The pharmacological management of chronic lower back pain

ABSTRACT

Introduction

Treating chronic low back pain (LBP) can be challenging, and the most effective pharmacological therapy is controversial. The present systematic review investigated the efficacy of various pharmacological compounds to achieve pain relief and improve disability in chronic LBP patients. The present study focused on acetaminophen, amoxicillin, flupirtine, baclofen, tryciclic antidepressants (TCAs), duloxetine, topiramate, gabapentinoids, non-steroid anti-inflammatory drugs (NSAIDs) and opioids.     

针刀治疗慢性下腰痛患者的临床疗效

目的：探讨针刀治疗慢性下腰痛的应用及疗效。方法：将147例慢性下腰痛患者分为两组。治疗组72例,依据关键性治疗点,采用针刀治疗,1次/7 d,3次为1个疗程,共2个疗程。对照组75例采用电针联合特定电磁波谱治疗,1次/2 d,10次为1个疗程,共2个疗程。对两组疗效进行比较。结果：治疗组治疗前与治疗近期和远期（4个月）的VAS差值分别为（4.14＆#177;0.98）分和（3.56＆#177;1.06）分,对照组则分别为（3.12＆#177;1.34）分和（2.47＆#177;1.28）分,组间差异有统计学意义（P〈0.01）。结论：针刀治疗慢性下腰痛有较好的临床疗效,明显优于电针联合特定电磁波谱治疗。     

Escitalopram 20 mg versus duloxetine 60 mg for the treatment of chronic low back pain

Background: Escitalopram has never been demonstrated to be useful in the treatment of chronic low back pain (CLBP), while duloxetine has demonstrated analgesic effect in chronic pain states. The aim of this trial was to examine the efficacy of escitalopram for the treatment of CLBP compared with duloxetine. Methods: A total of 85 adult patients with non-radicular CLBP entered a 13-week randomized study comparing escitalopram 20 mg with duloxetine 60 mg once daily. The primary measure was comparison of the two drugs on reduction in weekly mean 24-h average pain. Secondary measures included Clinical Global Impressions of Severity (CGI-S) and the 36-item Short-Form Health Survey (SF-36). Results: Eighty patients (n = 39 escitalopram, n = 41 duloxetine) completed the study. No significant differences existed between escitalopram and duloxetine on reduction in weekly mean 24-h average pain at end point. Both escitalopram and duloxetine demonstrated significant improvement on CGI-S and SF-36. Conclusions: Escitalopram and duloxetine demonstrated efficacy and safety in the management of CLBP, with no significant differences. Results of this study should be replicated in a larger sample of patients.     

Epiduroscopy in treatment of degenerative chronic low back pain: A prospective analysis and follow-up at 60 months

The aim of this prospective study was to evaluate the efficacy of endoscopic epidurolysis in the treatment of degenerative chronic low back pain. Three-hundred and fifty patients with Visual analog scale (VAS) and Oswestry Low Back Pain Disability Index (ODI) from 0–60% (0–20%, group A; 20–40%, group B; 40–60%, group C) were enrolled and treated prospectively with endoscopic epidurolysis by means of a Myelotec endoscope and by the intermittent instillation of saline solution added with hyaluronidase. Targeted application of ozone and ciprofloxacin close to the abnormal areas was also performed. Short- and long-term efficacy was prospectively evaluated. A VAS score?<?5 and ODI?<?40% were considered as a positive outcome. The treatment significantly reduces the VAS in all three groups of patients, starting from the first week and throughout the entire follow-up period (p?<?0.001), also the Disability Index (ODI) showed a statistically significant decrease of the score (p?<?0.001), that was particularly evident at 3 months and maintained up to long-term follow-up intervals. In conclusion, epiduroscopy by mechanical adhesiolysis and administration on targeted areas of ciprofloxacina and ozone seems to be, in this prospective study, an effective technique to provide sensible and persisting pain relief and act of improving ODI in chronic low back pain.     

Efficacy and safety of tapentadol extended release for the management of chronic low back pain: results of a prospective,randomized, double-blind,placebo- and active-controlled Phase III study

Objective: To evaluate the efficacy and safety of tapentadol extended release (ER) for the management of moderate to severe chronic low back pain.

Research design: Patients (N = 981) were randomized 1:1:1 to receive tapentadol ER 100 – 250 mg b.i.d., oxycodone HCl controlled release (CR) 20 – 50 mg b.i.d., or placebo over 15 weeks (3-week titration period, 12-week maintenance period).

Main outcome measures: Efficacy was assessed as change from baseline in average pain intensity (11-point NRS) at week 12 of the maintenance period and throughout the maintenance period; last observation carried forward was used to impute missing pain scores. Adverse events (AEs) were monitored throughout the study.

