OBJECTIVE: The aim was to compare the efficacy of intradiscal biacuplasty (IDB) with that of placebo treatment for discogenic low back pain.
DESIGN: This is a randomized, placebo-controlled trial. Subjects were randomized on a 1:1 basis to IDB and sham groups. Follow-ups were conducted at 1, 3, and 6 months. Subjects and coordinators were blinded to randomization until 6 months. Of the 1,894 subjects screened, 64 subjects were enrolled, and 59 were treated: 29 randomized to IDB and 30 to sham. All subjects had a history of chronic low back pain for longer than 6 months.
INTERVENTIONS: Two cooled radiofrequency (RF) electrodes placed in a bipolar manner in affected discs to lesion the nociceptive fibers of the annulus fibrosus. The sham procedure was identical to the active treatment except that probes were not directly inserted into the disc space, and RF energy was not actively delivered.
RESULTS: The principal outcome measures were physical function, pain, disability, and opioid usage. Patients in the IDB group exhibited statistically significant improvements in physical function (P = 0.029), pain (P = 0.006), and disability (P = 0.037) at 6-month follow-up as compared to patients who received sham treatment. Treatment patients reported a reduction of 16 mg daily intake of opioids at 6 months; however, the results were not statistically different from sham patients.
CONCLUSIONS: The results suggest that the clinical benefits observed in this study are the result of non-placebo treatment effects afforded by IDB. IDB should be recommended to select the patients with chronic discogenic low back pain. (Clinicaltrials.gov number, NCT00750191.).
OBJECTIVE: The objective of this study was to compare the efficacy of lateral branch neurotomy using cooled radiofrequency to a sham intervention for sacroiliac joint pain.
DESIGN: Fifty-one subjects were randomized on a 2:1 basis to lateral branch neurotomy and sham groups, respectively. Follow-ups were conducted at 1, 3, 6, and 9 months. Subjects and coordinators were blinded to randomization until 3 months. Sham subjects were allowed to crossover to lateral branch neurotomy after 3 months.
SUBJECTS: Subjects 18-88 years of age had chronic (>6 months) axial back pain and positive response to dual lateral branch blocks.
INTERVENTIONS: Lateral branch neurotomy involved the use of cooled radiofrequency electrodes to ablate the S1-S3 lateral branches and the L5 dorsal ramus. The sham procedure was identical to the active treatment, except that radiofrequency energy was not delivered.
OUTCOME MEASURES: The principal outcome measures were pain (numerical rating scale, SF-36BP), physical function (SF-36PF), disability (Oswestry disability index), quality of life (assessment of quality of life), and treatment success.
RESULTS: Statistically significant changes in pain, physical function, disability, and quality of life were found at 3-month follow-up, with all changes favoring the lateral branch neurotomy group. At 3-month follow-up, 47% of treated patients and 12% of sham subjects achieved treatment success. At 6 and 9 months, respectively, 38% and 59% of treated subjects achieved treatment success.
CONCLUSIONS: The treatment group showed significant improvements in pain, disability, physical function, and quality of life as compared with the sham group. The duration and magnitude of relief was consistent with previous studies, with current results showing benefits extending beyond 9 months.
OBJECTIVES: The goal of this study was to compare the effects of conventional radiofrequency (CRF) and pulsed RF (PRF) denervation to medial branches of dorsal rami in the treatment of facet joint pain.
METHODS: The patients greater than 17-year old, with continuous low back pain with or without radiating pain with focal tenderness over the facet joints, pain on hyperextension, absence of neurologic defect, unresponsiveness to conservative treatment, no radicular syndrome, and no indication for low back surgery were included in the study. Local anesthetic was applied in the control group (n=20), whereas 80 degrees C CRF were applied in the CRF (n=20) and 2 Hz PRF were applied in the PRF group (n=20). Pain relief was evaluated by visual analog scale (VAS) and Oswestry Disability Index (ODI) at preprocedure, at procedure, at 6 months and 1 year after the procedure. Reduction in analgesic usage, patients' satisfaction, and complications were assessed.
