Systematic Reviews
Copyright ©The Author(s) 2016.
World J Orthop. May 18, 2016; 7(5): 315-337
Published online May 18, 2016. doi: 10.5312/wjo.v7.i5.315
Table 6 Study characteristics of randomized controlled trials of lumbar radiofrequency neurotomy, facet joint nerve blocks, and intraarticular injections
Study/study characteristic/methodological quality ScoringNo. of patients and selection criteriaControlInterventionsOutcome measuresTime of measurementReported resultsStrengthsWeaknessesConclusion/comments
Radiofrequency neurotomy
Civelek et al[108], 2012100 patients with chronic low back pain with failed conservative therapy and strict selection criteria; however, without diagnostic blocksFacet joint nerve block with local anesthetic and steroids in 50 patientsConventional radiofrequency neurotomy at 80 °C for 120 s in combination with high dose local anesthetic and steroids, in 50 patientsVisual Numeric Pain Scale, North American Spine Society patient satisfaction questionnaire, Euro-Qol in 5 dimensions and ≥ 50% relief1, 6 and 12 moAt one year, 90% of patients in the radiofrequency group and 69% of the patients in the facet joint nerve block group showed significant improvement compared to 92% and 75% at 6-mo follow-upRandomized relatively large number of patients with 50 in each groupNo diagnostic blocks were performed. High dose steroids and local anesthetics were utilized in both groupsEfficacy was shown even without diagnostic blocks, both for facet joint nerve blocks and radiofrequency neurotomy
Randomized, active-control trial
Quality scores:
Cochrane = 9/12
IPM-QRB = 28/48
Cohen et al[109], 2010151 chronic low back pain, 51 patients with no diagnostic block, 50 patients a single diagnostic block, 50 patients in double diagnostic blockRadiofrequency neurotomy in patients without diagnostic blocksConventional radiofrequency neurotomy at 80 °C for 90 s in all patients; however, in 2 groups with either a single block paradigm or a double block paradigm testing for positive resultsGreater than 50% pain relief coupled with a positive global perceived effect persisting for 3 mo3 moDenervation success rates in groups 0, 1 and 2 were 33%, 39% and 64%, respectivelyMulticenter, randomized controlled trial with or without diagnostic blocksAuthors misinterpreted cost-effectiveness without consideration of many factors reportedResults showed efficacy when double diagnostic blocks were utilized
Randomized, double-blind, control trial
Quality scores:
Cochrane = 8/12
IPM-QRB = 28/48
Nath et al[105], 200840 patients with chronic low back pain for at least 2 yr with 80% relief of low back pain after controlled medial branch blocks. The patients were randomized into an active and a control groupControlled sham lesion in 20 patients in the control groupThe 20 patients in the active group received conventional lumbar facet joint radiofrequency neurolysis at 85 °C for 60 s. The 20 patients in the control group received sham treatment without radiofrequency neurolysis of the lumbar facet jointsNumeric Rating Scale, global functional improvement, reduced opioid intake, employment status6 moSignificant reduction not only in back and leg pain; functional improvement; opioid reduction; and employment status in the active group compared to the control groupRandomized, double-blind trial after the diagnosis of facet joint pain with triple diagnostic blocksShort-term follow-up with small number of patientsEfficacy of radiofreqency neurotomy was shown compared to local anesthetic injection and sham lesioning
Randomized, double-blind, sham control trial
Quality scores:
Cochrane = 12/12
IPM-QRB = 42/48
Tekin et al[96], 200760 patients with chronic low back pain randomized into 3 groups with 20 patients in each group. Single diagnostic block of facet joint nerves with 0.3 mL of lidocaine 2% with 50% or greater reliefSham control with local anesthetic injectionEither pulsed radiofrequency (42 °C for 4 min) or conventional radiofrequency neurotomy (80 °C for 90 s) in 20 patients in each groupVisual analog scale and Oswestry Disability Index3, 6 and 12 moVisual analog scale and Oswestry Disability Index scores decreased in all groups from 3 procedural levels. Decrease in pain scores was maintained in the conventional radiofrequency group at 6 mo and one year. However, in pulsed radiofrequency group, the improvement was significant only at 6 mo, but not 1 yrRandomized, double-blind, controlled trial comparing control, pulsed radiofrequency, and conventional radiofreqency neurotomy. Authors also utilized a parallel needle placement approachSmall sample size with a single block and 50% relief as inclusion criteria. Authors have not described the significant improvement percentagesEfficacy with conventional radiofreqency neurotomy up to one year, whereas efficacy with local anesthetic block with sham control radiofrequency neurotomy and pulsed radiofrequency neurotomy at 6 mo only