Results: Tapentadol ER significantly reduced average pain intensity versus placebo at week 12 (least squares mean difference vs placebo [95% confidence interval], ?0.8 [?1.22, ?0.47]; p < 0.001) and throughout the maintenance period (?0.7 [?1.06,?0.35]; p < 0.001). Oxycodone CR significantly reduced average pain intensity versus placebo at week 12 (?0.9 [?1.24,?0.49]; p < 0.001) and throughout the maintenance period (?0.8 [?1.16,?0.46]; p < 0.001). Tapentadol ER was associated with a lower incidence of treatment-emergent AEs (TEAEs) than oxycodone CR. Gastrointestinal TEAEs, including constipation, nausea, and vomiting, were among the most commonly reported TEAEs (placebo, 26.3%; tapentadol ER, 43.7%; oxycodone CR, 61.9%). The odds of experiencing constipation or the composite of nausea and/or vomiting were significantly lower with tapentadol ER than with oxycodone CR (both p < 0.001).

Conclusions: Tapentadol ER (100 – 250 mg b.i.d.) effectively relieved moderate to severe chronic low back pain over 15 weeks and had better gastrointestinal tolerability than oxycodone HCl CR (20 – 50 mg b.i.d.).     

针灸联合腰腿痛丸治疗慢性腰腿疼痛综合征的可行性及安全性

目的：探讨针灸联合腰腿痛丸治疗慢性腰腿疼痛综合征的可行性及安全性。方法选取本院2012年10月~2013年11月收入院的慢性腰腿疼痛综合征患者605例,随机分为观察组305例和对照组300例,观察组采用针灸联合腰腿痛丸治疗,对照组采用腰腿痛丸治疗,比较两组的临床疗效、关节疼痛评分及疼痛综合评分。结果观察组总有效率明显高于对照组,差异有统计学意义（P〈0.05）。观察组治疗后的关节疼痛评分明显低于对照组,疼痛综合评分明显高于对照组,差异有统计学意义（P〈0.05）。两组治疗后的关节疼痛评分低于治疗前,差异有统计学意义（P〈0.05）。结论采用针灸联合腰腿痛丸治疗慢性腰腿疼痛综合征,可明显缓解患者疼痛,疗效显著,安全可靠,值得推广应用。     

Pharmacotherapy for chronic non-specific low back pain: current and future options

Introduction: Low back pain is associated with a large burden-of-illness. It is responsible for the most years lived with disability as compared with any other medical condition. A comprehensive overview of the evidence on pharmacological treatment options for chronic low back pain is lacking. This review evaluates the evidence for the benefits and risks of currently available pharmacological treatments for chronic low back pain.

Areas covered: The authors focus on the recent (Cochrane) systematic reviews and meta-analyses of randomized clinical trials covering paracetamol (acetaminophen), NSAIDs, muscle relaxants, antidepressants, anticonvulsants, opioids, and other (new) drugs.

Expert opinion: The overall impression of the efficacy of pharmacological treatments for patients with chronic low back pain is rather sobering. The effects on pain reduction and improvement of function are commonly small to moderate and short lasting when compared to placebo. At the same time, the various types of drugs are not without side-effects. This holds especially true for serious side-effects associated with (prolonged) use of strong opioids. Future studies on patients with chronic back pain should aim to identify subgroups of patients with good response to specific pharmacological treatment to facilitate personalized care.     

A multicenter,randomized, double-blind,placebo-controlled trial to assess the efficacy and safety of single-entity,once-daily hydrocodone tablets in patients with uncontrolled moderate to severe chronic low back pain

Objectives: This multicenter, randomized, double-blind, placebo-controlled study with an enriched enrollment, randomized withdrawal design was conducted to evaluate the analgesic efficacy and safety of single-entity, once-daily hydrocodone 20 to 120 mg tablets (HYD) in opioid-naive and opioid-experienced patients with uncontrolled moderate to severe chronic low back pain (CLBP).

Research design and methods: The primary endpoint was week 12 pain intensity scores (11-point scale, 0 = no pain) using a mixed effect model with repeated measures incorporating a pattern mixture model framework. Responder analysis was a secondary endpoint. Safety was assessed.

Results: Out of 905 patients who were treated with HYD during the open-label titration period, 588 (65%) were randomized to continue to receive HYD (n = 296, 20 – 120 mg taken once daily, average daily dose 57 mg) or a matching placebo (n = 292). HYD demonstrated superior pain reduction (p = 0.0016); this result was supported by sensitivity analyses using different approaches to handling missing data. Proportions of patients achieving ≥ 30 and ≥ 50% improvement in pain from screening to week 12 also favored HYD (p = 0.0033 and 0.0225, respectively). HYD was generally well tolerated.

Conclusions: HYD was shown to be an efficacious treatment for CLBP in this study. There were no new or unexpected safety concerns detected.     

