Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

DRX9000TM

As published in: US Musculoskeletal Review,2007;50-52

Charlotte Richmond, PhD, Frank Florio, DC, Jonathan M Wilhelm, DC, CCEP and Martin Auster, MD

Magnetic Resonance Imaging Findings after Treatment witha Non-surgical Spinal Decompression System (DRX9000TM)-Case Report

DRX9000™ MRI

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

01-02

使用非手术脊柱减压系统（DRX9000™)

治疗后MRI 发现—病例报告

Charlotte Richmond, PhD, Frank Florio, DC, Jonathan M

Wilhelm, DC, CCEP and Martin Auster, MD

在过去十年中，用于治疗腰背痛的脊柱减压系统：如

DRX9000 被广泛的应用于临床实践。这个系统在治疗椎间

盘引起的腰背痛时运用了一种非介入的治疗方法。研究人

员也在探寻伴随简单的肌肉牵拉而引发的一系列问题，比

如疲劳（包括病人和治疗学家），病人无力忍受这种力量

或者位置，肌肉痉挛触发以及疼痛的加剧。

美国食品与药物管理局宣布 DRX9000——真正的非

手术脊柱减压系统（见图 1），通过应用一种具有感受性

的计算机化的反馈机制来施用于脊柱的撑开牵拉力，这个

系统能够缓解因椎间盘突出、膨出引发的症状，椎间盘突出，

退行性变引起的下腰痛和小关节紊乱综合症和坐骨神经痛。

DRX9000 使用一种可分离的桌面设计来减少患者和

设备之间的摩擦，病人仰卧， 胸和肩托系统控制上身，并

且膝部放松以减少骨盆旋转。这种器械内置气囊 , 与椎间

盘对应的角度肌肉牵拉调节器和固定带，在治疗的后期它

能够慢慢地增加减压的力量。DRX9000 使用一种传动器滑

轮来传递这种机械化的，节段的撑开牵引 , 预先选择好持

续时间，无论是在静止的状态或者振动的状态，这种牵拉

均能被传递。病变位置的定位决定了最佳的肌肉牵拉设置。

DRX9000 的主旨是在治疗过程中通过扩大椎间隙来

减轻痛苦，减少突出， 减轻椎间盘内的压力。一份关于 94

位病人的回顾性图解为 DRX9000 脊柱减压系统应用于治

疗慢性腰背病后病情有所改善提供了初步的资料 [1]。一项

通过 18 位病人所做的前瞻性试验显示，在使用 DRX9000

治疗后，病情得到极大的改善，镇痛药的使用减少，功能

得到改善 [2]。从这种发现可以看出，相应的影像学资料对

于解释 DRX9000 的治疗使痛苦和身体功能得到改善是有

帮助的。

As published in:

