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Pain Medicine: Research Report

A Comparison of Intraarticular Lumbar Facet Joint Steroid Injections and Lumbar Facet Joint Radiofrequency Denervation in the Treatment of Low Back Pain

A Randomized, Controlled, Double-Blind Trial

Lakemeier, Stefan, MD*; Lind, Marcel; Schultz, Wolfgang, MD*; Fuchs-Winkelmann, Susanne, MD; Timmesfeld, Nina, PhD; Foelsch, Christian, MD; Peterlein, Christian D., MD

Author Information
doi: 10.1213/ANE.0b013e3182910c4d

Chronic low back pain (CLP) has been described as a source of disability and work absence. CLP is associated with high social and health care costs in Western societies.1,2 Among the causes of CLP, lumbar facet joint (LFJ)–related pain is reported to have a prevalence of 15% to 45%.3 The LFJs form the posterolateral articulations connecting the vertebral arch of one vertebra to the arch of the adjacent vertebra. The LFJ capsule and surrounding structures are innervated. Chemical or mechanical stimulation of the LFJ and the nerve supply elicits back pain.4,5 Repetitive stress on the LFJ can lead to osteoarthritis, with subsequent inflammation and stretching of the joint capsule, leading to axial low back pain.6

Multiple therapeutic techniques with controversial results have been described and established in managing CLP caused by LFJ degeneration. Intraarticular LFJ injections, LFJ nerve blocks, and radiofrequency (RF) denervation have been shown to be effective.7 The aim of LFJ injections is to bring steroids into the degenerated joint based on the belief that there is inflammation. The exact mechanism underlying the therapeutic effect of LFJ injections is unknown, whereas RF aims to cause denaturation of the first medial branch of the ramus dorsalis.8

Whereas RF treatment of CLP has been shown to be superior to sham therapy9–12 in well-designed, placebo-controlled, randomized studies, the use of intraarticular corticosteroid injections remains controversial.4,7 Although uncontrolled studies have reported transient, beneficial effects, the results of controlled studies have been largely disappointing. Therefore, RF treatment is considered to be an important treatment for LFJ-mediated pain.13 Of note, the effects of RF treatment and the injection of intraarticular steroids have not been compared.

The aims of the present study were to evaluate and compare the effectiveness of LFJ intraarticular steroid injections and RF treatment in relief of chronic, function-limiting, low back pain in a randomized, double-blinded, controlled evaluation in patients with CLP of LFJ origin. This is a report of 56 patients from a study scheduled for a follow-up of 6 months.

METHODS

The study was conducted in a university hospital department of orthopedics in Germany. The study was performed according to the guidelines of the Declaration of Helsinki. The study was approved by the local Ethics Committee of the Medical Faculty at the University of Marburg, Marburg, Germany (Reg. No. 164/09). Written informed consent was obtained from all participants who were included in the study.

Participants

All patients were assigned to LFJ intraarticular steroid infiltrations or RF denervation. All of the enrolled patients were suffering from LFJ-related pain at the L3/L4–L5/S1 segments.

Preenrollment Evaluation

The preenrollment evaluation was performed by an experienced orthopedic surgeon (CDP) and included the diagnosis of LFJ pain based on physical examination, magnetic resonance imaging (MRI), and a diagnostic block of the L3/L4–L5/S1 LFJs with 0.5% bupivacaine. Only patients with nonspecific low back pain of at least 24 months duration were included in the study.

Inclusion Criteria

The inclusion criteria were as follows: LFJ-related low back pain for at least 24 months; ≥18 years of age; ability to understand the study protocol and to provide voluntary written informed consent and participate in outcome measurements; a benefit in pain reduction of at least 50% after a test injection of local anesthetics into the L3/L4–L5/S1 LFJs; and MRI-proven LFJ osteoarthritis and hypertrophy in the L3/L4–L5/S1 segments.

Exclusion Criteria

The exclusion criteria were as follows: a lack of positive response to a L3/L4–L5/S1 test infiltration; a history of osteoporosis or malignancies; allergies to local anesthetics; pregnancy or lactating; lumbar spinal stenosis or spinal instabilities; vertebral fractures; symptomatic radiculopathies; uncontrolled psychiatric disorders, uncontrolled medical illnesses, and any conditions that could interfere with the interpretation of the outcome assessments; and a history of adverse reactions to corticosteroids.

