this hypothesis, they should not have added the manual therapy. If they wanted to find out whether manual therapy is better that the other two treatments, they should not have added individualised exercise. As it stands, they cannot claim that either manual therapy or individualised exercise are effective (yet, I am sure that the chiropractic fraternity will claim that this study shows their treatment to be indicated for LSS [three of the authors are chiropractors and the 1st author seems to have a commercial interest in the matter!]).
Manual therapy procedures used in this trial included:
- lumbar distraction mobilization,
- hip joint mobilization,
- side posture lumbar/sacroiliac joint mobilization,
- and neural mobilization.
Is there any good reason to assume that these interventions work for LSS? I doubt it!
And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design.
And why do I find such studies objectionable?
Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective). To put it bluntly, such trials
- could harm patients,
- might waste money,
- and hinder progress.
27 Responses to Non-surgical Treatments for Lumbar Spinal Stenosis? How to make even a useless therapy appear to be effective
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Edzard,
I don’t entirely agree with your criticism of this trial.
”
lumbar distraction mobilization,
hip joint mobilization,
side posture lumbar/sacroiliac joint mobilization,
and neural mobilization.
”
This sounds like a description of the standard treatment I would expect from a physiotherapist for this sort of problem. Though to what extent this is based on evidence I’m not sure. In the trial this (and the exercise programme) was delivered by two physiotherapists and a chiropractor who had been trained in a specific protocol which had been designed with generalisability in mind (my reading of what they mean by this is that it could be delivered by chiropractors as well as physiotherapists).
So my interpretation is that the trial compared medical treatment vs. group exercise vs. more-or-less standard physiotherapy, which happened to be delivered by a chiropractor in some cases.
“The authors concluded that a combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity”
The authors found some differences in self-reported symptoms and self-reported activity at two months, but no differences between the groups in objective measures, and no differences in any measures between the groups at six months, though all groups showed improvements within the group over the study period.
They also looked at adverse effects, and not surprisingly the medical care group reported the known side-effects of the various drugs they were prescribed.
They discuss the limitations of the study, including to what extent the assessments they had used, which had been developed for post-surgical patients, were applicable to non-surgical patients. They also considered that there may have been different motivation between the groups (as evidenced by a greater drop-out rate in the group exercise group) which could have introduced bias (though they did their analysis on an intent-to-treat basis, and in any case motivation is surely one of the mechanisms whereby an intervention might work). They considered that the greater short-term benefit in the individual exercise and manual therapy group may have been due to the personal attention they received. Finally they admit that there should have been a no-intervention control since the changes seen could have been due to the natural history of the disese.
Their conclusion was:
“Mounting concern about the rising rates of spine surgery and opioid use in older adults makes a compelling case for the dissemination of new evidence about safe and effective nonsurgical and nonopioid pharmacologic treatment options for LSS. The results of this study provide new evidence about the comparative effectiveness of tailored medical care, group exercise, and a combination of chiropractic/physical therapy as viable nonsurgical and nonopioid treatment options for patients with LSS”
Oddly enough, this is somewhat different from the conclusion given in the abstract, which is the one you quote.
They finish with:
“Patients, health care professionals, and other stakeholders would benefit from the dissemination of these new research findings”
Which I suppose is a plea to be taken seriously.
You comment:
“And this is what makes the new study odd, in my view. Assuming I am correct in speculating that individualised exercise is better than group exercise, the trial would have yielded a similarly positive result, if the researchers had offered, instead of the manual therapy, a packet of cigarettes, a cup of tea, a chocolate bar, or swinging a dead cat. In other words, if someone had wanted to make a useless therapy appear to be effective, they could not have chosen a better trial design”
The authors have already discussed reasons why the differences between the arms may not be to do with the treatments themselves. It seems to me that you are suggesting that the manual therapy component of physiotherapy should be separated from the exercise component. This, of course, would be the subject of a completely different trial. I am not familiar with the physiotherapy literature, so I don’t know to what extent this has already been done. Possibly some of this information is in the references given by the authors but I don’t really have the time to look them up.
“1st author seems to have a commercial interest in the matter!”
Funnily enough, he doesn’t mention this in the Conflicts of Interest section of the paper, though he does give a funding source. However, as the paper doesn’t seem to be recommending chiropractic or has any pointer to his clinic I can’t detect any undue influence here.
“And why do I find such studies objectionable?
Mainly because they deliberately mislead many of us. In the present case, many non-critical observers might conclude that manual therapy is effective for LSS. Yet, the truth could well be that it is useless or even harmful (assuming that the effect size of individualised exercise is large, adding a harmful therapy would still render the combination effective).”