Fentanyl buccal tablet (FBT) for relief of breakthrough pain in opioid-treated patients with chronic low back pain: a randomized,placebo-controlled study

ABSTRACT

Background: Short-acting opioids are commonly used to treat breakthrough pain (BTP) and rapid-onset formulations are being developed to improve the effectiveness of this approach. Fentanyl buccal tablet (FBT) is a new formulation of fentanyl that enhances transbuccal drug delivery via an effervescent reaction and may provide relatively rapid-onset analgesia. FBT was evaluated for BTP in opioid-treated patients with chronic low back pain – the first such study in a population with chronic non-cancer pain.

Design: Randomized, double-blind, placebo-controlled.

Patients and setting: Patients with chronic low back pain receiving long-term opioid therapy at 16 pain treatment centers in the United States.

Procedures: Following open-label titration to identify an effective FBT dose, patients were randomly assigned to one of three double-blind dose sequences (six doses of FBT, three placebo) to treat nine BTP episodes. Pain intensity (PI), measured on an 11-point scale (0 = no pain; 10 = worst pain), and other outcomes were assessed for 2?h after dosing.

Data analysis: The primary efficacy measure was the sum of pain intensity differences (PIDs) for the first 60?min (SPID₆₀); secondary efficacy measures included PIDs at other time points, pain relief (PR), meaningful PR, time to meaningful PR, use of supplementary BTP medication, and self/investigator-reported adverse events.

Results: Of the 124 patients screened, 105 patients were enrolled, 84 identified an effective FBT dose, and 77 entered the double-blind phase. SPID₆₀ significantly favored FBT (?p < 0.0001). All secondary measures also favored FBT, with PIDs and PR showing significant differences versus placebo as early as 10 and 15?min, respectively. An improvement in PI score of ≥ 33% occurred in a significantly larger proportion of FBT-treated episodes versus placebo from 15?min (20% vs. 11%, p < 0.01) through 2?h (65% vs. 28%, p < 0.0001). Patients were approximately four times more likely to require supplemental opioids for BTP episodes following administration of placebo compared with episodes treated with FBT. AEs were typical for opioids, and were mostly reported during dose titration. Limitations of this study may be related to its open-label dose-titration phase (which has the potential to compromise blinding) and the recruitment of patients from pain clinics, which could potentially yield a study population that is not representative of the general population with BTP.

Conclusions: FBT was efficacious and well tolerated in the treatment of BTP in opioid-treated patients with chronic low back pain.     

筋膜释放技术治疗慢性非特异性腰痛的研究进展

慢性非特异性腰痛(CNLBP)是一种发病率较高的肌肉骨骼疾病,无明确的解剖学病因,主要表现为持续3个月以上的反复发作的腰部疼痛。由于治疗费用昂贵、疗效不显著且致残率高,慢性非特异性腰痛给病人和社会带来了很大的负担。筋膜释放技术是一种比较新的康复治疗手段,因其无创有效的特点,正逐步被应用于肌肉骨骼疼痛的辅助治疗。现对筋膜释放技术治疗慢性非特异性腰痛的研究进展进行综述,主要从作用机制、临床应用等方面展开论述,旨在为筋膜释放技术在慢性非特异性腰痛治疗方面提供依据。     

Anti-nerve growth factor antibodies for the treatment of low back pain

ABSTRACT

Introduction

The treatment of chronic low back pain (cLBP) often involves multimodal pharmacologic and non-pharmacologic strategies. There remain shortcomings with these tools with regards to both effect size and side effects.     

整复手法结合抗阻离心收缩治疗脊神经后支源性腰痛的临床研究

目的研究整复手法结合抗阻离心收缩对脊神经后支源性腰痛患者的治疗效果。方法对29例脊神经后支源性腰痛患者运用整复手法调整脊椎关节的同时进行腰背肌抗阻离心收缩训练,治疗前、治疗4周末以及治疗结束3个月后分别用目测类比评分(VAS)和Oswestry功能障碍指数(ODI)评价其疼痛程度和功能障碍程度。结果与治疗前相比,治疗4周末及治疗结束3个月后随访时,患者疼痛程度明显减轻(P0.05);患者功能障碍得到明显改善(P0.05)。结论整复手法结合腰背肌抗阻离心收缩训练是一种不损害脊神经后支的治疗脊神经后支源性腰痛的安全有效的疗法。     

降钙素联合钙尔奇D治疗骨质疏松性腰背痛的短期疗效评估

目的:评价降钙素联合钙剂治疗骨质疏松性腰背痛的短期疗效及安全性.方法:采用降钙素(50 IU,im,qd)联合钙尔奇D(1片,含碳酸钙1.5 g,维生素D 125IU po,qd)治疗120例骨质疏松性腰背痛患者,采用VAS评分法评价治疗前后的疼痛缓解情况.结果:降钙素联合钙剂治疗2周后的患者自发性腰背痛、前屈后伸、翻身痛以及负重痛的疼痛指数分别减轻了(4.3±1.53),(4.2±1.92),(4.6±1.81),(5.2±1.92)分,均较治疗前有显著改善(P＜0.05),不良反应发生率为5.83%,但无严重不良事件发生.结论:降钙素联合钙剂治疗骨质疏松性腰背痛的短期疗效良好.     

