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
Published online May 18, 2016. doi: 10.5312/wjo.v7.i5.315
Table 1 Modified grading of qualitative evidence with best evidence synthesis for diagnostic accuracy and therapeutic interventions
Level I | Evidence obtained from multiple relevant high quality randomized controlled trials |
or | |
Evidence obtained from multiple high quality diagnostic accuracy studies | |
Level II | Evidence obtained from at least one relevant high quality randomized controlled trial or multiple relevant moderate or low quality randomized controlled trials |
or | |
Evidence obtained from at least one high quality diagnostic accuracy study or multiple moderate or low quality diagnostic accuracy studies | |
Level III | Evidence obtained from at least one relevant moderate or low quality randomized controlled trial study |
or | |
Evidence obtained from at least one relevant high quality non-randomized trial or observational study with multiple moderate or low quality observational studies | |
or | |
Evidence obtained from at least one moderate quality diagnostic accuracy study in addition to low quality studies | |
Level IV | Evidence obtained from multiple moderate or low quality relevant observational studies |
or | |
Evidence obtained from multiple relevant low quality diagnostic accuracy studies | |
Level V | Opinion or consensus of large group of clinicians and/or scientists. |
Table 2 Quality appraisal of the diagnostic accuracy of lumbar facet joint nerve block diagnostic studies
Manchikanti et al[23] | Pang et al[25] | Schwarzer et al[22] | Schwarzer et al[84] | Manchikanti et al[86] | Manchikanti et al[79] | Manchikanti et al[85] | Manchikanti et al[93] | Manchikanti et al[94] | Manchikanti et al[88] | Manchikanti et al[82] | Manchikanti et al[90] | Manchukonda et al[91] | Manchikanti et al[92] | Manchikanti et al[95] | DePalma et al[24] | |
(1) Was the test evaluated in a spectrum of subjects representative of patients who would normally receive the test in clinical practice? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(2) Was the test performed by examiners representative of those who would normally perform the test in practice? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(3) Were raters blinded to the reference standard for the target disorder being evaluated? | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
(4) Were raters blinded to the findings of other raters during the study? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(5) Were raters blinded to their own prior outcomes of the test under evaluation? | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
(6) Were raters blinded to clinical information that may have influenced the test outcome? | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
(7) Were raters blinded to additional cues, not intended to form part of the diagnostic test procedure? | Y | N | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(8) Was the order in which raters examined subjects varied? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(9) Were appropriate statistical measures of agreement used? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(10) Was the application and interpretation of the test appropriate? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(11) Was the time interval between measurements suitable in relation to the stability of the variable being measured? | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
(12) If there were dropouts from the study, was this less than 20% of the sample | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
Total | 9/12 | 8/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 | 9/12 |
Table 3 Methodological quality assessment of randomized trials of lumbar facet joint interventions utilizing Cochrane review criteria
Manchikanti et al[102] | Carette et al[103] | Fuchs et al[104] | Nath et al[105] | van Wijk et al[97] | van Kleef et al[99] | Tekin et al[96] | Civelek et al[108] | Dobrogowski et al[98] | Cohen et al[109] | Ribeiro et al[107] | Moon et al[100] | Lakemeier et al[101] | Yun et al[106] | |
Randomization adequate | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
Concealed treatment allocation | Y | Y | N | Y | Y | Y | Y | Y | U | N | Y | Y | Y | Y |
Patient blinded | Y | Y | Y | Y | Y | Y | Y | N | Y | N | Y | Y | Y | N |
Care provider blinded | Y | Y | N | Y | Y | Y | Y | N | Y | U | N | Y | N | N |
Outcome assessor blinded | N | Y | Y | Y | Y | Y | Y | U | U | U | N | Y | N | N |
Drop-out rate described | Y | Y | N | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
All randomized participants analyzed in the group | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | N | Y | Y |
Reports of the study free of suggestion of selective outcome reporting | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
Groups similar at baseline regarding most important prognostic indicators | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