US Musculoskeletal Review,2007;50-52

DRX9000™

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

病例描述

一位 33 岁的男性到门诊病室就诊，他忍受腰背痛已

达 6 年之久，这 6 年的时间里病情逐渐恶化，并且妨碍了

工作和日常生活（包括走路），病人身高 73 英寸，体重

212 磅，曾经接受过按摩疗法和物理治疗，收效甚微。从

早期可得记录可以看出，在 2001 年 6 月，主诉中提到：慢

步长跑后疼痛向左臀部放射，进行了医疗会诊，做了 MRI

检查，病人指出在那时大约一年的时间里持续疼痛且四肢

僵硬，在弯腰、穿袜、跑步、咳嗽和喷嚏时病情加重。

2001 年 7 月做了 MRI，显示出在腰 2/3，腰 3/4 和腰 4/5 处

水合作用降低，在腰 4/5 和腰 5/ 骶 1 椎间盘高度降低，在

腰 3/4 和腰 4/5. 处椎间盘突出，在多个水平面出现关节面

改变。

2006 年 10 月 4 日，在运用 DRX9000 治疗之前做了

腰椎的 MRI（见图 2），显示出在大多数水平面上椎间盘

信号丧失，并且在腰 3/4，腰 4/5，腰 5/ 骶 1 处可观测到

椎间盘膨出。在初次治疗之前，病人反映在 0-10 的范围

内疼痛的水平为 6，这种疼痛复发率为 75%。病人接受了

DRX9000 的治疗，期限为 6 周以上，共计 20 次。在第一

个两周内，每周五次，再一个两周内，每周三次，然后在

最后两周内逐渐减为每周二次，每次治疗的时间在 28-35

分钟之间。初始参数以最大减压力 90 磅开始，45 磅的最

小减压力；最后治疗参数为最大减压力 115 磅，57 磅的

最小压力。在病人反馈的基础上，减压力增加，增加值

在 5-10 磅之间。治疗中实施压力的角度范围为 15-20 度。

辅助治疗包括冰敷、电刺激和利用光的康复活动。在最后

接受治疗时，这位病人认为疼痛水平为 0。2006 年 10 月

10 日通过 MRI（见图 3）进行随访，显示出在腰 2/3，腰

3/4，腰 4/5 和腰 5/ 骶 1 处 T2 加权像的矢状位上的椎间盘

信号增加，反映出椎间盘形态学上的改变。

图 2：使用 DRX9000 前的 MRI

图 3：使用 DRX9000 后的 MRI

As published in:US Musculoskeletal Review,2007;50-52

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

DRX9000™

03-04

讨 论

腰背痛在成年人中很常见。在一生中约 66% 的成年

人患过腰背痛 [3]，在第一次疼痛发作以后，25-60% 的患者

将会复发，一些人甚至会在短短一年内复发 [4]。腰背疼痛

是患者寻求就诊的最为通常的理由之一 [5,6]，在美国男性

中是导致劳动力丧失的最为通常的原因，经常导致提前退

休 [7,8]。机械性的腰背痛说明了在所有类型的腰背痛中，有

97% 的是由以下原因引起：腰骶骨肌肉和韧带的损伤，小

关节紊乱、骶髂关节病或由退行性变导致的椎间盘性疾病[9]。椎间盘疼痛，大部分是由于内在的椎间盘退行性变，

这会影响到下背和臀部 [9]。

尽管大多数腰背痛能够自然地消退，但是通过自我照

顾或者在医疗保健人的监督下的治疗则是必须的。腰背痛

的治疗应当在依靠诊断和医疗保健者提供照顾的基础上适

应个别需要 [10]，并且是能够变化的 [11]。治疗选项能被分成

药理学治疗，非手术治疗或者手术治疗。开始，病人应当

被确定为排除使用紧急外科手术，然而，对于外科手术的

益处却存在互相冲突的论据 [12,13]。药理学治疗包括扑热息

痛、非甾体抗炎药，如果疼痛持续，类似肌肉松弛剂 [14] 和

类罂粟碱 [15] 的处方药疗法则成为必要的。非外科治疗，非

药理治疗包括许多供选方案，比如背部锻炼 [16]，针灸 [18]，

推拿 [19] 或者牵引 [20]，然而，当保守治疗失败时，外科手

术或许能够减轻椎管内的压力（减压）。

最近一项关于评估脊柱减压系统有效性的临床试验的

回顾认为：目前有效数据非常有限，而不能决定脊柱减压（相

对其它非手术治疗而言）能否使腰背痛患者受益 [10]。以前

的研究包括苍白无力和矛盾的方法论，这是因为设计本身

包括不同的样本大小，临床病人的选择标准，调节勘漏水平，

诊断记录的长度和治疗后的随访。研究者使用不适当的终

点措施和可怜的结果标记，不适当地报告出了阳性结果，

并且忽视了应当包括安慰剂控制器。由于那份观察的原因，

两份研究评估 DRX9000 已经出现 [1,2]。第一个研究是回顾

性的，分析了从 2005 年 9 月到 2006 年 3 月接受 DRX9000

治疗的 94 位病人的治疗。治疗前的平均疼痛分数为 6.05（范

围为 0-10 分），在最后一次治疗后减少至 0.89，没有不良

反应的发生。研究表明，慢性腰背痛在治疗后有所缓解，

同时病人减少镇痛药的使用，收到了更好的功能效果。作

者承认，由于他们的研究设计是回顾性的，并且不包括可

控群体，所以这些发现具有不确定性。第二项研究具有前

瞩性，多中心性，非随机性。II 期实验试点研究进行了对

DRX9000 对慢性腰背痛的积极疗法的有效性和安全性的评

估。从 2007 年 1 月 5 日至 2007 年 4 月 27 日跟随受试者，

20 位患者慢性腰背痛的病人——建立在对于肌骨骼的或机

