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The Study | Results | Inconsistencies | Discussion | Favorite Quote | Final Comments

Saal & Saal, "Nonoperative Treatment of Herniated Lumbar IVD with Radiculopathy: An outcome Study." Spine - 1989; 14(4):431-437

Although this was quite an old investigation, it was one of the few that followed a group of moderate to severe sciatica-stricken patients, who were conservatively treated, over a relatively long period of time, i.e., a two year period with a 91% participation rate.

In a nutshell, the Saals collected a group of patients who all suffered from disc herniation-associated sciatica; all of these patients had MRI/CT evidence of disc herniation (>4mm in size), a positive EMG study demonstrating radiculopathy, a positive straight leg raise test, and had failed non-aggressive conservative care.

The cohort was then put through the Saals' "aggressive conservative care" program that consisted of epidural steroid injections, among other things.

The results demonstrated that although relatively few recovered 100%, the overwhelming majority recovered enough to return to work on a full-time basis and were able to participate in some limited recreational activity.

The most sobering piece of data, however, was that only 25% to 30% of these patient recovered enough to resume a basically normal recreational-activity filled life! This reality is confirmed by other investigations as well and confirms the fact that true disc herniation-associated sciatica has a very high morbidity rate. (20-25)

On the down side, I did have some 'bones-to-pick' with the Saals' regarding their method of reporting the results, and noted one rather strange inconsistency between the "Excellent" outcome group and their respective Oswestry scores. (here)

The Study:

The Saal brothers reviewed the records of 347 consecutive patients from their "Spine Specialty Clinic" that were treated for lumbar disc herniation and radiculopathy between 1985 and 1986. After all the screening was done, 64 patient were selected to participate in this investigation. The mean age of the participants was only 35 years of age, which is about 6 years younger than most investigations on this subject. The following entry criteria was used: 1) Lower limb pain (sciatica) greater than lower back pain. 2) CT and/or MRI evidence of a 5 millimeter or greater disc herniation; 3) EMG confirmed lower limb radiculopathy; 4) and a positive Straight Leg Raising Test. This cohort also all failed to improve after an average of 4.5 months of "passive conservative care" that included rest, exercise, and traction. 

Of particular interest was a small sub-group of 18 patients that had more severe symptomatology and had been advised by a spinal surgeon that "surgery was an absolute necessity and should not be delayed." I called this group the "Surgery Recommended Group".

The Treatment:

The patients were all put through what the authors called an "aggressive active treatment" protocol that included the following: back school classes, spinal stabilization training, general body exercises, flexibility exercises, epidural steroid injections and selective nerve root blocks.

The Assessment:

At 2 ½ years, 58 of the 64 patients (91%) completed (via mail) a "standardized questionnaire" including the 'Oswestry Low Back Pain Disability Questionnaire', Pain Self-rating form, work status form, and a 'Self-rating Out-come Criteria '.

The 'Self-rating Out-come Criteria ' allowed the patients to rate their recovery from sciatica by using one of the following descriptions:

Patient Self-Rating Outcome Criteria:

Excellent:

Working full-time, performing usual athletic activities.

Good:

Working full-time, but limited in performance of athletic activities.

Fair:

Working part-time only and Unable to participate in athletic activities.

Poor:

Unable to work and unimproved following treatment.

 

 

 

 

 

THE OVER-ALL RESULTS OF 'AGGRESSIVE CONSERVATIVE CARE':

Below we have the 'subjective' outcomes of the investigation, and the more 'objective' outcomes (return to work). Please keep in mind that I have also added the 6 patients into the results [brackets] that failed conservative care and were lost to surgery; the Saals, for some reason, didn't feel that these 6 surgically-lost patients should be included.

Self Rating Outcome: * Note that I'm giving Saals' results in two forms: one based upon the 52 patients and the other, in [brackets], based on all 58 patients. (the 6 patients that failed with conservative care, I've included in the 'failed' category'.

Number of Patients %

Oswestry Scores:

"Successful Out-come" Excellent & Good combined

96% [86%]

18.3 %

Excellent out-come: (15/52) [15/58]

29% [26%]

16.6 %

Good out-come: (35/52) [35/58]

67% [60%]

20 %

Fair out-come: (2/52) [2/58]

4% [ 3%]

32 %

Poor out-come: (0/52) [?/58]

0% [?]

 

Surgery recommended Group:

83% success (20% excellent, 80% good)

 

 

Groups:

Return to Work Percentages:

Entire Group:

92%

No job change needed!

Surgery recommended Group:

100%

 

Work Comp Group:

86%

 

Extruded Disc Group:

100%

 

Sub-group I - Surgery Recommended Group: There was small subgroup of 18 patients (31%) that were included in this conservatively treated bunch.   All of these 18 patients had been told that they needed a surgery as soon as possible to avoid long term complications. 15 ( 83% ) of them did well (good or excellent) with conservative care: 3 scored Excellent (17%), and 12 (80%) scored themselves as Good. 3 were lost to surgery.   All 15 returned to work.