Intraarticular Diagnostic Blocks

Patients were placed prone; all injections were performed under fluoroscopy. The tender LFJs were palpated, marked, and located using a portable radiograph machine. Under aseptic conditions, a 22-G needle was inserted until bone was contacted at the edge of the LFJ. Adequate needle positioning was confirmed by injecting 1 mL of contrast medium. When the needle was in place, 0.5 mL of 0.5% bupivacaine was injected into the LFJ.

Radiofrequency Denervation

RF was performed according to the International Spine Intervention Society practice standards.14–16 All RF procedures were performed under fluoroscopic guidance in the prone position. Under aseptic conditions, 20-G curved RF needles with 100-mm active tips (BMC RF Cannula; Baylis Medical, Montreal, Quebec, Canada) were placed at the site of the dorsal ramus medial branch of the relevant L3/L4–L5/S1 LFJs. Correct placement was confirmed using electrostimulation at 50 and 2 Hz for sensory and motor function, respectively. Then, 1 mL of 0.5% bupivacaine was injected through the cannula to decrease treatment-related pain, increase lesion size, and prevent postoperative neuritis.17,18 The RF probe was then reinserted into the cannula and lesion at a temperature of 80° for 90 seconds using a RF generator (Baylis Medical Pain Management Generator 115V; Baylis Medical).

Intraarticular Injection of Steroids

The same setting was used for LFJ infiltrations and RF denervation. After positioning the RF needles into the LFJ under fluoroscopy, needle placement was confirmed by injecting 0.5 mL of contrast medium into the L3/L4–L5/S1 joints. If optimal positioning was achieved, a mixture of 0.5 mL of 0.5% bupivacaine and 1 mL of betamethasone (3 mg) was injected into the target joint. The RF probe was then reinserted into the cannula and the denervation process (80° for 90 seconds) was begun, but the electrodes were not connected to the pain generator device (Baylis Medical Pain Management Generator 115V).

Additional Interventions

All patients underwent the treatment as assigned.

Cointerventions

Most of the patients were administered analgesics (an opioid and nonsteroidal anti-inflammatory drug [NSAID]). Some patients were performing therapeutic exercise programs. If the patients were improving significantly, the drug dosages were reduced or the medications were discontinued. However, dosages were increased if indicated. All patients continued their previously directed exercise programs, as well as their work. No specific physical exercise program, manual therapy, physiotherapy, or other interventions were offered to the patients.

Objective

The purpose of the present study was to evaluate the effectiveness of corticosteroid infiltration and RF denervation of LFJs in managing LFJ-related CLP, and to compare the role of both methods in providing effective, long-lasting pain relief.

Outcomes

In the present study, multiple outcome variables were used, including the Roland-Morris Questionnaire (RMQ) as a primary end point, and the visual analog scale (VAS) and Oswestry Disability Index (ODI) as secondary end points. The ODI and the RMQ are condition-specific health status measures (i.e., outcome instruments that focus on the specific symptoms or functional impact of a particular condition) for the assessment of low back pain-related disability.19 The ODI is a self-administered, 10-item questionnaire. The first section rates the intensity of pain, and the others describe its disabling effect on typical daily activities. The score for each item ranges from 0 to 5, and the sum of the 10 scores is expressed as a percentage of the maximum score and thus ranges from 0 (no disability) to 100 (maximum disability).20 The RMQ is a self-administered questionnaire derived from the Sickness Impact Profile that consists of 24 items reflecting a variety of daily living activities; each item is scored 1 if declared applicable to the respondent and 0 if not, and so the total score can vary from 0 (no disability) to 24 (severe disability). The VAS ranged from 0 (no pain) to 10 (worst pain imaginable). The RMQ, VAS, and ODI were used for functional assessment before treatment and after 6 months of treatment. All follow-up examinations were performed by blinded personnel (CDP, ML, CF).

Randomization and Blinding

Concealed randomization was performed through an independent institution (NT, Institute of Medical Biometry and Epidemiology) after the patient gave informed consent. Assignments were performed using a computer-generated random allocation sequence with permuted blocks, 4 and 6 in size (Fig. 1).

