Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain

OBJECTIVE: To evaluate the efficacy of intramuscular injection of thiocolchicoside (4 mg-2 ml) compared to placebo administered twice daily for 5 days in patients suffering from acute low back pain. PATIENTS AND METHODS: Multicenter, randomized, double-blinded, placebo-controlled trial. The study was conducted between July 1998 and March 2000 in five centers. Hospitalized patients with acute low back pain were included. The primary evaluation criterion was spontaneous pain at rest assessed by visual analog scale (VAS). Hand-to-floor distance, muscle spasm intensity, patients' global evaluation and analgesic tablet (paracetamol) consumption were used as secondary evaluation criteria. RESULTS: One hundred and forty nine patients were included. Both groups showed improvement on spontaneous pain assessed by VAS at the end of day 1; however, improvement was statistically significant in thiocolchicoside group on day 3 (P < 0.001). Hand-to-floor distance and muscle spasm determined by palpation decreased significantly on day 5 in thiocolchicoside group (P < 0.0005 for both). According to the patients' global evaluation, 76.8% of patients in thiocolchicoside group evaluated the treatment as very good/good (P < 0.0005). Also a significant difference was observed in favor of the thiocolchicoside group in the total paracetamol consumption (P < 0.001). Treatment was well tolerated in both groups and none of the patients was withdrawn from the study due to an adverse effect. CONCLUSION: Twice daily administration of 4 mg thiocolchicoside for 5 days provides an efficient and safe treatment for patients with acute low back pain accompanied by muscle spasm.     

Caudal epidural injection versus non-steroidal anti-inflammatory drugs in the treatment of low back pain accompanied with radicular pain

ObjectiveLow back pain is a highly common problem and causes much morbidity and socioeconomic loss in the community. Although the use of caudal epidural injections in the management of the low back pain with radicular signs is commonplace, it has not been well investigated.We compare the effectiveness of caudal epidural injection versus non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of low back pain accompanied with radicular pain.MethodsThe study was a controlled prospective unblinded trial. A total of consecutive 64 patients with subacute or chronic low back pain accompanied with radicular pain were included. The patients were randomly allocated to two groups. First group was caudal epidural injection plus therapeutic exercise group, and the second group was NSAIDs plus therapeutic exercise group. Patients were assessed with 10 cm visual analogue scale for pain, straight leg raising test and Oswestry low back pain disability questionnaire at the beginning and at 15th day, 1st and 3rd month.ResultsIt was seen that both groups' improvement were good and statistically significant. On the other hand, caudal epidural injection group's improvement was better and faster than the NSAID group's, and the differences between assessment scores of the groups were statistically significant, except the 3rd month Oswestry scores.ConclusionFinally, caudal epidural injection in the management of the subacute/chronic low back and radicular pain is a preferable choice, if applied by experienced specialists.     

Diagnosis and surgical treatment of back pain originating from endplate

Twenty-one patients with back pain originating from the endplate injuries were selected to explore the methods of diagnosis and surgical treatment. All patients underwent examinations using radiography, CT, and MR imaging. Pain level of disc was determined through discography in each patient. The principal outcome judgments were pain and disability, and the efficacy of surgical treatment was assessed through the use of the visual analog scale (VAS) for pain and the Oswestry disability index (ODI) for functional recovery. All 21 patients with a diagnosis of back pain originating from endplate injuries according to discography were treated with anterior or posterior fusion surgery. The mean follow-up period was 3 years and 5 months (range, 2–6 years). Of the 21 patients, 20 (20/21) reported a disappearance or marked alleviation of low back pain and experienced a definite improvement in physical function. Statistically significant and clinically meaningful improvements in the VAS and ODI scores were obtained after treatment in the patients with chronic low back pain originating from the endplate injuries (P = 0.0001). The study suggests that discography and fusion surgery may be very effective methods for the diagnosis and treatment, respectively, of chronic back pain originating from the endplate injuries.     