Randomized, active and sham, double-blind controlled trial
Quality scores:
Cochrane = 12/12
IPM-QRB = 37/48
van Wijk et al[97], 200581 patients with chronic low back pain were evaluated with radiofreqency neurotomy with 41 patients in the control group with at least 50% relief for 30 min with a single block with intraarticular injection of 0.5 mL lidocaine 2%Sham lesion procedure after local anesthetic injection40 patients received conventional radiofrequency lesioning at 80 °C for 60 s and 41 patients received sham lesioningPain relief, physical activities, analgesic intake, global perceived effect, short-form-36, quality of life measures3 moGlobal perceived effect improved after radiofrequency facet joint denervation. The visual analog scale in both groups improved. The combined outcome measures showed no difference between radiofreqency facet joint denervation (27.5% vs 29.3% success rate)Double-blind, sham control, randomized trialPoor selection with a single diagnostic block of 50% pain reduction even though 17.5% of the patients tested positive. Further, authors described that the needle was positioned parallel; however, the radiographic figures illustrate the needle was being positioned perpendicularly rather than parallel to the nerveLack of efficacy with methodological deficiencies and a short-term follow-up
Randomized, double-blind, sham control trial
Quality scores:
Cochrane = 12/12
IPM-QRB = 36/48
Dobrogowski et al[98], 200545 consecutive patients with chronic low back pain judged to be positive with controlled diagnostic blocksInjection of saline in patients after conventional radiofrequency (85 °C for 60 s) neurotomy to evaluate postoperative painConventional radiofrequency neurotomy at 85 °C for 60 s, followed by injection of either methylprednisolone or pentoxifyllineVisual analog scale, minimum of 50% reduction of pain intensity, patient satisfaction score1, 3, 6 and 12 moGreater than 50% of reduction of pain intensity was observed in 66% of the patients 12 mo later. There was no difference in the long-term outcomesRandomized, active control trialVery small study evaluating effectiveness of radiofrequency neurotomy and postoperative painRadiofrequency neurotomy effective with or without steroid injection after neurolysis
Randomized, active control trial
Quality scores:
Cochrane = 10/12
IPM-QRB = 29/48
van Kleef et al[99], 199931 patients with a history of at least one year of chronic low back pain randomly assigned to one of 2 treatment groups. Single diagnostic block with 50% reliefSham control of radiofrequency after local anesthetic injection in 16 patientsThe 15 patients in the conventional radiofrequency treatment group received an 80 °C radiofrequency lesion for 60 sVisual analog scale, pain scores, global perceived effect, Oswestry Disability Index3, 6 and 12 moAfter 3, 6 and 12 mo, the number of successes in the lesion and sham groups was 9 of 15 (60%) and 4 of 16 (25%), 7 of 15 (47%) and 3 of 16 (19%), and 7 of 15 (47%) and 2 of 16 (13%) respectively. There was a statistically significant differenceDouble-blind, randomized, sham controlled trialA single block with a small sample with inclusion criteria of 50% pain relief to enter the study. The study has been criticized that electrodes were placed at an angle to the target nerve, instead of parallel (51A)Efficacy shown in a small sample with a single diagnostic block
Randomized, double-blind, sham control trial
Quality scores:
Cochrane = 12/12
IPM-QRB = 40/48
Moon et al[100], 201382 patients were included with low back pain with 41 patients in each group either with a parallel placement of the needle or perpendicular placement of the needleAn active control trial with needle placement with perpendicular approach41 patients in each group were treated with radiofrequency (80 °C for 90 s) after appropriate diagnosis of facet joint pain with dual diagnostic blocks with 50% relief as the criterion standard. The needle was positioned either utilizing a discal approach or perpendicular or utilizing tunnel vision approach with parallel placement of the needleNRS, ODI1 and 6 moPatients in both groups showed a statistically significant reduction in NRS and Oswestry disability index scores from baseline to that of the scores at 1 and 6 mo (all P < 0.0001, Bonferroni corrected)Randomized, double-blind, controlled trial. The major strength is that authors have proven that parallel approach may not be the best as has been described. Diagnosis of facet joint pain by dual blocksActive controlled trial without placebo group. Short-term follow-upPositive results in an active controlled trial, in a relatively short-term follow-up of 6 mo, with positioning of the needle either with distal approach (perpendicular placement or tunnel vision) with parallel placement of the needle with some superiority with perpendicular approach. This trial abates any criticism of needle positioning one way or the other and the traditional needle positioning appears to be superior to parallel needle placement