Figure 1
Figure 1:
Schematic presentation of participant flow at the 6-month follow-up. LFJ = lumbar facet joint; ITT = intention-to-treat.

In both groups, all procedures were performed by the same experienced spine surgeon (SL). The only unblinded treatment personnel in this study were the primary spine surgeon (SL) and the study nurse assistant; neither the primary spine surgeon (SL) nor the study nurse assistant were involved in further treatment of the patients. The drugs used for intraarticular LFJ infiltrations and RF denervations were appropriately prepared by the operating room nurse. All drug mixtures appeared to be identical. Patients were unblinded after the 6-month follow-up examination or if requested before that time.

Statistical Methods

In this study, the null hypothesis “no difference between corticosteroid infiltration and RF denervation” were examined with primary outcome RMQ and secondary outcomes ODI and VAS. A sample size of 50 per group was calculated to achieve a power of 80% to show a difference of 2.5 units in the RMQ using a SD of 4.221 and a 2-sided type I error rate of 5%. A difference of 2.5 units in the RMQ was found to be clinically relevant in previous studies and was also used for sample size calculation.22,23 Due to very slow recruitment and other organizational reasons, the decision was made to halt the study after >2 years of enrollment with an inclusion of 56 patients. Initially, the recruitment duration was assumed to be <2 years. This decision was made without knowledge of any outcome results and was communicated to the local ethics committee. The power calculation with the reduced sample size shows that a difference of 3.2 units could be detected with a power of 80%, assuming a SD of 4.2. This difference was much <5 units, which is considered to be the minimal significant difference.20

For descriptive statistics, the mean and SD are given. For comparisons between treatments, improvements of the scores were used. These improvements were calculated as the difference between the baseline values and the values at the 6-month follow-up. Comparisons for primary and secondary outcomes were performed by Wilcoxon rank sum tests. Furthermore, the corresponding 95% confidence intervals (95%-CIs) for the median difference were calculated using the Hodges-Lehmann method. Sensitivity analyses for the primary and secondary end points were applied using Brunner-Munzel tests on the relative effects using Satterthwaite t-approximation.24 This test examines the null hypothesis that the probability for an improvement from the RF denervation group would be higher than an improvement from the other group is equal to 0.5. The results do not differ from the results of the primary analysis. Furthermore, the corresponding 95% CI were given for the probability that an improvement from the RF denervation group is higher than an improvement from the other group (Table 1). For all analyses, intention-to-treat principles were used. For missing outcomes, last-observation-carried forward at week 24 was used, if at least 1 observation after intervention was available.

Table 1
Table 1:
Patient Characteristics, Baseline and Follow-Up Values of Outcome Variables

The statistical analysis was performed using R statistical software (www.r-project.org, version 2.15.0) and packages coin and pairwise CI. P < 0.05 were considered statistically significant.

RESULTS

Recruitment

The recruitment period started in May 2009 and lasted until September 2011. All patients meeting the inclusion criteria were invited to take part in the evaluation by ML and CDP. The number of patients included in the study is illustrated in Figure 1.

Baseline Data

The patient demographics are listed in Table 1. There were no differences between the groups. In both treatment groups, 6 LFJs from L3/L4–L5/S1 were involved in therapy.

Outcomes

Roland-Morris Questionnaire

The RMQ improved in both groups; however, there was no significant (P = 0.90; 95% CI, −3 to 4) difference between the 2 groups (Table 1, Fig. 2A).

Figure 2
Figure 2:
Illustration of significant clinical improvement for the different outcome variables and comparison of both procedures: Roland-Morris Questionnaire (RMQ; A), visual analog scale (VAS; B), and Oswestry Disability Index (ODI; C). LFJ = lumbar facet joint; RF = radiofrequency.

Visual Analog Scale

The VAS was decreased in both groups. The RF denervation patients had a lower VAS than patients after LFJ steroid infiltration. There was no significant difference in reduction of VAS after 6 months between the 2 groups (P = 0.60; 95% CI, −2 to 1; Table 1, Fig. 2B).

Oswestry Disability Index

Compared with baseline values, the ODI was decreased in both groups after 6 months. There were no significant differences between the 2 groups (P = 0.069; 95% CI, −18 to0; Table 1, Fig. 2C).