Intradiscal methylene blue injection for the treatment of chronic discogenic low back pain

This article was a preliminary report of prospective clinical trial of a group of patients with chronic discogenic low back pain who met the criteria for lumbar interbody fusion surgery but were treated instead with an intradiscal injection of methylene blue (MB) for the pain relief. Twenty-four patients with chronic discogenic low back pain underwent diagnostic discography with intradiscal injection of MB. The principal criteria to judge the effectiveness included alleviation of pain, assessed by visual analog scale (VAS), and improvement in disability, as assessed with the Oswestry Disability Index (ODI) for functional recovery. The mean follow-up period was 18.2 months (range 12–23 months). Of the 24 patients, 21 (87%) reported a disappearance or marked alleviation of low back pain, and experienced a definite improvement in physical function. A statistically significant and clinically meaningful improvement in the changes in the ODI and the VAS scores were obtained in the patients with chronic discogenic low back pain (P=0.0001) after the treatment. The study suggests that the injection of MB into the painful disc may be a very effective alternative for the surgical treatment of chronic discogenic low back pain.     

Total hip arthroplasty outcomes correlate with spine disability

Functional deficits persist in a significant percentage of total hip arthroplasties (THA), leading to patient dissatisfaction. Spinal stenosis is a leading cause of chronic disability and lower extremity weakness. Although previous studies have evaluated the potential benefit of THA on back pain, none have reported the effects of spine disability on functional outcomes and patient satisfaction with THA. A total of 244 primary THAs (233 patients) with minimum 2-year follow-up rated their satisfaction, return to activity, and standard hip outcomes using the Oxford Hip Score (OHS). History of lumbar spine pain, lumbar surgery, and daily activity limitations was documented and an Oswestry Disability Index (ODI) score was calculated. Out of 244, 151 (62%) patients reported a history of back problems: 35 patients (14%)—history of lumbar surgery, 91 (37%)—daily low back pain, and 97 (40%)—back pain that limited activity. Patients with a history of back problems had lower OHS scores than those without back pain, p = 0.0001. Patients with daily low back pain or low back pain that limited activity had lower OHS scores, p < 0.0001. Increasing spine disability, as determined by ODI, correlated with poor OHS, p < 0.0001. Spine disability (ODI) was directly associated with patient dissatisfaction for pain relief (R = 0.41, p < 0.0001), return to activity (R = 0.34, p < 0.0001), and overall surgical results (ODI, R = 0.38, p < 0.0001) at 2 years after THA. ODI correlated strongly with poor THA outcomes. In conclusion, lumbar spine disability correlated directly with poor Oxford Hip Scores. Spine disability was directly associated with THA patient dissatisfaction with pain relief, return to activity, and overall outcome of surgery. This study demonstrates that poor functional results in THA patients correlate directly with spine disability.     

Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone

Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18–70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)–tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober’s test and lateral body bending test) and patient’s and investigator’s global efficacy assessment. aceclofenac–tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac–tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac–tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.     

