Chiropractic spinal manipulation and likelihood of tramadol prescription in adults with radicular low back pain: a retrospective cohort study using US data.

OBJECTIVES: Patients receiving chiropractic spinal manipulation (CSM) for low back pain (LBP) are less likely to receive any opioid prescription for subsequent pain management. However, the likelihood of specifically being prescribed tramadol, a less potent opioid, has not been explored. We hypothesised that adults receiving CSM for newly diagnosed radicular LBP would be less likely to receive a tramadol prescription over 1-year follow-up, compared with those receiving usual medical care. DESIGN: Retrospective cohort study. SETTING: US medical records-based dataset including >115 million patients attending academic health centres (TriNetX, Inc), queried 9 November 2023. PARTICIPANTS: Opioid-naive adults aged 18-50 with a new diagnosis of radicular LBP were included. Patients with serious pathology and tramadol use contraindications were excluded. Variables associated with tramadol prescription were controlled via propensity matching. INTERVENTIONS: Patients were divided into two cohorts dependent on treatment received on the index date of radicular LBP diagnosis (CSM or usual medical care). PRIMARY AND SECONDARY OUTCOME MEASURES: Risk ratio (RR) for tramadol prescription (primary); markers of usual medical care utilisation (secondary). RESULTS: After propensity matching, there were 1171 patients per cohort (mean age 35 years). Tramadol prescription was significantly lower in the CSM cohort compared with the usual medical care cohort, with an RR (95% CI) of 0.32 (0.18 to 0.57; p<0.0001). A cumulative incidence graph demonstrated that the reduced incidence of tramadol prescription in the CSM cohort relative to the usual medical care cohort was maintained throughout 1-year follow-up. Utilisation of NSAIDs, physical therapy evaluation and lumbar imaging was similar between cohorts. CONCLUSIONS: This study found that US adults initially receiving CSM for radicular LBP had a reduced likelihood of receiving a tramadol prescription over 1-year follow-up. These findings should be corroborated by a prospective study to minimise residual confounding.

Pain control and functional recovery as therapeutic goals in patients with chronic musculoskeletal pain: two experiences with tapentadol hydrochloride.

OBJECTIVE: This study aimed to evaluate pain control, functioning, and quality of life (QoL) recovery in patients with chronic low back pain (cLBP) or post-traumatic osteoarthritis (OA) pain in the ankle/foot area, treated with tapentadol prolonged release and unresponsive to other treatments. PATIENTS AND METHODS: Two observational retrospective studies were conducted using clinical practice datasets of patients with chronic pain in cLBP and OA foot/ankle at different time points (total follow-up=60-90 days). The studies assessed pain intensity by the Numerical Rating Scale (NRS) pain scale (patients were classified as responder in case of ≥30% pain reduction), QoL by the 5-level EQ-5D (EQ-5D-5L) questionnaire, patient satisfaction by the 7-point Patients' Global Impression of Change (PGIC) scale; cLBP health status by the Roland Morris Disability Questionnaire (RMDQ); foot and ankle functional status by European Foot and Ankle Society (EFAS) score; and treatment-related AEs. RESULTS: For the cLBP setting, 37 patients were enrolled, of which 86.50% were classified as responders (n=32; CI: 75.5% ÷ 97.5%). For the foot/ankle OA pain setting, 21 patients were enrolled. Pain assessment at final follow-up was available only for 11 patients, of which 72.73% (n=8; CI: 39.0% ÷ 94.0%) were classified as responders. Statistically significant improvements were seen in the RMDQ, EQ-5D-5L, and PGIC scores in cLBP. Improvements in the EFAS, EQ-5D-5L, and PGIC scores were seen in OA as well. The incidence of treatment-related adverse reactions was low in both studies. CONCLUSIONS: In the study population, tapentadol prolonged release was effective and well tolerated in treating cLBP and post-traumatic foot/ankle OA chronic pain when used in a multimodal manner. The reduction in pain was accompanied by clinically relevant improvements in patients' functionality and QoL.

