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Experimental Treatment May Help Relieve Back Pain

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3 Star

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Experimental Treatment May Help Relieve Back Pain

Our Review Summary

The story presents the results of a trial examining outcomes of patients with a disc herniation treated with a spinal injection of ozone and steroids. Because the story describes results presented at a meeting, it lacks details that are important to assess the quality of the study. Patients in this study had symptoms that weren’t improving with conservative treatment and were thought to be candidates for a steroid injection or surgery. Instead, they received a single injection of a combination of ozone gas and steroids. Six month outcomes are described – about a third had complete pain relief, another third had partial pain relief, 20% had little pain relief and 7% had no pain relief or were worse. Though promising, these results may be no better and possibly worse than steroid injections alone and probably worse than for surgery.

 

 

Why This Matters

Disc herniations can cause pain that radiates from the low back or buttocks into the legs, often below the knee – commonly called sciatica. Though the story refers to disc herniations as causing low back pain, leg symptoms are often more bothersome to patients than the back pain itself. Treatments for disc herniations such as surgery are also generally better at relieving leg than back pain.

For most patients with sciatica due to a disc herniation, the natural history is one of improvement over time. The body has the ability to shrink the disc material that is irritating the nerves that are causing the pain. However, some patients continue to have symptoms and these are the ones addressed in this study. Though not clear from the story, there are good treatments available for these patients. The standard of care for patients with persistent and bothersome symptoms for more than 6 weeks is surgical discectomy. It is common that patients may undergo an injection of steroids into the area where the disc is inflaming the nerve as an alternative to surgery. However, it is not clear that this results in outcomes that are the same or better than going directly to surgery. Indeed there is little data to suggest that steroid injections decrease the need for subsequent surgery.

With this background, the current study seeks to examine whether adding ozone to a steroid injection improves pain in patients with a disc herniation who aren’t getting better. The major problem is that the reader does not know whether the outcomes seen are as good as those with a steroid injection or surgery. The study didn’t compare these treatments, nor did the story describe the results of studies from patients with a steroid injection without ozone or surgery. If the story did, it would have to state that the outcomes may be similar but don’t appear to be better. With that context, the value of this treatment would appear less certain that implied.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

Though this is still an experimental approach, it would have been appropriate to discuss the costs in terms of the closest similar treatment – an epidural steroid injection. Since the story claims the experimental approach has been used thousands of times in Europe, some cost frame of reference was possible.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The story did a good job explaining the benefits observed in this study. However, where it fell short was in comparing these outcomes to those that may be expected with alternative treatments – specifically, an epidural steroid injection alone or disc surgery.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story explained that no side effects were observed and that a small percent of patients had more pain after the injection.

Bu the story does not talk about the potential risks of ozone gas to individuals as well as the environment. Ozone is a toxic gas and one would expect that the benefit of its use as a medical treatment would need to be clearly demonstrated prior to recommending it as a routine treatment option. Even if that is done, one would want to know that this gas can be safely generated and administered without causing toxicity to those administering it and to the environment itself. In this context, the mention of no risks seen in the study needs to be taken with considerable caution.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story did an adequate job explaining the preliminary nature of the results and that further research is needed before this can be considered for routine use. (But we think it could have done a better job of directly addressing supporters’ claims that the new approach “could become a standard treatment.” This came in the third paragraph. More conservative statements came much later.) It also described that the outcomes could be due to the ozone, the steroid, a combination of both or just the favorable natural history of a disc herniation. What the story didn’t do as well is describe outcomes of current treatments that would be alternatives.

 

Does the story commit disease-mongering?

Not Satisfactory

Though the story made the important point that the natural history of many disc herniations is to improve on their own with time, the story made an incorrect statement. By saying that, “As many as 80% of adults in the U.S. suffer from lower back pain at some point in their lives, and for many, the cause is a herniated disc,” it implies incorrectly that disc herniations are a common cause of low back pain. It isn’t. In fact, only a small percent of patients with low back pain have a disc herniation as the cause. It is true that patients with pain radiating into the leg are more likely to have a disc herniation, but this was not stated and most patients with low back pain do not have associated leg pain.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story quotes a spokesman for the American Academy of Orthopedic Surgeons and it is implied but not stated that this person was not associated with the study. The spokesman provided important context.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Though the study described alternative treatments, it didn’t actually state how the results reported here compare. A key deficiency of this study is that it didn’t compare the treatment to common alternatives. Since there are good treatments available for herniated discs that aren’t getting better on their own with conservative treatment, one can only comment on the current results in comparison to these alternatives. This was not done.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story made clear that this treatment is available in Europe, but not in the United States.

Does the story establish the true novelty of the approach?

Satisfactory

The story made clear that this is a relatively new experimental approach for a disc herniation.

Does the story appear to rely solely or largely on a news release?

Satisfactory

The story used several sources and did not appear to rely upon a press release.

Total Score: 6 of 10 Satisfactory

Comments (1)

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Mark Schoene, Editor, The BackLetter

December 5, 2011 at 11:04 am

Good review. But would respectfully suggest that discectomy should NOT be referred to as the “standard of care” for persistent, bothersome sciatica lasting more than six weeks.

If discectomy were to be regarded as the “standard of care”, all other treatment options would fall outside that medicolegal standard—which would be unfortunate, and out of line with reality. Also, If discectomy were the standard of care, surgery rates would go through the roof.

Discectomy is just one of several treatment options—depending on the patient’s preferences and values.

Here is the section on discectomy from the American Pain Society Guidelines by Chou et al (Spine, 2008; 34(10):1066-77), which offers a more nuanced recommendation:

“For persistent and disabling radiculopathy due to her-
niated lumbar disc, standard open discectomy and mi-
crodiscectomy are associated with moderate short-term
(through 6 to 12 weeks) benefits compared to nonsurgi-
cal therapy, though differences in outcomes in some trials
are diminished or no longer present after 1 to 2 years.104 –108
In addition, patients tend to improve substantially either
with or without discectomy, and continued nonsurgical
therapy in patients who have had symptoms for at least 6
weeks does not appear to increase risk for cauda equina
syndrome or paralysis.108

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