械性的腰背痛，椎间盘突出，膨出或突出型，退行性变或

者由 6 个月前失败的背部外科手术引发的疼痛的诊断基础

上，经过 DRX9000 的 6 个月 20 次治疗后（每一次持续 28

分钟），在第一个两周内每次五次，在最后的两周内逐渐

递减为每周两次，在 DRX9000 一系列治疗后的辅助治疗

包括冰敷，腰部牵张训练和必须的镇痛药，疼痛的评估，

止痛剂的使用，功能性，满意度，日常生活活动和安全可

以通过收集到的检查情况，调查表和病人的日记反映出

来。18 位可评价的研究参加人员（33.3% 的女性，83.3%

白人，平均年龄 46.6 岁，77.8% 雇工）得出在第一次使用

DRX9000 治疗前的平均分值为 6.4 分（在 0-10 范围内），

在最后一次治疗后减少到 0.8，其中有 16 位（占 88.9%）

反映了背部疼痛的改善和由日常生活活动测量的更好的功

能。在 0-10 满意度的范围内，病人给 DRX9000 打的平均

分为 8.1 分，没有一例需要任何一个有创的治疗（如硬膜

外注射，外科手术）。总体上来讲，患者在接受 DRX9000

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

治疗二个月后，疼痛减少了 50%，病人需要更少的止痛剂，

得到更好的功效，在多次常规治疗中没有出现一例安全问

题。我们的病例报告证明 DRX9000 在治疗椎间盘问题上

有积极的效果。对于椎间盘源性引起的腰背痛，治疗的目

标是扩大椎间隙，减少椎间盘突出和内核压力 [22,23]，这也

是 DRX9000 治疗的目标。MRI 对于测定椎间盘的容积和

水合作用变化是非常有用的 [24]。因此，磁共振影像的使用

用来解释 DRX9000 治疗后疼痛缓解和功能改善是非常有

益的。

我们的病例报告表明 DRX9000 在治疗椎间盘问题上

具有积极作用。当然，还需要进一步的前瞻性临床研究来

确认关于慢性腰背痛患者症状改善的临床有效性和影像学

改变。

AcknowledgmentThis case report has been underwritten with a grant from Axiom

Worldwide, LLC, Tampa, FL.

1. Macario A, Richmond C, Auster M, et al., Treatment of 94

outpatients with chronic discogenic low back pain with the

DRX9000: a retrospective chart review, Pain Pract, in press.

2. Leslie J, Richmond C, Macario A, et al., Pilot: Effectiveness

and safety of non-surgical spinal decompression, Paper

presented at: 18th Annual Meeting of the American Academy of

Pain Management September 27–30, 2007; Las Vegas, NV.

3. Quittan M, Management of back pain, Disabil Rehabil,

2002;24(8):423–34.

4. Boswell MV, Trescot AM, Datta S, et al., Interventional

techniques: evidence-based practice guidelines in the

management of chronic spinal pain, Pain Physic ian,

2007;10(1):117–111.

5. Deyo RA, Cherkin D, Conrad D, Volinn E, Cost, controversy,

crisis: low back pain and the health of the public, Annu Rev

Public Health, 1991;12:141–56.

6. Frymoyer JW, Cats-Baril WL, An overview of the incidences

and costs of low back pain, Orthop Clin North Am, 1991;22(2):

263–71.913–16.

12. Weinstein JN, Lurie JD, Tosteson TD, et al.,Surgical vs

nonoperative treatment for lumbar disk herniation: the Spine

Patient Outcomes Research Trial (SPORT) observational cohort,

JAMA, 2006;296(20):2451–9.

13. Weinstein JN, Tosteson TD, Lurie JD, et al., Surgical vs

nonoperative treatment for lumbar disk herniation: the Spine

Patient Outcomes Research Trial (SPORT): a randomized trial,

JAMA, 2006;296(20):2441–50.