The effect of long-term alendronic acid treatment on Modic changes in the lumbar spine: a gender and age-matched study.

BACKGROUND: Low back pain (LBP) affects a significant proportion of the adult population. Potent anti-resorptive drugs such as intravenous zoledronic acid have been demonstrated to reduce Modic changes (MCs) upon magnetic resonance imaging (MRI) of the spine and concomitantly decrease associated LBP. It is uncertain whether oral alendronic acid has a similar effect. METHODS: 82 subjects were recruited in this case-control study. Treatment subjects (n = 41) received oral alendronic acid treatment for at least 1-year and were matched by gender and age (± 2) to control subjects (n = 41) not receiving any anti-osteoporotic medication. The prevalence, type, and extent of MCs were quantified upon T1 and T2-weighted MRIs of the lumbosacral spine. RESULTS: Treatment subjects received oral alendronic acid for 124.0 ± 62.1 weeks at the time of MRI assessment and exhibited a lower prevalence of MCs over the lumbosacral spine (18/41 vs. 30/41, p < 0.001) as compared to control subjects. Amongst both groups, type 2 MCs were predominant. Quantification of type 2 MCs in treatment subjects revealed a significant reduction in area (113 ± 106 mm2 vs. 231 ± 144 mm2, p < 0.01) and volume (453 ± 427 mm3 vs. 925 ± 575 mm3, p < 0.01) affected by type 2 MCs in comparison to matched controls. CONCLUSION: Oral alendronic acid may be useful in the treatment of MC-associated LBP in patients with concomitant osteoporosis.

Predictors of success of pharmacological management in patients with chronic lower back pain: systematic review.

BACKGROUND: Conservative management is recommended as the first therapeutic step in chronic low back pain (LBP), but there is no available evidence regarding the possible effect of patients' baseline characteristics on the therapeutic outcomes. A systematic review of the literature was performed to investigate this point. METHODS: In February 2024, all the level I studies investigating the role of pharmacological management for chronic LBP were accessed. Data concerning the patient demographic at baseline were collected: number of patients and related mean BMI and age, duration of the symptoms, duration of the follow-up, percentage of females, Numeric Rating Scale (NRS), the Roland Morris Disability Questionnaire (RMQ), Oswestry Disability Index (ODI). The outcomes at the last follow-up were evaluated through NRS, RMQ, and ODI. A multiple linear model regression diagnostic through the Pearson Product-Moment Correlation Coefficient (r) was used. RESULTS: Data from 47 articles (9007 patients) were obtained. The analysis yielded the following significant associations: age at baseline and NRS at follow-up (r = - 0.22; P = 0.04), NRS at baseline with NRS (r = 0.26; P = 0.03) and RMQ (r = - 0.58; P = 0.02) at follow-up, RMQ at baseline and the same at follow-up (r = 0.69; P = 0.0001). CONCLUSION: Older age, higher BMI, presence of comorbidities, higher ODI and a long history of symptoms or surgical treatments do not reduce the efficacy of pharmacological management of chronic LBP. However, pharmacological therapy is not an effective option for patients with high baseline RMQ. LEVEL OF EVIDENCE: I systematic review of RCTs.

[Efficiency evaluation of the Neuromidin in the treatment of pain of the patients with discogenic lumbosacral radiculopathy: results of a multicenter post-registration prospective open comparative trial]. / Otsenka effektivnosti Neiromidina pri lechenii bolevogo sindroma u patsientov s diskogennoi poyasnichno-kresttsovoi radikulopatiei: rezul'taty mnogotsentrovogo postregistratsionnogo prospektivnogo otkrytogo sravnitel'nogo issledovaniya.

