The Predicted Outcome of Spinal Cord Stimulation in Patients With a Psychopathological Disorder and Persistent Spinal Pain Syndrome Type 2: A Systematic Review From 2009 to 2021.

OBJECTIVES: Psychologic screening is often included as a mandatory component of evaluation of the impact of psychopathology disorders on the predicted outcome of spinal cord stimulation (SCS) for patients with chronic pain due to persistent spinal pain syndrome type 2 (PSPS type 2). The conclusion of such screenings can influence the decision to offer SCS therapy to a patient. However, evidence on the impact of psychopathology on SCS outcomes is still scarce. MATERIALS AND METHODS: To address this knowledge gap, we systematically reviewed the literature from 2009 to 2021 to explore the correlation between the presence of a psychopathological disorder and the predicted outcome of SCS in patients with PSPS type 2. The literature search was conducted using various online data bases with "failed back surgery syndrome," "psychopathology," and "spinal cord stimulation" used as essential keywords. The identified studies were organized in a Rayyan AI data base, and the quality was analyzed with the Critical Appraisal Skills Program tool. RESULTS: Our search generated the identification of 468 original articles, of which two prospective and four retrospective studies met our inclusion criteria. These studies reported pain relief, a reduction of symptoms of anxiety and depression, and an improvement in rumination on the Pain Catastrophizing Scale in patients with PSPS type 2 after SCS therapy. The studies also found contradictory outcomes measured using the Oswestry Disability Index, and in terms of the impact of psychopathological disorder on the clinical outcome and revision rate of the SCS system. CONCLUSION: In this systematic review, we found no convincing evidence that the presence of a psychopathological disorder affects the predicted outcome of SCS therapy in patients with PSPS type 2.

Long-Term Clinical Results of Percutaneous Cervical Nucleoplasty for Cervical Radicular Pain: A Retrospective Cohort Study.

Purpose: Percutaneous cervical nucleoplasty (PCN) is a minimally invasive treatment for cervical radicular pain due to a disc herniation. Preliminary results show equivalent patient-reported outcomes of PCN as compared to conventional anterior cervical discectomy. However, there is a paucity of long-term outcome data. Therefore, the primary objective of this study is to investigate the long-term clinical results of PCN. Patients and Methods: A retrospective analysis was conducted on patients who underwent PCN at a secondary referral center between 2010 and 2014. Before surgery and five days after surgery, numeric rating scales (NRS) for arm pain and neck pain and data on complications were collected. To determine long-term follow-up outcomes, patients were sent a questionnaire booklet containing the Core Outcome Measures Index-Neck (COMI-Neck), NRS for arm pain and neck pain, Likert-scales on patient satisfaction and questions regarding the incidence of reoperations and complications. Results: The baseline characteristics were collected for 158 patients. At a median follow-up of 41.5 months (interquartile range (IQR) 27.0 to 57.5), data were available for 118 patients (74.7%). At short-term follow-up, patients that underwent PCN had a mean decrease of 3.0 on the NRS for arm pain (95% CI 2.5 to 3.6) compared to baseline, while at long-term follow-up, a mean decrease of 2.8 (95% CI 1.0 to 3.6) was observed. At the long-term follow-up, 67.8% of the patients were fully recovered from all symptoms and 93.3% remained satisfied with the PCN treatment results. The reoperation rate for recurrent disc herniation was 21.4% at long-term follow-up. Conclusion: PCN appears to be a safe and effective treatment at short-term and long-term follow-up of a specific selection of cervical herniated discs, with an acceptable long-term reoperation rate. These study results suggest a potential role of PCN as a less invasive treatment option for cervical radicular pain due to a soft disc herniation, before anterior cervical discectomy should be considered.

The Effect of Percutaneous Nucleoplasty vs Anterior Discectomy in Patients with Cervical Radicular Pain due to a Single-Level Contained Soft-Disc Herniation: A Randomized Controlled Trial.

