Chiropractic manipulation in the treatment of acute back pain and sciatica with disc protrusion: a randomized double-blind clinical trial of active and simulated spinal manipulation. [Spine J 2006; 6:131-137]
OPENING COMMENT: I have been aware of this paper for many years, but never publicly analyzed it because the verbiage in the results, discussion, and conclusions don’t match the actual data presented in table #3 – the two sources are contradictory. I’ve emailed the corresponding author several times over the years (in fact, I just emailed him again) but have never gotten an answer to which data is actually correct.
Nevertheless, since this is one of the papers that the New England Journal of Medicine used to support their opinion that the use of side-posture grade 5 manipulation for the treatment of disc-herniation-related back and leg pain is acceptable, I felt compelled to throw my hat in the arena. So here we go!
In 2006, Santilli et al publish the results of a randomized double-blind clinical trial to assess the efficacy of side-posture chiropractic manipulation for the treatment of acute back and leg pain, which were thought to be secondary to an MRI-confirmed disc protrusion. The study was conducted in Rome, Italy and published in the e-version of The Spine Journal.
It is important to understand that patients with positive neurological findings (which made them surgical candidates) and patients with the more serious types of disc herniation (i.e., an extrusion or sequestration) were not allowed to participate in the study.
STUDY DESIGN
One hundred and two (102) patients, all of whom had MRI-confirmed disc protrusions (NOT extrusions or sequestration), acute back, and leg pain were randomly placed into either a side posture manipulation treatment group (n=53) or a sham manipulation treatment group (clinician only touched/very quickly massaged their low back) (n=49).
Patients were evaluated every 30 days with regard to back pain, leg pain, functional status, and non-opioid medication use for six months. MRIs were also taken in all patients at the end of the study (six months after it began) to see if the disc herniations had diminished or worsened in size. The study was properly powered at 80% (this means it had enough patients to make a determination about the study topic); however, the follow-up period was not nearly long enough; the standard is at least a 24 month follow-up, not 6 months.
RESULTS
During the short follow-up, six patients left the study before its completion: five from the manipulation group, and one from the sham manipulation group. This is a problem!
In fact, if these dropouts were counted as treatment failures, then, as admitted by the authors, there would have been no difference with regard to pain intensity, or disability level between the treatment group and the sham group. An adequate explanation of what happened to the patients was not put forth.
However, if you simply remove the six patients from the study, a practice that is customary, then the treatment group patients did do statistically better with regard to back pain improvement when compared to the sham group with regard to pain and disability. With regard to leg pain (sciatica), there was no statistical difference between the groups.
With regard to functional disability (the patient’s ability to go about their normal activities of daily living) as measured by the often-used SF-36 there was no difference between the groups.
Although we don’t know specifically what happened to the five patients who left the treatment group, there were no serious adverse effects found in either group – it seemed like everybody tolerated the manipulation fairly well. Furthermore, although none of the disc protrusions decreased in size, none of them got worse.
The most impressive statistic from this paper, as picked up upon by the New England Journal of Medicine, was with regard to complete pain remission (these patients had no more complaints): at the end of the study (180 days) 28% and 55% of patients in the treatment group reported no back and leg pain, respectively. Only 6% and 20% of the sham treatment group reported no back and leg pain, respectively. This difference easily reached a level of statistical significance (P<0.005 and P<0.0001, respectively)
MY COMMENTS
Although I applaud the authors for carrying out this much needed study, I was disappointed with the short follow-up period (6 months) and fact they didn't include patients with disc extrusions or sequestrations, which are the more troublesome ones.
Chiropractors have been successfully sued for injuring patients with these types of herniations following spinal manipulation, and we need data on the efficacy (safety and effectiveness) of manipulation for them. So it was to bad they were not included in the study.
I think that the NEJM should have warned that disc extrusions and sequestrations should not be generally treated with grade V manipulation, for there is no data to support such treatment's efficacy, which is why chiropractors get sued over this.
Now I'm worried that chiropractors in the field are going to think it's safe to use grade V manipulation on any type of herniation, not relizing that the NEJM opinion that chiropractic grade 5 manipulation is safe for disc herniations was predicated on research that only studied this manipulation for disc protrusions and not to sequestration's or extrusions.
ChiroGeek's Rant
if you think about it, how in the world could a chiropractic grade 5 manipulation (the "cracking" of the backbones) help a disc that has been ripped through and released its insides to the outside? It certainly can’t reduce the size of the herniation, as clearly demonstrated in this study, and in fact has potential to turn a disc protrusion into a disc extrusion or even sequestration. Many a chiropractor, as well as other manual therapists have been sued over this form of treatment. So I don’t get it?
So, why did some of these patients in the treatment group get better compared to the fake treatment group? Most likely because their pain generator was not a disc protrusion! Remember, disc protrusions are very commonly seen in completely asymptomatic (have no pain) people. Specifically, disc protrusions are seen in about 30% of all people who don’t have low back pain.
Here’s an old analysis I did on this phenomenon: Herniations in People without Pain
So what was causing their pain if it wasn’t a disc protrusion? Most likely something that chiropractors and other manual therapists are very good at treating: an inflammation of the facet joint! Remember, an irritated facet joint can not only cause severe low back pain, it can also refer pain down the lower extremity, sometimes even past the knee and into the foot (although this is rare).
Anyway, I still strongly disagree with the use of grade 5 manipulation for any type of disc herniation. I think it’s just too risky and lawsuit inviting!
That said, there are other gentler techniques that chiropractors can use for treating patients with disc protrusions, such as Cox flexion distraction, a Leander table, or, just to make sure it’s not a facet problem, use an activator to mobilize the facet joints.