OBJECTIVE: Evaluation of the effect of Neuromidine on the dynamics of pain syndrome in the treatment of patients with discogenic lumbosacral radiculopathy. MATERIAL AND METHODS: Patients with a confirmed diagnosis of discogenic lumbosacral radiculopathy no more than one year old and moderate intensity of pain syndrome on a visual analog scale were included in the main group (OH, n=62, age - 53.1±15.6 yrs) and the comparison group (HS, n=40, age - 53.7±12.9 yrs). OG patients received Neuromidine (15 mg/1 mL 1 once a day IM for 10 days, then 20 mg 3 times a day for 8 weeks) in addition to the standard drug therapy, HS patients received only standard drug therapy. The duration of the study was 8 weeks. The degree of decrease in the intensity and dynamics of pain syndrome, activity and frequency of pain in the lumbar spine, changes in the level of physical activity, and the severity of emotional disorders were evaluated. The level of inflammatory markers in the blood and the dynamics of monosynaptic spinal H-reflex parameters were evaluated. RESULTS: Before the study, there were no statistically significant differences there were no results of clinical and laboratory-instrumental examination between groups. After 8 weeks, the reduction of pain by VAS in the main group was statistically significant in contrast to the comparison group (p=0.0001). In the main group there was a statistically significant increase in the mean cognitive impairment score (p=0.0029), as well as an improvement in psycho-emotional state with a significant decrease in GAD-7 (p=0.0002) and PHQ-9 (p=0.0096). After 8 weeks of therapy, IL-6 level in the main group was statistically significantly lower (p=0.0027) than in the comparison group. The results of H-reflex study revealed an increase in its amplitude and some shortening of latency at the end of Neuromidine therapy. The drug had no undesirable side effects and was well tolerated. CONCLUSION: Administration of Neuromidine 15 mg/1 ml once a day intramuscularly for 10 days followed by 20 mg 3 times a day for 8 weeks has an effective analgesic effect as adjuvant therapy in patients with discogenic lumbosacral radiculopathy. The inclusion of Neuromidine in the complex treatment of patients with pain syndrome in discogenic radiculopathy is superior in efficacy to standard drug therapy.

Case 328.

HISTORY: A 45-year-old female patient with diffuse osteoarticular pain, particularly low back pain, was referred by a rheumatologist for an updated radiologic evaluation. The patient had experienced these symptoms for many years and was diagnosed with human leukocyte antigen B27-negative spondyloarthritis approximately 11 years prior, based on findings of bilateral erosive sacroiliitis at pelvic radiography (Fig 1A) and bone scintigraphy with technetium 99m methylene diphosphonate (Fig 1B). After 3 years of treatment with a tumor necrosis factor-α inhibitor (adalimumab), which was effective for pain, the patient was lost to follow-up. At the current presentation, approximately 8 years after being lost to follow-up, the patient presented with worsening low back pain. The presence of nonobstructing kidney stones on US images confounded the underlying cause of worsening pain. The patient also experienced fatigue and depressed mood. Routine blood tests revealed a normal blood cell count, creatinine level of 0.64 mg/dL (56.58 µmol/L) (normal range, 0.30-1.1 mg/dL [26.52-97.24 mmol/L]), C-reactive protein level of 1.1 mg/dL (normal, <1 mg/dL), and vitamin D level of 21 ng/mL (52.42 nmol/L) (normal range, 30-100 ng/mL [74.88-249.60 nmol/L]). Noncontrast MRI of the thoracic and lumbar spine (Fig 2), MRI of the sacroiliac joints (Fig 3), and CT of the abdomen and pelvis (Fig 4) were performed.

Relationships between the Spinal Dural Pulsations and the Short-Term Efficacy of Lumbar Epidural Steroid Injection.

