Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial.

Importance: Low back and neck pain are often self-limited, but health care spending remains high. Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain. Design, Setting, and Participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021). Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150). Main Outcomes and Measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance. Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT. Conclusions and Relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year. Trial Registration: ClinicalTrials.gov Identifier: NCT03083886.

A First Estimate of the Annual Prevalence of Basivertebral Nerve Ablation Candidates in a Spine Clinic.

BACKGROUND: Emerging literature supports the use of basivertebral nerve ablation (BVNA) for a specific cohort of patients with chronic low back pain and Type 1 or Type 2 Modic changes from vertebral levels L3-S1. The early literature warrants further evaluation. Studies establishing the efficacy of BVNA use highly selective patient criteria. OBJECTIVE: Provide a first estimate of the prevalence of BVNA candidates in a spine clinic over a year using the foundational studies patient selection criteria? METHODS: A retrospective review of four fellowhsip trained spine physiatrists patient encounters at a large academic medical center using relevant ICD-10 codes to isolate chronic low back pain without radiating symptoms from January 1, 2019 to January 1, 2020. Charts were then reviewed by a team of physicians for exclusionary criteria from the foundational studies which have demonstrated benefit from BVNA. MRI's from qualifying charts which did not meet exclusionary criteria were then independently reviewed by four physician for localization and characterization of Modic changes. RESULTS: The relevant diagnostic codes query yielded 338 unique patient records. Based on exclusionary criteria or lack of imaging availability, 318 charts were eliminated. The remaining 20 charts qualified for imaging review. There were 11 charts in which there was 100% agreement between all reviewers regarding the presence and either Type 1 or Type 2 Modic changes between vertebral levels L3 to S1. Accordingly, the prevalence of eligibility for BVNA was 3% (11/338, 95% CI 1-5%). CONCLUSION: The population which may benefit from BVNA is small. Our study demonstrated that over a year, the prevalence for BVNA candidacy using the foundational studies criteria was 3% (95% CI 1% - 5%). While physicians may be tempted to use less stringent selection criteria in practice, upon doing so they cannot cite the foundational studies as evidence for the outcomes they expect to achieve. Those outcomes will require more studies which formally assess the benefits of BVNA when selection criteria are relaxed.

Sacroiliac Joint Interventions.

The sacroiliac joint complex (SIJC) is composed of complex anatomy of numerous potential pain generators that demonstrate varying pathophysiology and differing innervations. This heterogeneity has been a challenge to advancing research and clinical care. Moving forward, individualized approaches taking these factors into account may be a path forward to improved outcomes. Thus, as we move toward precision medicine in interventional spine care, it is imperative to investigate more targeted diagnostic and therapeutic approaches to the SIJC.

The effectiveness of intradiscal biologic treatments for discogenic low back pain: a systematic review.

BACKGROUND CONTEXT: There are limited treatments for discogenic low back pain. Intradiscal injections of biologic agents such as platelet-rich plasma (PRP) or stem cells (SC) are theorized to have regenerative properties and have gained increasing interest as a possible treatment, but the evidence supporting their use in clinical practice is not yet well-defined. PURPOSE: Determine the effectiveness of intradiscal biologics for treating discogenic low back pain. STUDY DESIGN: PRISMA-compliant systematic review. PATIENT SAMPLE: Patients with discogenic low back pain confirmed by provocation discography or clinical and imaging findings consistent with discogenic pain. OUTCOME MEASURES: The primary outcome was the proportion of individuals with ≥50% pain relief after intradiscal biologic injection at 6 months. Secondary outcomes included ≥2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI. METHODS: Comprehensive literature search performed in 2018 and updated in 2020. Interventions included were biologic therapies including mesenchymal stem cells, platelet rich plasma, microfragmented fat, amniotic membrane-based injectates, and autologous conditioned serum. Any other treatment (sham or active) was considered for comparative studies. Studies were independently reviewed. RESULTS: The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. The quality of evidence on effectiveness of intradiscal biologics was very low. A single randomized controlled trial evaluating platelet-rich plasma reported positive outcomes but had significant methodological flaws. A single trial that evaluated mesenchymal stem cells was negative. Success rates for platelet-rich plasma injectate in aggregate were 54.8% (95% Confidence Interval: 40%-70%). For mesenchymal stem cells, the aggregate success rate at six months was 53.5% (95% Confidence Interval: 38.6%-68.4%), though using worst-case analysis this decreased to 40.7% (95% Confidence Interval: 28.1%-53.2%). Similarly, ≥30% functional improvement was achieved in 74.3% (95% Confidence Interval: 59.8%-88.7%) at six months but using worst-case analysis, this decreased to 44.1% (95% Confidence Interval: 28.1%-53.2%). CONCLUSION: Limited observational data support the use of intradiscal biologic agents for the treatment of discogenic low back pain. According to the Grades of Recommendation, Assessment, Development and Evaluation System, the evidence supporting use of intradiscal mesenchymal stem cells and platelet-rich plasma is very low quality.

Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group.

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.

Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group.

BACKGROUND: The past two decades have witnessed a surge in the use of cervical spine joint procedures including joint injections, nerve blocks and radiofrequency ablation to treat chronic neck pain, yet many aspects of the procedures remain controversial. METHODS: In August 2020, the American Society of Regional Anesthesia and Pain Medicine and the American Academy of Pain Medicine approved and charged the Cervical Joint Working Group to develop neck pain guidelines. Eighteen stakeholder societies were identified, and formal request-for-participation and member nomination letters were sent to those organizations. Participating entities selected panel members and an ad hoc steering committee selected preliminary questions, which were then revised by the full committee. Each question was assigned to a module composed of 4-5 members, who worked with the Subcommittee Lead and the Committee Chairs on preliminary versions, which were sent to the full committee after revisions. We used a modified Delphi method whereby the questions were sent to the committee en bloc and comments were returned in a non-blinded fashion to the Chairs, who incorporated the comments and sent out revised versions until consensus was reached. Before commencing, it was agreed that a recommendation would be noted with >50% agreement among committee members, but a consensus recommendation would require ≥75% agreement. RESULTS: Twenty questions were selected, with 100% consensus achieved in committee on 17 topics. Among participating organizations, 14 of 15 that voted approved or supported the guidelines en bloc, with 14 questions being approved with no dissensions or abstentions. Specific questions addressed included the value of clinical presentation and imaging in selecting patients for procedures, whether conservative treatment should be used before injections, whether imaging is necessary for blocks, diagnostic and prognostic value of medial branch blocks and intra-articular joint injections, the effects of sedation and injectate volume on validity, whether facet blocks have therapeutic value, what the ideal cut-off value is for designating a block as positive, how many blocks should be performed before radiofrequency ablation, the orientation of electrodes, whether larger lesions translate into higher success rates, whether stimulation should be used before radiofrequency ablation, how best to mitigate complication risks, if different standards should be applied to clinical practice and trials, and the indications for repeating radiofrequency ablation. CONCLUSIONS: Cervical medial branch radiofrequency ablation may provide benefit to well-selected individuals, with medial branch blocks being more predictive than intra-articular injections. More stringent selection criteria are likely to improve denervation outcomes, but at the expense of false-negatives (ie, lower overall success rate). Clinical trials should be tailored based on objectives, and selection criteria for some may be more stringent than what is ideal in clinical practice.

Design of the Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure Trial (SPINE CARE) study: Methods and lessons from a multi-site pragmatic cluster randomized controlled trial.

BACKGROUND: Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. METHODS: The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. DISCUSSION: The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care. TRIAL REGISTRATION NUMBER: NCT03083886.

Radiofrequency Ablation for Chronic Posterior Sacroiliac Joint Complex Pain: A Comprehensive Review.

Radiofrequency ablation of the sacral lateral branches targets the innervation of the posterior sacroiliac ligaments and posterior portion of the sacroiliac joint. These structures are also collectively referred to as the posterior sacroiliac joint complex. This review will discuss current diagnostic block paradigms and selection criteria for sacral lateral branch radiofrequency ablation, varying techniques and technologies utilized for sacral lateral branch radiofrequency ablation, and updates on the clinical outcome literature. The current evidence suggests that sacral lateral branch radiofrequency ablation can provide relief for posterior sacroiliac joint complex pain, but the literature is limited by variability in selection criteria, the specific nerves targeted by radiofrequency ablation, and the types of radiofrequency ablation technology and techniques utilized in clinical outcome studies.

Characteristics of ambulatory spine care visits in the United States, 2009-2016.

BACKGROUND: Back pain is a leading reason for seeking care in the United States (US), and is a major cause of morbidity. OBJECTIVE: To analyze demographic, patient, and visit characteristics of adult ambulatory spine clinic visits in the United States from 2009-2016. METHODS: Data from the National Ambulatory Medical Care Survey from 2009-2016 were used and were sample weighted. RESULTS: Most patients presenting for ambulatory spine care were 45-64 years (45%), were most commonly female (56.8%), and private insurance (45%) and Medicare (26%) were most common payors. The percentage of visits for spine care done at a primary care setting was 50.1% in 2009-2010 and 48.3% in 2014-2015. Approximately 15.5% were seen in orthopedic surgery clinics in 2009-2010 and 7.3% in 2015-2016. MRI was utilized in 11.7% in 2009-2010 and 11.0% in 2015-2016. Physical therapy was prescribed in 13.2% and narcotic analgesic medications were prescribed in 36.2% of patients in 2015-2016. CONCLUSIONS: MRI was used more frequently than guidelines recommended, and physical therapy was less frequently utilized despite evidence. A relatively high use of opiates in treatment of back pain was reported and is concerning. Although back pain represents a substantial public health burden in the United States, the delivery of care is not evidence-based.

Ultrasound-guided cervical selective nerve root injections: a narrative review of literature.

