Original Article
A Controlled Trial of Corticosteroid Injections into Facet Joints for Chronic Low Back Pain
N Engl J Med 1991; 325:1002-1007October 3, 1991
- Abstract
- Abstract
Background
Chronic low back pain is a common problem with many treatments, few of which have been rigorously evaluated. This randomized, placebo-controlled trial was designed to evaluate the efficacy of injections of corticosteroid into facet joints to treat chronic low back pain.
Methods
Patients with chronic low back pain who reported immediate relief of their pain after injections of local anesthetic into the facet joints between the fourth and fifth lumbar vertebrae and the fifth lumbar and first sacral vertebrae were randomly assigned to receive under fluoroscopic guidance injections of either methylprednisolone acetate (20 mg; n = 49) or isotonic saline (n = 48) in the same facet joints. Ninety-five patients were followed for six months and their condition assessed with scales of pain severity, back mobility, and limitation of function.
Results
After one month, none of the outcome measures evaluating pain, functional status, and back flexion differed clinically or statistically between the two study groups. Forty-two percent of the patients who received methylprednisolone and 33 percent of those who received placebo reported marked or very marked improvement (95 percent confidence interval for the difference, -11 to 28 percentage points; P = 0.53). The results were similar after three months. At the six-month evaluation, the patients treated with methylprednisolone reported more improvement, less pain on the visual-analogue scale, and less physical disability. The differences were reduced, however, when concurrent interventions were taken into account. Moreover, only 11 patients (22 percent) in the methylprednisolone group and 5 (10 percent) in the placebo group had sustained improvement from the first month to the sixth month (95 percent confidence interval for the difference, -2 to 26; P = 0.19).
Conclusions
We conclude that injecting methylprednisolone acetate into the facet joints is of little value in the treatment of patients with chronic low back pain. (N Engl J Med 1991;325:1002–7.)
Media in This Article
Table 1
Demographic and Clinical Characteristics of the Study Patients at Randomization.Table 2
Outcomes of Facet-Joint Injections with Methylprednisolone or Placebo Evaluated after One and Six Months.Article Activity
- Article
THE effect of chronic low back pain on our society is enormous, in terms of both human suffering and cost.1 Many treatments have been advocated, but few have been rigorously tested in controlled trials.
The facet joints of the vertebrae have been suspected as a source of low back pain since the early 1900s,2 but it was mainly the experiments of Hirsh et al. in 1963,3 Mooney and Robertson in 1976,4 and McCall et al. in 19795 that confirmed their role in low back pain.
Corticosteroid injections into facet joints were first used in 1976 by Mooney and Robertson, who claimed significant long-term improvement in 52 percent of their patients.4 Others have since reported success rates ranging from 10 to 63 percent.6 7 8 9 10 11 In the only randomized trial, corticosteroid injections were no better than saline injections.12 In that study, however, no attempt was made to ensure that the patients actually had back pain originating in their facet joints, concurrent interventions were not monitored, and follow-up was limited to three months.
Facet-joints injections are now routinely performed across North America. Although they are considered safe, they remain an expensive treatment of unproved efficacy. We report a double-blind, placebo-controlled trial evaluating this treatment in patients with chronic low back pain.
Methods
The study was conducted at the Centre Hospitalier de l'Université Laval in Quebec City, Canada. The protocol was approved by the institutional ethics committee, and all the patients gave written informed consent.
Phase I of the study was designed to identify the patients with chronic low back pain whose pain was most likely to originate in the facet joints. Phase II evaluated the efficacy of injections of methylprednisolone acetate or isotonic saline into the facet joints of patients whose back pain had been documented in phase I to originate in those joints.
