Henrik Weber , '1982 Volvo Award in Clinical Science' "Lumbar Disc Herniation: A controlled, Prospective Study with Ten Years of Observation." Spine - 1983; 8(2):131-140
In 1982, Weber et al. published the results of a rare randomized controlled trial which compared standard discectomy against conservative care for the treatment of disc-herniation-related-back and leg pain. In fact, so impressive was the design, follow-up, and quality of the study, that it was awarded the prestigious Volvo Award, which is like the Nobel Prize of spine surgery.
In a nutshell, 126 patients with moderately severe back and leg pain (so severe they were admitted to the hospital) were randomly placed into one of two treatment groups: a discectomy group or a conservative care group. Then they were followed for 10 years to see how they did with their respective treatments.
At the one year mark, approximately 70% of the conservative care group were still suffering debilitating back and leg pain; they were not happy. On the other hand, over 60% of the patients in the discectomy group were satisfied with the treatment outcomes. The Researchers concluded that, at the early outcome mark, discectomy had a clear, statistically significant advantage over conservative care.
But, by the four-year mark, things had changed. Specifically, the conservatively treated patients had statistically "caught-up" with the surgical group, in terms of clinical improvement:
At the 10 year follow-up, the groups remained the same with respect to satisfaction and pain levels, and the lingering sciatica had improved even more:
The results of this study, which have been confirmed in several modern huge investigations (eg, the SPORT study), suggest that discectomy is very good at getting patients out of pain and back to work much faster than conservative care does. However, in the long run (i.e., 4-10 years), it doesn't seem to matter whether you go the surgical route or stick with conservative care; the results are the same.
*One important thing to remember, however, is that none of these patients were absolute surgical indications. They were all "on the fence" so to speak with regard to surgery. More specifically, none of them had cauda equina signs and symptoms; severe or progressive motor loss; or severe unrelenting back and/or leg pain. If they did have any of the after mentioned signs and symptoms, then they went right to surgery.
Two hundred eighty Norwegians, suffering from sciatica were admitted into the hospital for a minimum of 14 days in 1970 and 1971. One hundred twenty-six patients of these were selected to participate in a ten year randomized study of their recovery. These 126 were considered 'boarder line surgical candidates' and all had sciatica (aka: radicular lower limb pain) which was worsened by sitting, bearing down (coughing), and exercise. 90% percent of these patients had "definite disc herniation's" as confirmed by myelogram. The other 10% were suspicious for herniation as there myelogram's were only partially positive.
I'll point one criticism right now - as noted by Saal & Saal. One hundred fifty-four of the study patients were cast out of the study right from the start because: A) Their symptoms were too severe and they were operated on, or B) there symptoms were NOT strong enough (maybe they had negative myelograms or negative root tension signs) so they couldn't be randomized. Its too bad that they could have followed these two groups as well for completeness but they didn't. Saal & Saal did include a small sub group of patients in their study that were told they better have surgery or else! (go here for the famous Saal & Saal study)
The patients were examined at 1 year, 4 years, and 10 years by the author. A complete neurological examination, psychosocial assessment, and lots of questions regarding work status, medication use, continued pain amount, and the ability participate in leisure activities were posed. From the answers to these questions, the author then 'somehow' put the patients into one of four categories:
See the full results HERE:
This is it, the study of all studies, the only major study to date that was 'allowed' to randomize a group of symptomatic confirmed disc herniation suffers into either a surgery (discectomy) group or a conservatively treated group, by lottery. This study had an absolutely amazing retention rate of 96% (121/126) for 10 years in group one which was the main focus group within the study!! There were some motivated and dedicated patients! Only 5 patients were lost: 3 died in the surgical group (2 heart, 1 cancer) and two no-showed at four years - again in the surgical group. The only thing I was very disappointed in, besides the fact that its 20 years old, was the very non-specific patient assessment method.
Famed Italian researcher F. Postacchini (21) noted that "The main defect of this study is that only the patients with uncertain indications for surgery were randomized for treatment.
I still wonder what happened to the other two groups in this study; the really bad that were forced into surgery and the best of the bunch?