Prospective, randomized, comparative study
Quality scores:
Cochrane = 9/12
IPM-QRB = 38/48
Lakemeier et al[101], 201356 patients were randomized into 2 groups with 29 patients receiving intraarticular steroid injections and 27 patients receiving radiofrequency denervation after the diagnosis was made with intraarticular injection of local anesthetic with a single blockIntraarticular injection of local anesthetic and steroidRadiofrequency neurotomy for 90 s at 80 °CRoland-Morris questionnaire, VAS, ODI, analgesic intake6 moPain relief and functional improvement were observed in both groups. There were no significant differences between the 2 groups for pain relief and functional status improvementLack of placebo group. Relatively short-term follow-upRandomized, double-blind trial with single diagnostic block with intraarticular injectionBoth groups showed improvement. Effectiveness at 6 mo in both groups with intraarticular injection or radiofrequency neurotomy
Randomized, double-blind, active controlled trial
Quality scores:
Cochrane = 9/12
IPM-QRB = 37/48
Lumbar facet joint nerve blocks
Civelek et al[108], 2012100 patients with chronic low back with failed conservative therapy and strict selection criteria; however, without diagnostic blocksBlocks of facet joint nerves with local anesthetic and steroidsConventional radiofrequency neurotomy at 80 °C for 120 s in combination with high dose local anesthetic and steroidsVisual Numeric Pain Scale, North American Spine Society patient satisfaction questionnaire, Euro-Qol in 5 dimensions and ≥ 50% relief1, 6 and 12 moAt the end of one year, 90% of patients in the radiofrequency group and 69% of the patients in the facet joint nerve block group showed significant improvement vs 92% and 75% at 6-mo follow-upRandomized active-control trial with relatively large number of patients with 50 in each groupNo diagnostic blocks were performed. High dose steroids and local anesthetics were provided in both groupsResults showed efficacy even without diagnostic blocks, both for facet joint nerve blocks and radiofrequency neurotomy
Randomized, active-control trial
Quality scores:
Cochrane = 9/12
IPM-QRB = 28/48
Manchikanti et al[102], 2010120 patients with chronic low back pain of facet joint origin treated with therapeutic lumbar facet joint nerve blocks Double diagnostic blocks with 80% reliefLocal anesthetic onlyTotal of 120 patients with 60 patients in each group with local anesthetic alone or local anesthetic and steroids. Both groups were also divided into 2 categories each with the addition of SarapinNumeric Rating Scale, Oswestry Disability Index, employment status, and opioid intake3, 6, 12, 18 and 24 moSignificant pain relief was shown in 85% in local anesthetic group and 90% in local anesthetic with steroids group at the end of the 2 yr study period in both groups, with an average of 5-6 total treatmentsRandomized trial with relatively large proportion of patients with 2-yr follow-up, with inclusion of patients diagnosed with controlled diagnostic blocksLack of placebo groupEffectiveness demonstrated with facet joint nerve blocks with local anesthetic with or without steroids
Randomized, double blind, active control trial
Quality scores:
Cochrane = 11/12
IPM-QRB = 45/48
Lumbar intraarticular injections
Carette et al[103], 1991Patients with chronic low back pain who reported immediate relief of their pain after injection of local anesthetic into the facet joints. Single diagnostic blocks with 50% relief were randomly assigned to receive injections under fluoroscopic guidanceIntraarticular injection of isotonic salineInjection of either sodium chloride or methylprednisolone into the facet joints (49 for isotonic saline and 48 for sodium chloride). Only one injection was providedVisual Analog Scale, McGill Pain Questionnaire, mean sickness impact profile1, 3 and 6 moAfter 1 mo, 42% of the patients in the methylprednisolone group and 33% in the sodium chloride group reported marked or very marked improvement. At the 6 mo evaluation, 46% in the methylprednisolone group and 15% in the placebo group showed sustained relief. Revised statistics showed 22% improvement in active group and 10% in control groupWell-performed randomized, double-blind controlled trialOnly single block was applied and patients were treated with steroids without local anesthetic with only one treatment and expected 6 mo of reliefThe authors concluded that results were negative in an active-control trial with injection of either sodium chloride solution or steroid into the facet joints after diagnosis with a single block