RESULTS: Mean preprocedural VAS and ODI scores were higher than postprocedural scores in all groups. Both VAS and ODI scores of PRF and CRF groups were lower than the score of the control group at the postprocedural evaluation. Although decrease the pain score was maintained in the CRF group at 6 months and 1-year period, this decrease discontinued in the PRF group at the follow-up periods. The number of patients not using analgesics and patient satisfaction were highest in CRF group.
DISCUSSION: PRF and CRF are effective and safe alternatives in the treatment of facet joint pain but PRF is not as long lasting as CRF.
OBJECTIVES: Radiofrequency facet joint denervation procedures have been common practice for 2 decades in treatment of chronic low back pain. We designed this multicenter, randomized, double-blind, sham treatment controlled trial to determine the efficacy of radiofrequency facet joint denervation, as it is routinely performed.
METHODS: Inclusion criteria were low back pain, duration more than 6 months, and >or=50% Visual Analog Scale (VAS) reduction on diagnostic block. Exclusion criteria were prior radiofrequency treatment, radicular syndrome, coagulopathies, specific allergies, cancer, and pregnancy. A total of 81 out of 462 patients were randomized to undergo radiofrequency facet joint denervation or sham treatment. The first evaluation was carried out 3 months after treatment. Primary outcome was determined with a combined outcome measure comprising VAS, physical activities, and analgesic intake, from a twice-weekly recorded diary. Secondary outcome measures were the separate diary parameters, global perceived effect (complete relief, >50% relief, no effect, pain increase), and SF-36 Quality of Life Questionnaire.
RESULTS: There were no dropouts before the first evaluation. The combined outcome measure showed no differences between radio- frequency facet joint denervation (n=40; success 27.5%) and sham (n=41; success 29.3%) (P=0.86). The VAS in both groups improved (P<0.001). Global perceived effect improved after radiofrequency facet joint denervation (P<0.05). The other secondary outcome parameters showed no significant differences. Relevant costs were evaluated.
DISCUSSION: The combined outcome measure and VAS showed no difference between radiofrequency and sham, though in both groups, significant VAS improvement occurred. The global perceived effect was in favor of radiofrequency. In selected patients, radiofrequency facet joint denervation appears to be more effective than sham treatment.
STUDY DESIGN: A prospective double-blind randomized trial in 28 patients.
OBJECTIVES: To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain, functional disability, and physical impairment in patients with chronic discogenic low back pain.
SUMMARY OF BACKGROUND DATA: Chronic discogenic low back pain is a challenging problem in western countries. A treatment option is radiofrequency heating of the affected disc. Its clinical efficacy has never been formally tested in a controlled trial.
METHODS: Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs. Only patients with one putative painful level were selected and randomly assigned to one of two treatment groups. Each patient in the radiofrequency treatment group (n = 13) received a 90-second 70 C lesion of the intervertebral disc. Patients in the control group (n = 15) underwent the same procedure, but without use of radiofrequency current. Both the treating physician and the patients were blinded to the group assignment. Before treatment, physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator.
RESULTS: Eight weeks after treatment, there was one success in the radiofrequency group (n = 13) and two in the control group (n = 15). The adjusted and unadjusted odds ratio was 0.5 and 1.1, respectively (not significant). Also, visual analog scores for pain, global perceived effect, and the Oswestry disability scale showed no differences between the two groups.
CONCLUSIONS: Percutaneous intradiscal radiofrequency thermocoagulation (90 seconds, 70 C) is not effective in reducing chronic discogenic low back pain.
STUDY DESIGN: A prospective double-blind randomized controlled trial was performed.
OBJECTIVE: To assess the efficacy of percutaneous radiofrequency articular facet denervation for low back pain.
SUMMARY OF BACKGROUND DATA: Uncontrolled observational studies in patients with low back pain have reported some benefits from the use of facet joint radiofrequency denervation. Because the efficacy of percutaneous radiofrequency had not been clearly shown in previous studies, a randomized controlled trial was conducted to assess the efficacy of the technique for improving functional disabilities and reduce pain.
METHODS: For this study, 70 patients with low back pain lasting of more than 3 months duration and a good response after intraarticular facet injections under fluoroscopy were assigned randomly to receive percutaneous radiofrequency articular facet denervation under fluoroscopic guidance or the same procedure without effective denervation (sham therapy). The primary outcomes were functional disabilities, as assessed by the Oswestry and Roland-Morris scales, and pain indicated on a visual analog scale. Secondary outcomes included spinal mobility and strength.
