DOI: 10.11152/mu.2013.2066.151.jo1ugc2 Abstract Objectives: A prospective randomized clinical trial was conducted to evaluate accuracy, time-saving, radiation doses and pain relief of ultrasound-guided (US) facet joint injections versus Computed Tomography (CT)-controlled interventions in the cervical spine. Material and methods: Forty adult patients were consecutively enrolled and randomly assigned to the US- or CT group. US-guided facet joint injections were performed on a standard ultrasound device using a broadband linear-array transducer. The corresponding comparison group underwent CT-guided instillations which were performed under standard- ized procedures using the CT-positioning laser function. Results: The accuracy of ultrasound-guided interventions was 100%. The mean time (min:sec) to fnal needle placement in the US group was 04:46 versus 11:12 (p<0.05) in the CT group for one injected level, and 05:49 in the US group versus 14:32 (p<0.05) in the CT group for two injected levels. The mean dose-length product (DLP, mGy*cm) radiation dose, including CT confrmation for study purposes only, was 27.6 for the US group versus 88.2 in the CT group (p<0.05) for one injected level, and 32.5 in the US group versus 205.0 in the CT group (p<0.05) for two injected levels. Both groups showed the same signifcant visual-analog-scale (VAS) relief in pain (p<0.05), without any inter- methodic differences (p>0.05). Conclusions: US-guided intra-articular injections show the same therapeutic effect as CT- guided intra-articular injections and result in a signifcant reduction of procedure duration without any exposure to radiation. Keywords: facet joints injections, cervical spine, ultrasound, computed tomography, radiation dose Ultrasound-guided versus Computed Tomography-controlled facet joint injections in the middle and lower cervical spine: a prospective randomized clinical trial. Jochen Obernauer 1 , Klaus Galiano 2 , Hannes Gruber 3 , Reto Bale 3 , Alois Albert Obwegeser 1 , Reinhold Schatzer 4 , Alexander Loizides 3
1 Innsbruck Medical University, Department of Neurosurgery, 2 Innsbruck Medical University, WIK (Spine Center Inns- bruck), Sanatorium Kettenbrcke, 3 Innsbruck Medical University, Department of Radiology, 4 University of Innsbruck, C. Doppler Laboratory for Active Implantable Systems, Institute of Ion and Applied Physics, Innsbruck, Austria Received 23.11.2012 Accepted 27.12.2012 Med Ultrason 2013, Vol. 15, No 1, 10-15 Corresponding author: Jochen Obernauer, MD Innsbruck Medical University, Department of Neurosurgery Anichstrasse 35, 6020 Innsbruck, Austria Tel: +43/512/504 27452 Fax: +43/512/504 27453 E-mail: jochen.obernauer@i-med.ac.at Introduction Injection therapies play a major role in the manage- ment of various pain conditions [1,2]. With a 12-month prevalence that varies between 30% and 50%, neck pain is common in the general population. It occurs more of- ten in women and shows a peak of prevalence at middle age [3]. Facet joints are well innervated by the medial branches of the dorsal rami and contain free and encapsu- lated nerve endings, nociceptors and mechanoreceptors [4]. They have been shown to be a source of pain in the neck and related pain in the head and upper extremities [5-10]. In 2% to 10% of the cases, facet-joint-associated pain results in incapacity to perform daily activities. If, despite non-steroidal anti-infammatory drug administra- tion and nonspecifc physical therapy measures, pain be- comes unremitting, it may be managed by intra-articular injections or medial branch blocks [2,4,11]. The majority of such infltrations is performed under fuoroscopy- or computed tomography (CT) control [12]. Recently, vari- ous groups, including ourselves, have shown the reliabil- ity of ultrasound (US) guidance for different infltrations, and US has been demonstrated to facilitate the locali- 11 Med Ultrason 2013; 15(1): 10-15 zation and imaging of spinal nerve roots and also bony parts of the spine such as facet joints [13-22]. US-guided approaches tailored for spinal interventions are already available but only proven for their topographic feasibility [1,13-22]. The aim of this study was to show the feasibility and accuracy of a methodological US-based approach as described by Galiano et al 2006 [13] for inter-articular instillations in the middle to lower cervical spine in a pro- spective randomized clinical trial. Materials and methods