Comparison between retrolaminar and medial branch block in cervical facet joint arthropathy: Randomized, controlled trial

DOI: https://doi.org/10.21203/rs.3.rs-2258987/v1

Abstract

Background

Cervical facet joints are considered one of the causes of chronic posterior neck pain by 54–67%. Cervical medial branch nerve blocks (CMBB) or neurolysis and intra-articular injections have been described for relieving the neck pain originate from facet joint.

Methods

Patients were randomly allocated into one of two groups: CMBB group where CMBB was performed at the affected dermatomal level and one level above using 0.5 mL dexamethasome (8mg/2ml) and 0.5 mL 1% lidocaine in each level, while in the cervical retrolaminar block (CRB) group, CRB was performed using 2 mL dexamethasone (4mg/1ml) and 3 mL 1% lidocaine for each affected dermatomal level. Numerical rating score (NRS) was carried out for all patients before the procedure, 2 weeks, 2 and 3 months after the procedure (where zero equals no pain and 10 equals the worst pain). Neck Disability Index (NDI) was done before the procedure and 2 weeks after the procedure. Any complication has been monitored as vascular injury, pneumothorax and epidural or spinal injection.

Results

NRS and NDI improved in both group with no statistically significant difference between them. The time of the procedure was shorter in CRB group, while the vascular injury was higher in CMBB group.

Conclusions

CRB is a good alternative to CMBB in the management of cervical facet joint pain with similar pain relief, better NDI, shorter time of procedure and no serious complications.

Trial registration:

registered in the clinical trials.gov (NCT05184881 ) at 11/01/2022

Introduction

Cervical facet joints are considered one of the causes of chronic neck pain (1). Cervical medial branch block (CMBB) or neurolysis and intra-articular injections have been described for relieving the neck pain originate from the facet joint (2).

The evidences for long-term therapeutic benefits of intra-articular facet joints injections are limited while for the medial branch blocks are moderate with possible adverse effects (3).

Paraneuraxial nerve blocks have become clinically very common, due to their anatomical and clinical characteristics. They also offer a remarkable success rate with a good analgesic efficacy. Moreover, they may give many of benefits over the neuraxial nerve blocks (4).

Retrolaminar blocks are one of these groups of paraneuraxial blocks that are close but not within the neuraxis like epidurals or spinals (5). Most researches have studied the retrolaminar blocks on the truncal pain syndromes (abdominal and thoracic) or anesthesia for truncal surgery (6). But the studies on the cervical retrolaminar blocks (CRB) are currently very limited (4).

The main advantage of CRB is to minimize or even to eliminate the risk of pneumothorax. Furthermore, the accidental injections into the epidural or intrathecal spaces and the risks of nerve root damage have become very rare (7).

The study was conducted to assess the effectiveness and safety of CRB in managing the cervical facet joint arthropathy pain as an alternative to CMBB.

Materials And Methods

This randomized prospective open comparative study was conducted in pain clinics of Mansoura University Hospitals from January 2022 to August 2022. The study was accepted by the Institutional Research Board of the Faculty of Medicine, Mansoura University (R.21.11.1534) on 21/12/1021 in compliance with the Helsinki Declaration and registered in the clinical trials.gov (NCT05184881) on 11/01/2022. Informed written consent was obtained from all study participants.

We included patients with cervical facet joint arthropathy not responding to conservative treatments. All patients should be more than 18 years old, and had a body mass index ˂ 30 with numeric rating scale (NRS) ≥ 4 and American society of Anesthesiology (ASA) Physical Status class I and II. Physical examination of the neck (kemp tests is a provocative test for diagnosing pain arising from facet joint by combined extension and rotation of the cervical spine) and imaging of the cervical spine (magnetic resonance imaging) were done to diagnosis the cervical facet joint arthropathy.

Patient refusal to participate, local or systemic sepsis, bleeding disorder, unstable respiratory or cardiovascular problems, history of drug abuse, allergy to used drugs, disturbed local anatomy and history of neurological or psychiatric disorders were excluded from our study.

All the patients were educated about the numerical rating score (NRS) to express their pain from zero to ten (where zero = no pain and ten = the worst pain).

Sample Size

Sample size was calculated using the Power Analysis and Sample Size software program (PASS) version 15.0.5 for windows 2017 using data got from a pilot study conducted on ten patients at Mansoura University Hospital using the numerical rating score (NRS) after injection as the primary outcome. Patients were allocated into two groups: CMBB group and the CRB group. NRS were 2.89 ± 0.23 for the CMBB group and 2.54 ± 0.53 for the CRB group. A sample size of 31 patients in each group was required to achieve 95% power (the probability of rejecting the null hypothesis when it was false or 1-β) in the proposed study using two-sided two-sample unequal-variance t-test with a significance level (the probability of rejecting the null hypothesis when it was true or α) of 5% and an effect size of 0.85. 10% drop-out was anticipated, so 35 patients were listed to each group.