Co-intervention avoided or similar in all groups | Y | N | N | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y |
Compliance acceptable in all groups | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | N | N | Y |
Time of outcome assessment in all groups similar | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | N | Y | Y |
Score | 11/12 | 11/12 | 8/12 | 12/12 | 12/12 | 12/12 | 12/12 | 9/12 | 10/12 | 8/12 | 10/12 | 9/12 | 9/12 | 9/12 |
Table 4 Methodological quality assessment of randomized trials utilizing Interventional Pain Management techniques - Quality Appraisal of Reliability and Risk of Bias Assessment criteria
Manchikanti et al[102] | Carette et al[103] | Fuchs et al[104] | Nath et al[105] | van Wijk et al[97] | van Kleef et al[99] | Tekin et al[96] | Civelek et al[108] | Dobrogowski et al[98] | Cohen et al[109] | Ribeiro et al[107] | Moon et al[100] | Lakemeier et al[101] | Yun et al[106] | |
I Trial design and guidance reporting | ||||||||||||||
(1) Consort or spirit | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 3 | 2 | 2 | 2 | 2 |
II Design factors | ||||||||||||||
(2) Type and design of trial | 2 | 3 | 2 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
(3) Setting/physician | 2 | 1 | 1 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 2 | 1 | 1 |
(4) Imaging | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 |
(5) Sample size | 3 | 2 | 2 | 1 | 1 | 1 | 1 | 1 | 1 | 3 | 2 | 2 | 2 | 2 |
(6) Statistical methodology | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
III Patient factors | ||||||||||||||
(7) Inclusiveness of Population | ||||||||||||||
For facet joint interventions: | 2 | 1 | 0 | 2 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 2 | 1 | 0 |
(8) Duration of pain | 2 | 2 | 1 | 2 | 2 | 3 | 2 | 0 | 2 | 0 | 0 | 2 | 2 | 0 |
(9) Previous treatments | 2 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 2 | 2 | 1 |
(10) Duration of follow-up with appropriate interventions | 3 | 2 | 1 | 2 | 2 | 2 | 2 | 2 | 1 | 0 | 1 | 1 | 2 | 1 |
IV Outcomes | ||||||||||||||
(11) Outcomes assessment criteria for significant improvement | 4 | 4 | 2 | 4 | 4 | 2 | 2 | 2 | 2 | 0 | 2 | 2 | 2 | 1 |
(12) Analysis of all randomized participants in the groups | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 0 | 2 | 2 |
(13) Description of drop out rate | 2 | 1 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
(14) Similarity of groups at baseline for important prognostic indicators | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
(15) Role of co-interventions | 1 | 0 | 0 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
V Randomization | ||||||||||||||
(16) Method of Randomization | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 | 2 |
VI Allocation concealment | ||||||||||||||
(17) Concealed treatment allocation | 2 | 2 | 1 | 2 | 2 | 2 | 2 | 2 | 2 | 0 | 2 | 2 | 2 | 2 |
VII Blinding | ||||||||||||||
(18) Patient blinding | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 1 | 1 | 1 | 0 |
(19) Care provider blinding | 1 | 1 | 0 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 |
(20) Outcome assessor blinding | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
VIII Conflicts of interest | ||||||||||||||
(21) Funding and sponsorship | 2 | 3 | 1 | 2 | 0 | 3 | 2 | 0 | 0 | 2 | 2 | 2 | 2 | 1 |
(22) Conflicts of interest | 3 | 3 | 1 | 3 | 0 | 3 | 2 | 0 | 0 | 2 | 3 | 3 | 3 | 0 |
Total | 45 | 40 | 26 | 42 | 36 | 40 | 37 | 28 | 29 | 28 | 32 | 32 | 38 | 37 |
Table 5 Characteristics of studies assessing the accuracy of diagnostic facet joint injections and nerve blocks in the lumbar spine
Study/methods | Participants | Intervention(s) | Outcome measures | Comments | Results | |
Methodological quality scoring | Prevalence with 95%CI and criterion standard | False-positive rate with 95%CI | ||||
Pang et al[25], 1998 | 100 consecutive adult patients with chronic low back pain with undetermined etiology were evaluated with spinal mapping | Single block was performed by injecting 2% lidocaine into facet joints | Verbal analog scale | This is the first study evaluating application of diagnostic blocks in the diagnosis of intractable low back pain of undetermined etiology with facet joint disease in potentially 48% of patients with a single block | Single block 90% pain relief | NA |
Prospective, single block | Pain mapping | Only facet joint pain = 24% | ||||
8/12 | 90% pain relief | Lumbar nerve root and facet disease = 24% | ||||
Total = 48% | ||||||
Schwarzer et al[22], 1994 | 176 consecutive patients with chronic low back pain after some type of injury | Zygapophysial joint nerve blocks or intraarticular injections were performed with either 2% lignocaine or 0.5% bupivacaine | At least 50% pain relief concordant with the duration of local anesthetic injected | First study of evaluation of controlled prevalence and false-positive rates | 50% pain relief | 38% (95%CI: 30%-46%) |
Prospective, controlled diagnostic blocks | 15% (95%CI: 10%-20%) | |||||
9/12 | ||||||
