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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 34  |  Issue : 2  |  Page : 94-100

Comparative analysis of fluoroscopic-guided and ultrasound-guided sacroiliac joint injection in patient with clinical sacroiliitis


1 Department of Anaesthesiology, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
2 Department of Anaesthesiology, Guru Hospital, Madurai, Tamil Nadu, India
3 Department of Anaesthesiology, Narayana Hrudayalaya, Bommasandra Industrial Estate, Bengaluru, Karnataka, India

Date of Submission03-Mar-2020
Date of Decision29-Mar-2020
Date of Acceptance19-Apr-2020
Date of Web Publication06-Aug-2020

Correspondence Address:
Dr. Chetna Shamshery
M-139, Aashiana Colony, Kanpur Road, Lucknow - 226 012. Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijpn.ijpn_27_20

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  Abstract 


Background: The complex anatomy of sacroiliac joint (SIJ) mandates an imaging modality to perform the diagnostic or therapeutic joint injection. Methods: Thirty-eight patients with sacroiliitis were randomly allocated into two groups, and were given SIJ injection using either fluroscopy (FL) or ultrasound (USG) as a guide to intervene. The assessment of pain by numerical rating scale (NRS), psychological and quality of life assessment by Depression Anxiety Stress Scale (DASS) and Oswestry Disability Index (ODI), respectively, learning curve evaluation by the number of attempts, time taken and subjective ease of performing the procedure were evaluated. Results: Decreased numerical rating score (NRS) of pain from preprocedure mean value of 7.39 ± 0.20–0.94 ± 0.15 in the FL grp and 7.22 ± 0.21 to 2.78 ± 0.32 in the USG group at 4 weeks was significant and comparable (P < 0.001). The improvement in DASS from 40.78 ± 1.96–22.78 ± 0.49 (P < 0.001) in FL grp and 41.33 ± 1.62–25.22 ± 0.73 (P < 0.001) in USG group were significant and comparable after 12 weeks' follow-up. ODI decreased from 45.44 ± 0.99–20.78 ± 0.84 (P < 0.001) and 46.33 ± 0.98–24.11 ± 0.95 (P < 0.001) in FL and USG grp after 12 weeks. Fluoroscopic procedure took 1–3 attempts compared to 2–4 for USG. The average time taken to perform fluoroscopic intervention was 6.89 ± 0.23 min as compared to 9.32 ± 0.87 min by USG. Conclusion: USG and FL both are effective tools to intervene the SIJ but USG requires greater skill.

Keywords: Fluoroscopy, low back pain, sacroiliac joint, sacroiliitis, ultrasonography


How to cite this article:
Shamshery C, Kumar VV, Agarwal A, Madubashi R, Aggarwal A. Comparative analysis of fluoroscopic-guided and ultrasound-guided sacroiliac joint injection in patient with clinical sacroiliitis. Indian J Pain 2020;34:94-100

How to cite this URL:
Shamshery C, Kumar VV, Agarwal A, Madubashi R, Aggarwal A. Comparative analysis of fluoroscopic-guided and ultrasound-guided sacroiliac joint injection in patient with clinical sacroiliitis. Indian J Pain [serial online] 2020 [cited 2020 Sep 27];34:94-100. Available from: http://www.indianjpain.org/text.asp?2020/34/2/94/291540




  Introduction Top


The sacroiliac joint (SIJ) is a diarthro-amphiarthrosis joint containing synovial fluid enclosed by an outer fibrous joint capsule in the lower two-third of the joint space.[1] The SIJ has restricted mobility due to its ligaments, fibrous attachments, and sinusoidal structure.[2] With age sacral cartilages maintain their anatomical integrity but the cartilages attached to the ilium thin out and undergo arthritic changes. The pathologic or predisposing conditions that affect the SIJ could be older age, true and apparent leg length discrepancy, inflammatory arthritis, previous spine surgery, pregnancy, trauma,[3] etc.