BACKGROUND: Cervical radicular pain (CRP) is a common problem in the adult population. When conservative treatment fails and the severe pain persist, surgical treatment is considered. However, surgery is associated with some serious risks. To reduce these risks, new minimally invasive techniques have been developed, such as percutaneous nucleoplasty. Several studies have shown that percutaneous nucleoplasty is a safe and effective technique for the treatment of CRP, but until now no randomized controlled trials have been conducted that compare percutaneous cervical nucleoplasty (PCN) to anterior cervical discectomy (ACD) in patients with a single-level contained soft-disc herniation. OBJECTIVES: To compare the effects of PCN and ACD in a group of patients with CRP caused by a single-level contained soft-disc herniation. STUDY DESIGN: A randomized, controlled, multi-center trial. SETTING: Medical University Center and local hospitals. METHODS: Forty-eight patients with CRP as a result of a single-level contained soft-disc herniation were randomized to one of the following 2 treatments: PCN or ACD. The primary outcome measure was arm pain intensity, measured with a Visual Analog Scale (VAS). Secondary outcomes were arm pain intensity during heavy effort, neck pain, global perceived effect, Neck Disability Index (NDI), and the patients' general health (Short Form Generated Health Survey [SF-36]). All parameters were measured at baseline (T0), 3 months after intervention (T2), and one year after intervention (T3). One week after the intervention (T1), an intermediate assessment of arm pain, arm pain during heavy effort, neck pain, satisfaction, and improvement were performed. RESULTS: At 3 months, the intention to treat analyses revealed a statistical significant interaction between the groups on the primary outcome, arm pain intensity, and on the secondary outcome of the SF-36 item pain, in favor of the ACD group. On the other secondary outcomes, no statistical significant differences were found between the groups over time. At 12 months, there was a trend for more improvement of arm pain in favor of the ACD group and no statistical interactions were found on the secondary outcomes. LIMITATIONS: Firstly, the inclusion by the participating hospitals was limited. Secondly, the trial was ended before reaching the required sample size. Thirdly, at baseline, after the inclusion by the neurosurgeon, 13 patients scored less than 50.0 mm on the VAS. Fourthly, the withdrawal of the physiotherapy (PT) group and finally, the patients and interventionists could not be blinded for the treatment. CONCLUSIONS: At 3 months, the ACD group performed significantly better on arm pain reduction than the PCN group in patients with CRP as a result of a single-level contained soft-disc hernia. However, the clinical relevancy of this treatment effect can be debated. For all parameters, after one year, no significant differences between the groups were found. When it comes to the longer-term effectiveness, we conclude that PCN can be a good alternative for ACD.

High-Dose Spinal Cord Stimulation for Treatment of Chronic Low Back Pain and Leg Pain in Patients With FBSS, 12-Month Results: A Prospective Pilot Study.

OBJECTIVES: To investigate the long-term effect of high-dose spinal cord stimulation (HD-SCS) in patients with chronic refractory low back and leg pain due to failed back surgery syndrome (FBSS). STUDY DESIGN: Prospective case series; pilot study. MATERIALS AND METHODS: Patients with chronic low back and leg pain (CBLP) due to failed back surgery syndrome (FBSS) were screened for SCS according to the Dutch Neuromodulation Society guidelines. Patients with a pain score of >50 (on a visual analogue scale from 0 to 100) for both low back and leg pain, were selected for participation in this study. During intraoperative screening one or two electrodes were implanted to ensure adequate paresthesia coverage of the back and leg pain area. During the 14 days trial period patients received two programs: a conventional or low-dose (LD) program with 30 Hz; 390 µsec and a high-dose (HD) program with 420 Hz, 400 µsec. They all started with LD-SCS and changed to HD-SCS after three days. If patients reported more than 50% pain relief with either program a rechargeable neurostimulator was implanted for permanent SCS. The scores for low back pain and leg pain were recorded separately. Other therapy related outcomes that were collected are pain medication use, Quebec back pain disability scale (QBPDS), patient satisfaction, employment status, stimulation settings, and adverse events. We present the 6- and 12-months results. Results are presented as mean ± SD. RESULTS: Thirteen patients, nine females and four males (mean age: 49.7 ± 8.1 years), were included between July 2015 and March 2016. Eleven patients responded to SCS during the trial period and were implanted with a neurostimulator. Most patients preferred HD-SCS over LD-SCS and the overall use of HD-SCS increased over time. At 6 to 12 months follow-up, two patients discontinued the study. In one patient low back pain returned despite optimal stimulation settings. The second patient was neither satisfied with LD nor HD and had the system explanted. VAS Leg pain at baseline was 71.2 ± 33.8 and reduced to 25.7 ± 24.0 at 6 months and 23.4 ± 32.0 at 12 months. VAS Back pain at baseline was 66.7 ± 33.2 and reduced to 36.8 ± 41.6 at 6 months and 26.1 ± 33.2 at 12 months. Pain medication was significantly reduced and QBPDS improved from 59.2 ± 12.2 at baseline to 44.1 ± 13.7 at 12 months. Five patients returned to work and overall patient satisfaction at the end of the study was high. CONCLUSION: This pilot study shows promising results of offering HD-SCS in addition to LD-SCS for treatment of chronic back and leg pain in patients with failed back surgery syndrome.

Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study.