I can’t see that this paper is deliberately misleading at all. I agree that non-critical observers may come to the wrong conclusions, and that is true of all medical papers, which require a certain level of expertise to read. For that matter, the medical therapy group includes a number of different interventions (opiates, NSAID’s, antidepressant and neurmodulator drugs, and steroid injections) which would be expected to vary in their safety and effectiveness, and it may be that the benefits of some of them are hiding the harms of others.
I think you are unfair on this study, which sets out to fill a gap where the evidence so far is lacking, and where the authors do not seem to be drawing unwarranted conclusions at all, except inasmuch as the abstract isn’t an entirely accurate summary of the whole paper. Of course it is easier to read an abstract than to evaluate a paper critically, but those writing guidelines such as the North America Spinal Society would take the totality of evidence into consideration, and those practitioners who go outside the guidelines should be using more than just an abstract to justify their policies.
the point I wanted to make (but might have failed) is this:
any comparison of an effective treatment (exercise) and a better version of this treatment (individualised exercise) plus some rubbish will show that the combination is better even thought the added bit is rubbish.
such a trial design leads to misleading interpretations.
They compared three commonly used nonsurgical interventions and reported the outcomes. It’s a starting point.
“To help bridge this gap, we performed a randomized clinical trial to compare the effectiveness of 3 nonsurgical interventions.”
that’s where to oddity of this trial begins:
they compared not 3 but 4 non-surgical interventions:
1) medical care,
2) group exercise,
3) individualised exercise,
4) manual therapy
It was a more pragmatic research design. Based upon the results one can begin to tease out.
tease out what?
Granted surgery is expensive and generally not necessary but how expensive is this manual-therapy prestidigitation? I’m sure in private practice it’s $65-125.00 per session….or more. And gave short term value blurred out at 6mos? Flexion-distraction is a table used 99% by DCs. It’s replete with hogwash mechanisms of action and subluxation overlays (specificity, direction-of-thrust, angle, motion-palpation, sucking-discs back-in via body position etc). Whatever contrivance can make it appear like it isn’t a gypsy-trick which could be learned in an hour. I’d bet the exercise bike and walking were the source of any relief. I understand the need for PT: stroke, CP, elder-care, hospital-mobility-help, exercise-instruction, temporary pain relief etc under the carapace of sanctioned medical respectability. The arcane $200K, 6 year DC clown-college thing makes this study stink. Why the hell add these buffoons into the mix? Anything they do has to be learned from PT. What ISN’T “chiropractic” IF “neural mobilization, exercise, distraction, hip-mobilization, stretching AND strength training ARE ALL “chiropractic” as well?? Are THESE the focus of their “education” today? What about mis-alignments, fixations, subluxated-vertebra, blocked innate-flow and dis-ease? Why ever becomeva DC when being a PT would at least obviate the need to only and always be in private-fraud-practice? Isnt this just more bait-and-switch??
Why not use RNs? Or LPNs? NOTHING this study claims to use is hard to learn. And since NONE of it has one wit of true validity or reliability anyway it’s all just meant to add one more layer of indispensablity to DCs and these pricey, dubious antics. It’s got catechism written all over it.
Why is the result in the abstract so different from the conclusion in the main study? This seems to me to be a huge flaw in the whole thing. If I had read the abstract I would have – like EE- concluded that this might be a vehicle yet again for promoting chiropractic. However as I read EE comments I must confess that I thought that the same conclusion could be applied if the paper was from physiotherapists. This part of manual therapy being common to both ‘professions’
If in fact this paper is intended to further research into non-surgical and non drug-therapy solutions in a climate of rising levels of surgical intervention/opioid use for LSS then why has this bit been missed from the abstract result. How is it that this is not picked up at peer -review stage?
I do not think that the manual therapies used here are typical of physiotherapy; they are more typical of chiropractic.
in any case, it’s a mess.
EE: I do not think that the manual therapies used here are typical of physiotherapy; they are more typical of chiropractic
Really? No manipulation, mainly mobilization with exercises…that’s more typical of chiropractic than PT?
Ernst, what are the standard approaches for LSS within the PT profession?
FOR INSTANCE:
” manual therapy, stretching and strengthening exercises, and body weight-supported treadmill walking” (https://www.ncbi.nlm.nih.gov/pubmed/29395806)
“exercise” (https://www.ncbi.nlm.nih.gov/pubmed/29351748)
“Physical Therapy: Patients were treated with a physical therapy program emphasizing lumbar flexion exercises, general conditioning exercises, and patient education.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6252248/)
Better description… https://www.physio-pedia.com/Lumbar_spinal_stenosis
Are there any physiotherapists reading this who can enlighten us?