Randomization

The participants were randomly grouped by a computer-generated list of random numbers on a scale of 1:1.The distribution results were placed in closed opaque envelopes and were held by the study administrator. On the day of the procedure, the anesthesiologist who performed the block took the envelope from the study manager.

Grouping (Fig. 1)

- CMBB group (n = 35): CMBB was performed at the affected dermatomal level and one level above 0.5 mL dexamethasone (4mg/1ml) and 0.5 mL 1% lidocaine in each level.

- CRB group (n = 35): CRB was performed using 2 mL dexamethasone (4mg/1ml) and 3 mL 1% lidocaine for each affected dermatomal level.

Techniques:

Patient entered the operating room, 20 G cannula was secured and 500 ml 0.9% normal saline was slowly taken. Non-invasive blood pressure, electrocardiogram (ECG) and pulse oximetry were monitored.

Cervical medial branch block (CMBB)

Patient was in the supine-position. Under fluoroscopic visualization, the waist of the articular pillars of the desired level was identified. After skin sterilization, a 25-gauge 3.5-inch spinal needle was introduced then the location of the needle tip at the mid-point of the waists of articular pillars was confirmed by fluoroscopy. After suction to avoid any blood aspiration, 0.5 mL dexamethasone (4mg/1ml) and 0.5 mL 1% lidocaine were injected at each level (Fig. 2). Because of each facet joint receives innervation from the medial branch of the same level and the one above. So the procedure was repeated at the level above the affected facet joint.

Cervical retrolaminar block (CRB)

Patient was in the prone-position. Under fluoroscopic visualization, the cervical lamina of the desired level was identified. After skin sterilization, a 25-gauge 3.5-inch spinal needle was introduced. The location of needle tip at the posterior aspect of the cervical lamina of the corresponding facet arthropathy level was assured by fluoroscopy. Aspiration was done to avoid blood suction then 2 mL dexamethasone (4mg/1ml) and 3 mL 1% lidocaine were injected (Fig. 3).

Then all patients were transferred to the postoperative care unit to be observed for half to one hour.

Outcomes

  1. Numerical rating score (NRS) was carried out for all patients before the procedure, 2 weeks, 2 and 3 months after the procedure (where zero equals no pain and 10 equals the worst pain).

  2. Neck Disability Index (NDI) was done before the procedure and 2 weeks after the procedure (8).

  3. Any complication has been monitored as vascular injury, pneumothorax and epidural or spinal injection.

Statistical analysis

SPSS (version 25) was used for the statistical analysis of the collected data. The normality of the data distribution was checked by Shapiro-Wilk test. Mean ± SD expressed the normally distributed continuous variables while categorical variables and non-normally distributed continuous were expressed as median and inter-quartile range or number and percentage (as appropriate). One-way ANOVA test was used for normally distributed continuous data and for abnormally distributed continuous data, Kruskal Wallis tests was used. Chi square test using the crosstabs function was used for categorical data. All tests were conducted with 95% confidence interval. Bivariate correlations using Spearman’s or Pearson’s correlation coefficient were assessed if needed depending on the nature of data. P ≤ 0.05 was considered statistically significant.

Results

Table 1 shows the demographic characteristics of the studied groups with no statistically significant difference.

Table 1

Demographic characteristics of the study groups.

Characteristics

CMBB group (n= 35)

CRB group (n= 35)

95% CI

P

Age (years)

38.86 ± 11.685

40.31 ± 12.778

-7.3, 4.38

0.62

Gender: Male

Female

20 (57.1%)

17 (48.6%)

-

0.473

15 (42.9%)

18 (51.4%)

Data is expressed as mean and standard deviation or as percentage and frequency.
CI: Confidence interval, CMBB: Cervical medial branch block, CRB: Cervical retrolaminar block. P ≤ 0.05 is significant.

The time to perform the block was shorter in the CRB group than the CMBB group (16.94 ± 2.363 vs. 23.74 ± 3.062 minutes, respectively) (P ˂ 0.001, Table 2).

Table 2

Time to perform the block (minutes) in the studied groups.

 

CMBB group (n= 35)

CRB group (n= 35)

95% CI

P

Time to perform the block (minutes)

23.74 ± 3.062

16.94 ± 2.363

-8.10, - 5.50

˂ 0.001

Data is expressed as mean and standard deviation. 95% CI: 95% confidence interval of the mean difference between both groups. CMBB: Cervical medial branch block, CRB: Cervical retrolaminar block. P is significant when ≤ 0.05.

The incidence of the vascular injury was higher in the CMBB group than the CRB group (11.4% vs. 0%, respectively) (P ˂0.039, Table 3).