微创和传统开放后路腰椎椎间融合术治疗腰椎退行性疾病的远期预后

目的探讨微创后路腰椎椎间融合术(MIS-PLIF)和传统开放PLIF对腰椎退行性疾病(LDD)远期疗效及安全性的影响。方法 2011年1月-2014年12月收治LDD患者182例,其中96例采用传统开放PLIF治疗(PLIF组),86例采用MIS-PLIF治疗(MIS-PLIF组)。比较2组腰椎矢状位参数、多裂肌横截面积及萎缩率、融合率、疼痛视觉模拟量表(VAS)评分、日本骨科学会(JOA)评分、Oswestry功能障碍指数(ODI)及术后并发症发生情况,分析多裂肌萎缩率与顽固性腰背痛的相关性。结果 2组术后各随访时间点椎间隙高度恢复值和节段性前凸角恢复值差异均无统计学意义(P > 0.05)。2组术后1年腰椎前凸角恢复值差异无统计学意义(P > 0.05);但术后5年和末次随访时,MIS-PLIF组腰椎前凸角恢复值显著高于PLIF组,差异均有统计学意义(P < 0.05)。MIS-PLIF组术后各随访时间点多裂肌横截面积大于PLIF组,多裂肌萎缩率低于PLIF组,差异均有统计学意义(P < 0.05)。2组术后随访6个月融合率差异无统计学意义(P > 0.05)。2组术后各随访时间点下肢痛VAS评分差异无统计学意义(P > 0.05);MIS-PLIF组术后各随访时间点腰痛VAS评分、JOA评分及ODI均优于PLIF组,差异有统计学意义(P < 0.05)。MIS-PLIF组顽固性腰背痛发生率显著低于PLIF组,差异有统计学意义(P < 0.05)。合并顽固性腰背痛患者多裂肌萎缩率高于未合并顽固性腰背痛的患者,差异有统计学意义(P < 0.05)。结论术后多裂肌萎缩可能是导致顽固性腰背痛的重要原因,相较于传统开放PLIF,MIS-PLIF治疗LDD能够更有效地保持腰椎生理曲度,改善肢体活动功能,降低多裂肌萎缩程度,有助于避免顽固性腰背痛的发生。     

盐酸氨基葡萄糖联合低剂量NSAIDS类药物与单纯用药治疗小关节骨关节炎伴下腰痛的随机对照研究

背景：腰背痛是一个常见的临床问题。盐酸氨基葡萄糖对膝关节骨关节炎的治疗作用已得到证实,在治疗腰背痛中的有效性仍有待进一步研究。目的：探讨盐酸氨基葡萄糖与低剂量非甾体类抗炎药（non-steroid anti-inflammator ydrug,NSAID）联用与常规剂量NSAID、相同剂量盐酸氨基葡萄糖、小剂量NSAID相比治疗腰椎小关节骨关节炎伴下腰痛的临床效果。方法：160例小关节骨关节炎伴下腰痛患者,男93例,女67例,年龄29-65岁,平均（46．4±10．9）岁。随机分为A、B、C、D组。A组口服盐酸氨基葡萄糖750mg,1日2次,加用双氯酚酸钠片25mg,1日1次;B组口服双氯酚酸钠缓释片75mg,1日1次;C组口服盐酸氨基葡萄糖750mg,1日2次;D组口服双氯酚酸钠片25mg,1日1次。治疗前（0周）、8周和16周使用Oswestry残疾指数（Oswestry disability index,ODI）、视觉模拟疼痛评分（vis．ual analog score,VAS）和SF-36量表进行评估。结果：147例获得随访,失访率为8．13％。各组患者的腰痛VAS评分、ODI评分和SF-36评分在治疗前后比较均有显著性改善（P〈0．05）。A、B两组间的各个评价参数在各随访点比较均无显著性差异（P〉0．05）,但A、B两组的疗效明显优于C、D两组。无一例出现药物不良反应。结论：联合盐酸氨基葡萄糖可减少治疗小关节骨关节炎伴下腰痛中NSAID类药物的用量,可成为降低NSAID药物相关风险的替代治疗选择。     

腰椎后路不同显露方式对椎旁肌影响的临床研究

目的比较胸腰椎骨折后路内固定两种不同显露方式对椎旁肌的影响。方法将2010年3月至2011年8月期间入院的75例病例分成两组：A组40例,肌间隙入路显露,B组35例,传统后入路显露。搜集数据：手术时间、术中出血量;血肌酸激酶值;椎体前后缘高度、Cobb角及CT横截面上椎旁肌面积;VAS疼痛、Oswestry功能障碍评分等。结果两组手术时间、术中出血、术后4天及末次随访VAS疼痛评分、术后Oswestry功能障碍指数、术后第1、3天血肌酸激酶值、术后及末次随访椎旁肌面积等方面比较差异有统计学意义（P〈0.05）,A组优于B组。结论椎旁肌间隙入路显露方式与传统后入路显露方式比较,具有手术操作简单、术中出血少、对椎旁肌影响小,从而减少术后腰背痛残留,减轻患者痛苦,利于胸腰椎骨折患者康复,是临床上胸腰椎骨折后入路显露方式的最佳选择。     