The protocol of this prospective randomized study was reviewed and approved by the ethical committee of the Innsbruck Medical University (IMU, Protocol UN3959). The patient selection was performed consec- utively during daily routine at the Department of Neu- rosurgery at IMU and was performed on the basis of standard neurological diagnostics and clinical methods by neurosurgical specialists following evidence-based- medicine recommendations [3]. Forty adult patients (24 women and 16 men) were prospectively enrolled, after having given written informed consent. All subjects had to fulfll the following inclusion criteria: (1) subacute- chronic facet-joint-associated neck pain of the middle or lower cervical spine; (2) available recent CT or MRI of their cervical spine; (3) aged over 18 years old. Exclu- sion criteria were (1) neurological defcit, (2) local or systemic infections and discitis (3) running anticoagula- tion therapy or uncorrectable coagulopathy, (4) allergies to steroids, anesthetics or contrast agents, (5) diabetes, (6) pregnancy or (7) spinal tumors. After recording the subjects demographic data, preceding surgeries, body- mass-index and visual analog scale (VAS) score regard- ing their neck pain, patients were assigned to one of two groups by chance, using a computer-generated randomi- zation-table. One group consisted of candidates for US- guided infltrations (US group), the other group consisted of candidates for Computed Tomography (CT group). To guarantee for patient safety the study was planned to be aborted if in more than two patients of the US group the target was not visible or CT-control scans showed an in- correct needle position after US-guided intervention. Ultrasound-Guided-Procedure Ultrasound interventions were performed on a stand- ard US device (iU22; Philips Ultrasound, Bothell, Wash- ington), using a 12-5 broadband linear array transducer, by a radiological specialist with relevant experience of more than 10 years in musculoskeletal US imaging and spinal injection therapies. Under sterile circumstances and after covering the US probe with a sterile wrap, Fig 1. Posterior axial scan plane of the right facet-joint C6/7 af- ter US-guided needle-placement. Left image without and right image with notations (joint space= yellow, superior and inferior articular process=light blue. Arrow at needle tip). patients were placed in prone position and the region of interest was washed sterile and covered accordingly. The time was taken from the moment the investigator touched the skin the frst time with the probe after sterile US gel was applied. Following the systematic procedure described by Galiano et al. [13], the facet joint of inter- est was sought through a paraxial scan position, and the sonographer classifed the target as clearly visible, par- tially visible or not visible. If clearly or partially visible, a spinal needle (20 GA 3.00 IN, 0.9 x 75 mm; BD Spinal Needle, Becton Dickinson, Madrid, Spain) was inserted from dorsal exactly within the echo plane (fg 1). When the sonographer was sure to have placed the needle tip directly at the inter-articular space of the targeted facet joint, the elapsed time was recorded. Then the accuracy of the positioning was verifed by CT (Somatom - Sensation Open, Siemens, Erlangen, Germany). If the sonographer classifed the target as partially visible, the time of the following CT verifcation was included in the procedure time measurement. To keep the radiation dose as low as possible, a topogram centered on the needle tip and a few axial slices - using a low dose protocol (120 kV, 120 mA) - were obtained. If the needle placement was correct, 1 mL mixture of betamethasone (CELESTAN solubile 4 mg/ml; essex-pharma GmbH, Munich, Germany) and bupivacainehydrochloride (Bucain 0.25%, 2.5 mg/ml, Delta Select GmbH, Pfullingen, Germany) was injected. If the needle tip was not in correct position, it was re- placed again under ultrasound guidance followed by CT control, with the time measurement running on. Computed-Tomography-Controlled Procedure The CT-guided interventions were performed with the same CT device as used for the verifcation of the US pro- cedure and were executed by a radiology specialist with more than 10 years of relevant experience in CT-guided interventions. After placing the candidates in a prone po- sition, a radio-opaque marker was positioned on the skin 12 Jochen Obernauer et al