Schwarzer et al[84], 1995 | 63 patients with low back pain lasting for longer than 3 mo underwent computed tomography and blocks of the zygapophysial joints | Patients underwent a placebo injection followed by intraarticular zygapophysial joint injections with 1.5 mL of 0.5% bupivacaine | At least 50% reduction in pain maintained for minimum of 3 h | This study shows that computed tomography has no place in the diagnosis of lumbar zygapophysial joint pain, with an impure placebo design | 50% pain relief | NA |
Randomized, impure placebo, controlled diagnostic blocks | 40% (95%CI: 27%-53%) | |||||
9/12 | ||||||
Manchikanti [95], 2010 | 491 patients with chronic low back pain undergoing evaluation for facet joint pain with 80% pain relief and 181 patients with 50% pain relief | Controlled diagnostic blocks of lumbar facet joint nerves with 1% preservative-free lidocaine and 0.25% preservative-free bupivacaine 1 mL | At least 80% pain relief with the ability to perform previously painful movements | Higher prevalence than with 50% pain relief, but still higher than double block algorithmic approach | 50% pain relief | 50% pain relief |
Retrospective, controlled diagnostic blocks | 61% (95%CI: 53%-81%) | 17% (95%CI: 10%-24%) | ||||
9/12 | 80% pain relief | 80% pain relief | ||||
31% (95%CI: 26%-35%) | 42% (95%CI: 35%-50%) | |||||
Manchikanti et al[85], 2000 | 200 consecutive patients with chronic low back pain were evaluated | Controlled diagnostic blocks with 1% lidocaine and 0.25% bupivacaine were injected over facet joint nerves with 0.4 to 0.6 mL | 75% pain relief with ability to perform previously painful movements | The study showed that the clinical picture failed to diagnose facet joint pain | 75% pain relief | 37% (95%CI: 32%-42%) |
Prospective, controlled diagnostic blocks | 42% (95%CI: 35%-42%) | |||||
9/12 | ||||||
DePalma et al[24], 2011 | A total of 156 patients with chronic low back pain were assessed for the source of chronic low back pain including discogenic pain, facet joint pain, and sacroiliac joint pain | Dual controlled diagnostic blocks with 1% lidocaine for the first block with 0.5% bupivacaine for the second | Concordant relief with 2 h for lidocaine and 8 h for bupivacaine with 75% pain relief as the criterion standard | This is the third study evaluating various structures implicated in the cause of low back pain with controlled diagnostic blocks[23,25] | 75% pain relief | NA |
Retrospective, controlled diagnostic blocks | 31% (24%-38%) | |||||
9/12 | ||||||
Manchikanti et al[93], 2001 | Prevalence study in 100 patients with 50 patients below age of 65 and 50 patients aged 65 or over was assessed | Controlled diagnostic blocks | 75% pain relief with ability to perform previously painful movements was utilized as the criterion standard | This study showed higher prevalence of facet joint pain in the elderly compared to the younger age group in contrast to the latest study by Manchikanti et al[117] which showed no differences | 75% pain relief | < 65 yr = 26% (95%CI: 11%-40%) |
Prospective, controlled diagnostic blocks | < 65 yr = 30% (95%CI: 17%-43%) | > 65 yr = 33% (95%CI: 14%-35%) | ||||
> 65 yr = 52% (95%CI: 38%-66%) | ||||||
9/12 | ||||||
Manchikanti et al[94], 2001 | 100 patients with low back pain were evaluated. Patients were divided into 2 groups, group I was normal weight and group II was obese | Facet joints were investigated with diagnostic blocks using lidocaine 1% initially followed by bupivacaine 0.25%, at least 2 wk apart | A definite response was defined as relief of at least 75% in the symptomatic area | This study showed no significant difference between obese and non-obese individuals either with prevalence or false-positive rate of diagnostic blocks in chronic facet joint pain | 75% pain relief | Non-obese individuals = 44% (95%CI: 26%-61%) |
Prospective, controlled diagnostic blocks | ||||||
9/12 | Prevalence: | Obese individuals = 33% (95%CI: 16%-51%) | ||||
Non-obese individuals = 36% (95%CI: 22%-50%) | ||||||
Obese individuals = 40% (95%CI: 26%-54%) | ||||||
Manchikanti et al[23], 2001 | 120 patients were evaluated with chief complaint of chronic low back pain to evaluate relative contributions of various structures in chronic low back pain. All 120 patients underwent facet joint nerve blocks | Controlled diagnostic blocks with 1% lidocaine followed by 0.25% bupivacaine | 80% pain relief with ability to perform previously painful movements | This study evaluated all the patients with low back pain, even with suspected discogenic pain | 80% pain relief | 47% (95%CI: 35%-59%) |
Prospective, controlled diagnostic blocks | 40% (95%CI: 31%-49%) | |||||
9/12 | ||||||
Manchikanti et al[86], 1999 | 120 patients with chronic low back pain after failure of conservative management were evaluated | Controlled diagnostic blocks with 1% lidocaine followed by 0.25% bupivacaine | Concordant pain relief with 75% or greater criterion standard with ability to perform previously painful movements | This was the first study performed in the United States in the heterogenous population as previous studies were performed in only post-injury patients | 75% pain relief | 41% (95%CI: 29%-53%) |
