Combined Spinal Surgery and Tertiary Rehabilitation: A Prospective Evaluation Study of Treatment Efficacy
T.G. Mayer, MD; R.J. Gatchel, PhD; P. McMahon, BA; B. Sparks; MA, P. Pegues, RN
Introduction. With the increased prevalence and cost of low back pain in industrialized countries, finding appropriate methods for effective treatment has become paramount. One long-standing method of treatment in spinal surgery in alleviating disability has been raised recently in the literature, particularly for fusion for degenerative conditions. Meta-analyses of the efficacy of surgery have thus far been inconclusive. In other musculoskeletal regions, however, particularly the knee, aggressive sports medicine rehabilitation customarily follows surgery and is essential in achieving successful outcomes. No such surgery/rehabilitation combination has been carefully evaluated with disabled workers undergoing spine surgery. Functional restoration is a tertiary, medically directed, interdisciplinary rehabilitation program based on a “sports medicine” approach, which monitors specific socioeconomic outcomes as part of its treatment process for end stage chronically disabled workers with spinal disorders, primarily in a compensation environment.
Methods. In order to systematically evaluate the effectiveness of a combined treatment of spinal surgery followed by aggressive rehabilitation, the present study prospectively evaluated a cohort of consecutive functional restoration program graduates (n=1202). It assessed a discectomy group D (n=123, mean age=38.4, 77% male) and a fusion group F (n=101, mean age=39.0, 78% male). They were compared to two groups of matched controls (no pre-rehabilitation surgery) selected from the same large cohort of rehabilitated chronic spinal disorder patients with work disability: nondiscectomy group C/D (n=123, main age=38.5, 77% male) and nonfusion group C/F (n=101, mean age=39.5, 78% male). Nonsurgery control groups were matched to the preprogram surgery groups by age, sex, race, length of disability and workers’ compensation venue (eg, federal or specific state system). A structured clinical interview aimed at specific socioeconomic outcomes (return to work, medical utilization, recurrent injury, etc.) was administered twelve months after program completion.
Results. The two groups of patients who had spinal surgery made significant functional improvements on physical measures such as range of motion, strength, isokinetic and isoinertial lift that were similar to the nonsurgery groups measured pre- and six weeks post-treatment. A contact rate for various outcomes of 95%-99% revealed that 86.7% of the D group returned to work within the twelve month period following rehabilitation compared to a 90.3% return to work rate for the C/D group. Return to work was 87.0% for the F group compared to 88.0% for C/F group. There were no statistically significant differences among the groups. The C/D, C/F and D groups all had significantly more visits to other health care professionals following rehabilitation (1/5 time greater frequency) than the F group (p<.005). Surgery over the next year was lowest for the fusion group and highest for the discectomy group, with F=2.0% rate of post program surgeries, D=8.2%, C/F=3.0% and C/D=4.0% (D vs. F, p<.0001). There were no statistically significant differences in recurrent lost time re-injury rates for the groups: F=2.0%, C/F=3.0%, D=3.3% and C/D=2.3%.
Conclusions. This study represents the largest evaluation to date of treatment outcome of a combination of spinal surgery followed by tertiary rehabilitation. Overall, these results demonstrate remarkable successful socioeconomic outcomes of spine surgery in a compensation setting, if accompanied by medically directed tertiary care. Surprisingly, fusion patients had work outcomes comparable to discectomy and control patients, with lower future health utilization and comparable recurrent injury outcomes. This occurred in spite of the fact that fusion patients generally had longer periods of disability and more major structural intervention than discectomy patients. Prospective randomized trials of spine surgery plus rehabilitation are called for to replicate these findings.
Effects of Intradiscal Proliferant Solutions on Fibroplasia Growth
V. Mooney, MD; J.B. Massie, MS; C.S. Yu; S.R. Garfin, MD
Introduction. Medical treatment today for recurring and chronic low back pain has been varied and not always successful. Clinically, some patients claim to have had a cure from chronic low back pain with the use of prolotherapy. In the literature, there does not appear to be any studies describing the use of proliferant injections into the intervertebral disc. Previous animal studies have shown that injections of sclerosant agents can stimulate fibroplasia growth in ligaments and tendons. The purpose of this study was to document the effects of proliferants to stimulate fibroplasia growth within the intervertebral disc.
Methods. Thirty-eight, 3–4 year old (degenerative disc model) New Zealand white rabbits under anesthesia were placed in a left, lateral position on an X-ray table. Using fluoroscopy to confirm needle placement, a sterile twenty-two gauge spinal needle was inserted into the L2-3, L3-4, L4-5 and L5-6 disc. Randomly the discs were injected with 0.1cc of either sodium morrhuate, 12/5% dextrose or the disc was stab only. The injections were repeated every two weeks for a total of three separate injection periods. The survival periods were 7 and 10 weeks, at which time the rabbits were euthanized. An additional group of rabbits were injected only once with the above proliferants. These rabbits were then euthanized at one week, two weeks and three weeks. A portion of each disc was removed for histological H&E staining and then the numbers of nuclei present were counted. The other portion of the disc was used to measure hydroxyproline and proline levels (indicators of collagen content).
Results. On no occasion were inflammatory, histocytes or eosinophil cells seen. Clumps of fibroblasts were seen. The statistical analysis was done by doing a one way ANOVA and paired t-test. Hydroxyproline versus cell count and the differences between the proliferants showed that there was no significant differences between any of the combinations of groups, with p-values >0.05. Looking at sodium morrhuate versus 12/5% dextrose only, we found that there were no significant differences with a p-value of 0.3088. However with respect to the time intervals, there was a significant difference between three and seven weeks and three and ten weeks, with p-values <0.0065, in both the 12/5% dextrose and the sodium morrhuate groups. There were higher cell counts in the three week groups.
Summary. The results of this study suggest that there is an early inflammatory reaction in the disc at earlier time periods. Other articles have shown that there is a decrease in the number of cells the longer the time after sodium morrhuate injections. This suggests that we look at later time periods (six months) in relationship to the cascade of mature fibroplasia growth, which is much later. The literature shows that sodium morrhuate represents an injury repair response in tendons and ligaments. Not seeing the same response in the disc could be related to the differences between the annulus fibrosis consists more of noncollagenous materials, contains both types I and II collagen and is avasular and alymphatic. There is still a need for further studies in understanding the role of proliferant injections in the intervertebral disc and its relationship to the degenerate disc.