Background: Lumbar spinal stenosis (LSS) causes low back pain, leg pain, numbness in the leg, and neurogenic intermittent claudication. Epidural steroid injection (ESI) has been used for treating spinal stenosis symptoms. We hypothesized that dural pulsation was variable for lumbar spinal stenosis. In cases of the presence of dural pulsation, the pain relief after the ESI was better than in the absence of dural pulsation. This study aimed at investigating the relationships between the presence or absence of spinal dural pulsations and the efficacy of ESI. Methods: A total of 71 patients were enrolled in this prospective study. Prior to the ESI, the dural pulsation was measured using a 5-1 MHz array ultrasound transducer. The visual analogue scale (VAS) score was measured pre-ESI and 2 weeks post-ESI and 4 weeks post-ESI. At 4 weeks post-ESI, dural pulsation was rechecked. Results: The VAS scores improved after the ESI procedure regardless of the presence or absence of dural pulsation. There was a correlation between the pulsation of the dura and post-ESI VAS scores. However, VAS was not significantly different for different grades of stenosis. Conclusion: The ESI was effective in patients with spinal stenosis in short-term follow-up. Dural pulsation of the spinal cord was a positive predictive factor for the ESI effect, but the grade of spinal stenosis severity had no effect on the effectiveness of ESI.

Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study.

STUDY OBJECTIVE: Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are useful for a variety of musculoskeletal injuries. It is not known whether topical NSAIDs should be used for patients presenting with acute nonradicular musculoskeletal low back pain. METHODS: We conducted a randomized, placebo-controlled double-blind study in which patients 18 to 69 years of age visiting the emergency department (ED) with acute, nontraumatic, nonradicular, musculoskeletal low back pain were randomized at the time of discharge to treatment with 400 mg oral ibuprofen + placebo topical gel, 1% diclofenac topical gel + oral placebo, or 400 mg ibuprofen + 1% diclofenac topical gel. We measured outcomes using the Roland Morris Disability Questionnaire (RMDQ), a 24-item yes/no instrument about the effect of back pain on a respondent's daily activities. The primary outcome was change in RMDQ score between ED discharge and 2 days later. Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms. RESULTS: In total, 3,281 patients were screened for participation, and 198 were randomized. Overall, 36% of the population were women, the mean age was 40 years (standard deviation, 13), and the median RMDQ score at baseline was 18 (25th to 75th percentile: 13 to 22), indicating substantial low back-related functional impairment. In total, 183 (92%) participants provided primary outcome data. Two days after the ED visit, the ibuprofen + placebo group had improved by 10.1 (95% confidence interval [CI] 7.5 to 12.7), the diclofenac gel + placebo group by 6.4 (95% CI 4.0 to 8.8), and the ibuprofen + diclofenac gel by 8.7 (95% CI 6.3 to 11.1). The between-group differences were as follows: ibuprofen versus diclofenac, 3.7 (95% CI 0.2 to 7.2); ibuprofen versus both medications 1.4 (95% CI -2.1 to 4.9); and diclofenac versus both medications, 2.3 (95% CI -5.7 to 1.0). Medication-related adverse events were reported by 3/60 (5%) ibuprofen patients, 1/63 (2%) diclofenac patients, and 4/64 (6%) patients who received both. CONCLUSION: Among patients with nontraumatic, nonradicular acute musculoskeletal low back pain discharged from an ED, topical diclofenac was probably less efficacious than oral ibuprofen. It demonstrated no additive benefit when coadministered with oral ibuprofen.

Reinforcing informed medication prescription for low back pain in the emergency department (RIME): a controlled interrupted time series implementation study protocol.