Prospective, controlled diagnostic blocks | 45% (95%CI: 36%-54%) | |||||
9/12 | ||||||
Manchikanti et al[79], 2014 | 180 consecutive patients with chronic low back pain were evaluated after having failed conservative management | Controlled diagnostic blocks with 1% lidocaine and 0.25% bupivacaine with or without Sarapin and/or steroids | 75% pain relief with ability to perform previously painful movements | This study showed no significant difference if the steroids were used or not | 75% pain relief | 25% (95%CI: 21%-39%) |
Prospective, controlled diagnostic blocks | 36% (95%CI: 29%-43%) | |||||
9/12 | ||||||
Manchikanti et al[88], 2003 | At total of 300 patients with chronic low back pain were evaluated to assess the difference based on involvement of single or multiple spinal regions | Controlled diagnostic blocks with 1% lidocaine followed by 0.25% bupivacaine | 80% pain relief with ability to perform previously painful movements | This study shows a higher prevalence when multiple regions are involved | 80% pain relief | Single region: |
Prospective, controlled diagnostic blocks | Single region: | 17% (95%CI: 10%-24%) | ||||
21% (95%CI: 14%-27%) | Multiple regions: | |||||
9/12 | Multiple regions: | 27% (95%CI: 18%-36%) | ||||
41% (95%CI: 33%-49%) | ||||||
Manchikanti et al[82], 2014 | 120 consecutive patients with chronic low back pain and neck pain were evaluated to assess involvement of facet joints as causative factors | Controlled diagnostic blocks with 1% lidocaine followed by 0.25% bupivacaine | 80% pain relief with ability to perform previously painful movements | The results are similar to involvement of multiple regions with a prevalence of 40% as illustrated in another study | 80% pain relief | 30% (95%CI: 20%-40%) |
Prospective, controlled diagnostic blocks | 40% (95%CI: 31%-49%) | |||||
9/12 | ||||||
Manchikanti et al[90], 2004 | 500 consecutive patients with chronic, non-specific spinal pain were evaluated of which 397 patients suffered with chronic low back pain | Controlled diagnostic blocks with 1% lidocaine followed by 0.25% bupivacaine | 80% pain relief with ability to perform previously painful movements | Largest study performed involving all regions of the spine | 80% pain relief | 27% (95%CI: 22%-32%) |
Prospective, controlled diagnostic blocks | 31% (95%CI: 27%-36%) | |||||
9/12 | ||||||
Manchukonda et al[91], 2007 | 500 consecutive patients with chronic spinal pain were evaluated of which 303 patients were evaluated for chronic low back pain | Controlled diagnostic blocks with 1% lidocaine followed by 0.25% bupivacaine | 80% pain relief with ability to perform previously painful movements | Second largest study performed involving all regions of the spine | 80% pain relief | 45% (95%CI: 36%-53%) |
Retrospective, controlled diagnostic blocks | 27% (95%CI: 22%-33%) | |||||
9/12 | ||||||
Manchikanti et al[92], 2007 | A total of 117 consecutive patients with chronic non-specific low back pain were evaluated, after lumbar surgical interventions, with postsurgery syndrome and continued axial low back pain | Controlled, comparative, local anesthetic blocks with 1% lidocaine and 0.25% bupivacaine | 80% relief as the criterion standard with ability to perform previously painful movements | Lower prevalence in postsurgery patients | 80% pain relief | 49% (95%CI: 39%-59%) |
Prospective, controlled diagnostic blocks | 16% (95%CI: 9%-23%) | |||||
9/12 |
Table 6 Study characteristics of randomized controlled trials of lumbar radiofrequency neurotomy, facet joint nerve blocks, and intraarticular injections
Study/study characteristic/methodological quality Scoring | No. of patients and selection criteria | Control | Interventions | Outcome measures | Time of measurement | Reported results | Strengths | Weaknesses | Conclusion/comments |
Radiofrequency neurotomy | |||||||||
Civelek et al[108], 2012 | 100 patients with chronic low back pain with failed conservative therapy and strict selection criteria; however, without diagnostic blocks | Facet joint nerve block with local anesthetic and steroids in 50 patients | Conventional radiofrequency neurotomy at 80 °C for 120 s in combination with high dose local anesthetic and steroids, in 50 patients | Visual Numeric Pain Scale, North American Spine Society patient satisfaction questionnaire, Euro-Qol in 5 dimensions and ≥ 50% relief | 1, 6 and 12 mo | At 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-up | Randomized relatively large number of patients with 50 in each group | No diagnostic blocks were performed. High dose steroids and local anesthetics were utilized in both groups | Efficacy 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], 2010 | 151 chronic low back pain, 51 patients with no diagnostic block, 50 patients a single diagnostic block, 50 patients in double