A prospective, randomized, double-blind study was performed to evaluate the clinical efficacy of intradiscal steroid injections. Criteria for entrance were one-level internal disc disruption or nonsequestered nuclear prolapse with or without sciatica and a positive pain response on awake discography. Exclusion criteria were multilevel disease, central or lateral stenosis, prior lumbar surgery, or medical disease requiring systemic steroids. A total of 25 patients were randomly assigned to Treatment Group A (methylprednisolone, Depo-Medrol 80 mg/ml, The Upjohn Co., Kalamazoo, Michigan) or Treatment Group B (bupivacaine, Marcaine .5% 1.5 ml, Sanofi Winthrop Pharmaceuticals, New York, New York). Fourteen patients received Depo-Medrol, with 21% showing subjective improvement and 79% no improvement; 0% were clinically worse. Eleven patients received intradiscal Marcaine, with 9% showing clinical improvement and 91% no improvement; 0% were clinically worse. To quantify clinical response, a pain diagram grid score, a visual analog scale, and the Oswestry Pain Questionnaire were used before injection and 10-14 days after injection. No statistically significant benefit was identified in the use of intradiscal steroids.
Eighty-six patients with refractory chronic low back pain were randomly assigned to receive either facet joint injection or facet nerve block, using local anaesthetic and steroid. There was no significant difference in the immediate response. The duration of response after facet joint injection was marginally longer than after facet nerve block (P less than 0.05 1 month after infiltration), but for both groups the response was usually short-lived; by 3 months only 2 patients continued to report complete pain relief. Patients who had complained of pain for more than 7 years were more likely to report good or excellent pain relief than those with a shorter history (P less than 0.005), but no other clinical feature was of value in predicting the response to infiltration. Facet joint injections and facet nerve blocks may be of equal value as diagnostic tests, but neither is a satisfactory treatment for chronic back pain.
This paper describes a prospective, double blind, randomised and dummy-controlled trial in 28 patients with chronic mechanical low back pain presenting to the York Pain Clinic. The therapeutic effects of epidural methyl prednisolone (80 mg) were compared with intrathecal midazolam (2 mg). All the patients had pain for a considerable length of time (range: 1-35 years) and all had received previous treatments which had failed. The two groups of patients were comparable in terms of pain duration, demography, extent of disability, anxiety and depression and pain locus of control. The pain was assessed before and for 2 months after treatment using the short form McGill Pain Questionnaire as well as visual analogue and verbal rating scales for sensory and affective components of their pain experience; patients also completed a pain diary. Both treatments caused a similar improvement in one-half to three-quarters of the patients for 2 months in patterns of activity and sleep as well as in the sensory and affective components of the pain. However, although the improvement in the two groups was similar, all the patients treated with steroid were either taking more or the same amount of self-administered analgesic medication after their treatment, whereas between one-third and one-half of the midazolam-treated patients took less medication during the 2 month follow-up period. We conclude that intrathecal midazolam is an effective treatment for chronic mechanical low back pain. The mechanism responsible for this effect is discussed.
In a 2-week, double blind, randomized study we compared the efficacy of a single local injection of 5 ml lignocaine, 0.5% (L) with 5 ml isotonic saline (S) in 41 patients with the iliac crest pain syndrome (ICPS), recruited from a rheumatology clinic and from a general practice. For the purpose of comparing both treatment, 2 major outcome variables at the end of the study were defined at the outset: (1) Pain score. In the L group the mean pain score at Day 14 was 30.5, in the S group 43.8; the difference between both treatment groups was significant (p less than 0.05). On subgroup analysis similar results were found in the rheumatology setting (p less than 0.05) but not in the general practice setting (NS). (2) Pain severity compared with baseline. In the L group 52% of patients improved and in the S group 30% (NS). In the general practice clinic there was no significant difference (44 vs 62%); however, in the rheumatology setting 58% of those treated with L were improved compared with 8% in the S group (p less than 0.01). Our data demonstrate an effect of a local injection with lignocaine that is somewhat larger than an injection with saline which also has some beneficial effect. The difference is evident in the rheumatology setting but not in the general practice setting.
The management of sciatica due to lumbar nerve root compromise remains controversial, probably because few well-controlled studies of conservative management have been performed. This preliminary study assesses the efficacy of epidural injections of 80 mg triamcinolone acetonide plus 0.5% procaine hydrochloride in saline, administered via the caudal route, in a double-blind, placebo controlled trial with 1 year follow-up. Twenty-three patients were entered into the study: 12 received treatment and 11 placebo. The active group showed significant pain relief (P = 0.02) and a significant increase in mobility (P = 0.01) at 4 weeks, which resulted in improved quality of life (P = 0.02). At 1 year, subjective and objective measures improved in both groups. The improvement was greater in the actively treated group, but only the objective assessment (straight leg raise) was statistically significant.
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.