Phase I: Identification of Patients
Selection Criteria
All the patients with back pain who were referred to the rheumatology outpatient clinic between July 1987 and March 1989 were eligible for phase I of our study if they were between 18 and 65 years old and had a first or recurrent episode of low back pain, buttock pain, or both, that had lasted for at least six months. The pain could be intermittent or constant, unilateral or bilateral, radiating or not, but it had to be present, at rest or during movement, on the day of entry into the study. Normal results on neurologic examination were required. The criteria for exclusion were the presence of back pain whose cause was not mechanical (tumor, infection, or spondylitis, for example); previous injections into the facet joints or low back surgery; pregnancy; known allergy to local anesthetic or radiologic contrast agents; and the presence of a blood coagulation disorder.
Injections with Lidocaine
After completing a visual-analogue scale evaluating the intensity of pain at rest or during movement, whichever was worse, the patients received injections of local anesthetic in the lower two lumbar facet joints (L4–L5 and L5–S1), either unilaterally or bilaterally, depending on whether they had pain on one or both sides of the spine.
We used the technique described by Mooney and Robertson.4 Lying prone on the fluoroscopic table, the patient was rotated in the oblique position until the facet-joint space could be visualized. The skin overlying the facet joint was prepared, draped, and infiltrated with 1 percent lidocaine. Under fluoroscopic guidance, a 90-mm, 22-gauge spinal needle was then directed vertically into the joint space. Aqueous contrast material (0.2 to 0.5 ml, Omnipaque, Winthrop Laboratories) was injected to confirm that the tip of the needle was in the joint, and 2 ml of 1 percent lidocaine was then injected into the facet joint. The response to the injections of lidocaine was assessed 30 minutes later by a second visual-analogue pain scale. The patients whose pain was reduced by less than 50 percent were considered to have low back pain originating from sources other than the injected facet joints, and they were not studied further. The patients who reported relief of 50 percent or more of their pain after the injections of lidocaine were considered to have pain originating predominantly in their facet joints, and they were invited to participate in phase II of the study.
Phase II: Injections with Methylprednisolone or Placebo
Selection of Patients
The patients who had substantial relief after the injections of lidocaine were reevaluated two weeks later. During this interval, they were asked to discontinue any ongoing treatment and take only acetaminophen. They were considered eligible for the randomized trial if during the two weeks they had a recurrence of their low back pain, defined as a pain-scale value that was at least 50 percent of the value before the initial injections of local anesthetic.
Treatment Assignment
The patients were divided into two groups according to whether they were receiving disability compensation or not. The assignment scheme was generated from a table of random numbers. The randomization was balanced after every eight patients were enrolled to ensure an approximately equal number in each group.
The patients received injections of either 20 mg (1 ml) of methylprednisolone acetate mixed with 1 ml of isotonic saline or 2 ml of isotonic saline in each of the facets injected during phase I. All the injections were preceded by arthrography and were performed under fluoroscopic guidance, as in phase I. The syringes were prepared by the hospital pharmacist and covered with aluminum foil so that the physician administering the injections was not aware of the treatment.
Other Interventions
A letter was sent to the referring physicians explaining the trial and the importance of limiting concurrent interventions. The patients received similar explanations. At each visit, we gave the patients a supply of acetaminophen tablets (Merck Frosst) and a form on which to record every tablet taken. Information on acetaminophen intake and any other medication or treatment was obtained at each follow-up visit.
Follow-up and Assessment of Outcome
The patients were reassessed one month, three months, and six months after randomization and treatment. Measures of outcome were grouped into four categories. First, the patients rated the overall effect using a seven-point scale that ranged from very marked improvement to very marked deterioration. Second, several methods were used to rate pain at rest and on lumbar flexion and extension. They included a visual-analogue pain scale ranging from 0 (no pain) to 10 (very severe pain), and the McGill pain questionnaire,13 which consists of a scale of 0 to 5 assessing the present intensity of pain and a list of 78 descriptive terms (e.g., "lancinating," "cramping," and "burning") from which two measures are derived: the number of words chosen, and the pain-rating index, which is based on the numerical value assigned to each word chosen. Higher scores on these two measures are related to more severe pain. Third, we measured functional status, using primarily a modified version of the Sickness Impact Profile, a multidimensional health status questionnaire previously validated in patients with low back pain.14 The questionnaire was modified in two minor ways. Since they are poorly related to back pain, the eating and communication categories were omitted, as suggested by Deyo and Diehl.15 And, as proposed by Roland and Morris,16 each statement in the questionnaire was preceded by the words "because of my back," to focus on disability due to back pain. The patients also completed a short questionnaire reporting the number of days in the previous two weeks on which their activity had been limited by back pain. Fourth, the distance from the fingers to the floor on maximal forward flexion was measured.