“Interviews with physical therapists and chiropractors revealed there were common LSS treatment themes, including the use of spinal de-weighting or traction, spine and hip mobilization, and individualized exercise.
The three intervention arms of this study will utilize a pragmatic effectiveness design, using protocols that allow for some individualized variation, rather than comparing strict mono-therapy approaches in an efficacy design. Our approach is designed to provide more generalizable results by simulating the real-world delivery of these treatment methods.
The procedures and protocols within each treatment group were informed by reviews of the literature, as well as by interviews with patients and providers.”
https://chiromt.biomedcentral.com/articles/10.1186/2045-709X-22-19
The manual therapy techniques described which are mobilisations are indeed commonly used by physiotherapists and chiropractors. The limitations of this study are clearly outlined by the authors, they are not hiding the shortcomings.
A lumbar spinal stenosis is an anatomical fixed abnormal narrowing of the spinal canal and / or neural foramina which causes pressure on the spinal cord or nerve roots mostly combined with a regionally and chronically high tonus of the paravertebral muscles and sometimes also combined with partial calcifications of the regional soft tissues. The people’s steps are getting smaller and smaller and it becomes a painful situation and a lot of other neurological symtoms can occur. Anatomical fixed conditions cannot be changed without surgery. So if manual therapy or exercises might have an effect it could only change the accompanying higher tonus in the soft tissue / muscles partially which might give some release to some areas only for a short time (hours or a few days) but this will never change the anatomically converted structures (osteophytes, hypertrophic ligamenta flawa, narrowing by deformations caused by osteoporosis a.s.o.) So to argue this interventions can be used in general to improve spinal stenosis is implausible.
There are situations where surgical intervention is not an option or the intervention may be applied while on a wait list for surgery. But no, one is not going to reverse LSS due to degeneration with conservative care, but that is not the goal.
“to argue this interventions can be used in general to improve spinal stenosis is implausible.”
There is a difference between what ought to be and what is. The authors found an improvement over time in all treatment groups without surgery, and I don’t find this as implausible as you do.
If there is an inflammatory component either to the stenosis or to the nerve compression within the stenosed canal, then a resolution of the inflammation with time could give an improvement in function and a reduction in pain, helped (as you suggest) by a concomitant reduction in reflex muscle spasm. Perhaps also atrophy of some nerve fibres might make more room for others. I am suggesting mechanisms here; I don’t know what happens in practice, and indeed the authors of the paper make the point that the natural history of unoperated spinal stenosis is not well documented.
Admittedly my experience of managing spinal stenosis is limited to malignant disease, where rapid deterioration is usual unless the patient is treated urgently with either surgery or radiotherapy.
let me try this:
a trial tests a new cancer treatment against an established one and in a third group they decide to administer the new cancer treatment in a special, individualised fashion. oddly they add to the latter also some crystal healing. the results show improvements in all groups with the third group faring best. what does that say about crystal healing?
I am not saying that manual therapy is as whacky as crystal healing; I am however saying that such a trial design does not allow a conclusion about it.
EE…such a trial design does not allow a conclusion about it.
Yet in the title of this blog you called it a useless therapy.
no, I didn’t!
“How to make even a useless therapy appear to be effective”
Perhaps you meant a potentially useless therapy?
‘how to make a useless therapy appear to be effective’ refers to the trial design that can make any useless therapy, even ‘swinging a cat’ [see article], appear effective.
sorry you fail to understand English/logic
EE…”sorry you fail to understand English/logic.”
EE….”the point I wanted to make (but might have failed)…”
Exactly- that was my point. Physiotherapists do use mobilisation techniques- they do not use manipulation- which I infer to mean that which chiros do ( cracking the back). I see an MSK physio regularly and this is how he explained it to me.
My problem is with the lack of rigour in the paper itself. How does it get past peer review with such muddled thinking and sloppy result/conclusion? It leads me to wonder who these sort of articles are for? I assumed they were not just for the medical profession but a contribution to patient-centred care thus encouraging patients to do their own research and evaluation of their care? If so are these sort of errors deliberate by the authors who are hoping that most of their audience cannot think critically because they are probably not scientists?
Burdle….Physiotherapists do use mobilisation techniques- they do not use manipulation
Last I saw physical therapists are allowed to do spinal manipulation in or around 26 states.
In UK physios don’t crack the back- is that what manipulation is? maybe I have the incorrect terminology. In UK physios distance themselves from chiropractors- physio training is not ‘self regulated’ ? Maybe a UK physio could come on and explain exactly how they differ from chiropractic when dealing with MSK issues?