Analgesic Intake

The majority of patients at baseline and at the primary end point of the study received moderate doses of analgesics with no measurable differences between the 2 treatment groups in absolute terms.

Adverse Events

There were no major adverse events reported during the observation period of 6 months.

DISCUSSION

This randomized, double-blind, controlled trial revealed that relief of LFJ-related low back pain and functional improvement can be achieved by RF and intraarticular LFJ steroid injections. No significant differences were noted between the 2 procedures.

In the current study, we used strict inclusion criteria; specifically, only patients with LFJ-related pain involving the L3/L4–L5/S1 segments and having significant pain relief after intraarticular test infiltration with local anesthetics were included. This is the first study comparing the results of intraarticular LFJ steroid infiltration and RF denervation in the treatment of CLP.

The clinical results of RF denervation in patients with CLP have been shown to be superior compared with sham therapy in double-blind studies; other studies did not demonstrate any significant differences with respect to functional improvement and pain relief.11,12,25 However, several comprehensive literature reviews concluded that RF denervation to be moderate-to-fair in achieving functional improvement7,26 and moderate-to-strong in short- and long-term pain relief in patients with CLP.27

Proper patient selection and RF correctly placed anatomically have been described as important outcomes.28 Anatomically correct placement of the needles can be achieved by sensory and motor stimulation of the multifidus muscle, because this structure is innervated by the same medial branch as the target LFJ.9,15 Furthermore, all RF needles were placed under fluoroscopy. Thus, it is possible to perform RF denervation safely in a properly selected patient group with LFJ-related low back pain.

The value of intraarticular LFJ infiltration for the treatment of LFJ osteoarthritis remains a subject of discussion. In uncontrolled studies, the long-term relief of back pain after intraarticular steroid injections ranges between 18% and 63%.4,29 In the controlled studies in the literature, results are mixed. Whereas Lilius et al.30 reported no differences in outcome between the placebo and steroid groups, Carette et al.31 showed a significant improvement after 6 months in the steroid group. Fuchs et al.32 compared the clinical outcomes in patients with CLP after LFJ steroid or hyaluronic acid infiltration and reported pain relief and functional improvement after both procedures. However, the evidence for intraarticular steroid injections is considered fair or moderate based on reviews of the literature.27,33

The rationale for intraarticular LFJ infiltration is to treat inflammation due to osteoarthritis that is suspected within the degenerated LFJ. In other joints, such as the knee or hip, there is good evidence that intraarticular joint injections lead to functional improvement and pain relief.34,35 Although it is relatively simple to diagnose knee- or hip osteoarthritis–related pain, the proper diagnosis of LFJ-related pain is demanding, because many different etiologies can lead to the same symptoms, influencing each symptom and existing simultaneously.36 Accordingly, Pneumaticos et al.37 and Dolan et al.38 showed that the effectiveness of pain relief after LFJ infiltration is improved if the inflammatory process is confirmed within the LFJ using single-photon emission computed tomography (CT). In the present study, degeneration of all LFJs was diagnosed using MRI, the most sensitive available diagnostic tool.39,40 Thus, hypertrophy, degeneration, and the accumulation of fluid within the joints are signs of LFJ degeneration and were found in all treated L3/L4–L5/S1 LFJs. Furthermore, it was possible to exclude confounding sources of pain, such as spinal canal stenosis, disc herniation, or tumor-related pain. In addition, all patients included in the study had significant pain relief after the test infiltration. One further problem regarding intraarticular LFJ infiltration is false-negative and false-positive results, due to a lack of infiltration accuracy.4 LFJ size is small compared with other joints, therefore the ability to reach the LFJ securely with needles for steroid injections might be limited; however, it could be shown that the effectiveness of LFJ intraarticular injections can be improved under CT guidance.41

In the present trial, we used a technique that is well described in literature in combination with the contrast agent.42 Thus, it was possible to perform safe intraarticular injections of either local anesthetics for the test block or steroids for the therapy. CT guidance was not possible in the current study for 2 reasons: radiation exposition for the patients would have been too high and blinding of the patients was impossible.