Statistical Analysis
Before the trial began, we decided that only patients who reported very marked or marked improvement would be considered to have benefited significantly from treatment. Using this definition, we calculated that a sample size of 50 patients per group would be adequate at 80 percent power to detect at the 5 percent level of significance (by one-sided test) an estimated improvement in 50 percent of the patients given corticosteroid as compared with 25 percent of those given placebo. Smaller differences were considered to be of no clinical importance. For analysis, the patients remained in the groups to which they had been assigned (intention-to-treat analysis). All tests of significance were two-sided. Comparisons of proportions were based on the chi-square test or Fisher's exact test. Individual analyses of covariance were performed for the following continuous variables: visual-analogue pain score, number of words chosen and pain-rating index on the McGill questionnaire, Sickness Impact Profile scores, and finger-to-floor distance. The base-line value of the variable was entered as a covariate when there was no statistical interaction between the covariate and the study group. The difference between adjusted means was calculated, and the statistical significance of the difference was assessed by the 95 percent confidence interval. The Wilcoxon test was used to compare the number of days on which activity was limited in the two groups. For the McGill score of present intensity of pain, we checked whether parametric and nonparametric tests yielded similar results. Since they did, we estimated the differences between the crude means in the two groups and calculated the 95 percent confidence intervals for these differences.
Results
Study Patients
One hundred ninety patients entered phase I of the study. Of these, 110 (58 percent) reported a reduction of 50 percent or more in their pain after the injections of lidocaine. Two patients had no recurrence of pain in the next two weeks, and seven chose not to participate in the trial because the first injections had been too painful. Thus, 101 patients entered the randomized trial (phase II), 51 in the methylprednisolone group and 50 in the placebo group.
Four randomized patients were later excluded from the analysis: one (in the methylprednisolone group) had sacroiliitis, and three (one in the methylprednisolone group and two in the placebo group) had had their pain for less than six months. Follow-up data were obtained on 96 of the 97 remaining patients after one month, on 94 after three months, and on 95 after six months.
The patients' base-line demographic and clinical characteristics are shown in Table 1Table 1
Demographic and Clinical Characteristics of the Study Patients at Randomization.. The two study groups did not differ significantly with respect to age, sex, educational level, or marital status. Nearly 30 percent of the patients in each group were not working because of their low back pain. The proportion of patients who were receiving disability compensation was similar in both groups. The patients in both groups had responded similarly to the injections of local anesthetic, with mean immediate reductions in pain intensity of 76 percent and 79 percent in the methylprednisolone and placebo groups, respectively. Seventy-nine percent of the patients in each group had bilateral injections, and more than 80 percent of the facets were successfully entered, as assessed on arthrography. The two groups did not differ significantly with regard to base-line measures of pain intensity. The base-line Sickness Impact Profile scores, however, were slightly lower in the methylprednisolone group than in the placebo group.Concurrent Interventions
The major concurrent interventions during the study were physical therapy, antidepressant medication, and peridural injections. At the one-month visit, one patient in the methylprednisolone group had received physical therapy and one in the placebo group was taking new antidepressant medication. At the three-month evaluation, five patients in the methylprednisolone group and two in the placebo group had received other treatments, including a second corticosteroid injection in the facet joints in two of those in the methylprednisolone group. Ten patients in the methylprednisolone group and three in the placebo group received other treatments between the three-month and six-month evaluations. Since some patients reported concurrent interventions at more than one visit, these other treatments involved a total of 11 patients in the methylprednisolone group and 6 in the placebo group. No patient in the placebo group received an injection of methylprednisolone in the facet joints. No patients were hospitalized for back pain. There was no difference in acetaminophen intake between the two groups during the follow-up period.