RESULTS: At 4 weeks, the Roland-Morris score had improved by a mean of 8.4% in the neurotomy group and 2.2% in the placebo group, showing a treatment effect of 6.2% (P = 0.05). At 4 weeks, no significant treatment effect was reflected in the Oswestry score (0.6% change) or the visual analog pain score (4.2% change). At 12 weeks, neither functional disability, as assessed by the Roland-Morris scale (2.6% change) and Oswestry scale (1.9% change), nor the pain level, as assessed by the visual analog scale (-7.6% change), showed any treatment effect.
CONCLUSIONS: Although radiofrequency facet joint denervation may provide some short-term improvement in functional disability among patients with chronic low back pain, the efficacy of this treatment has not been established.
STUDY DESIGN: A prospective double-blind randomized trial in 31 patients.
OBJECTIVES: To assess the clinical efficacy of percutaneous radiofrequency denervation of the lumbar zygapophysial joints in reducing pain, functional disability, and physical impairment in patients with back pain originating from the lumbar zygapophysial joints.
SUMMARY OF BACKGROUND DATA: Chronic low back pain is a major health problem in the industrialized world. A treatment option is percutaneous radiofrequency denervation of the lumbar zygapophysial joints. Its clinical efficacy has never been formally tested in a controlled trial.
METHODS: Thirty-one patients with a history of at least 1 year of chronic low back pain were selected on the basis of a positive response to a diagnostic nerve blockade and subsequently randomly assigned to one of two treatment groups. Each patient in the radiofrequency treatment group (15 patients) received an 80 C radiofrequency lesion of the dorsal ramus of the segmental nerve roots L3, L4, and L5. Patients in the control group (n = 16) underwent an the same procedure but without use of a radiofrequency current. Both the treating physician and the patients were blinded to the group assignment. Before treatment, physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator.
RESULTS: Eight weeks after treatment, there were 10 success patients in the radiofrequency group (n = 15) and 6 in the sham group (n = 16). The unadjusted odds ratio was 3.3 (P = 0.05, not significant), and the adjusted odds ratio was 4.8 (P < 0.05, significant). The differences in effect on the visual analog scale scores, global perceived effect, and the Oswestry disability scale were statistically significant. Three, 6, and 12 months after treatment, there were significantly more success patients in the radiofrequency group compared with the sham group.
CONCLUSIONS: Radiofrequency lumbar zygapophysial joint denervation results in a significant alleviation of pain and functional disability in a select group of patients with chronic low back pain, both on a short-term and a long-term basis.
The aim was to compare the efficacy of intradiscal biacuplasty (IDB) with that of placebo treatment for discogenic low back pain.
DESIGN:
This is a randomized, placebo-controlled trial. Subjects were randomized on a 1:1 basis to IDB and sham groups. Follow-ups were conducted at 1, 3, and 6 months. Subjects and coordinators were blinded to randomization until 6 months. Of the 1,894 subjects screened, 64 subjects were enrolled, and 59 were treated: 29 randomized to IDB and 30 to sham. All subjects had a history of chronic low back pain for longer than 6 months.
INTERVENTIONS:
Two cooled radiofrequency (RF) electrodes placed in a bipolar manner in affected discs to lesion the nociceptive fibers of the annulus fibrosus. The sham procedure was identical to the active treatment except that probes were not directly inserted into the disc space, and RF energy was not actively delivered.
RESULTS:
The principal outcome measures were physical function, pain, disability, and opioid usage. Patients in the IDB group exhibited statistically significant improvements in physical function (P = 0.029), pain (P = 0.006), and disability (P = 0.037) at 6-month follow-up as compared to patients who received sham treatment. Treatment patients reported a reduction of 16 mg daily intake of opioids at 6 months; however, the results were not statistically different from sham patients.
CONCLUSIONS:
The results suggest that the clinical benefits observed in this study are the result of non-placebo treatment effects afforded by IDB. IDB should be recommended to select the patients with chronic discogenic low back pain. (Clinicaltrials.gov number, NCT00750191.).