OBJECTIVE: Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously randomized 52 FBSS patients to be treated with spinal cord stimulation (SCS) and additional peripheral nerve field stimulation (PNFS) or SCS alone. At three months, we found a significant reduction of back pain in the PNFS-SCS group compared to the SCS group. In the subsequent open phase part of the study, all patients received optimal SCS and PNFS simultaneously. Here, we present the 12-month follow-up data on back and leg pain. MATERIALS AND METHODS: Data regarding back and leg pain, function, quality of life, patient satisfaction, anxiety and depression, and use of medication were collected by analyzing patients' questionnaires at 12 months and compared with data collected at baseline. Data were analyzed using multilevel regression models. RESULTS: A combined group of 50 subjects completed the 12-month follow-up. Back pain, measured on a 100-mm visual analog scale (VAS), significantly decreased over this period by 30.0 mm (95% CI: [-37.7/-22.4]; p < 0.001), while leg pain decreased by 43.7 mm (95% CI: [-51.5/-36.2]; p < 0.001). We observed statistically significant improvement in almost all secondary outcome measurements. CONCLUSIONS: At 12-month follow-up, PNFS in addition to SCS continues to provide a statistically significant and clinically relevant relief of low back pain in FBSS patients in whom SCS alone is effective for relief of leg pain only.

Percutaneous Nucleoplasty for the Treatment of a Contained Cervical Disk Herniation.

Cervical radiculopathy is characterized by compression of the roots of the nerve. When conservative treatment fails and symptoms persist or increase in severity, surgical treatment is considered. Anterior cervical discectomy with or without fusion is regarded as the standard treatment for cervical disk herniation. Recently, there is an evolving trend in spinal surgery towards less invasive techniques. Nucleoplasty is a minimally invasive technique in which radiofrequency technology is used for percutaneous decompression. During the last years nucleoplasty has been proven to be a safe and effective treatment to alleviate radiculopathy, caused by a contained disk herniation. Nucleoplasty is usually performed on an outpatient basis and is associated with a fast recovery time. This paper will describe the preoperative and postoperative management of cervical nucleoplasty as well as the surgical technique, accompanied by a video.

Subcutaneous Stimulation as an Additional Therapy to Spinal Cord Stimulation for the Treatment of Low Back Pain and Leg Pain in Failed Back Surgery Syndrome: Four-Year Follow-Up.

OBJECTIVE: The objective of this study is to investigate the efficacy of long-term follow-up of subcutaneous stimulation (SubQ) as an additional therapy for patients with failed back surgery syndrome (FBSS) with chronic refractory pain, for whom spinal cord stimulation (SCS) alone was unsuccessful in treating low back pain. STUDY DESIGN: Prospective case series. MATERIALS AND METHODS: FBSS patients with leg and/or low back pain whose conventional therapies had failed, received a combination of SCS (8-contact Octad lead, 3877-45 cm, Medtronic, Minneapolis, MN, USA) and/or SubQ (4-contact Quad Plus lead (s), 2888-28 cm, Medtronic). Initially, an Octad lead was placed in the epidural space for SCS for a trial stimulation to assess the suppression of leg and/or low back pain. Where SCS alone was insufficient in treating low back pain, lead(s) were placed superficially in the subcutaneous tissue of the lower back, exactly in the middle of the pain area. A pulse generator (Prime Advanced, 37702, Medtronic) was implanted if the patient reported more than 50% pain relief during the trial period. We investigated the long-term effect of neuromodulation on pain with the visual analog scale (VAS), and disability using the Quebec Pain Disability Scale. The results after 46 months are presented. RESULTS: Eleven patients, five men and six women (age 51 ± 8 years, mean ± SD) were included in the pilot study. In nine cases, SCS was used in combination with SubQ leads. Two patients received only SubQ leads. In one patient, the SCS + SubQ system was removed after nine months and these results were not taken into account for the analysis. Baseline scores for leg (N = 8) and low back pain (N = 10) were VASbl: 59 ± 15 and VASbl: 63 ± 14, respectively. The long-term follow-up period was 46 ± 4 months. SCS significantly reduced leg pain after 12 months (VAS12: 20 ± 11, p12 = 0.001) and 46 months (VAS46: 37 ± 17, p46 = 0.027). Similarly, SubQ significantly reduced back pain after 12 months(VAS12: 33 ± 16, p12 = 0.001) and 46 months (VAS46: 40 ± 21, p46 = 0.013). At 12 months, the Quebec Pain Disability Scale (QPDS) was 49 ± 12 and after 46 months, 53 ± 15. Both at 12 and 46 months, the QPDS values were statistically significantly better (p12 = 0.001, p46 = 0.04) compared with baseline values (QPDSbl: 61 ± 15). In one patient, the pain suppressive effect of SCS/SubQ had disappeared completely over time and the pain scores returned to prestimulation values. In four, patients back pain scores increased over time due to new issues (SI-joint problems, degenerative spine problems, disc problems, and hip pain) unrelated to FBSS and for which SCS/SubQ was not targeted or a reason for implantation at the start of the pilot study. DISCUSSION: This is the first prospective report on the combined use of SCS and SubQ with a follow-up period of four years. These data show that SCS and/or SubQ provide persistent long-term pain relief for leg and back pain in patients with FBSS. One should also take into account that new back/leg pain problems may evolve over time and increase the pain score which impact overall pain treatment. CONCLUSION: SCS combined with SubQ can be considered an effective long term treatment for low back pain in patients with FBSS for whom SCS alone is insufficient in alleviating their pain symptoms.