Ultrasound-guided versus Computed Tomography-controlled facet joint injections of the area of interest. Consistent with the US procedure, elapsing time was recorded with the start of the initial scan. For a precise calculation of the needle pathway, a topogram through the targeted area was obtained with a low-dose protocol (120 kV, 120 mA) at 3 mm slice thick- ness. The point of entry, the angle and the depth of ap- proach were selected and calculated. The needle entry point was marked on the patients skin using the obtained calculations and the CT-positioning laser function. Then a spinal needle (20 GA 3.00 IN, 0.9 x 75 mm; BD Spinal Needle, Becton Dickinson, Madrid, Spain) was advanced toward the facet joint of interest, according to the prelimi- nary calculations. To control the present and fnal needle tip position, several CT scans were obtained repeatedly, i.e. after each reposition, until the needle was estimated to be the in correct position. At that time the elapsed time was recorded. Exactly as in the US procedure, 1 mL mixture of betamethasone (CELESTAN solubile 4 mg/ ml; essex-pharma GmbH, Munich, Germany) and bupi- vacainehydrochloride (Bucain 0.25%, 2.5 mg/ml, Delta Select GmbH, Pfullingen, Germany) was injected. Measurements and Statistics For both groups the periods of intervention time and the radiation doses (as dose-length products; DLPs) are reported. Time and radiation dose were compared sepa- rately for one- and two-leveled injections. To follow up the clinical beneft, neck pain was assessed via a visual analog scale (VAS) before, 30 minutes after and 4 weeks after the intervention. Feasibility of the US procedure was defned as percentage of patients with clearly, partially, or invisible targets (respectively inter-articular space). Accu- racy was calculated as CT-verifed exact needle tip place- ment. The number of repositions, unexpected problems and complications were also recorded for both groups. Statistical analyses were done according to the intention- to-treat principle [23]. The primary outcomes were accu- racy and time to fnal needle placement. For the evaluation of VAS changes we used the comparison of percentage VAS reduction from pre- to 30-minutes post-intervention- al and from pre- to 4-weeks post-interventional interval. The trial was designed to detect an absolute difference of one standard deviation with a power of 80% at a two-sid- ed signifcance level of 0.05 and a maximum dropout rate of 20%. Comparisons between groups were performed with an unpaired t-test, or in case of nonparametric val- ues, with a Mann-Whitney U-test. Results After randomization there were no signifcant differ- ences between the two groups (table I). All patients who were randomly assigned to the US group were judged to be feasible for the US-guided procedure. In 20 pa- tients the inter-articular space of the targeted facet joint, as well as the bony landmarks, were clearly depicted by US (100%). In 19 of these patients (95%) the interven- tion was performed as planned and the needle was posi- tioned correctly, as also confrmed by CT (95%). In one case (5%) the intervention was aborted because of the patients missing compliance (the patient was unable to deal with the pain of needle positioning). In the US group no needle had to be repositioned (accuracy = 100%). In the CT group a needle reposition was necessary in 13 cases (65%): in 3 cases (15%) the respective needle po- sition was changed once, in 6 cases (30%) twice, in 2 cases (10%) three times and in another 2 cases (10%) even four times. Regarding the necessary needle reposi- tions the US-guided procedure statistically showed a sig- nifcantly higher accuracy (p<0.05). The mean duration (min:sec) to needle placement for one-leveled injections was 4:46 in the US group and 11:12 in the CT group. The US group showed signifcant time savings (p<0.05). The mean duration (min:sec) of two-leveled injections was 5:49 for US-guided and 14:32 for CT-controlled procedures. US guidance again showed statistically sig- nifcant time savings (p<0.05). The mean DLP radiation doses, including CT confrmation for study purposes only in the US group, were 27.55 mGy*cm (one level) and 32.5 mGy*cm (two levels) for US-guided interven- tions, versus 88.2 mGy*cm (one level) and 205 mGy*cm (two levels) for CT-guided procedures. US guidance Table I. Patient-related pre-interventional data for both groups CT-guided US-guided