One hundred nine patients with chronic (3-36 months; mean, 13.4 months) unilateral low-back pain and no signs of sciatica were subjected to facet joint injection, randomized in three therapy groups: cortisone and local anesthetic injected intra-articularly, the same mixture injected pericapsularly, and physiologic sodium hydrochloride injected intra-articularly into two facet joints. To evaluate the results, three outcome variables were formed: work, subjective, and disability outcome. The inappropriate signs (IAS) recorded before injections had the best predictability for a good outcome. The mode of injection or duration of symptoms had no significance as a predictor. It was concluded that the outcome after facet joint injection depends on the patient's biopsychosocial chances of self-facilitated improvement. If abnormal illness behavior and distress are found, it helps to estimate the response for treatment and to choose a realistic method of treatment.
The efficacy of trigger-point injection therapy in treatment of low-back strain was evaluated in a prospective, randomized, double-blind study. The patient population consisted of 63 individuals with low-back strain. Patients with this diagnosis had nonradiating low-back pain, normal neurologic examination, absence of tension signs, and lumbosacral roentgenograms interpreted as being within normal limits. They were treated conservatively for 4 weeks before entering the study. Injection therapy was of four different types: lidocaine, lidocaine combined with a steroid, acupuncture, and vapocoolant spray with acupressure. Results indicated that therapy without injected medication (63% improvement rate) was at least as effective as therapy with drug injection (42% improvement rate), at a P value of 0.09. Trigger-point therapy seems to be a useful adjunct in treatment of low-back strain. The injected substance apparently is not the critical factor, since direct mechanical stimulus to the trigger-point seems to give symptomatic relief equal to that of treatment with various types of injected medication.
Epidural morphine injection followed by a steroid has been reported to be effective for the post-laminectomy pain ('failed back') syndrome. This double-blind, parallel study was undertaken to evaluate that mode of therapy. Twenty-two patients who had undergone at least one prior laminectomy, who were still symptomatic, were randomized to receive 50 mg of lidocaine epidurally with: (a) 75 mg triamcinolone diacetate (TR); or (b) 8 mg of preservative-free morphine (MP); or (c) both (TR and MP), at 1 month intervals for 3 consecutive months. The spinal interspace identified with the patients' pain complaint was the site of injection. For each treatment, patients were admitted to the Clinical Research Center for 24 h and their condition continuously monitored with a pulse oximeter and apnea monitor. Five to 7 patients in each group had pain relief for less than 1 month. No patient given morphine had pain relief for more than 1 month. Life-threatening ventilatory depression occurred in the group given triamcinolone and morphine. The use of morphine alone or combined with slow release triamcinolone does not appear to be appropriate for the treatment of the post-laminectomy pain syndrome.
In a randomised double-blind study of 20 patients with chronic pain, epidural morphine 5 mg in 5 ml of saline was compared with epidural clonidine 150 micrograms in 5 ml of saline. Thirteen patients had a clinical and radiological diagnosis of arachnoiditis, 6 had low back pain and 1 had post-operative scar pain. There were 18 females and 2 males with an average age of 52 years, range 22-76 years. There was no difference found between the 2 solutions in the resultant analgesia measured by the visual analogue scale for pain, pain relief or the pain word score during the 3 h period of the study. No difference was found in the patient's mood which was also measured with the visual analogue scale. Two patients had no analgesia from either injection, 2 patients did not obtain any relief from clonidine and another 2 obtained no relief from morphine. Six patients reported that clonidine was better than morphine, 5 reported that morphine and clonidine were the same and 3 reported that morphine was better than clonidine. The duration of analgesia from the clonidine varied from 6 h to 1 month; the duration of analgesia from morphine varied from 6 to 24 h. Clonidine was associated with sedation and a fall in blood pressure of greater than 20 mm Hg in all patients, 1 patient required ephedrine to treat hypotension. Twelve patients had pruritus, 7 nausea and 2 vomiting following the morphine. Statistically there was no difference found between morphine and clonidine for short-term (3 h) analgesia in these patients. The duration of analgesia from clonidine in 2 patients was about 1 month while that from morphine did not exceed 24 h. The side effects from clonidine were less than those for morphine. This group of patients was unable to differentiate between epidural morphine and clonidine for short-term analgesia. Further evidence of the importance of the spinal noradrenergic system in the transmission and treatment of patients with chronic pain.
A prospective, randomized, double-blind study was performed to evaluate the clinical efficacy of intradiscal steroid injections. Criteria for entrance were one-level internal disc disruption or nonsequestered nuclear prolapse with or without sciatica and a positive pain response on awake discography. Exclusion criteria were multilevel disease, central or lateral stenosis, prior lumbar surgery, or medical disease requiring systemic steroids. A total of 25 patients were randomly assigned to Treatment Group A (methylprednisolone, Depo-Medrol 80 mg/ml, The Upjohn Co., Kalamazoo, Michigan) or Treatment Group B (bupivacaine, Marcaine .5% 1.5 ml, Sanofi Winthrop Pharmaceuticals, New York, New York). Fourteen patients received Depo-Medrol, with 21% showing subjective improvement and 79% no improvement; 0% were clinically worse. Eleven patients received intradiscal Marcaine, with 9% showing clinical improvement and 91% no improvement; 0% were clinically worse. To quantify clinical response, a pain diagram grid score, a visual analog scale, and the Oswestry Pain Questionnaire were used before injection and 10-14 days after injection. No statistically significant benefit was identified in the use of intradiscal steroids.