The long-term efficacy and safety of percutaneous cervical nucleoplasty in patients with a contained herniated disk.

BACKGROUND: Percutaneous cervical nucleoplasty (PCN) is a safe and effective treatment in symptomatic patients with contained cervical herniated disks. It provides simple and efficient disk decompression, using a controlled and highly localized ablation, but evidence regarding long-term efficacy is limited. We conducted a retrospective study to investigate the long-term efficacy and safety of PCN, and the influence of ideal selection settings. METHODS: A total of 27 patients treated with PCN fulfilling ideal selection criteria (Group A) were studied and compared to 42 patients not meeting these criteria (Group B). Outcomes were assessed using the Visual Analogue Scale (VAS) and a four-level Likert item for perceived pain and satisfaction, the Neck Disability Index (NDI), and the Short Form 36 (SF-36). Additional relevant outcomes were retrieved from medical records. RESULTS: The postoperative mean VAS pain for Group A was 29.9 (SD ± 32.6) at a mean follow-up of 24 months (range: 2-45). Only 10% of these patients reported mild transient adverse events. There was a trend, but no difference between both groups in pain scores; however, treatment satisfaction was higher for Group A (74.1 ± 27.2-55.5 ± 31.4, P = 0.02). Group A also reported better physical functioning based on the Physical Component Summary (43.6 ± 10.6-37.3 ± 12.0, P = 0.03) and showed a larger proportion of patients no longer using any medication postoperatively (63-26%, P = 0.01). CONCLUSION: These results show long-term effectiveness and safety of PCN in patients with a one-level contained cervical herniated disk, and the reliance of selecting patients meeting ideal criteria for successful PCN.

Subcutaneous stimulation as an additional therapy to spinal cord stimulation for the treatment of lower limb pain and/or back pain: a feasibility study.

OBJECTIVE: The objective of this study was to demonstrate the efficacy of subcutaneous stimulation (SubQ) as an additional therapy in patients with failed back surgery syndrome (FBSS) with chronic refractory pain, for whom spinal cord stimulation (SCS) was unsuccessful in treating low back pain. STUDY DESIGN: Case series. MATERIALS AND METHODS: FBSS patients with chronic limb and/or low back pain whose conventional therapies had failed received a combination of SCS (8-contact Octad lead) and/or SubQ (4-contact Quad Plus lead(s)). Initially leads were placed in the epidural space for SCS for a trial stimulation to assess response to suppression of limb and low back pain. Where SCS alone was insufficient in treating lower back pain, leads were placed superficially in the subcutaneous tissue of the lower back, directly in the middle of the pain area. A pulse generator was implanted if patients reported more than 50% pain relief during the trial period. Pain intensity for limb and lower back pain was scored separately, using visual analog scale (VAS). Pain and Quebec Back Pain Disability Scale (QBPDS) after 12-month treatment were compared with pain and QBPDS at baseline. RESULTS: Eleven FBSS patients, five male and six female (age: 51 ± 8 years; mean ± SD), in whom SCS alone was insufficient in treating lower back pain, were included. In nine cases, SubQ was used in combination with SCS to treat chronic lower back and lower extremity pain. In two cases only SubQ was used to treat lower back pain. SCS significantly reduced limb pain after 12 months (VAS(bl) : 62 ± 14 vs. VAS(12m) : 20 ± 11; p= 0.001, N= 8). SubQ stimulation significantly reduced low back pain after 12 months (VAS(bl) : 62 ± 13.0 vs. VAS(12m) : 32 ± 16; p= 0.0002, N= 10). Overall pain medication was reduced by more than 70%. QBPDS improved from 61 ± 15 to 49 ± 12 (p= 0.046, N= 10). Furthermore, we observed that two patients returned to work. CONCLUSION: SubQ may be an effective additional treatment for chronic low back pain in patients with FBSS for whom SCS alone is insufficient in alleviating their pain symptoms.