Male/Female 5/15 11/9 Age (y) 54.7 9.5 49.6 6.0 BMI 25.8 5.1 23.9 3.8 Visual Analog Score 7.1 0.9 7.1 1.6 LEVELS One level injected Two levels injected 12 8 14 6 C2/3 C3/4 C4/5 2 3 4 0 2 4 C5/6 10 12 C6/7 6 7 C7/Th1 3 1 NOTE. Gender, age, BMI and VAS are reported as mean standard deviation. Other values are numbers of patients for each sub- group. There were no signifcant differences between the groups (p>0.05) 13 Med Ultrason 2013; 15(1): 10-15 showed a signifcant DLP saving for one- (p<0.05) and two-leveled (p<0.05) injections. Both groups showed a signifcant beneft from inter-articular injections 30 min- utes (p<0.05) and one month (p<0.05) after the injection: 30 minutes post-interventional there was a mean VAS re- duction of 72% (one level) and 69% (two levels) in the US group versus 50% (one level) and 52% (two levels) in the CT group. One month post-interventional, US guid- ance showed a mean VAS reduction of 91% (one level) and 50% (two levels) versus 59% (one level) and 55% (two levels) under CT guidance (table II). There were no signifcant differences between the US and CT groups (p>0.05) after two-leveled injections (table II). Howev- er, there was a procedure-dependent beneft for the US group with one-leveled injections (p<0.05). There were no complications or unexpected side ef- fects. Discussion The aim of this study was to demonstrate and to com- pare accuracy, effcacy, time saving, radiation doses, safety and pain relief of US-guided intra-articular facet joint injections in the middle to lower cervical spine to CT-guided interventions in a prospective randomized clinical trial. Although the pain relief was signifcant af- ter a 30-minute- and one-month follow-up in both groups and a possible signifcance of an inter-modality differ- ence was assessed in a prospective randomized manner, the study was neither intended to evaluate the overall effectiveness of intra-articular injected steroids (as in a drug study) nor to compare intra-articular injections to medial branch blocks, which are popular as well. According to clinical studies evaluating lumbar facet joint and lumbar periradicular injections under US-guid- ance and according to anatomical studies in which accu- racy of US-guided cervical facet joint injections has been analyzed, the present study demonstrated that in 100% of the performed US-guided procedures the needle place- ment was correct, as the procedure mainly relyied on the visibility of cervical facet joints [1,13-17,20-22]. The study population showed BMI-values ranging up to 33.2 and different anatomical conditions, e.g. short necked patients. An important consideration is that all cervical injec- tion therapies can be technically challenging, as acciden- tal puncture of paraspinal vessels may lead to severe and irreversible spinal complications [24-29]. This is par- ticularly relevant for cervical injections performed under fuoroscopic control, where the needle placement is more or less a blind fight until contrast agent is administered [27,30]. Following current recommendations for cervical spinal injections, the application of contrast agent under real-time digital subtraction fuoroscopy should thus be Table II. Results CT-guided US-guided p value Time (min:sec) One level Two levels 11:12 ( 03:43) 14:32 ( 02:58) 04:46 ( 02:49) 05:49 ( 02:16) <0.05 <0.05 Radiation dose (mGy*cm) One level Two levels 88.2 ( 58.2) 205.0 ( 199.7) 27.6 ( 21.4) 32.5 ( 29.2) <0.05 <0.05 Needle repositions (total) 1 repositions 2 repositions 3 repositions 4 repositions 13 3 6 2 2 0 <0.05 VAS reduction (30 min) One level Two levels VAS reduction (1 month) One level Two level 50.1 % ( 13.8) 52.0 % ( 19.7) 58.6 % ( 44.7) 55.3 % ( 40.0) 72.0 % ( 14.0) 69.2 % ( 19.7) 91.3 % ( 24.5) 50.3% ( 40.3) <0,05 >0.05 <0.05 >0.05 NOTE. Time, radiation dose and VAS reduction are reported as mean standard deviation. Other values are numbers of patients for each subgroup. 14 Jochen Obernauer et al Ultrasound-guided versus Computed Tomography-controlled facet joint injections performed to reduce the risk of unintentional injection in such paraspinal, e.g. radicular, vessels [27].