Saal and Saal (19) also noted that the Weber study did NOT exclude patients that cases were complicated by lateral stenosis. (Lateral stenosis is a major complicating factor in failed lumbar disc surgery (20)) The Saal's also noted as I did, that Weber's success rating categories were not very precise.
This study will be de- throned soon, for a new gold standard is under way at this very moment ( 11-09-03 ). It's called the SPORT study and it headed by Birkmeyer & Weinstein (18).
The study in Detail:
The author's idea was to further investigate that past finding of Hakelius (16) and Nashold and Hrubec (17); who found that at 7 and 20 year follow-ups, there was no significant difference between those treated surgically and those treated non-surgically.
Two hundred eighty Norwegians, suffering from sciatica were admitted into the hospital in 1970 and 1971. Two weeks of therapy were given (1 week bed rest & isometric exercise, then 1 week easy walking, PT, back school.) Myelograms were positive in 90% and suggestive in 10% of the patients for either a L5 or S1 root lesion. Exclusions : Spondylolisthesis and past surgical patients were excluded. During their two week stay in the hospital, three groups were formed:
Re-Operations : Only 4% (5 of 121 patients) had to have re-operations (3 one surgery, 2 two surgeries). All but one of these five had fair/good result. (I didn't include the five patient that were knocked out of the study)
Group 1 (This was the main focus group in this study) had 126 patients that: 1) still had radicular pain provoked by Valsalva's test, sitting, moderate exercise, positive SLR, muscle weakness, decreased ROM, and lateral tilt (antalgia). These 126 were ' randomized ' into either a surgical group, or into a continued therapy group. Just by the luck of the draw so to speak! The non-surgical group received "an average of six weeks more of physical therapy" at a rehabilitation hospital.
Group 2 consisted of the worst of the bunch, 67 patients that definitely had surgical indications: severe and immobile scoliosis, intolerable pain, suddenly occurring and/or progressive muscle weakness, and/or cauda equina syndrome.
Group 3 consisted of 87 patients who had moderate symptoms, and/or signs, and showed continued signs of improvement with bed rest, physical therapy, and medication.
Surgical treatment: consisted of removal of the ligamentum flavum and some of the lamina, removal of the herniated portion of the disc, and "excochleation" of the disc. Kind of a partial laminectomy.
Conservative treatment: 6 more weeks of Physical therapy. That's it. I'm hoping they were at least given some home exercise and stretches or something!
The patients were examined at 1 year, 4 years, and 10 years by the author. A complete neurological examination, psychosocial assessment, and lots of questions regarding; work status, medication use, continued pain amount, and the ability participate in leisure activities. The author then 'somehow' put the patients into one of four categories:
Things got a little complicated, for 17 of the 66 were lost to surgery at 1 to 11 months. So now we have three groups: conservative, delayed surgical, prompt surgical:
Conservative Group : Only 32% (16/50) were completely satisfied with their outcome at one year! One chickened out of surgery: I put this 'fair' outcome into the conservative group. 18% (9/50) were poor or bad.
Delayed Surgery Group : 47% (8/17) were completely satisfied with their outcome at one year. This group did not do as well as the surgical group. Maybe this is because their condition severely worsened or maybe the delay ??? Lets see how the stack up against Group 2. 29% (5/17) were poor or bad.
Surgical Group : 66% (39/59) were completely satisfied with their outcome at one year. 8% (5/59) were poor or bad
Conservative Group : Only 52% (26/50) were completely satisfied with their outcome at four years! The chicken lady improved into the completely satisfied group! Good move. 10% (5/50) patients were Poor or Bad.
Delayed Surgery Group : 52% (9/17) were completely satisfied with their outcome at four years. 18% (3/17) patients were Poor or Bad.
Surgical Group : 66% (39/59) were completely satisfied with their outcome at four years . 14% (8/59) patients were Poor or Bad. [Note: Three were not examined (2 no show, and 1 died of natural causes). ) (70%: nice 39/56) but the author left it at 66% probably because that 39 completely satisfied did not change.] (The Saal's would have used the 70% LOL)
Conservative Group : Only 56% (28/50) were completely satisfied with their outcome at ten years! 8% (4/50) patients were Poor or Bad. The chicken-lady stayed in the completely satisfied group!