Treatment of SIJ pain most commonly involves conservative strategies such as exercises or medications, and in nonresponders, an intra-articular injection of SIJ with local anesthetic ± steroid provides, short- to medium-term therapeutic benefit.[4] Anatomic landmark-guided intra-articular injection of SIJ is successful in 12%–22% patients.[5] Fluoroscopic (FL) guidance improves the accuracy of this procedure to 60% in 1st attempt but is limited by the requirement of proper infrastructure, radiation exposure, and additional cost. Another imaging modality is ultrasound (US) which is cost-effective, easily available, avoids radiation exposure, gives a “real-time” visualization of the needle tip and surrounding structures. Studies have already shown feasibility of the ultrasound (USG)[5] to image the SIJ, with the intra-articular placement of needle ranging from 40% to 80% depending on the expertise of the performer.[6],[7],[8] Studies have evaluated and concluded the equivocal analgesic and functional outcome of SIJ injection using either US or fluoroscopy as an imaging modality.[9],[10] The results of these studies have also identified accuracy, efficacy and patient satisfaction but the quality of life and psychological impact is yet to be established.

As pain management becomes an acknowledged super-specialty involving invasive interventions there is need to properly train the fellows/residents, so that they become better interventionists without harming the patients in the process of learning. To address this gap of technical skill and difficulty, and analyze the learning curve of a novice using two different image-guided techniques (US and FL), we conducted a randomized parallel group trial with the primary objective to evaluate the pain scores at the end of 1 month after SIJ intervention and secondary objectives of comparing the pain scores at 24 h, 1 week, and 3 months; level of disability and psychological aspects affecting quality of life at 1 month and 3 months postintervention; assess learning curve of a novice in terms of time taken, number of attempts, and ease of performance between the two imaging modalities.


  Methods Top


Study design

This was prospective randomized, double-blinded, parallel trial study.

Participants

After getting approval from research ethics board of our institute, the study was undertaken in the department of anesthesiology and retrospectively registered at Clinical Trial Registry– India (2017/10/009958 [Registered on: 03/10/2017]). Thirty-eight patients with chronic low back pain secondary to sacroiliitis were prospectively enrolled. After obtaining written and informed consent, patients were randomly divided into two groups: Group A included patients receiving injection using fluoroscopic guidance and Group B included patients receiving injection using USG.

Inclusion criteria

1. Patient diagnosed as sacroiliitis with characteristic history and at least 3 positive physical examination maneuvers ([flexion, abduction, and external rotation], GAENSLEN'S test, YEOMAN'S test, GILLETT's test, SHEAR test),[11] ASA physical status classification I/II, Moderate-to-severe pain (NRS pain score >3/10) refractory to oral anti-inflammatory therapy and exercises for at least 3 months.

Exclusion criteria

1. Age <18 years or >60 years, Body mass index above 35 kg/m2, diagnosed case of severe anxiety or depression, allergy to local anesthetics or steroids, pregnancy or multiple co morbidities.

Randomization and blinding

The study followed the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Of 47 patients who were clinically diagnosed as case of sacroiliitis there were 8 who responded to conservative management by exercises and medications. One patient had bilateral sacroiliitis and hence excluded. Remaining 38 patients posted for SIJ injection were randomly distributed into two groups using chit method which was assisted by a pain clinic nurse. The patients were blinded in terms of group allocation. The follow-up of cases in the pain clinic, and assessment was done by a fellow who did not perform the intervention, and was blind to the group allocation of the case. Flowchart according to Consolidated Standards of Reporting Trials statement is shown in [Figure 1].
Figure 1: Flowchart according to consolidated standards of reporting trials statement

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Interventions

After securing an intravenous line, standard monitors (Electrocardiogram, Pulse oximeter, Noninvasive blood pressure) were applied and patients were positioned prone with pillow below the lumbosacral spine to neutralize lumbar lordosis. With the patient lying prone, the skin over the sacroiliac region was painted using betadine with alcohol and draped for a sterile procedure. Under aseptic precautions all patients were given 1.5 ml lignocaine 2% and triamcinolone 40 mg for SIJ injection.