In the present US technique, the advantage of utilizing a real-time in- plane needle access from dorsal is striking: any relevant vessel is so avoided, as based on normal topography none usually crosses the needle pathway. Also, if the target is clearly visible under US guidance, no further radiographic control and no systemic application of con- trast agents or other ionizing modalities are necessarily required. In this context, the use of Duplex-mode US im- aging as a further guidance tool is conceivable, but was not used in the present study because of its questionable additional beneft. In this trial, CT controls in the US group were per- formed only for study purposes. The recordings of these DLPs showed that the mean radiation dose in the US group was signifcantly lower than the mean dose of patients who had undergone CT-guided-only interven- tions, which implies a beneft of US guidance even if performed with subsequent CT control (maybe due to forensic necessities). Although the necessary radiation dose for one single CT-guided intervention may be rather low, our study showed that cumulative effects have to be taken into account, as some CT-guided instillations in our trial required up to four CT scans. For such repeated and multilevel injections, which are quite popular, US guid- ance would be the recommended procedure. A further beneft of US guidance is that it helps to minimize the risk of unexpected side effects, as those are often associated to the application of contrast agents re- quired for the positioning control under CT- or fuorosco- py-guided procedures. The fact that US-guided injections can be performed rather easily is mostly based on the di- rect depiction of the structures of interest, i.e. cervical facet joints, by US. Thus, with a little exercise, a needle can be advanced to the target structure itself in just a few seconds under safe and real-time controlled conditions [1,13,16].
If such an intervention is performed under CT- guidance, calculations on access angles and entry points of the needle are based on landmarks, followed by an actually blind needle-positioning which is then control- led by a subsequent scan and often followed by multiple repositions. Control scans, if necessary, are potentially harming to the patients, as described above, but are also laborious and costly compared to the US procedure pre- sented here. US-guided facet joint instillations may even be performed very effciently under bed-side condi- tions, e.g. in outpatients. This saves time and resources, as US is comparatively inexepensive and broadly avail- able, and does not imply any therapeutic compromises for the patient, as accuracy is obviously suffcient for the purpose described here [13]. According to the analysis on increasing numbers and costs of spinal injection therapies, published by Carrino et al 2002 [11], the overall cost-effectiveness of cervical instillations must be evaluated as well. This is however beyond the scope of this study. Limitations Limiting factors might be that outcome was only measured by patient satisfaction and that the long-term follow-up was only performed four weeks after the in- stillation. Conclusion The US-guided facet joint injection in the middle and lower cervical spine is accurate, feasible, and bears minimal risk. It results in a signifcant pain reduction, not different from CT-guided instillations. Addition- ally a reduction of time, radiation dose and resources is highly evident. However, as with any form of instillation therapy needing practice for good results, a specifc and mandatory learning curve to achieve good visualization and guidance of the instillation needle has to be taken into account with US guidance. Upcoming projects are supposed to evaluate this and the value of the US-guided procedure during daily routine. Confict of interest: none References 1 Galiano K, Obwegeser AA, Bale R, et al. Ultrasound -guid- ed and CT-navigation-assisted periradicular and facet joint injections in the lumbar and cervical spine: a new teach- ing tool to recognize the sonoanatomic pattern. Reg Anesth Pain Med 2007; 32: 254-257. 2 Kim PS. Role of injection therapy: Review of indications for trigger point injections, regional blocks, facet joint in- jections, and intra-articular injections. Curr Opin Rheuma- tol 2002; 14: 52-57. 3 van Eerd M, Patijn J, Lataster A, et al. 5. Cervical facet pain. Pain Pract 2010; 10: 113-123. 4 Boswell MV, Shah RV, Everett CR, et al. Interventional tech- niques in the management of chronic spinal pain: evidence- based practice guidelines. Pain Physician 2005; 8:-47. 5 Senoglu N, Senoglu M, Safavi-Abbasi S, Shedd SA, Craw- ford NR. Morphologic evaluation of cervical and lumbar facet joints: intra-articular facet block considerations. Pain Pract 2010; 10: 272-278. 