LUMBAR DISC DEGENERATION AND SURGERY

LUMBAR DISC DEGENERATION AND SURGERY

METHOD: The question asked is whether surgery of any sort for only a degenerated lumbar disc is better than physical therapy and back education. Peer reviewed English language literature for therapeutic randomized controlled trials comparing treatment of lumbar disc degeneration with operative treatment compared to physical therapy and education. Studies of surgery for specific accepted indications such as herniation, fracture, instability and scoliosis were excluded as much as possible. Pub Med search of >100 studies yielded only 4 high level studies meeting this criteria..

TOTAL: 4 STUDIES

0 Studies

3 Studies

1 Studies

3 Level I

1 Level I

The preponderance of studies are high levels of evidence and are unfavorable for the prediction of success of surgery for lumbar disc degeneration without instability, fracture, or scoliosis. This means that the predictive value for success in non-operative care is excellent (greater than 25% level I studies). This also means that the success of operative care is very poor. Since the question is usually asked whether an operation will be successful in this case, we have chosen to answer that as above.

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LUMBAR DISC DEGENERATION AND SURGERY:
Studies Favorable: Total 0

LUMBAR DISC DEGENERATION AND SURGERY:
Studies Unfavorable: Total 3

Level I: 3 Studies

1. Lumbar instrumented fusion compared with cognitive intervention and exercises in patients with chronic back pain after previous surgery for disc herniation: A prospective randomized controlled study.
Brox JI, Reikeras O, Nygaard O, et al.
Pain 2006;122:145–55
No clinically significant difference was seen between surgery and non-surgery patients, including those with a discectomy done >2 years prior to the study.
Level I Study Rating Unfavorable for surgery.

2. Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.
Brox JI, Sorensen R, Friis A, et al.
Spine 2003;28:1913–21.
76% of non-surgery patients treated with physical therapy and back education improved compared with 70% of surgically treated patients that also had 17% complication rate.
Level I Study. Rating Unfavorable for surgery.

3. Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial.
Fairbank J, Frost H, Wilson-MacDonald J, et al.
BMJ 2005;330:1233.
394 patients randomized to surgery or physical therapy (rehab). No evidence that surgery better in outcomes. 19 patients with surgical complications
Level I Study . Rating Unfavorable for surgery.

LUMBAR DISC DEGENERATION AND SURGERY:
Studies Neutral: Total 1

Level I: 1 Study

1. 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: A multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group.
Fritzell P, Hagg O, Wessberg P, et al.
Spine 2001;26:2521–32.
Study funded by spinal implant manufacturer had 294 patients – 10% with accepted indications for fusion of instability – showed a minimal short term improvement with surgery but accompanied by a 17% complication rate – versus 0% without surgery. Criteria for evaluation limited and groups had statistical problems with treatments being changed mid study.
Level I study. Rating Neutral for surgery.

LEVEL I

Randomized, controlled clinical trials. Researchers would use a computer program to randomly assign patients with back pain into two groups of 20. The first group (placebo group known as the control) would drink water (that only tasted like pomegranate juice but was not) for 10 days. The second group would drink real pomegranate juice for 10 days. None of the patients would know if they were drinking the real pomegranate juice or not. (This is called a blinded study). Then a researcher who does not know which person drank what (which now makes this a what’s called a “double blinded” study) would interview the patients to determine if their back pain was reduced, worsened or stayed the same. After this was all done, the information about which patients drank what would then be revealed. One could then see if those who drank the real pomegranate juice were better or not than the water drinking group.

LEVEL II

Non-randomized, prospective comparative study. A researcher looks at 40 patients medical records to select 20 patients for the pomegranate drinking group and 20 patients for the control group who will drink water. This is called a “cohort,” namely a control and experimental patient make a cohort. Here the researcher may introduce his own bias whether he intends to or not. If he believes pomegranate is a safe, effective treatment for back pain then whether he means to or not he may put the healthier patients with less back pain in the pomegranate group and patients complaining of more back pain in the water-drinking group. (This particular bias is called “selection bias.” See section on types of research bias.)

LEVEL III

Retrospective (already occurred) comparative study or case controlled study (each “experimental“ patient is matched to a patient that never had the experimental). This is not a reliable standard for determining one treatment over another, though it can be helpful to, say, see how many complications a certain treatment has. Researchers do a retrospective study for example reviewing 20 patient records of patients who reported they have been drinking pomegranate juice in the past and then 20 patients who have not reported drinking pomegranate juice. Then the researchers review the patients’ medical records determine if the back pain was reported better, worse or stayed the same. Here again, the selection process may introduce bias intentionally or not. In this case it may not only be selection bias, but could involve “recall” bias, or “expectation bias” or “attention bias.” (See Bias in Research section).

LEVEL IV

Case series do not determine success or failure of a treatment compared to other treatments or no treatment at all. Researchers or a physician does a case study on 20 patients who drink pomegranate juice for 10 days and then report the results. In this case there is no control group or comparison to patients who are not drinking pomegranate juice. It does not take into consideration that back pain could get better in 10 days if the patient takes nothing at all for the pain. These studies are easier and cheaper. They can be of value to determine better methods of doing a particular treatment, or what the complications of a certain treatment are, but NOT for determining if one treatment is better than another.

LEVEL V

Expert opinion. One physician expert’s opinion on if pomegranate juice helps reduce back pain. No original research is conducted. Instead, just a written opinion or editorial that may talk about other research and give opinions, but no clinical study is conducted. AME considers this to be one step above hearsay for determining one treatment over another, though it may be valuable for stimulating discussion and ideas on a particular topic.

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