INTRODUCTION: Management guidelines for low back pain (LBP) recommend exclusion of serious pathology, followed by simple analgesics, superficial heat therapy, early mobilisation and patient education. An audit in a large metropolitan hospital emergency department (ED) revealed high rates of non-recommended medication prescription for LBP (65% of patients prescribed opioids, 17% prescribed benzodiazepines), high inpatient admission rates (20% of ED LBP patients), delayed patient mobilisation (on average 6 hours) and inadequate patient education (48% of patients). This study aims to improve medication prescription for LBP in this ED by implementing an intervention shown previously to improve guideline-based management of LBP in other Australian EDs. METHODS AND ANALYSIS: A controlled interrupted time series study will evaluate the intervention in the ED before (24 weeks; 20 March 2023-3 September 2023) and after (24 weeks; 27 November 2024-12 May 2024) implementation (12 weeks; 4 September 2023-26 November 2023), additionally comparing findings with another ED in the same health service. The multicomponent implementation strategy uses a formalised clinical flow chart to support clinical decision-making and aims to change clinician behaviour, through clinician education, provision of alternative treatments, educational resources, audit and feedback, supported by implementation champions. The primary outcome is the percentage of LBP patients prescribed non-recommended medications (opioids, benzodiazepines and/or gabapentinoids), assessed via routinely collected ED data. Anticipated sample size is 2000 patients (n=1000 intervention, n=1000 control) based on average monthly admissions of LBP presentations in the EDs. Secondary outcomes include inpatient admission rate, time to mobilisation, provision of patient education, imaging requests, representation to the ED within 6 months and healthcare costs. In nested qualitative research, we will study ED clinicians' perceptions of the implementation and identify how benefits can be sustained over time. ETHICS AND DISSEMINATION: This study received ethical approval from the Metro North Human Research Ethics Committee (HREC/2022/MNHA/87995). Study findings will be published in peer-reviewed journals and presented at international conferences and educational workshops. TRIAL REGISTRATION NUMBER: ACTRN12622001536752.

EMERGENCY DEPARTMENT INTRAARTICULAR CORTICOSTEROID INJECTION FOR SACROILIAC JOINT DYSFUNCTION.

BACKGROUND: Sacroiliac joint (SIJ) dysfunction is a common but underrecognized source of low back pain (LBP). With provocative testing, emergency physicians can diagnose SIJ dysfunction and begin appropriate treatment in the emergency department (ED). DISCUSSION: For patients with significant pain from SIJ dysfunction, ultrasound-guided SIJ injection of anesthetic and corticosteroid can reduce patients' pain considerably. CONCLUSIONS: For patients who are good candidates for SIJ injection, emergency physicians can begin treatment in the ED, before the patient follows up with a specialist.

Techniques in medicine: ipsilateral transforaminal epidural steroid injection in Bertolotti's syndrome.

Bertolotti's syndrome, also known as lumbosacral transitional vertebrae, is a relatively rare spinal condition characterized by an anatomical variation in the lower spine. Conservative approaches such as physical therapy, anti-inflammatory medications and lifestyle modifications may be recommended for mild cases. In more severe cases or when conservative measures fail to provide relief, injections such as may be considered to alleviate pain. This case is unique in that we document a challenging technique of ipsilateral transforaminal epidural steroid injection in a patient with Bertolotti's syndrome.

What a pain in the back: a review of current treatment options with a focus on naproxen sodium.

Non-specific low back pain (LBP) represents a challenging and prevalent condition that is one of the most common symptoms leading to primary care physician visits. While established guidelines recommend prioritizing non-pharmacological approaches as the primary course of action, pharmacological treatments are advised when non-pharmacological approaches are ineffective or based on patient preference. These guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs) or skeletal muscle relaxers (SMRs) as the first-line pharmacological options for acute or subacute LBP, while NSAIDs are the exclusive first-line pharmacological option for chronic LBP. Although SMRs are generally effective for acute LBP, the available evidence does not support the view that they improve functional recovery, and their comparative efficacy to NSAIDs and other analgesics remains unknown, while studies have shown them to introduce adverse events without significantly reducing LBP. Moreover, opioids continue to be widely prescribed for LBP, despite limited evidence for effectiveness and known risks of addiction and overdose. Broader use of non-opioid pharmacotherapy, including the appropriate use of OTC options, is critical to addressing the opioid crisis. The balance of evidence indicates that NSAIDs have a favorable benefit-risk profile when compared to other available pharmacological treatment options for non-specific LBP, a condition that is primarily acute in nature and well-suited for self-treatment with OTC analgesics. While clinical guidelines do not differentiate between NSAIDs, evidence indicates that OTC naproxen sodium effectively relieves pain across multiple types of pain models, and furthermore, the 14-h half-life of naproxen sodium allows sustained, all day pain relief with reduced patient pill burden as compared to shorter acting options. Choosing the most appropriate approach for managing LBP, including non-pharmacological options, should be based on the patient's condition, severity of pain, potential risks, and individual patient preference and needs.