14. Shen FH, Samartzis D, Andersson GB, Nonsurgical

management of acute and chronic low back pain, J Am

Acadchronic low back pain: design of a randomised controllede

trial with an economic evaluation, BMC Musculosket Disord,

2004;23;5(1):45.

15. Hale ME, Dvergsten C, Gimbel J, Efficacy and safety of

oxymorphone extended release in chronic

low back pain: Results of a randomized, double-blind, placebo-

and active –controlled phase III study, J Pain, 2005;6(1):21–8.

16. Long A, Donelson R, Fung T, Does it matter which exercise?

A randomized control trial of exercise for low back pain, Spine,

2004;29(23):2593–2602.

17. van der Roer N, van Tulder MW, Barendse JM, et al.,

Costeffectiveness of an intensive group training protocol

As published in:US Musculoskeletal Review,2007;50-52

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

DRX9000™

05-06

compared to physiotherapy guideline care for sub-acute and

18. Leibing E, Leonhardt U, Koster G, et al., Acupuncture

treatment of chronic low-back pain – a randomized, blinded,

placebocontrolled trial with 9-month follow-up, Pain, 2002;96(1–

2): 189–96.

Orthop Surg, 2006;14(8):477–87.

19. Gay RE, Bronfort G, Evans RL, Distraction manipulation of

lumbar spine: a review of the literature, J Manipulative Physiol

Ther, 2005;28(4):266–73.

20. Meszaros TF, Olson R, Kulig K, et al., Effect of 10%, 30%,

and 60% body weight traction on the straight leg raise test of

symptomatic patients with low back pain, J Orthop Sports Phys

Ther, 2000;30(10):595–601.

21. Ramos G, Martin W, Effects of vertebral axial decompression

on intradiscal Pressure, J Neurosurg, 1994;81(3):350–53.

22. Gupta RC, Ramarao SV, Epidurography in reduction of

lumbar disc prolapse by traction, Arch Phys Med Rehabil,

1978;59(7):322–7.

23. Onel D, Tuzlaci M, Sari H, Demir K, Computed tomographic

investigation of the effect of traction on lumbar disc herniations,

Spine, 1989;14(1):82–90.

24. Mullan C, Kelly B, Magnetic resonance (MR) imaging of

lumbar spine: use of a shortened protocol for initial investigation

of degenerative disease, Ulster Med J, 2005; 74(1):29–32.

As published in:US Musculoskeletal Review,2007;50-52

As published in:

US Musculoskeletal Review,

2007;50-52

DRX9000™

临床报告5.indd 6 2010-6-30 9:49:13

Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

a report by

Charlotte Richmond, PhD1, Frank Florio, DC2, Jonathan M Wilhelm, DC, CCEP3 and Martin Auster, MD, MBA4

Director of Clinical Research, NEMA Research, Inc., and CEO Biomedical Research and Education Foundation,

LLC; 2. Director of Clinical Research, Axiom Worldwide, LLC; 3. Big Sky Spinal Care Center; 4. Assistant

Professor, Department of Radiology, Johns Hopkins University School of Medicine

Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000)-case report

S p i n a l d e c o m p r e s s i o n s y s t e m s s u c h a s t h e DRX9000(TM) (Axiom Worldwide, Tampa, FL) have been launched into clinical practice in the last 10 years for the treatment of low-back pain (LBP). These systems were developed to provide a non-invasive intervention for the treatment of LBP of discogenic origin. They also address some of the problems associated with simple traction such as fatigue (both patient and therapist), the patient’s inability to tolerate the force or position, triggering of muscle spasm, and the exacerbation of pain.