Randomized, double blind, impure placebo or active- control trial
Quality scores:
Cochrane = 11/12
IPM-QRB = 40/48
Fuchs et al[104], 200560 patients with chronic low back pain were included with patients randomly assigned into 2 groups. No diagnostic blocksActive-control study with no control groupIntraarticular injection of hyaluronic acid vs glucocorticoid injectionVAS, Rowland-Morris Questionnaire, ODI, low back outcomes score, short form-363 and 6 moPatients reported lasting pain relief, better function, and improved quality of life with both treatmentsRandomized, active-control, double-blind studyRelatively small sample of patients with 6 mo follow-up without a placebo group, without diagnostic blocksUndetermined (clinically inapplicable) results with high number of injections during a 6-mo period
Randomized, double-blind, active-control trial
Quality scores:
Cochrane = 8/12
IPM-QRB = 26/48
Ribeiro et al[107], 201360 patients with a diagnosis of facet joint syndrome randomized into experimental and control groupsTriamcinolone acetonide intramuscular injection of 6 lumbar paravertebral pointsIntraarticular injection of 6 lumbar facet joints with triamcinolone hexacetonidePain visual analogue scale, pain visual analogue scale during extension of the spine, Likert scale, improvement percentage scale, Roland-Morris, 36-Item Short Form Health Survey, and accountability of medications taken1, 4, 12 and 24 wkBoth groups showed improvement with no statistical difference between the groups. Improvement "percentage" analysis at each time point showed significant differences between the groups at week 7 and week 12. Improvement percentage was > 50% at all times in the experimental group with intraarticular steroids; however, significant difference was noted at 24 wkRandomized, double-blind controlled trialDiagnostic blocks were not employed, thus, many patients without facet joint pain may have been included in this trialOverall intraarticular steroids showed positive effectiveness for 24 wk compared to intramuscular steroids provided in a double-blind manner
Randomized, double-blind, active control
Quality scores:
Cochrane = 10/12
IPM-QRB = 32/48
Lakemeier et al[101], 201356 patients were randomized into 2 groups receiving intraarticular steroid injections or radiofrequency denervation after the diagnosis was made with intraarticular injection of local anesthetic with a single blockIntraarticular injection of local anesthetic and steroid in 29 patientsRadiofrequency neurotomy for 90 s at 80 °C in 27 patientsRoland-Morris questionnaire, VAS, ODI, analgesic intake6 moPain relief and functional improvement were observed in both groups. There were no significant differences between the 2 groups for pain relief and functional status improvementLack of placebo group. Relatively short-term follow-upRandomized, double-blind trial with single diagnostic block with intraarticular injectionBoth groups showed improvement. Effectiveness of both modalities at 6 mo in both groups
Randomized, double-blind, active controlled trial
Quality scores:
Cochrane = 9/12
IPM-QRB = 37/48
Yun et al[106], 201257 patients with facet syndrome were assigned to 2 groups with 32 patients in the fluoroscopy group and 25 patients in the under ultrasonography group without diagnostic blocksIntraarticular injection of lidocaine and triamcinolone under fluoroscopic guidanceIntraarticular injection of lidocaine and triamcinolone under ultrasonic guidanceVAS, physician’s and patient’s global assessment (PhyGA, PaGA), modified ODI1 wk, 1 and 3 moEach group showed significant improvement from the facet joint injections. However at a week, a mo, and 3 mo after injections, no significant differences were observed between the groupsRandomized trialShort-term follow-up with no diagnostic blocks, thus increasing the potential for inclusion of patients without facet joint pain. The aim of study mainly was to confirm if ultrasonic imaging was appropriateThe study showed positive results in both groups with intraarticular steroid injections with a short-term follow-up whether performed under ultrasonic guidance or fluoroscopy
Randomized, active controlled trial
Quality scores:
Cochrane = 9/12
IPM-QRB = 26/48