diagnostic block | Radiofrequency neurotomy in patients without diagnostic blocks | Conventional 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 results | Greater than 50% pain relief coupled with a positive global perceived effect persisting for 3 mo | 3 mo | Denervation success rates in groups 0, 1 and 2 were 33%, 39% and 64%, respectively | Multicenter, randomized controlled trial with or without diagnostic blocks | Authors misinterpreted cost-effectiveness without consideration of many factors reported | Results 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], 2008 | 40 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 group | Controlled sham lesion in 20 patients in the control group | The 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 joints | Numeric Rating Scale, global functional improvement, reduced opioid intake, employment status | 6 mo | Significant reduction not only in back and leg pain; functional improvement; opioid reduction; and employment status in the active group compared to the control group | Randomized, double-blind trial after the diagnosis of facet joint pain with triple diagnostic blocks | Short-term follow-up with small number of patients | Efficacy 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], 2007 | 60 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 relief | Sham control with local anesthetic injection | Either pulsed radiofrequency (42 °C for 4 min) or conventional radiofrequency neurotomy (80 °C for 90 s) in 20 patients in each group | Visual analog scale and Oswestry Disability Index | 3, 6 and 12 mo | Visual 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 yr | Randomized, double-blind, controlled trial comparing control, pulsed radiofrequency, and conventional radiofreqency neurotomy. Authors also utilized a parallel needle placement approach | Small sample size with a single block and 50% relief as inclusion criteria. Authors have not described the significant improvement percentages | Efficacy 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], 2005 | 81 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 injection | 40 patients received conventional radiofrequency lesioning at 80 °C for 60 s and 41 patients received sham lesioning | Pain relief, physical activities, analgesic intake, global perceived effect, short-form-36, quality of life measures | 3 mo | Global 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 trial | Poor 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 nerve | Lack 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], 2005 | 45 consecutive patients with chronic low back pain judged to be positive with controlled diagnostic blocks | Injection of saline in patients after conventional radiofrequency (85 °C for 60 s) neurotomy to evaluate postoperative pain | Conventional radiofrequency neurotomy at 85 °C for 60 s, followed by injection of either methylprednisolone or pentoxifylline | Visual analog scale, minimum of 50% reduction of pain intensity, patient satisfaction score | 1, 3, 6 and 12 mo | Greater 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 outcomes | Randomized, active control trial | Very small study evaluating effectiveness of radiofrequency neurotomy and postoperative pain | Radiofrequency 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], 1999 | 31 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% relief | Sham control of radiofrequency after local anesthetic injection in 16 patients | The 15 patients in the conventional radiofrequency treatment group received an 80 °C radiofrequency lesion for 60 s | Visual analog scale, pain scores, global perceived effect, Oswestry Disability Index | 3, 6 and 12 mo | After 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 difference | Double-blind, randomized, sham controlled trial | A 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], 2013 | 82 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 needle | An active control trial with needle placement with perpendicular approach | 41 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 needle | NRS, ODI | 1 and 6 mo | Patients 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 blocks | Active controlled trial without placebo group. Short-term follow-up | Positive 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], 2013 | 56 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 block | Intraarticular injection of local anesthetic and steroid | Radiofrequency neurotomy for 90 s at 80 °C | Roland-Morris questionnaire, VAS, ODI, analgesic intake | 6 mo | Pain relief and functional improvement were observed in both groups. There were no significant differences between the 2 groups for pain relief and functional status improvement | Lack of placebo group. Relatively short-term follow-up | Randomized, double-blind trial with single diagnostic block with intraarticular injection | Both 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], 2012 | 100 patients with chronic low back