US-guided sacroiliac joint injection

A Sonosite M-Turbo US machine with a linear transducer probe (frequency6–13 MHz) was used. The probe was placed transversely over the distal sacrum in midline to identify the sacral cornu and hiatus [Figure 2]. It was then moved laterally and cephalad to visualize the lowermost part of SIJ as a hypoechoic shadow[12] [Figure 3]. A marker placement over this hypoechoic shadow was confirmed by fluoroscopy [Figure 4]. If not found appropriate, the scanning was repeated and counted as one. If found satisfactory, local anesthetic infiltration was followed by the insertion of 22-G, 8 cm long Quincke spinal needle using USG for real time visualization to reach inside the joint. The needle placement was reconfirmed by 0.5 ml iohexol dye injection through fluoroscopy. If placement was not intra-articular, a new attempt was undertaken from the start. Although studies have shown comparable effects of intra-articular versus periarticular SIJ injection,[13] we chose to declare the intervention complete only if intra-articular needle position was achieved. This was done to make uniformity in all the end points. All the procedures were done by a single interventionist, who was taught and demonstrated the procedure 5 times before hands-on.
Figure 2: Identification of the caudal space and sacral cornu by ultrasound

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Figure 3: Lateral and cranial scanning by ultrasound from cornu to visualise the lower part of the sacroiliac joint as a hypoechoic shadow

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Figure 4: Placement of the marker over inferior most part of sacroiliac joint and validation by fluoroscope

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Fluroscopy-guided sacroiliac joint injection

After patient positioning, C-arm was rotated contralateral oblique by 5–20° and cranio-caudally 5–10° to identify inferior most aspect of the joint. After local anesthetic infiltration 1 cm–2 cm cephalad fromits most caudal end a 22-gauge spinal needle was advanced coaxially with intermittent fluoroscopic images. When the posterior surface of SIJ was contacted, needle was advanced to penetrate the joint capsule following which 0.5 ml of water soluble radio-opaque dye, iohexol was given intra-articularly in the SIJ [Figure 5]. Postprocedure patients were observed for 2 h before discharge. NSAIDS (Tablet Etoricoxib 60 mg once daily) were given for 5 days followed by paracetamol tablets (650 mg) if needed in all the patients.
Figure 5: Confirmation of needle tip position by fluoroscope and dye

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Data collection

To assess the efficacy of the procedure numerical rating score (NRS), Depression Anxiety Stress Scale (DASS), Oswestry Disability Index (ODI) were measured before intervention and 24 h, 1 week, 1 month, 3 months after the intervention.

Numeric rating scale

It is a 11-point scale for patient self-reporting of pain where 0 represents “no pain” and 10 represents “the worst pain possible,” using whole numbers.[14]

The depression, anxiety and stress test (Depression Anxiety Stress Scale 21)

A questionnaire designed to measure the severity of three related negative emotional states of depression, anxiety, and stress.[15]

Oswestry Disability Index

Quantifies the level of disability due to low back pain.[16] The self-completed questionnaire contains ten topics, describing different potential scenarios. The scores range from 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.

Learning curve

The following data were collected and analyzed for the learning curve namely number of attempts required; ease of performance of block scored from 0 to 10 (0 being very easy and 10 being extremely difficult); time taken to perform the procedure (in minutes).

In the FL group, time was recorded from the first fluoroscopic image until dye injection including radiographic confirmation of the dye. In the US group, timing was calculated from first probe placement till intra-articular needle placement. The fluoroscopy timing was deducted.

Statistical analysis

Assuming patients with sacroiliitis have pain of NRS score of 8/10 and postintervention this would decrease by 40%, along with minimum confidence interval 95% and power of study 80%, 18 patients had to be enrolled in each group, although we enrolled 19 patients in each group to overcome any loss to follow-up.[9]

Data were summarized as Mean ± SE (standard error of the mean). Groups were compared by independent Student's t-test and analysis of variance and the significance of mean difference between (intra) the groups were done by Newman-Keuls post hoc test after ascertaining normality by Shapiro–Wilk's test and homogeneity of variance between groups by Levene's test. Categorical (discrete) groups were compared by Chi-square (χ2) test. A two-tailed (α =2) analyses were performed on SPSS software (Windows version 17.0, IBM Corp., Armonk, N.Y., USA). P < 0.05 was considered statistically significant.