Targeting the endocannabinoid system for the management of low back pain.

Low back pain (LBP) is a major unmet clinical need. The endocannabinoid system (ECS) has emerged as a promising therapeutic target for pain, including LBP. This review examines the evidence for the ECS as a therapeutic target for LBP. While preclinical studies demonstrate the potential of the ECS as a viable therapeutic target, clinical trials have presented conflicting findings. This review underscores the need for innovative LBP treatments and biomarkers and proposes the ECS as a promising avenue for their exploration. A deeper mechanistic understanding of the ECS in LBP could inform the development of new pain management strategies.

A randomized controlled trial: The efficacy and safety of Bushen Huoxue formula in the management of lower back pain from lumbar disc herniation.

BACKGROUND: Lower back pain (LBP) arising from lumbar disc herniation (LDH) poses a challenging health issue, often necessitating therapeutic interventions. Bushen Huoxue formula (BSHXF) has proved as a potential treatment option with great clinical effect. However, comprehensive investigations into its efficacy and safety in conjunction with celecoxib for managing LBP from LDH are lacking. The objective of this article is to investigate the efficacy and safety of BSHXF in the management of patients with LBP from LDH. METHODS: This single center, randomized clinical trial was conducted from March 2023 to September 2023 and all patients suffered from LBP of LDH. Participants were randomly assigned to the BSHXF group (celecoxib and BSHXF) or the control group (celecoxib and placebo). The patients received treatment for 2 weeks. Assessment was conducted before treatment, the last day of the treatment, 4 weeks and 8 weeks after the treatment. Oswestry Disability Index (ODI), Visual Analog Scale (VAS), Roland-Morris Disability Questionnaire (RMDQ), Timed up and go test (TUGT), trunk range of movement (Trunk ROM), Hospital Anxiety and Depression Scale (HADS) were used for the evaluation. RESULTS: A total of 206 subjects completed treatment, among whom 104 participants were randomized to the BSHXF group and 102 participants were randomized to the control group. There were no significant differences between groups in terms of the observed indicators (P > .05). After treatment, patients in BSHXF group obtained significant lower scores at 2-week, 4-week, 8-week of VAS, ODI, RMDQ, TUGT, Trunk ROM and HADS than the baseline data (P < .05). The ODI score was significantly lower than the control group at 2-week, 4-week, 8-week (2w: 11.30 ±â€…5.80 vs 14.23 ±â€…6.33, P < .001; 4w: 10.95 ±â€…4.93 vs 13.54 ±â€…6.35, P < .001; 8w: 10.27 ±â€…5.25 vs 12.84 ±â€…6.57, P = .002). Similarly, the scores of VAS, RMDQ, TUGT, Trunk ROM scores of the BSHXF group markedly decreased at 2, 4, and 8-week when compared to their control group (P < .05). Furthermore, no significant difference showed up in the score of HADS between the between the BSHXF and the control group after treatment (P > .05). CONCLUSION: This randomized clinical trial found that BSXHF can help significantly improve the clinical outcomes of celecoxib including pain intensity reduction and lumbar function improvement in LBP patients.

"Percutaneous Ultrasound Treatment of Lumbar Facet Syndrome: A Systematic Review."

OBJECTIVE: Lumbar facet syndrome is a cause of pain. The diagnosis iconfirmation is achieved through a selective block. Although this procedure is standardized under fluoroscopic or computed tomography (CT) guidance, the current use of ultrasound may provide an alternative to its implementation. METHODS: A systematic literature search was conducted. "ultrasound-guided lumbar" and "lumbar facet joint." RESULTS: Twenty articles were included. Five randomized clinical trials, 4 observational studies, 2 clinical trials, 1 retrospective study, 2 metanalysis and 5 cadaveric studies, and 1 feasibility study. The studies demonstrated a improvement in pain with ultrasound. However, no significant differences in these outcomes were found when comparing ultrasound with fluoroscopy or CT. It was also observed that the procedural time was longer with ultrasound. Finally, success rates in correctly locating the injection site ranged from 88% to 100% when confirmed with fluoroscopy or CT. CONCLUSIONS: Although the use of ultrasound for regional anesthesia is on the rise, there are no results that can replace those found with fluoroscopy or CT for performing the dorsal and medial branch block of the spinal root in the treatment of lumbar facet syndrome.