慢性腰痛对脊旁多裂肌萎缩影响的临床研究

目的：明确慢性腰痛对脊旁多裂肌净横截面积大小及脂肪化程度的影响。方法：2010年3月至2013年8月对门诊治疗的腰痛患者进行回顾性分析,最终筛选出31例符合非特异性慢性腰痛患者,其中男19例,女12例;年龄23～55岁,平均36.4岁。主要症状是反复腰痛,病程大于1年,X线、CT、MRI均未见明显异常。采用MRI成像测量同一病例先后不同时间点多裂肌净横截面积及T2信号比率的变化,再获取2次MRI检查时VAS和Oswestry功能障碍评分,分析先后2次测量多裂肌净面积及T2信号比率的变化与腰痛的病程、VAS、Oswestry功能障碍评分的相关性,从而得出腰痛对脊旁多裂肌的影响。结果：同一病例第2次MRI检查多裂肌净横截面积明显小于第1次MRI检查,T2信号比率则明显高于第1次MRI检查（P<0.05）.多裂肌净横截面积减小率与VAS评分、病程和Oswestry功能障碍评分均呈正相关（P<0.001）,而T2信号比率增加率与VAS评分、病程和Oswestry功能障碍评分均无相关性（P>0.05）.结论：慢性腰痛是脊旁多裂肌萎缩和脂肪化的重要原因,腰痛时间、程度和功能障碍程度均与多裂肌萎缩呈正相关。     

Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2‐year results from a randomized trial

Vertebral fractures are often painful and lead to reduced quality of life and disability. We compared the efficacy and safety of balloon kyphoplasty to nonsurgical therapy over 24 months in patients with acute painful fractures. Adults with one to three vertebral fractures were randomized within 3 months from onset of pain to undergo kyphoplasty (n = 149) or nonsurgical therapy (n = 151). Quality of life, function, disability, and pain were assessed over 24 months. Kyphoplasty was associated with greater improvements in Short‐Form 36 (SF‐36) Physical Component Summary (PCS) scores when averaged across the 24‐month follow‐up period compared with nonsurgical therapy [overall treatment effect 3.24 points, 95% confidence interval (CI) 1.47–5.01, p = .0004]; the treatment difference remained statistically significant at 6 months (3.39 points, 95% CI 1.13–5.64, p = .003) but not at 12 months (1.70 points, 95% CI ?0.59 to 3.98, p = .15) or 24 months (1.68 points, 95% CI ?0.63 to 3.99, p = .15). Greater improvement in back pain was observed over 24 months for kyphoplasty (overall treatment effect ?1.49 points, 95% CI ?1.88 to ?1.10, p < .0001); the difference between groups remained statistically significant at 24 months (?0.80 points, 95% CI ?1.39 to ?0.20, p = .009). There were two device‐related serious adverse events in the second year that occurred at index vertebrae (a spondylitis and an anterior cement migration). There was no statistically significant difference between groups in the number of patients (47.5% for kyphoplasty, 44.1% for control) with new radiographic vertebral fractures; fewer fractures occurred (～18%) within the second year. Compared with nonsurgical management, kyphoplasty rapidly reduces pain and improves function, disability, and quality of life without increasing the risk of additional vertebral fractures. The differences from nonsurgical management are statistically significant when averaged across 24 months. Most outcomes are not statistically different at 24 months, but the reduction in back pain remains statistically significant at all time points. © 2011 American Society for Bone and Mineral Research.     