In addition, only 0.5 mL of local anesthetics for the test block or 1 mL of steroid plus 0.5 mL of local anesthetic solution for the steroid infiltration was used because a large injection volume might lead to rupture of the joint capsule with subsequent efflux of steroid or local anesthetics into the surrounding tissue, leading to false-negative or false-positive results. Our proceeding approach is in agreement with the literature.43 For the RF denervation, 1 mL of bupivacaine was used following the manufacturers’s instructions of the pain generator device (Baylis Medical Pain Management Generator 115V).17,18

In summary, together with characteristic MRI findings and clear temporary pain relief after facet blocks, we were able to create a heterogeneous patient group with comparable diagnoses and facet joint-related low back pain involving the L3/L4–L5/S1 segments. Furthermore, it was possible to perform secure intraarticular injections and correctly place the RF anatomically. In this setting, with the clearly circumscribed group of patients, we did not find any significant difference in pain relief and functional outcome between intraarticular steroid injection and RF after an observation period of 6 months.

Our study had several limitations and might be criticized for the lack of a placebo group. However, since both therapies are well established and both RF denervation and steroid injection are proven to be superior to placebo,9,11,12,31 recruitment of a placebo group would have been unethical. In addition, we used a sham denervation procedure to achieve blinding of the patients. Furthermore, both therapies are very similar in their invasiveness and hence no difference in the placebo effects would be expected between groups.

Second, especially in Germany, physiotherapy is widely used for the conservative treatment of low back pain.44 Therefore, we cannot ignore that physiotherapy has confounding effects in pain relief and functional improvement that was recognized. However, the patient inclusion criteria were strict and patients were only included in the study if they were suffering from long-lasting low back pain for at least 24 months. As treatment is first performed by generalists with prescriptions of physiotherapy and analgesics, patients are only admitted to our university hospital department for an ineffective treatment response. Analgesic intake of all patients was noted before treatment and after 6 months of treatment. An increase of analgesic intake especially for the opioids could not be monitored. However, statistical analysis of the different analgesics intake was not possible. On one hand, patients were taking a multitude of different NSAIDs and opioids in different dosages and they were not of comparable active ingredient content, especially the opioids. On the other hand, in some patients, NSAIDs were taken for the treatment of comorbidities such as rheumatoid arthritis or osteoarthritis of the knee or hip. Nevertheless, the intensity of pain and its disabling effect on typical daily activities is part of the ODI. There was no significant difference in ODI between the 2 groups after treatment. Therefore, it seems likely that analgesic intake and physiotherapy are not the only basis for pain relief and functional improvement.

Furthermore, considering that practical trials are best designed to provide results of benefits, risks, and costs as occur in routine clinical practice, the results of the present study are not only appropriate, but also applicable.

CONCLUSIONS

The evidence of the present study demonstrates that facet-related CLP can be treated with intraarticular steroid injections or RF denervation with appropriate pain relief and functional improvement over a period of at least 6 months, with no differences between treatments.

DISCLOSURES

Name: Stefan Lakemeier, MD.

Contribution: This author helped design the study, performed the interventions, and prepared the manuscript.

Attestation: The author declares to have approved the final manuscript. The author serves as archival author.

Name: Marcel Lind.

Contribution: This author helped design the study and the preparation of the manuscript.

Attestation: The author declares to have approved the final manuscript.

Name: Wolfgang Schultz, MD.

Contribution: This author helped design the study and the preparation of the manuscript.

Attestation: The author declares to have approved the final manuscript.

Name: Susanne Fuchs-Winkelmann, MD.

Contribution: This author helped in the correction and preparation of the final manuscript.

Attestation: The author declares to have approved the final manuscript.

Name: Nina Timmesfeld, PhD.

Contribution: This author helped design the study and performed the statistical calculations and the randomization of the study.

Attestation: The author declares to have approved the final manuscript.

Name: Christian Foelsch, MD.

Contribution: This author helped in patient enrollment and examination of the patients.

Attestation: The author declares to have approved the final manuscript.

Name: Christian D. Peterlein, MD.

Contribution: This author helped design the study and the correction and preparation of the final manuscript.

Attestation: The author declares to have approved the final manuscript.

This manuscript was handled by: Spencer S. Liu, MD.

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