Response to Treatment
One month after the injections of methylprednisolone or placebo, the two groups did not differ clinically or statistically in any of the outcome measures (Table 2Table 2
Outcomes of Facet-Joint Injections with Methylprednisolone or Placebo Evaluated after One and Six Months.). Twenty patients in the methylprednisolone group (42 percent) and 16 in the placebo group (33 percent) reported very marked or marked improvement. The 95 percent confidence interval for the difference (9 percent) overlapped the null value (- 11 to 28 percentage points, P = 0.53). In both groups, the Sickness Impact Profile scores, McGill test scores, and scores on the visual-analogue pain scale improved slightly over base-line values, but none of the differences between the two groups were statistically significant.The results at the three-month evaluation were very similar to those after one month (data not shown). Seventeen patients (36 percent) in the methylprednisolone group reported marked or very marked improvement over base line, as compared with 13 patients (28 percent) in the placebo group (95 percent confidence interval for the difference, -10 to 27 percentage points; P = 0.51). The other outcome variables changed little between the one-month and three-month evaluations, and the two groups did not differ in any of the outcome variables at three months.
The proportion of patients treated with methylprednisolone who reported marked or very marked improvement six months after the injections increased to 46 percent, whereas it decreased to 15 percent for the patients who received placebo (Table 2). This difference was statistically significant (P = 0.002). The visual-analogue pain score and the Sickness Impact Profile physical-dimension score followed the same pattern, and the differences between the two groups for these variables were also statistically significant.
Since concurrent interventions were reported more frequently among the patients in the methylprednisolone group, we explored whether those other treatments could explain the differences after six months. We first carried out a worst-case analysis. In this analysis, we assumed that none of the patients with concurrent interventions had improved after six months, regardless of study group. According to this analysis, 31 percent of the patients treated with methylprednisolone had improved after six months, as compared with 13 percent of those given placebo (95 percent confidence interval for the difference, 2 to 35 percentage points; P = 0.05). We then carried out a second type of analysis in which, for the patients who had concurrent interventions, the results of the last evaluation before the other interventions were substituted for the results of all subsequent evaluations. The number of patients who reported improvement after six months was 15 (31 percent) in the methylprednisolone group and 8 (17 percent) in the placebo group (95 percent confidence interval for the difference, -3 to 31 percentage points; P = 0.17). The difference in the visual-analogue pain scores decreased to -0.7 (95 percent confidence interval, -1.6 to 0.2; P>0.05). The differences in mean present intensity of pain (-0.6; 95 percent confidence interval, -1.0 to -0.2) and adjusted mean Sickness Impact Profile physical-dimension score ( - 3.0; 95 percent confidence interval, -5.5 to -0.5) were still statistically significant, however.
Few patients in either group reported sustained improvement — that is, marked or very marked improvement over base line at each of the three follow-up visits. Only 11 of the 20 patients in the methylprednisolone group and 5 of the 16 patients in the placebo group who had improvement at the one-month visit still had improvement at the six-month evaluation. They represented 22 percent of the 49 patients who received methylprednisolone and 10 percent of the 48 patients who received placebo (difference, 12 percent; 95 percent confidence interval, -2 to 26 percentage points; P = 0.19).
No adverse effects were reported, other than transient local pain at the injection sites.
Discussion
The results of this randomized, double-blind, placebo-controlled trial suggest that injections of methylprednisolone into facet joints have very little efficacy in patients with chronic low back pain. One of the most important and difficult issues in designing this trial was to ensure that the patients studied had primarily facet-joint pain. Determining the anatomical structure responsible for a given patient's low back pain is notoriously difficult.1 , 17 To overcome this problem, we randomized only patients who reported a reduction of at least 50 percent in their pain after lidocaine was injected into their facet joints. We thus selected a population of patients more likely to respond to facet-joint injections of corticosteroid.