经皮射频热凝治疗椎间盘源性下腰痛106例

目的：观察应用经皮射频热凝治疗椎间盘源性下腰痛的临床疗效。方法：应用北京北琪医疗科技有限公司R-2000B射频控温热凝器治疗仪对2009年10月～2011年11月收治的106例椎间盘源性下腰痛患者行经皮射频热凝治疗。结果：疗效评价采用Macneb腰腿痛手术评价标准进行,通过3～12个月的随访,很好70例;好21例;轻度好转10例;差5例。总有效率为95.28%,无效为4.72%。结论：经皮射频热凝是治疗椎间盘源性下腰痛的有效方法。     

Buprenorphine transdermal system and quality of life in opioid-experienced patients with chronic low back pain

Objectives: To evaluate the impact of 12 weeks of treatment with Butrans® (buprenorphine) transdermal system (BTDS) on the health-related quality of life (HRQoL) for patients with chronic low back pain (CLBP), and the maintenance of effects over 52 weeks.

Research design and methods: A multicenter, enriched, double-blind (DB), randomized trial comparing BTDS 20 μg/h (BTDS 20) against 5 μg/h (BTDS 5) for treatment of opioid-experienced patients with moderate-to-severe CLBP, including a 52-week open-label (OL) extension phase.

Main outcome measures: QoL was measured with the SF-36v2 survey before and after an OL run-in period with BTDS 20, three times during the DB phase, and seven times over the extension phase. This post hoc analysis tested for SF-36v2 score differences between treatment groups during the DB phase and maintenance of effects over the extension phase.

Results: At 12 weeks, BTDS 20 produced larger improvements than BTDS 5 in role limitations due to physical health, bodily pain and overall physical QoL (p < 0.01). Treatment group differences in overall physical QoL were sustained throughout the DB phase. Quality-of-life improvements associated with BTDS 20 persisted through the extension phase.

Conclusions: These data suggest that opioid-experienced moderate-to-severe CLBP patients receiving BTDS 20 exhibited better QoL than patients receiving BTDS 5.     

Treatment for chronic low back pain: the focus should change to multimodal management that reflects the underlying pain mechanisms

Chronic low back pain: Chronic pain is the most common cause for people to utilize healthcare resources and has a considerable impact upon patients’ lives. The most prevalent chronic pain condition is chronic low back pain (CLBP). CLBP may be nociceptive or neuropathic, or may incorporate both components. The presence of a neuropathic component is associated with more intense pain of longer duration, and a higher prevalence of co-morbidities. However, many physicians’ knowledge of chronic pain mechanisms is currently limited and there are no universally accepted treatment guidelines, so the condition is not particularly well managed.

Diagnosis: Diagnosis should begin with a focused medical history and physical examination, to exclude serious spinal pathology that may require evaluation by an appropriate specialist. Most patients have non-specific CLBP, which cannot be attributed to a particular cause. It is important to try and establish whether a neuropathic component is present, by combining the findings of physical and neurological examinations with the patient's history. This may prove difficult, however, even when using screening instruments.

Multimodal management: The multifactorial nature of CLBP indicates that the most logical treatment approach is multimodal: i.e. integrated multidisciplinary therapy with co-ordinated somatic and psychotherapeutic elements. As both nociceptive and neuropathic components may be present, combining analgesic agents with different mechanisms of action is a rational treatment modality. Individually tailored combination therapy can improve analgesia whilst reducing the doses of constituent agents, thereby lessening the incidence of side effects.

Conclusions: This paper outlines the development of CLBP and the underlying mechanisms involved, as well as providing information on diagnosis and the use of a wide range of pharmaceutical agents in managing the condition (including NSAIDs, COX-2 inhibitors, tricyclic antidepressants, opioids and anticonvulsants), supplemented by appropriate non-pharmacological measures such as exercise programs, manual therapies, behavioral therapies, interventional pain management and traction. Surgery may be appropriate in carefully selected patients.     

Extended-release tramadol/paracetamol in moderate-to-severe pain: a randomized,placebo-controlled study in patients with acute low back pain

Abstract

Objective:

Combinations of oral analgesics may offer several potential benefits compared with an individual agent. The objective of this study was to investigate the efficacy and safety of an extended-release, twice-daily fixed combination of 75?mg tramadol/650?mg paracetamol (DDS-06C) in the treatment of moderate-to-severe pain, using acute low back pain as a model.