水冷式双极射频纤维环成形术治疗盘源性腰痛

目的 探讨水冷式双极射频纤维环成形术治疗盘源性腰痛的临床效果.方法 随机选取23例经椎间盘造影诊断为盘源性腰痛、经过正规保守治疗3个月无效的患者,采用水冷式双极射频纤维环成形术治疗.所有患者术后随访6个月.对患者术后第7天与6个月后的疗效、视觉模拟评分(VAS)、Oswestry功能评分(ODI)和阿片类药物使用量进行比较.结果 术后第7天的优良率为87%(20/23);VAS由术前(7.6±0.7)分降至(3.1±0.9)分(P<0.01);ODI评分由术前(71.4±16.2)%降至(31.2±15.2)%(P<0.01);美施康定和曲马多的使用量分别由术前(35.0±10.3)mg和(300.0±19.6)mg降至(5.0±1.1)mg和(50.0±14.7)mg(P<0.05).6个月后的优良率为78.2%(18/23);VAS和ODI评分分别为(3.3±1.0)分和(35.6±16.9)%,明显低于术前(P<0.01).本组未见严重并发症发生.结论 水冷式双极射频纤维环成形术操作简单、安全,是治疗盘源性腰痛的有效微创手术.     

Epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica: a prospective randomized blinded clinical trial

Background Epidural neuroplasty seems to be one of the promising minimally invasive techniques for adhesiolysis in patients with chronic sciatica with or without low back pain. However, because no data exist from randomized studies the aim was to investigate whether this procedure is superior to conservative treatment with physiotherapy. Methods A total of 99 patients with chronic low back pain were enrolled in this study and randomly assigned into either a group with physiotherapy (n = 52) or a second group undergoing epidural neuroplasty (n = 47). Patients were assessed before and 3, 6, and 12 months after treatment by a blinded investigator. Results After 3 months, the visual analog scale (VAS) score for back and leg pain was significantly reduced in the epidural neuroplasty group, and the need for pain medication was reduced in both groups. Furthermore, the VAS for back and leg pain as well as the Oswestry disability score were significantly reduced until 12 months after the procedure in contrast to the group that received conservative treatment. Conclusions Epidural neuroplasty results in significant alleviation of pain and functional disability in patients with chronic low back pain and sciatica based on disc protrusion/prolapse or failed back surgery on a short-term basis as well as at 12 months of follow-up.     

The efficacy of oral nonsteroidal anti-inflammatory medication (NSAID) in the treatment of plantar fasciitis: a randomized, prospective, placebo-controlled study

BACKGROUND: Plantar fasciitis frequently responds to a broad range of conservative therapies, and there is no single universally accepted way of treating this condition. Modalities commonly used include rest, ice massage, stretching of the Achilles tendon and plantar fascia, nonsteroidal anti-inflammatory medications (NSAIDs), corticosteroid injections, foot padding, taping, shoe modifications (steel shank and anterior rocker bottom), arch supports, heel cups, custom foot orthoses, night splints, ultrasound, and casting. To our knowledge, no prospective, randomized, placebo controlled double-blind study has evaluated the efficacy of oral NSAIDs in the treatment of plantar fasciitis. METHODS: Twenty-nine patients with the diagnosis of plantar fasciitis were treated with a conservative regimen that included heel-cord stretching, viscoelastic heel cups, and night splinting. They were randomly assigned to either a placebo group or an NSAID group. In the NSAID group, celecoxib was added to the treatment regimen. RESULTS: Pain and disability mean scores improved significantly over time in both groups, although there was no statistical significance between the placebo and NSAID groups at 1, 2, or 6 months. There was a trend towards improved pain relief and disability in the NSAID group, especially in the interval between the 2 and 6-month followup. Pain improved from baseline to 6 months by a factor of 5.2 and disability by 3.8 in the NSAID group compared to 3.6 and 3.5, respectively, in the placebo group. Even though at baseline the pain and disability scores were higher in the NSAID group, the final pain and disability scores were subjectively lower in the NSAID group than in the placebo group (1.43 for pain and 1.16 for disability in the NSAID group, compared to 1.86 and 1.49, respectively, in the placebo group). CONCLUSIONS: These results provide some evidence that the use of an NSAID may increase pain relief and decrease disability in patients with plantar fasciitis when used with a conservative treatment regimen.     