The US Food and Drug Administration (FDA)-cleared DRX9000 True Non-surg ica l Sp ina l Decompress ion System(TM) (see Figure1) applies spinal distraction forces by using a sensitive computerized feedback mechanism to provide relief of LBP and symptoms associated wi th herniated discs, bulging or protruding inter-vertebral discs, degenerative disc disease, posterior facet syndrome, and sciatica. The DRX9000 uses a split-table design to reduce friction between the patient and the device. The patient lays supine; a chest and shoulder

support system controls the upper body and a knee rest is used to eliminate pelvic rotation. The apparatus has built-in air bladders, disc-anglepull adjusters, and harnesses, and it can increase the decompression force more slowly in the latter part of the therapy. The DRX9000 uses a motor pulley to deliver mechanized segmental distraction, which can be delivered in a static or oscillatory fashion for a pre-selected duration; the location of lumbar spinal disease determines the best pull-angle settings.The DRX9000 aims to relieve pain by enlarging intra-discal spaces, reducing herniation, and decreasing intra-

discal pressure during treatment. A retrospective chart audit of 94 patients provided preliminary data that chronic LBP may improve with DRX9000 spinal

decompression1 . A prospective trial on 18 patients found that pain improved significantly after DRX9000

treatment, requiring fewer analgesics and resulting in better function. 2 In view of such findings, corresponding

radiographic data may be helpful to explain improvement in pain and function after DRX9000 treatment.

Figure1: The DRX9000

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

DRX9000™

07-08

Presentation of CaseA 33-year-old male was seen at an outpatient facility with persistent LBP of six-year duration that was progressively worsening and interfering with work and daily life, including walking The patient was 73 inches tall and weighed 212 pounds. He had undergone previous chiropracti treatment and physical therapy with little benefit The earliest available records revealed a medicaconsultation and magnetic resonance imaging (MRI) in June 2001 for a complaint of LB radiating into his right buttock after jogging. The patient indicated at that time that he had been experiencing pain and stiffness for approximately one year. The patient reported that his symptom were aggravated with bending, putting on his socks, running, coughing, and sneezing. The MRI performed in June 2001 demonstrated los of hydration at L2/L3, L3/L4, and L4/L5, with loss of disc height at L4/L5 and L5/S1. Disprotrusions were identified at L3/L4 and L4/L5. Hypertrophic facet changes were noted a multiple levels.MRI of the lumbar spine performed on August 4, 2006 (see Figure 2) prior to treatment with the DRX9000 revealed mild to moderate degenerative disc disease of the lumbar spine with loss of disc signal at most levels, as well as disc bulges identified at L3/L4, L4/L5, and L5/S1. Prior to initial treatment, the patient reported an overall pain level of 6 on a 0–10 scale; this pain occurred 75% of the time. The patient underwent 20 treatments on the DRX9000 over a six-week period. Treatment was administered five times per week for the first two weeks and three times per week for a further two weeks, then tapered to two sessions per week for the last two weeks. Treatment length varied between 28 and 35 minutes. Initial parameters began at a maximum decompressive force of 90 pounds with a minimum force of 45 pounds. Final treatment parameters were 115 pounds at maximum decompressive force with a minimum force of 57 pounds. The decompressive force was increased in increments of fi ve to 10 pounds based on patient response. The angle

of treatment force ranged from 15 to 20o. Adjunctive therapies included ice, electric stimulation, and light rehabilitation activities. At his final DRX9000 treatment, the patient reported a pain level of 0. Follow-up MRI (see Figure 3) of the same patient performed on October 10, 2006 showed an increase in intra-discal signal on T2-weighted sagittal images at L2/3, L3/4, L4/5, and L5/S1, reflecting an improvement in disc morphology. The incidental small annular tears were unchanged.

Figure2: Pre-DRX9000 Magnetic Resonance Imaging

Figure3: Post-DRX9000 Magnetic Resonance Imaging

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

DiscussionIn adults, LBP is not uncommon Approximately 66% of adults will suffer LBP at least once in their lifetime3 and, following the first episode, 25–60% of patients will report recurrence of LBP, some within as little as one year4. Back pain, one of the most frequent reasons for seeking medical care5,6, is the most common reason for work disability among American men, often resulting in early retirement7,8 . Mechanical back pain, which accounts for 97% of all LBP, is attributed to injury to the lumbosacral muscles and ligaments, facet joint or sacroiliac joint arthropathy, or discogenic disease due to degenerative changes9. Discogenic pain, most probably due to internal disc degeneration, affects the lower back, buttocks, and hips. 9