BACKGROUND/IMPORTANCE: Ultrasound (US)-guided cervical selective nerve root injections (CSNRI) have been proposed as an alternative to fluoroscopic (FL) -guided injections. When choosing US guidance, the proceduralist should be aware of potential issues confirming vertebral level, be clear regarding terminology, and up to date regarding the advantages and disadvantages of US-guided CSNRI. OBJECTIVE: Review the accuracy and effectiveness of US guidance in avoiding vascular puncture (VP) and/or intravascular injection (IVI) during CSNRI. EVIDENCE REVIEW: Queries included PubMed, CINAHL and Embase databases from 2005 to 2019. Three authors reviewed references for eligibility, abstracted data, and appraised quality. FINDINGS: The literature demonstrates distinct safety considerations and limited evidence of the effectiveness of US guidance in detecting VP and/or IVI. As vascular flow and desired injectate spread cannot be visualized with US, the use of real-time fluoroscopy, and if needed digitial subraction imaging, is indicated in cervical transforaminal epidural injections (CTFEIs). Given the risk of VP and/or IVI, the ability to perform and to retain FL images to document that the procedure was safely conducted is valuable in CTFEIs. CONCLUSION: US guidance remains to be proven as a non-inferior alternative to FL guidance or other imaging modalities in the prevention of VP and/or IVI with CTFEIs or cervical selective nerve root blocks. There is a paucity of adequately powered clinical studies evaluating the accuracy and effectiveness of US guidance in avoiding VP and/or IVI. US-guided procedures to treat cervical radicular pain has limitations in visualization of anatomy, and currently with the evidence available is best used in a combined approach with FL guidance.

Cervical medial branch block progression to radiofrequency neurotomy: A retrospective clinical audit.

BACKGROUND: Chronic axial neck pain (CANP) due to zygapophysial joint arthropathy is best diagnosed via cervical medial branch block (MBB). However, the paradigm by which MBB is used to select patients for cervical radiofrequency neurotomy (RFN) is contested. Dual diagnostic cervical MBB with a minimum of ≥80% pain relief to diagnose cervical zygapophysial joint pain has been accepted by some Medicare Local Coverage Determinations as the method for selecting patients for cervical RFN. There are some who would argue that the utility of the dual diagnostic MBB and the ≥80% pain relief cut off lacks utility in clinical practice. The suspicion being those who progress from MBB1 to MBB2 will then flow from MBB2 to RFN without fail. Does clinical practice using dual diagnostic MBBs and using an ≥80% pain relief cut off reduce patient eligibility for cervical RFN after both MBB1 and MBB2? METHODS: A retrospective clinical audit was carried out at an academic institution spine center from January 1st to December 31st, 2019. Charts were selected based on Current Procedural Terminology codes for MBB, then included if the cervical medial branches were targeted. Charts were then reviewed for procedural progression. RESULTS: 21/51 (24%, 95% Confidence Interval 12-35%) patients progressed from MBB1 to MBB2. Of those 21 patients, 13 patients progressed from MBB2 to RFN (62%, 95% CI 41-83%). In total, 13/51 (14%, 95% CI 14-37%) patients who were initially suspected to have CANP due to zygapophysial joint pain progressed to RFN. Both MBB1 and MBB2 hindered the progression of 30/51 patients (59%, 95% CI 45-72%) and 8/21 patients (38%, 95% CI 17-59%), respectively. CONCLUSION: Both MBB1 and MBB2 served to filter patients from progression to RFN using dual MBBs with an ≥80% pain relief cutoff.

The Effectiveness of Cervical Medial Branch Thermal Radiofrequency Neurotomy Stratified by Selection Criteria: A Systematic Review of the Literature.

OBJECTIVE: To determine the effectiveness of cervical medial branch thermal radiofrequency neurotomy in the treatment of neck pain or cervicogenic headache based on different selection criteria. DESIGN: Comprehensive systematic review. METHODS: A comprehensive literature search was conducted, and the authors screened and evaluated the studies. The Grades of Recommendation, Assessment, Development, and Evaluation system was used to assess all eligible studies. OUTCOME MEASURES: The primary outcome measure assessed was the success rate of the procedure, defined by varying degrees of pain relief following neurotomy. Data are stratified by number of diagnostic blocks and degree of pain relief. RESULTS: Results varied by selection criteria, which included triple placebo-controlled medial branch blocks, dual comparative medial branch blocks, single medial branch blocks, intra-articular blocks, physical examination findings, and symptoms alone. Outcome data showed a greater degree of pain relief more often when patients were selected by triple placebo-controlled medial branch blocks or dual comparative medial branch blocks, producing 100% relief of the index pain. The degree of pain relief was similar when triple or dual comparative blocks were used. CONCLUSIONS: Higher degrees of relief from cervical medial branch thermal radiofrequency neurotomy are more often achieved, to a statistically significant extent, if patients are selected on the basis of complete relief of index pain following comparative diagnostic blocks. If selected based on lesser degrees of relief, patients are less likely to obtain complete relief.