Delayed Surgery Group : 59% (10/17) were completely satisfied with their outcome at ten years. 0% (0/17) were Poor or Bad.
Surgical Group : 58% (34/59) were completely satisfied with their outcome at ten years. 7% (4/59) were Poor or Bad. [Note: Five were not examined (2 no show, and 3 died) (63%: nice 34/54) but the author left it at 58% - maybe he just left them in their original groups??]
Motor comes back much better than sensory loss does but boy did it take a long Time!
Motor Loss: It takes a long time but it comes back! 51% (64/126) patients had demonstrable motor loss (most in foot dorsiflexion) at the beginning hospitalization period. The recovery rate was NOT related to either treatment. At four years only 16% (20/123) had motor loss, meaning the motor power only came back in 31% of the patients after 4 years! At ten years, only 4% (5/121) still had muscle weakness. The weakness was evenly distributed between the surgical and non-surgical patients.
Sensory Loss: After 10 years, 35% of the patients still had a sensory deficit which did not favor either group, Meaning that in 65% of the patients sensory loss (leg and foot numbness) never was normal again!
Prognostic indicators at four years:
Male patients, patients without psychosocial problems, prior physically active patients, all had better outcomes than their opposites.
Occupation, build (body type), pre-existing sciatica (earlier attack of sciatica), duration of radiating symptoms, age of patient when they had their first attack of LBP and sciatica, and interval between the onset of LBP and the radiating symptoms, all did NOT have any prognostic value.
Surgery is more efficient and quicker at getting patients out of pain than conservative therapy as treatment for low-back pain and sciatica caused by disc herniation - at a one year follow-up. Surgery holds its 'lead of success' over the next ten years, but the non-surgically treated patients 'narrowed the gap' to a point where the surgical groups improvement in no longer "statistically significant" to that of the non-surgically treated group.
"The fact that the immediate prognosis after surgery is better than that of the non-surgical group does not alter the author's view that an operation should NOT be performed if other treatment (conservative non-surgical) will give equivalent results within an acceptable period of time." My question is; is 4 or even 10 years an acceptable period of time? Carragee had some opinion on this. something to the effect that it may not be economically feasible to a self employed brick layer to be laid up for this long. They would go broke.
The author recommends a three month "observation period" for all patients with "doubtful surgical indications".
"If the pressure on the root can be relieved immediately after the appearance of the paresis, surgery has been regarded as the therapy of choice and has also been the rule in this series."
"Acute lumbago, as experienced by the majority of the patients at an early stage, occurred rarely after the attack of sciatica that led to the hospital admission."
Most of the patients ridded themselves of the chronic lower back pain between the fourth and tenth year.
After operation, the sciatica usually disappeared promptly or in the course of a few days.
The author noted that "sometimes the site of pain changed from the lower leg to the region of the hip or sacroiliac joint and the pain became permanent. No explanation can be offered."
"The natural course of the radiculopathy's in disc disease is more encouraging than expected."
"Back insufficiency was the main complaint at the final examination, equally distributed in the two treatment groups."
16) Hakelius A, "Prognosis in sciatica: A clinical follow-up of surgical and nonsurgical treatment." Acta orthop Scand ( Suppl ) - 1970; 129
17) Nashold BS, et al. "Lumbar disc disease: A twenty-year clinical follow-up study." Saint Louis , Mosby , 1971
18) Birkmeyer NJO, Weinstein JN, et al. "Design of the Spine Patient Outcomes Research Trial (SPORT)." Spine - 2002; 27(12):1361-1372
19) Saal JA, Saal JS, "Nonoperative Treatment of Herniated Lumbar Intervertebral Disc with Radiculopathy." Spine - 1989; 14(4):431-437
20) Burton C, Kirkaldy -Willis W, et al. "Causes of failure of surgery on the lumbar spine." Clin Orthop 157:191-199 1981
21) Postacchini F, "Management of Herniation of the Lumbar disc: Review article" J Bone Joint Surg [Br] 1999; 81- b( 4):567-576
© Copyright 2002 – 2005 by Dr. Douglas M. Gillard DC - All rights reserved