  Results and Observations Top


Demographics

Comparing the mean age of two groups, Student's t-test showed comparable age between the two groups (χ2 = 0.47, P = 0.69). For sex proportions (F/M), χ2 test showed statistically significant difference of sex proportions between the two groups (χ2 = 5.60, P = 0.018). Patients of two groups were age matched but not matched for sex and this may influence the study outcome measures [Table 1].
Table 1: Demographics pattern

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Outcome measures

NRS

The mean NRS score decreased significantly from 7.39 ± 0.20 (FL group) and 7.22 ± 0.21 (US group) to 2.33 ± 0.24 (P < 0.001) and 2.78 ± 0.32 (P < 0.001) respectively after 1 month of treatment in both the groups. The decrease was evident higher in fluoroscopy group (88%) than USG group (75.4%) especially at 12th week follow-up [Table 2] and [Table 3].
Table 2: Numerical rating scale, depression anxiety stress scale, Oswestry disability index score (mean±standard deviation, n=19) of two groups over the periods

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Table 3: For each period, comparison of difference in mean numerical rating scale, depression anxiety stress scale, Oswestry disability index score between the groups by Newman-Keuls test

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Depression Anxiety Stress Scale 21

The pre and postprocedure DASS score of two groups is summarized in [Table 2]. In both groups, the mean DASS score decreased significantly after the treatment from 40.78 ± 1.96 (FL group) and 41.33 ± 1.62 (US group) to 22.78 ± 0.49 (P < 0.001) and 25.22 ± 0.73 (P < 0.001), respectively. The decrease in mean DASS score (i.e., mean change from preprocedure to 12th week) of Fluoroscopy group (44.1%) was found to be 5.2% higher than USG group (43.8%) [Table 3]. In conclusion, both the procedures are equally effective in the management of DASS.

Oswestry Disability Index

The pre- and post-procedure ODI score of two groups is summarized in [Table 2]. In both groups, the mean ODI score decreased after the treatment from 45.44 ± 0.99 (FL group) and 46.33 ± 0.98 (US group) to 20.78 ± 0.84 (P < 0.001) and 24.11 ± 0.95 (P < 0.001), respectively. The decrease in score was evident slightly higher in fluoroscopy group than USG group [Table 3].

The curve of learning

The ease of performance score of fluoroscopy and USG groups ranged from 3 to 7 and 5–7, respectively. Comparing these scores Student's t-test showed significantly different and lower (21.1%) ease of performance score in FL group (5.00 ± 0.27) as compared to USG group (6.33 ± 0.14, t = 4.41 P < 0.001).

The mean number of attempt of two groups were 2.11 ± 0.16 (FL group) and 2.67 ± 0.16 (USG group). Student's t-test showed significantly lower (20.8%) number of attempts in fluoroscopy group as compared to USG group (t = 2.45, P = 0.020). Intra-articular needle placement was achieved in 21%, 53%, and 26% cases in 1st, 2nd, and 3rd attempt in the FL group and 11%, 26%, 47%, and 16% cases in 1st, 2nd, 3rd, and 4th attempt in the USG group [Figure 6].
Figure 6: Graph showing no. of attempts to perform sacroiliac joint injection. Series 1: FL group. Series 2: Ultrasound group

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Comparing the mean time taken of two groups, Student's t-test showed significantly lower (26.1%) time taken in Fluoroscopy group as compared to USG group (6.89 ± 0.23 min vs. 9.32 ± 0.87 min, t = 2.70, P = 0.011). The procedure-related variables between the two groups are summarized in [Table 4].
Table 4: Procedure related variables - outcome measures (mean±standard error) between two groups

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Graph was also plotted based on number of attempts taken by the novice while using fluoroscopy and USG to give SIJ injection which shows that after 8th and 13th case, there was consistency in needle positioning using fluoroscopy and USG, respectively.


  Discussion Top


The complex and undulating anatomy of SIJ mandates use of either fluoroscopy, USG, CT, or MRI to access the joint. Certain circumstances compel us to prefer one mode over other, for example, a patient who is bedridden or a female who is pregnant and is liable to face SIJ pain in 16%–25% cases. These reasons mandate us to learn the skill of performing chronic pain interventions using both fluoroscopy as well as USG. Bearing this in mind, we compared the patient and procedure-related variables while performing SIJ procedure.

In our study, mean decrease in NRS post-SIJ intervention was significant at all-time points and comparable in the two groups. Studies in the past comparing FL and US guidance for SIJ injection showed mean NRS scores of 2.59 and 2.56 respectively at the end of 12th week compared to 0.89 ± 0.14 and 1.78 ± 0.22 in our study.[10] There could be two reasons for this difference; (1) End point in our study was intra-articular as against intra-articular and periarticular injections in other studies; (2) The end point was validated by fluoroscopy in both the groups hence increasing the accuracy of the performed intervention.