Table 3

Incidence of the vascular injury of the studied sample.

 

CMBB group(n= 35)

CRB group(n= 35)

Odds ratio

P

Vascular injury

4 (11.4%)

0 (0%)

0.47

0.039

Data is expressed as percentage and frequency. Odds ratio was calculated for Retrolaminar group compared to Medial group. CMBB: Cervical medial branch block, CRB: Cervical retrolaminar block. P is significant when ≤ 0.05.

In Table 4, there was improvement in NRS during the follow-up period in both groups with no statistically significant difference between them. While there were statistically significant differences in each group at 2 weeks, 2 and 3 months intervals compared to the baseline (P ˂ 0.001).

Table 4

Baseline and post-block NRS follow-up in the studied groups

NRS

CMBB group (n= 35)

CRB group (n= 35)

95% CI

P

Baseline

6.40 ± 1.376

6.26 ± 1.462

-0.53,0.82

0.679

2 weeks interval

1.80 ± 1.232*

1.94 ± 1.371*

-0.76,0.48

0.726

P1

˂ 0.001

˂ 0.001

   

2 months interval

2.23 ± 1.140*

2.46 ± 1.421*

-0.84,0.39

0.671

P1

˂ 0.001

˂ 0.001

   

3 months interval

3.09 ± 1.245*

3.23 ± 1.416*

-0.78,0.49

0.563

P1

˂ 0.001

˂ 0.001

   
Data is expressed as mean and standard deviation. CI: Confidence interval, CMBB: Cervical medial branch block, CRB: Cervical retrolaminar block, NRS: Numerical rating scale. P ≤ 0.05 is significant.
P1 represents the comparison between the follow up period to the baseline value.
* indicates significant statistical difference compared to the respective baseline value.

The baseline NDI showed no statistically significant difference according to pain, personal care, reading, headache, concentration, work, driving, sleeping and recreation between the studied groups, while lifting showed statistically significant difference (Table 5).

Table 5

Baseline Neck disability index in the studied groups

Baseline

CMBB group (n= 35)

CRB group (n= 35)

95% CI

P

Pain

3.71 ± 0.710

3.60 ± 0.695

-0.22, 0.45

0.478

Personal care

2.14 ± 0.879

2.40 ± 0.847

-0.67, 0.15

0.214

Lifting

3.46 ± 1.010

2.94 ± 0.938

0.05, 0.98

0.032

Reading

2.31 ± 0.796

2.66 ± 0.873

-0.74, 0.06

0.119

Headache

3.09 ± 1.121

2.97 ± 1.175

-0.43, 0.66

0.752

Concentration

2.29 ± 0.860

2.06 ± 0.873

-0.18, 0.64

0.238

Work

3.29 ± 0.926

3.29 ± 0.926

-0.44, 0.44

1

Driving

3.31 ± 0.993

3.66 ± 0.838

-0.78, 0.10

0.110

Sleeping

3.40 ± 0.914

3.60 ± 0.914

-0.64, 0.24

0.370

Recreation

3.69 ± 0.832

3.89 ± 0.832

-0.60, 0.20

0.377

Data is expressed as mean and standard deviation. CI: Confidence interval, CMBB: Cervical medial branch block, CRB: Cervical retrolaminar block. P is significant when ≤ 0.05.

Table 6 shows no statistically significant difference in the post-block NDI between the groups, except in driving which was better in the CRB group than the CMBB group with statistically significant difference (P ˂ 0.046). Also there were statistically significant differences according to pain, personal care, headache, work, driving, sleeping and recreation when compared to the baseline in each group.

Table 6

Post-block Neck disability index in the studied groups.

After treatment

CMBB group(n= 35)

CRB group (n= 35)

95% CI

P

Pain

1.60 ± 1.035*

1.60 ± 0.976*

-0.48, 0.48

1

P1

˂ 0.001

˂ 0.001

   

Personal care

1.71 ± 0.926*

1.94 ± 0.998*

-0.69, 0.23

0.309

P1

0.05

0.04

   

Lifting

3.17 ± 0.985

2.94 ± 0.998

-0.24, 0.70

0.344

Reading

1.97 ± 1.175

2.34 ± 1.187

-0.93, 0.19

0.174

Headache

1.51 ± 0.853*

1.43 ± 0.850*

-0.32, 0.49

0.696

P1

˂ 0.001

˂ 0.001

   

Concentration

2.11 ± 1.105

2.09 ± 1.011

-0.48, 0.53

0.961

Work

2.11 ± 0.900*

1.97 ± 0.923*

-0.29, 0.58

0.515

P1

˂ 0.001

˂ 0.001

   

Driving

2.63 ± 1.003*

2.11 ± 0.993*

0.04, 0.99

0.046

P1

0.0058

˂ 0.001

   

Sleeping

1.43 ± 0.979*

1.43 ± 0.850*

-0.44, 0.44

0.956

P1

˂ 0.001

˂ 0.001

   

Recreation

2.37 ± 1.060*

2.26 ± 1.010*

-0.38, 0.61

0.524

P1

˂ 0.001

˂ 0.001

   
Data is expressed as mean and standard deviation. CI: Confidence interval, CMBB: Cervical medial branch block, CRB: Cervical retrolaminar block. P is significant when ≤ 0.05. * indicates significant statistical difference compared to the respective baseline value.