Although most LBP spontaneously resolves,treatment, whether through self-care or underthe supervision of a healthcare practitioner,is often needed. Treatment for LBP should be individualized10 and is variable, depending on the diagnosis and the type of healthcare practitioner providing care11. Treatment options can be divided into pharmacological, non-surgical, or surgical therapies. Initially, the patient should be evaluated to rule out the need for urgent surgical intervention; however, there is conflicting evidence as to the benefits of surgery. 12,13 Pharmacological therapy includes acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs); if pain persists, prescription medications such as muscle relaxants and opioids14 may be needed. Non-surgical, non-pharmacological treatment consists15 of many alternatives, such as back exercise16 back school17, acupuncture18, manipulation19, or traction.20 However, when conservative methods fail, surgery may be needed to reduce the pressure in the intervertebral spaces (decompression). A recent review of clinical trials evaluating the efficacy of spinal decompression systems concluded that currently available data in the peer-reviewed press are too limited to determine whether spinal decompression

provides benefits to individuals with LBP over other non-surgical treatments10. Previous studies include weak and inconsistent methodologies because of designs that included different sample sizes, clinical patient inclusion criteria, regulatory oversight levels, protocol lengths, and post-therapy follow-up. Investigators used inappropriate end-point measures and poor outcome markers, reported negative results inadequately, and neglected to include placebo controls. Since that review, two studies evaluating the DRX9000 have emerged1,2. The first study is retrospective and analyzes the treatment of 94 patients from September 2005 to March 2006 with the DRX9000.1 The mean pre-DRX9000 pain score was 6.05 (0–10 scale) and decreased to 0.89 after the final DRX9000 session. No adverse events were noted. Results suggest that chronic LBP improved after treatment, with patients requiring fewer analgesics and achieving better function. The authors acknowledge the inconclusiveness of these findings as their study design was retrospective and did not include control groups. The second study, a prospective, multicenter, non-randomized, phase II pilot study to evaluate the effectiveness and safety of the DRX9000 for the active treatment of chronic LBP, followed subjects from January 5, 2007 to April 27, 2007. Twenty patients with chronic LBP—based on a diagnosis of musculoskeletal or mechanical LBP, herniated discs, bulging or protruding discs, degenerative disc disease, or pain from failed back surgery more than six months previously—underwent a series of 20 DRX9000 treatments (each session lasting 28 minutes) for six weeks, with fi ve sessions per week in the fi rst two weeks tapering to two sessions per week in the last two weeks. Adjunctive treatment included ice afte DRX9000 sessions, lumbar stretching exercises and analgesics as required. Assessments of pain analgesic use, functionality, satisfaction, activitie of daily living, and safety were collected through examinations, questionnaires, and patient diariesEighteen evaluable

As published in:US Musculoskeletal Review,2007;50-52

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Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

DRX9000™

09-10

study participants (33.3% female; 83.3% white; mean age 46.6 years; 77.8% employed) had a mean pain score of 6.4 on a 0–10 scale prior to the fi rst DRX9000 treatmentthis decreased to 0.8 after the final DRX9000 treatment. Sixteen out of the 18 subjects (88.9% reported an improvement in back pain and bette function as measured by activities of daily living On a 0–10 satisfaction scale, patients gave the DRX9000 an average score of 8.1. No patien required any invasive therapies (e.g. epidural injections, surgery). Overall, the pain of patient decreased by 50% after two weeks of DRX9000 treatment. Patients required fewer analgesics and experienced better function. No safety issue were identified with the multimodal treatmen routine.For LBP of discogenic origin, the goal of therapy is to expand the intervertebral space and reduce disc protrusion and intra-discal pressure21–23, which are the goals of DRX9000 treatment. MRI is useful to quantify the volume and hydration variation of the inter-vertebral disc24. Therefore, the use of MRI to explain improvement in pain and function after DRX9000 treatment may be benefi cial.Our case report demonstrates the positive hydrating effect that the DRX9000 treatment has on the inter-vertebral disc. Further prospective clinical studies are needed to further validate clinical and radiographic improvement in patients with chronic LBP.

AcknowledgmentThis case report has been underwritten with a grant from Axiom

Worldwide, LLC, Tampa, FL.