Sub-group II - Extruded Fragments: 15 (26%) of the 58 patients had 'extruded disc fragments seen on CT'.   87% were a treatment success (Excellent or Good); 3 were lost to surgery; and 92% returned to work.   Saal states: "it appears that disc extrusion by itself is not an adequate indication for surgery."

Sub-group III - Weakness +EMG: 37 (64%) of the patients had weakness on exam with a positive EMG.   There outcome was no different from the rest; 84% achieved excellent or good outcomes. Saal states: "We did not consider patients with a non-progressive neurologic deficit (weakness) to be surgical candidates without an adequate trial of nonoperative care.   Any patients with a progressive neurologic deficit (one in this study) were sent to surgery without delay."   They noted that Weber would have included "profound" weakness in the surgical group, where as Saal's did not.

Inconsistencies and Problems with Methodology:

I've got a real problem with the Saals leaving the 6 patients who failed the prescribed 'aggressive conservative care' out of the results! For the life of me I can't figure out why they would do this. It skewed the data, although I tried to correct for it by including the 6 into the negative results [brackets].

My second problem with the study was the inconsistency between the Oswestry Scores and the "Excellent category". Despite claiming an "Excellent" result, they still claimed an average Oswestry score of 18.3 (which is a significant disability). This make absolutely no sense at all and I can only hope it is a typo. (I've e-mailed the authors but have gotten no response on this matter.)

Discussion:

The most sobering finding in this study (which was never mentioned by the Saals) was the fact that after two years, only 25% to 30% of these relatively young patients (median age 35) with confirmed disc herniation and radiculopathy recovered without significant disability and were not only able to return to work but were able to return to all athletic activities like softball, biking, bowling, swimming etc. This confirms what other investigation have said: It's fairly rare to completely recover from sciatica (20-25).

On the other hand, the overwhelming majority (85% to 95%) of these patients did subjectively recover enough to return to their regular work on a full-time basis and even do some limited athletic activities. These numbers seem to indicate, as was also noted in the Volvo Award winning investigation by Weber, that surgery is no more effective and "aggressive conservative care" and the passage of time when it comes to treating moderate to severe disc herniation-associated sciatica.

The Saals noted that the 'Return To Work' percentages for their non-operative group (92%) matched and even surpassed the results of several other out-come studies that examined surgically treated patients: Hurme and Alaranta (14) reported a return-to-work rate of 85% and a 12% job change rate; Frymoyer et al. (8) reported a 75% return-to-work rate; and Kahanovitz et al. (15) reported that 77% of their study group had returned to work and that 12% needed to change jobs to accommodate their disability.

Favorite Saal Brothers Quote:

Passive conservative treatment will lead to progressive deconditioning, and may thereby result in greater functional disability. However, active physical rehabilitation will enhance conditioning and function, thereby improving prognosis whether surgery is necessary or not.

Final Comments:

It was this investigation that convinced me NOT to try an early surgery. I felt that the odds were excellent that I would recover with epidural injections, exercise, and the passage of time. Unfortunately, I never got well enough to enter either the 'Excellent' or 'Good' category and tried a surgery (probably way too late) that still didn't help me. Now that I have re-visited this investigation, I wonder if the Oswestry scores told the real story of the effects of conservative care upon disc herniation-associated sciatica.

References:

7) Herme M, et al. "Factors predicting the result of surgery for lumbar intervertebral disc herniation." Spine - 1987; 12:933-938

8) Frymoyer J, et al. "disc excision and spine fusion in the management of lumbar disc disease." Spine 1978; 3:1-6

9) Kahanovitz N, et al. "A multi-center comparative analysis of workers compensation and private patients undergoing surgical discectomy." Presented at ISSLS, Miami , Florida , April 13-18, 1988 , p2

14) Hurme M, Alaranta H. "Factors predicting the result of surgery for lumbar intervertebral disc herniation." Spine 1987; 12:933-938

15) Kahanovitz N, Weinstein J, et al. "A multicenter comparative analysis of workers' compensation and private patients undergoing surgical discectomy." Presented at ISSLS, Miami, Florida, April 13-18, 1988, p-2

20) Saal & Saal, "Nonoperative Treatment of Herniated Lumbar IVD with Radiculopathy: An outcome Study." Spine 1989; 14(4):431-437

21) Atlas SJ, et al. "Surgical & nonsurgical management of sciatica secondary to a lumbar disc herniation: Five year outcomes from the Maine Lumbar Spine Study." Spine - 2001; 26(10):1179-1187

22) Nykvist F, et al. "A prospective 5-year follow-up study of 276 patients hospitalized because of suspected lumbar disc herniation" Int. Disabil. Studies - 1989; 11(2):61-67

23) 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

24) Weber H, et al. "The Natural Course of Acute Sciatica with Nerve Root Symptoms in a Double-Blind Placebo-Controlled Trial" Spine 1993; 18(11):1433-1438

25) Balague F, et al. "Recovery of Severe Sciatica." 1999; 24(23):2516-2524

 

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