Discussion

The cervical facet joint is one of the synovial joints which allows the joint for the extension and flexion of the spine with limiting rotation and prevent slipping of the vertebrae over each other. Facet joint mediated pain is a common reason of disability among people, with a significant financial impact (9). The hypothesis of the cervical facet joint as a source of chronic neck pain was established by many studies that confirmed the effectiveness of CMBB for the diagnosis as well as for the management of this pain (10, 11). However, Many complications have been reported in CMBB as vascular injury, pneumothorax and epidural or spinal injection. (12). The current study, for the first time, assessed the effectiveness of CRB as an alternative procedure to CMBB for treatment of cervical facet joint pain.

Within groups, pain was improved during the follow-up periods (2 weeks, 2 and 3 months) compared to the baseline P ˂ 0.001. While, there was no statistical significant deference between both groups.

This is a positive aspect for CRB because despite the advantages of CMBB which provide an effective treatment for chronic neck pain of facet joint origin, it may cause major problems (13). As Miller et al. reported a 27-year-old man who did an outpatient CMBB and after the procedure he suddenly developed neck pain, right shoulder allodynia and severe quadriparesis. Cervical spine imaging revealed an evidence of intramedullary injection and contusion at the level of C4 vertebra (14). Moreover Park et al. who compared ultrasound versus fluoroscopy guided CMBB, and reported that blood was aspirated in 12 patients in the fluoroscopy group. Also our study documented the occurrence of blood aspiration in four patients in CMBB group during suction and before injection, so the needle was withdrawn and compression was done for 3 minutes. After close monitoring of the patients, bleeding stopped and the procedure was redone.

Regarding the procedure duration, it was shorter in the CRB group than the CMBB group. Voscopoulos et al. descried CRB as an easy technique to access, requires less skill and minimizes or eliminates the risk of pneumothorax, nerve root damage and injection into the epidural or intrathecal spaces and this may explain our result (15).

NID showed statistical significant improvement in both groups regarding pain, personal care, headache, work, driving, sleeping and recreation compared to before injection. At the same time, there was no statistical deference between groups except in driving which improved in the CRB group than the CMBB group.

The outcome results of our study were comparable to previously published prospective studies proving the effectiveness of CMBB in chronic facet joint pain. Machikanti et al showed that CMBB provide significant pain relief in 80–93% of patients with chronic neck pain at 3, 6 and 12 months intervals (16). Moreover, Hussain et al. reported that CMBB with local anesthetic agent and steroid may provide pain relief and improvement in neck pain disability index scores up to 12 weeks in patients with chronic neck pain (10).

Hochberg et al. evaluated the spread of the solution injected in CRB in a cadaver, and they found that it can diffuse in the cranial-caudal axis up to C2-T3 vertebrae and laterally to the cervical neural foramen and the facet joints. They also assessed the effect of the ultrasound guided CRB in cervical radiculopathy and found that the average NRS improved from 7.25 to 2.83 after the injection (P < 0.001) (4).

Also Khashan et al. suggested that CRB can be an alternative to cervical epidural injection and decompressive surgery in patients with cervical radiculopathy (17).

Conclusions

CRB is a good alternative to CMBB in the management of cervical facet joint pain with similar pain relief, better NDI, shorter time of procedure and no serious complications.

Abbreviations

CMBB

Cervical medial branch block.

CRB

Cervical retrolaminar block.

NDI

Neck Disability Index.

NRS

Numerical rating scale.

Declarations

Ethics approval and consent to participate: The study accepted by the Institutional research board, of Faculty of Medicine of the corresponding University, registered in the ClinicalTrials.gov and carried out in compliance with the Helsinki Declaration. Every patient participating in this study signed an informed written consent after full explanation of all details of every aspect in this study.   

Consent for publication: Not applicable

Availability of data and materials: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Competing interests: The authors declare that they have no conflict of interest.

Authors' contributions: N.A. and B.A did the practical part of the research, N.A. wrote the main manuscript text, BA. prepared figures and tables and all authors reviewed and approved the final manuscript.

Acknowledgement:  Not applicable.

Declarations of interest: none

Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. 

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