It could be argued that only the patients with a 100 percent reduction in pain after the lidocaine injections should have been enrolled in the trial. Had this been the entry criterion, only 11 of the 190 patients (6 percent) would have been eligible, suggesting that a facet syndrome involving the fourth and fifth lumbar vertebrae and the fifth lumbar and first sacral vertebrae is a rare entity. Similarly, Jackson et al. found that among 454 patients with back pain in whom conservative treatment had failed, only 7.7 percent had complete relief after injections of local anesthetic.17 Study patients who did not have a facet syndrome and who were therefore unlikely to respond to facet-joint injections could have diluted the treatment effect. Post hoc subgroup analyses suggest that this was unlikely, however. For example, of the nine patients in the methylprednisolone group who had at least a 90 percent reduction in pain after the lidocaine injections, only two (22 percent) had sustained improvement during the six-month follow-up period.
We do not believe that other characteristics of our study group can explain the poor efficacy of the injections of methylprednisolone. The duration of low back pain in our patients was shorter than that usually reported in studies of chronic back pain.18 We excluded patients who had had back surgery. Patients receiving workers' compensation constituted approximately 25 percent of our study population. A subgroup analysis restricted to the patients who were not receiving compensation yielded conclusions similar to those of the main analysis.
The injection of corticosteroids into peripheral joints usually results in rapid clinical improvement that tends to subside with time.19 We had therefore expected that if the methylprednisolone injections were effective, their benefit would be evident at the one-month follow-up visit. The difference between groups in the proportion of patients with marked or very marked improvement was only 9 percent, however. Although the confidence interval around this difference was rather wide, the confidence intervals for other outcome variables were reasonably small, supporting the lack of benefit of methylprednisolone injections.
The differences in several measures of outcome six months after the injections deserve comment. First, 11 of the 22 patients assigned to corticosteroid who reported substantial improvement at the six-month evaluation reported no benefit at the earlier evaluations. We could find no plausible pharmacologic or biologic basis for such a pattern. Second, concurrent interventions were more frequently reported by the patients assigned to methylprednisolone than by those assigned to placebo. If these other interventions were effective, the results could have been biased in favor of the methylprednisolone injections. Third, the discrepancy between the self-rated effect-of-treatment scale and most other outcome measures at the six-month evaluation leads to questions about the reliability of the self-rated assessment. When we considered all the patients who reported having benefited (i.e., including those with minimal improvement), the percentage of patients reporting improvement after one month was 54 in the methylprednisolone group and 44 in the placebo group (P = 0.41); after six months the percentages were 54 and 36, respectively (P = 0.12).
These results suggest that injections of methylprednisolone into facet joints are of little value in the treatment of patients with chronic low back pain. Despite the fact that our patients were selected for their positive response to facet-joint injections with a local anesthetic, only 1 in 5 had sustained improvement in the six months after the injection of steroid, as compared with 1 in 10 after the injection of placebo.
Supported by a research grant from the Medical Research Council of Canada and by a scholar grant to Dr. Carette from the Canadian Life and Health Insurance Association.
We are indebted to Patrice Montminy, M.D., Jean-Yves Lang, M.D., André St.-Pierre, M.D., Gaétan Lévesque, M.D., André Beaulieu, M.D., Gilles Mathon, M.D., and Patrice Poubelle, M.D., who referred patients to the study; and to Winthrop Laboratories and Merck Frosst Canada for kindly providing Omnipaque contrast material and the acetaminophen tablets, respectively.
Source Information
From the Departments of Medicine (S.C., C.G., Y.A., M.L.), Social and Preventive Medicine (S.M.), Anesthesiology (R.T.), and Radiology (J.G.), Laval University, Quebec City, Quebec, Canada. Address reprint requests to Dr. Carette at the Centre Hospitalier de l'Université Laval, 2705 Blvd. Laurier, Sainte-Foy, PQ G1V 4G2, Canada.
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