6 Fukui S, Ohseto K, Shiotani M, et al. Referred pain dis- tribution of the cervical zygapophyseal joints and cervical dorsal rami. Pain 1996; 68: 79-83. 15 Med Ultrason 2013; 15(1): 10-15 7 Dwyer A, Aprill C, Bogduk N. Cervical zygapophyseal joint pain patterns. I: A study in normal volunteers. Spine 1990; 15: 453-457. 8 Aprill C, Dwyer A, Bogduk N. Cervical zygapophyseal joint pain patterns. II: A clinical evaluation. Spine 1990; 15: 458-461. 9 Pawl RP. Headache, cervical spondylosis, and anterior cer- vical fusion. Surg Annu 1977; 9: 391-498. 10 Windsor RE, Nagula D, Storm S, Overton A, Jahnke S. Electrical stimulation induced cervical medial branch refer- ral patterns. Pain Physician 2003; 6: 411-418. 11 Carrino JA, Morrison WB, Parker L, Schweitzer ME, Lev- in DC, Sunshine JH. Spinal injection procedures: volume, provider distribution, and reimbursement in the U.S. medi- care population from 1993 to 1999. Radiology 2002; 225: 723-729. 12 Gangi A, Dietemann JL, Mortazavi R, Pfeger D, Kauff C, Roy C. CT-guided interventional procedures for pain management in the lumbosacral spine. Radiographics 1998;18:621-633. 13 Galiano K, Obwegeser AA, Bodner G, et al. Ultrasound- guided facet joint injections in the middle to lower cervi- cal spine: a CT-controlled sonoanatomic study. Clin J Pain 2006; 22: 538-543. 14 Pekkafahli MZ, Kiralp MZ, Basekim CC, et al. Sacroiliac joint injections performed with sonographic guidance. J Ul- trasound Med 2003; 22: 553-559. 15 Galiano K, Obwegeser AA, Bodner G, et al. Ultrasound guidance for facet joint injections in the lumbar spine: a computed tomography-controlled feasibility study. Anesth Analg 2005; 101: 579-583. 16 Galiano K, Obwegeser AA, Bodner G, et al. Ultrasound- guided periradicular injections in the middle to lower cervi- cal spine: an imaging study of a new approach. Reg Anesth Pain Med 2005; 30: 391-396. 17 Galiano K, Obwegeser AA, Bodner G, et al. Realtime sono- graphic imaging for periradicular injections in the lumbar spine: a sonographic anatomic study of a new technique. J Ultrasound Med 2005; 24: 33-38. 18 Eichenberger U, Greher M, Kapral S, et al. Sonographic visualization and ultrasound-guided block of the third oc- cipital nerve: prospective for a new method to diagnose C2- C3 zygapophysial joint pain. Anesthesiology 2006; 104: 303-308. 19 Greher M, Scharbert G, Kamolz LP, et al. Ultrasound-guid- ed lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Anesthesiology 2004; 100: 1242- 1248. 20 Loizides A, Gruber H, Peer S, Brenner E, Galiano K, Ober- nauer J. A new simplifed sonographic approach for para- radicular injections in the lumbar spine: a CT-controlled cadaver study. AJNR Am J Neuroradiol 2011; 32: 828-831. 21 Loizides A, Peer S, Plaikner M, et al. Ultrasound-guided injections in the lumbar spine. Med Ultrason 2011; 13: 54- 58. 22 Loizides A, Obernauer J, Peer S, Bale R, Galiano K, Gruber H. Ultrasound-guided injections in the middle and lower cervical spine. Med Ultrason 2012;14):235-238. 23 Lachin JM. Statistical considerations in the intent-to-treat principle. Control Clin Trials 2000; 21: 167-189. 24 Baker R, Dreyfuss P, Mercer S, Bogduk N. Cervical trans- foraminal injection of corticosteroids into a radicular artery: a possible mechanism for spinal cord injury. Pain 2003;103: 211215. 25 Benny B, Azari P, Briones D. Complications of cervical transforaminal epidural steroid injections. Am J Phys Med Rehabil 2010; 89: 601-607. 26 Brouwers PJ, Kottink EJ, Simon MA, Prevo RL. A cervical anterior spinal artery syndrome after diagnostic blockade of the right C6-nerve root. Pain 2001; 91: 397399. 27 Verrills P, Nowesenitz G, Barnard A. Penetration of a cervi- cal radicular artery during a transforaminal epidural injec- tion. Pain Med 2010; 11: 229231. 28 Heckmann JG, Maihofner C, Lanz S, Rauch C, Neundorfer B. Transient tetraplegia after cervical facet joint injection for chronic neck pain administered without imaging guid- ance. Clin Neurol Neurosurg 2006; 108: 709-711. 29 Edlow BL, Wainger BJ, Frosch MP, Copen WA, Rathmell JP, Rost NS. Posterior circulation stroke after C1-C2 in- traarticular facet steroid injection: evidence for diffuse mi- crovascular injury. Anesthesiology 2010; 112: 1532-1535. 30 Jasper JF. Role of digital subtraction fuoroscopic imaging in detecting intravascular injections. Pain Physician 2003; 6: 369372.