Getting what you pay for: impact of copayments on physical therapy and opioid initiation, timing, and continuation for newly diagnosed low back pain.

BACKGROUND CONTEXT: Physical therapy (PT) is an important component of low back pain (LBP) management. Despite established guidelines, heterogeneity in medical management remains common. PURPOSE: We sought to understand how copayments impact timing and utilization of PT in newly diagnosed LBP. STUDY DESIGN/SETTING: The IBM Watson Health MarketScan claims database was used in a longitudinal setting. PATIENT SAMPLE: Adult patients with LBP. OUTCOME MEASURES: The primary outcomes-of-interest were timing and overall utilization of PT services. Additional outcomes-of-interest included timing of opioid prescribing. METHODS: Actual and inferred copayments based on nonnonprimary care provider visit claims were used to evaluate the relationship between PT copayment and incidence of PT initiation. Multivariable regression models were used to evaluate factors influencing PT usage. RESULTS: Overall, 2,467,389 patients were included. PT initiation, among those with at ≥1 PT service during the year after LBP diagnosis (30.6%), occurred at a median of 8 days postdiagnosis (IQR 1-55). Among those with at least one PT encounter, incidence of subsequent PT visits was significantly lower for those with high initial PT copayments. High initial PT copayments, while inversely correlated with PT utilization, were directly correlated with subsequent opioid use (0.77 prescriptions/patient [$0 PT copayment] versus 1.07 prescriptions/patient [$50-74 PT copayment]; 1.15 prescriptions/patient [$75+ PT copayment]). Among patients with known opioid and PT copayments, higher PT copayments were correlated with faster opioid use while higher opioid copayments were correlated with faster PT use (Spearman p<.05). For multivariable whole-cohort analyses, incidence of PT initiation among patients with inferred copayments in the 50-75th and 75-100th percentiles was significantly lower than those below the 50th percentile (HR=0.893 [95%CI 0.887-0.899] and HR=0.905 [95%CI 0.899-0.912], respectively). CONCLUSIONS: Higher PT copayments correlated with reduced PT utilization; higher PT copayments and lower opioid copayments were independent contributors to delayed PT initiation and higher opioid use. In patients covered by plans charging high PT copayments, opioid use was significantly higher. Copays may impact long-term adherence to PT.

Treatment characteristics of chronic low back pain patients treated with buprenorphine buccal film or transdermal patch.

Aims: Retrospective insurance claims analysis exploring treatment characteristics in chronic low back pain patients prescribed buprenorphine buccal film (Belbuca®) or transdermal patches. Patients and methods: The first buprenorphine prescription (buccal film or transdermal patch) was an index event. Patients were observed over 6 month pre- and post-index periods. Propensity score matching minimized the selection bias. Results: Buccal film patients had a higher buprenorphine daily dose (501.7 vs 270.9 µg; p < 0.001). The patch-to-film switching rate was higher than vice versa (11.5 vs 3.8%; p < 0.001). The buccal film showed a greater reduction in opioid prescriptions (-1.1 vs -0.7; p = 0.012), daily morphine milligram equivalents (-12.6 vs -7.3; p < 0.001) and opioid treatment duration (-13.4 vs -7.6 days; p = 0.022). Conclusion: Buccal film was associated with higher buprenorphine doses and a greater reduction of opioid burden.