Chronic pain is frequently accompanied by distressing emotions, cognitions, and behaviors, ultimately leading to stress, anxiety, lack of sleep, anger, and depression,[17] which have not been quantified till date in cases of SIJ-related pain. We quantified the psychological impact of this pain and its relief using the DASS score. An absolute decrease in mean DASS score at 12 weeks was 18% and 16% with FL and US group respectively, indicating transformation of patients from severe state of distress to mild state. The comparable effect between the two groups can be related to equivalent decrease in chronic pain thus increasing nor-epinephrine, dopamine, and serotonin levels of body which would have depleted overtime.

A minimum clinically important difference of at least 10–12 for change in ODI has been found to be clinically meaningful in patients with chronic back pain.[18],[19] In our study, the mean absolute ODI reductions at the end of 3 months were 24.7 and 22.22, with FL and US groups, respectively. The decrease in ODI scores was significant in both the groups although better in FL group. Similar results with absolute reduction to 20.4 and 25.4 in FL and US groups at the end of 3 months have been studied before.[10]

In terms of procedure, the novice performed the intervention only after observing and assisting 5 cases each using both the modalities. The ease of performance as answered subjectively by the interventionist for FL and USG ranged from 3 to 7 and 5–7, respectively with mean (± SE) 5.00 ± 0.27 and 6.33 ± 0.14, respectively. The difference could be because of anatomical clarity which is more obvious by fluoroscopy than USG.

Fluoroscopy is the conventional aid for SIJ injection and Zhou et al. showed a meantime of 50.6 s required for the purpose whereas it was 6.89 ± 0.23 min in our study.[20] More time can be due to two reasons: We used pulse fluoroscopy rather than continuous mode; second could be the expertise of the interventionist, which in our case was a novice. Reason for using pulse fluoroscopy could be justified by approximate dose of radiation exposure to skin calculated by Henderix et al. which was 12–30 mGy by pulsed fluoroscopy for SIJ procedure[21] as against 108 mGy and 37.4 mGy in some phantom studies.[22],[23] Physicians performing the FL procedures had higher rates of cancer-related deaths than any other physicians. Injuries to skin, muscle, and eye lens due to the radiation from fluoroscopic procedures have been widely documented.[24],[25] Greater time requirement emphasizes more technical expertise required to appreciate the inflamed bony margins using USG. While positioning the marker, most of the times the interventionist got confused between the sacral foramina and SIJ, both of which appear hypoechogenic, although these anatomic distinctions were very clear with fluoroscopy.

Pain relief following intra articular lignocaine injection confirms the diagnosis of pain arising from SIJ joint, and it decreases the incidence of clinical diagnosis by 50%.[26] It has been found that the neural innervations and nociceptors of SIJ are located in the joint capsule as well as in the posterior ligamentous tissue, thus enabling them as additional sources of SIJ related pain.[27] Hence intra-articular or peri-articular SIJ diagnostic or therapeutic injections give equal pain relief.[13] We used intra-articular placement of the needle as the end point, using either of the imaging modalities to maintain uniformity in the comparator groups. This could have been the reason for increased number of attempts using USG. USG-guided SIJ IA approach has accuracy ranging from 50% to 87.3% with 40% successful intra-articular needle placement in 1st attempt by experts, compared to fluoroscopy which has accuracy up to 65%–98.2% and 60% successful rate in 1st attempt.[9],[10] This justifies the low 1st attempt success rate of 11% and 21% in USG and FL group and requirement of 13 procedures before giving consistent results with USG compared to 8 for FL group.

We acknowledge that this study has several limitations. There was single novice involved to assess learning curve but studies including more number of novice performers should be undertaken in future. Both intra-articular as well as periarticular injections could be included in either group. Rather than dye confirmation, needle position should be validated by fluoroscopy.

The study conveys the message that both US and FL guidance provides equivalent outcomes of pain, disability, and psychological impact in SIJ interventions. USG is technically more challenging and requires greater skill. Hence, a novice should be 1st trained using fluoroscopy, followed by USG for these procedures. A minimum of 8 FL guided and 13 USG guided interventions under supervision are required to attain a consistent performance.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form, the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflict of interest.



 
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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