1. Macario A, Richmond C, Auster M, et al., Treatment of 94

outpatients with chronic discogenic low back pain with the

DRX9000: a retrospective chart review, Pain Pract, in press.

2. Leslie J, Richmond C, Macario A, et al., Pilot: Effectiveness

and safety of non-surgical spinal decompression, Paper

presented at: 18th Annual Meeting of the American Academy of

Pain Management September 27–30, 2007; Las Vegas, NV.

3. Quittan M, Management of back pain, Disabil Rehabil,

2002;24(8):423–34.

4. Boswell MV, Trescot AM, Datta S, et al., Interventional

techniques: evidence-based practice guidelines in the

management of chronic spinal pain, Pain Physic ian,

2007;10(1):117–111.

5. Deyo RA, Cherkin D, Conrad D, Volinn E, Cost, controversy,

crisis: low back pain and the health of the public, Annu Rev

Public Health, 1991;12:141–56.

6. Frymoyer JW, Cats-Baril WL, An overview of the incidences

and costs of low back pain, Orthop Clin North Am, 1991;22(2):

263–71.913–16.

12. Weinstein JN, Lurie JD, Tosteson TD, et al.,Surgical vs

nonoperative treatment for lumbar disk herniation: the Spine

Patient Outcomes Research Trial (SPORT) observational cohort,

JAMA, 2006;296(20):2451–9.

13. Weinstein JN, Tosteson TD, Lurie JD, et al., Surgical vs

nonoperative treatment for lumbar disk herniation: the Spine

Patient Outcomes Research Trial (SPORT): a randomized trial,

JAMA, 2006;296(20):2441–50.

14. Shen FH, Samartzis D, Andersson GB, Nonsurgical

management of acute and chronic low back pain, J Am

Acadchronic low back pain: design of a randomised controllede

trial with an economic evaluation, BMC Musculosket Disord,

2004;23;5(1):45.

15. Hale ME, Dvergsten C, Gimbel J, Efficacy and safety of

oxymorphone extended release in chronic

low back pain: Results of a randomized, double-blind, placebo-

and active –controlled phase III study, J Pain, 2005;6(1):21–8.

16. Long A, Donelson R, Fung T, Does it matter which exercise?

A randomized control trial of exercise for low back pain, Spine,

2004;29(23):2593–2602.

临床报告5.indd 10 2010-6-30 9:49:14

Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system(DRX9000TM)-case report

17. van der Roer N, van Tulder MW, Barendse JM, et al.,

Costeffectiveness of an intensive group training protocol

compared to physiotherapy guideline care for sub-acute and

18. Leibing E, Leonhardt U, Koster G, et al., Acupuncture

treatment of chronic low-back pain – a randomized, blinded,

placebocontrolled trial with 9-month follow-up, Pain, 2002;96(1–

2): 189–96.

Orthop Surg, 2006;14(8):477–87.

19. Gay RE, Bronfort G, Evans RL, Distraction manipulation of

lumbar spine: a review of the literature, J Manipulative Physiol

Ther, 2005;28(4):266–73.

20. Meszaros TF, Olson R, Kulig K, et al., Effect of 10%, 30%,

and 60% body weight traction on the straight leg raise test of

symptomatic patients with low back pain, J Orthop Sports Phys

Ther, 2000;30(10):595–601.

21. Ramos G, Martin W, Effects of vertebral axial decompression

on intradiscal Pressure, J Neurosurg, 1994;81(3):350–53.

22. Gupta RC, Ramarao SV, Epidurography in reduction of

lumbar disc prolapse by traction, Arch Phys Med Rehabil,

1978;59(7):322–7.

23. Onel D, Tuzlaci M, Sari H, Demir K, Computed tomographic

investigation of the effect of traction on lumbar disc herniations,

Spine, 1989;14(1):82–90.

24. Mullan C, Kelly B, Magnetic resonance (MR) imaging of

lumbar spine: use of a shortened protocol for initial investigation

of degenerative disease, Ulster Med J, 2005; 74(1):29–32.

Magnetic resonance imaging findings after treatment with a non-surgical spinal decompression system (DRX9000)-case report

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DRX9000™

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