What is this article about? The analysis explored treatment patterns in chronic low back pain patients treated with different buprenorphine drugs. The use of other pain medications was also evaluated. Buprenorphine buccal film (Belbuca^®) was compared with transdermal patches. This study used commercial insurance data of US patients. What were the results? The most relevant findings were: Patients using buccal film had about two-times higher buprenorphine daily doses. About 12% of patch patients switched to film, while approximately 4% of film patients switched to patch. Initiation of both buprenorphine drugs led to reduced usage of opioids and other pain drugs. Despite a shorter buprenorphine treatment, the film was associated with a greater reduction in opioid use than the patch. What do the results of the study mean? The results showed that patients prescribed buprenorphine buccal film would be able to achieve higher daily doses required for appropriate chronic low back pain management. The buccal film will also lead to a great reduction in concomitant opioid use. These advantages may explain why more patients switched from buprenorphine transdermal patch to buccal film than the other way around.

Post-Operative Complications Associated with Long-Term NSAID or Long-Term Opioid Use Prior to Lumbar Spinal Fusion Surgery.

OBJECTIVE: Lower back pain (LBP) has been implicated as a significant cause of chronic pain in the United States, often requiring analgesic use. In this study, we investigate the trends in long-term preoperative NSAID (LTN) and Opioid (LTO) use in patients with low back pain in the United States, and the resultant postoperative complications following lumbar fusion. METHODS: In this retrospective cohort study of patients with lumbar pathologies, multivariate population-based regression models were developed using the 2010-2017 National Readmission Database. Short-term complications (30-, 90-day) and long-term complications (180-, 300-day) were analyzed at readmission. RESULTS: Of patients diagnosed with LBP (N = 1427,190) we found a rise in LTO users and a fall in LTN users following 2015. We identified 654,264 individuals who received a lumbar spine fusion, of which 22,975 were LTN users and 11,213 were LTO users. LTO users had significantly higher total inpatient charges (p-value<0.0001) and LOS (p-value<0.0001), while LTN users had lower rates of acute infection (OR: 0.993, 95% CI: 0.987-0.999, p = 0.017) and acute posthemorrhagic anemia (OR: 0.957, 95% CI: 0.935-0.979, p < 0.001) at primary admission. Readmission analysis showed that LTN use had significantly lower odds of readmission compared to LTO use at all time points (p < 0.01 for all). LTN use had significantly higher odds of hardware failure (OR: 1.134, 95% CI: 1.039-1.237, p = 0.005) within 300-days of receiving a lumbar fusion. CONCLUSIONS: LTO users had significantly higher readmission rates compared to LTN. In addition, we found that LTN use was associated with significantly higher odds of hardware failure at long-term follow-up in patients receiving lumbar fusion surgery.

Preclinical Animal Study and Pilot Clinical Trial of Using Enriched Peripheral Blood-Derived Mononuclear Cells for Intervertebral Disc Degeneration.

Low back pain (LBP) is a leading cause of long-term disability globally. Intervertebral disk degeneration (IVDD) is mainly responsible for discogenic pain in LBP-affected young patients. There is no effective therapy to reverse disease severity and IVDD progression. This study investigates the effect of human peripheral blood-derived mononuclear cells (PBMCs) on pain relief and life quality improvement in IVDD patients. The enriched monocytes of the PBMCs could differentiate into CD14 and CD206 double-positive M2 macrophages in vitro. Preclinical evidence in rats showed that the transplanted PBMCs exhibited anti-inflammatory and moderate tissue-repair effects on controlling IVDD progress in the rat model. The PBMCs significantly steered the aggrecan and type II collagen expressions and attenuated the pro-inflammatory cytokines in the affected disk. Based on the animal results, 36 patients with chronic low back pain (CLBP) were included in clinical trials. The control group was conservative care only, and the experimental group was platelet-rich plasma (PRP) and PBMCs intradiscal injections. We first confirmed the single lumbar disk causing the discogenic pain by provocative discography or magnetic resonance imaging (MRI). Discogenic LBP participants received one intradiscal injection of autologous PBMCs and followed for 6 months. Our clinical trial showed that patients' LBP and disability were significantly ameliorated after the PBMCs transplantation rather than PRP. These preclinical and pilot clinical studies indicate that intradiscal injection of the enriched PBMCs might be a feasible and potential cell therapy to control pain and disability in IVDD patients.