Validation of the Japanese version of the Roland-Morris Disability Questionnaire

The study was designed to validate a translated, culturally adapted questionnaire. We examined the reliability, validity, and responsiveness of the Japanese version of the Roland-Morris Questionnaire (RDQ) when assessing disability in Japanese patients with low back pain. The RDQ is a reliable, validated scale used to measure disability caused by low back pain. However, no validated Japanese version of this questionnaire is available. A series of 214 outpatients with low back pain participated in this validation study. The patients were given the RDQ and the SF-36, and assessed their pain and global rating of health. Among them, 57 who were clinically stable were given the RDQ again 2 weeks later. The reliability was examined based on the test-retest method and internal consistency. Sufficient reliability was demonstrated with a Chronbach's · coefficient of 0.85, and the reproducibility for the 30 patients was r = 0.91. The principal component analysis showed unidimensionality. The RDQ score of the 133 patients was significantly improved after treatment. The Japanese version of the RDQ is a useful scale that is easy to use with reliability, validity, and responsiveness when assessing patients with low back pain.     

Kyphosis in older women and its relation to back pain,disability and osteopenia: The study of osteoporotic fractures

To test the hypothesis that thoracic kyphosis is associated with substantial pain, disability, and height loss, we measured thoracic curvature, using an architect's flexicurve, of 610 women aged 65–91 years who were recruited from population-based listings. We assessed study subjects for back pain, back-related disability, height loss since age 25 years, perceived state of health, and bone mineral density (BMD) at the spine, calcaneus, proximal radius, and distal radius. Compared with the rest of the cohort, the 10% of women with the most severe kyphosis had 7% –17% lower BMD (p<0.001) and had lost an additional 2.4 cm height (p<0.001). However, kyphotic women had no greater back pain, disability caused by back problems, or poorer health. This cross-sectional study suggests that kyphosis is associated with decreased BMD and loss of height but does not cause substantial chronic back pain, disability, or poor health in older women.     

A systematic review of paracetamol for non-specific low back pain

The objective of this study was to assess the efficacy of paracetamol (acetaminophen) in the treatment of pain and disability in patients with non-specific low back pain. We conducted a systematic review of randomized controlled trials to assess the efficacy of paracetamol in the treatment of pain and disability in patients with non-specific low back pain. A search for randomized controlled trials was conducted using the Medline, Embase and CINAHL databases. Trials were eligible if they were randomized controlled trials comparing paracetamol to no treatment, placebo or another treatment in patients with non-specific low back pain. Two of the authors independently assessed trials for methodological quality on the PEDro Scale and extracted data. Continuous pain and disability data were converted to a common 0–10 scale; ordinal data were dichotomized (e.g., no pain, pain). The data was analyzed using the MIX version 1.61 meta-analysis software. Out of 205 unique articles found in the searches, 7 eligible trials were identified. The trials enrolled a total of 676 participants with 5 investigating acute low back pain, 1 investigating chronic low back pain and 1 investigating both. No trial provided data comparing paracetamol to placebo and only one trial compared paracetamol to no treatment. In general the trials were small (only 1 trial had >25 subjects per group) and of low methodological quality (only 2 had a score above 6 on the quality scale). All but one of the trials provided imprecise estimates of the effects of treatment with confidence intervals spanning clinically important beneficial and also harmful effects of paracetamol. No trial reported a statistically significant difference in favor of paracetamol. There is insufficient evidence to assess the efficacy of paracetamol in patients with low back pain. There is a clear need for large, high quality randomized controlled trials evaluating paracetamol, to provide reliable evidence of paracetamol’s effectiveness in patients with low back pain and to establish the validity of the recommendations in clinical guidelines.