Department of Research Development and Education, Sint Maartenskliniek, PO Box 9011, 6500 GM, Nijmegen, The Netherlands.
Eur Spine J. 2009 Dec;18(12):1843-50. doi: 10.1007/s00586-009-1044-3. Epub 2009 May 31.
Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person's body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (+/-25) to 32 (+/-27) with the IDD protocol and 53 (+/-26) to 36 (+/-27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.
下背痛(LBP)给社会带来了重大问题。尽管初始的保守治疗可能是有益的,但持续的慢性 LBP 仍经常导致昂贵的侵入性干预。一种新的非侵入性治疗方法,专注于椎间盘源性 LBP 的治疗,是椎间差异动力学治疗(IDD 治疗,北美医疗公司。美国监管)。IDD 治疗包括在 Accu-SPINA 设备(Steadfast Corporation Ltd,Essex,UK)中进行间歇性牵引治疗,该设备是一种获得 FDA 批准的 II 类医疗设备。椎间盘和小关节通过轴向牵伸、定位和放松循环卸载。本研究的目的是研究 IDD 治疗在慢性 LBP 患者的标准分级活动方案中添加时的效果。在一项单盲、单中心、随机对照试验中;60 名连续患者被分配到 SHAM 或 IDD 治疗组。所有受试者均接受标准的保守治疗(分级活动)和 20 次 Accu-SPINA 治疗。在 IDD 治疗中,牵引重量逐渐增加,直到达到体重的 50%加 4.45 公斤(10 磅)。在所有治疗中,SHAM 组接受非治疗性牵引重量为 4.45 公斤。主要结局采用 100 毫米视觉模拟量表(VAS)评估腰痛。次要结局为腿痛 VAS 评分、Oswestry 残疾指数(ODI)、简短形式 36(SF-36)。所有参数在治疗开始前和 2、6 和 14 周后进行测量。在治疗开始前和 14 周时记录因运动或活动而产生的(再)受伤恐惧(运动恐惧量表)、应对策略(乌得勒支应对清单)和止痛药的使用情况。进行了重复测量分析。两组在人口统计学、临床和心理特征方面在基线时具有可比性,表明随机分组成功。ID 协议下的 VAS 腰痛从 61(+/-25)显著改善至 32(+/-27),SHAM 协议下的 VAS 腰痛从 53(+/-26)改善至 36(+/-27)。此外,腿痛、ODI 和 SF-36 评分均显著改善,但在两组中均有改善。止痛药的使用显著减少,而运动恐惧和应对评分仍保持在非病理性水平。两个协议的参数均无差异。两种治疗方案在 14 周后均对 LBP、腿痛、功能状态和生活质量有显著的有益影响。在标准分级活动方案中加入 IDD 治疗的轴向、间歇性、机械牵引,并未显示出有效性。
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