with failed conservative therapy and strict selection criteria; however, without diagnostic blocks | Blocks of facet joint nerves with local anesthetic and steroids | Conventional radiofrequency neurotomy at 80 °C for 120 s in combination with high dose local anesthetic and steroids | Visual Numeric Pain Scale, North American Spine Society patient satisfaction questionnaire, Euro-Qol in 5 dimensions and ≥ 50% relief | 1, 6 and 12 mo | At 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-up | Randomized active-control trial with relatively large number of patients with 50 in each group | No diagnostic blocks were performed. High dose steroids and local anesthetics were provided in both groups | Results 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], 2010 | 120 patients with chronic low back pain of facet joint origin treated with therapeutic lumbar facet joint nerve blocks Double diagnostic blocks with 80% relief | Local anesthetic only | Total 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 Sarapin | Numeric Rating Scale, Oswestry Disability Index, employment status, and opioid intake | 3, 6, 12, 18 and 24 mo | Significant 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 treatments | Randomized trial with relatively large proportion of patients with 2-yr follow-up, with inclusion of patients diagnosed with controlled diagnostic blocks | Lack of placebo group | Effectiveness 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], 1991 | Patients 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 guidance | Intraarticular injection of isotonic saline | Injection of either sodium chloride or methylprednisolone into the facet joints (49 for isotonic saline and 48 for sodium chloride). Only one injection was provided | Visual Analog Scale, McGill Pain Questionnaire, mean sickness impact profile | 1, 3 and 6 mo | After 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 group | Well-performed randomized, double-blind controlled trial | Only single block was applied and patients were treated with steroids without local anesthetic with only one treatment and expected 6 mo of relief | The 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], 2005 | 60 patients with chronic low back pain were included with patients randomly assigned into 2 groups. No diagnostic blocks | Active-control study with no control group | Intraarticular injection of hyaluronic acid vs glucocorticoid injection | VAS, Rowland-Morris Questionnaire, ODI, low back outcomes score, short form-36 | 3 and 6 mo | Patients reported lasting pain relief, better function, and improved quality of life with both treatments | Randomized, active-control, double-blind study | Relatively small sample of patients with 6 mo follow-up without a placebo group, without diagnostic blocks | Undetermined (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], 2013 | 60 patients with a diagnosis of facet joint syndrome randomized into experimental and control groups | Triamcinolone acetonide intramuscular injection of 6 lumbar paravertebral points | Intraarticular injection of 6 lumbar facet joints with triamcinolone hexacetonide | Pain 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 taken | 1, 4, 12 and 24 wk | Both 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 wk | Randomized, double-blind controlled trial | Diagnostic blocks were not employed, thus, many patients without facet joint pain may have been included in this trial | Overall 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], 2013 | 56 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 block | Intraarticular injection of local anesthetic and steroid in 29 patients | Radiofrequency neurotomy for 90 s at 80 °C in 27 patients | Roland-Morris questionnaire, VAS, ODI, analgesic intake | 6 mo | Pain relief and functional improvement were observed in both groups. There were no significant differences between the 2 groups for pain relief and functional status improvement | Lack of placebo group. Relatively short-term follow-up | Randomized, double-blind trial with single diagnostic block with intraarticular injection | Both 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], 2012 | 57 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 blocks | Intraarticular injection of lidocaine and triamcinolone under fluoroscopic guidance | Intraarticular injection of lidocaine and triamcinolone under ultrasonic guidance | VAS, physician’s and patient’s global assessment (PhyGA, PaGA), modified ODI | 1 wk, 1 and 3 mo | Each 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 groups | Randomized trial | Short-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 appropriate | The 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 |
- Citation: Manchikanti L, Hirsch JA, Falco FJE, Boswell MV. Management of lumbar zygapophysial (facet) joint pain. World J Orthop 2016; 7(5): 315-337
- URL: https://www.wjgnet.com/2218-5836/full/v7/i5/315.htm
- DOI: https://dx.doi.org/10.5312/wjo.v7.i5.315