DRX9000TM

Joseph Pergolizzi,1 Charlotte Richmond,2 Martin Auster,3 Frank Florio4 and Jonathan Wilhelm5

As published in:US Musculoskeletal Review,Vol. 3 Issue 2 European

Non-surgical Spinal Decompression (DRX9000TM) for theTreatment of Chronic Low-back Pain – A Case Report

临床报告8.indd 1 2010-6-29 14:34:39

病例综述

一位 35 岁女性于 2006 年 7 月在门诊主诉下腰痛。背

部疼痛与麻木伴有经常性右腿疼痛。治疗的医生指出，病

人的下腰痛已经是慢性的，始发于 2004 年 12 月。这些症

状影响了她提升客户的能力（她职责的必要部分），并加

剧了坐和长时间站立。病人体重 291 镑和 5 尺 8 英寸高。

她的病史很重要，有两次车祸（1994 年和 2002 年）。

2006 年 7 月 19，腰部 MRI 显示： L5/S1 椎间盘突出，轻

度到中度，偏右，压迫右侧 S1 神经根（见图 1）。L2/L3

和 L3/L4 轻度退行性伴有轻度膨出。经初步检查，病人腰

部活动受限，疼痛累计所有平面，神经根张力试验阳性和

右下肢感觉和运动功能下降。

病人在大约 5.5 周接受 20 次 DRX9000 的治疗。初始

参数，最大减压力 90 磅减压，最低 45 镑。最后治疗参数，

最大 101 磅和最低 55 磅。减压力由医护人员斟酌提高 10

磅。治疗的角度（医生可以根据腰椎间盘突出症的影响区

域做出调整）介于 10 至 20º。辅助治疗包括电疗，冰敷和

康复训练。

最初治疗时，病人疼痛在 0-10 级中报告 7；治疗结

束时，她报告的疼痛 1。疼痛的时间也从疼痛最初发生的

75 ％下降到完成治疗时的 10 ％。在最后评价时，考官指

出腰部活动度得到改善：弯曲度从 42 上升至 58 º，延展

由 12 增至 26 º，左外侧弯曲从 14 增加至 25 º 和右外

侧弯曲从 12 增加至 24º。骨科和神经系统的检查结

果正常。2006 年 9 月 22 日，腰椎 MRI，T2 加权像显示：

L5/S1 椎间盘突出减少。

图 1：治疗前 MRI 图 2：治疗后 MRI

使用 DRX9000 治疗下腰痛

——病例报告

背部疼痛影响全球数以百万计的工人。背痛普遍存在于那些数小时做重复性工作的人 [1] 和高风险职业 [2]。1938 年，

有人提出，没有任何一种疾病可以比下腰痛有更高的致残率和产生更多的经济损失 [3]。尽管是 70 年前提出的，可它

正好反映了现在的状况 [4-6]。

目前，在治疗下腰痛方面，有非常丰富的选择。然而，对于哪种治疗方法更适当或更可取，还没有一个统一的意

见：外科手术，非手术或药物。背部手术的结果难以预测，并且伴随着手术的风险。当前的循证医学指导方针是：在

最终决定手术前，至少保守治疗两个月，甚至更长的时间 [7,8]。

美国疼痛协会的下腰痛治疗指南，已经驳回了一些干预措施，如介入性诊断测试，各种脊髓注射和对非根性疼痛

的融合性手术治疗 [9]。使用 DRX9000 非手术脊柱减压系统治疗下腰痛的初步研究结果表明，它是有前途的 [10]。它提

供了治疗慢性下腰痛的另一种新选择。因此，在这里报道，通过 DRX9000 成功治疗慢性下腰痛的案例。

Joseph Pergolizzi,1 Charlotte Richmond,2 Martin Auster,3 Frank Florio4 and Jonathan Wilhelm5

01

临床报告8.indd 2 2010-6-29 14:34:40

02

讨 论DRX9000 真正的非手术脊柱减压系统通过使用敏感

的电脑反馈机制对脊柱减压，可以减轻下腰痛和治疗症状

合并椎间盘突出，膨出或突出型，腰椎间盘退行性变，后

关节综合征和坐骨神经痛 [11]。在一篇系统性回顾文献里，

Macario 和 Pergolizzi 认为：现在的数据太少，不足以确定

脊柱减压系统比其他非手术疗法提供了更大的效益 [12]。然

而，两个新的研究结果表明，DRX9000 治疗慢性下腰痛

病人是安全的和有效的 [10,13]。

在第一个研究，一项回顾性研究，用以评价非手术

脊柱减压系统 DRX9000 的有效性。94 例图表回顾性调查

研究，从 2005 年 9 月至 2006 年 3 月在 4 个门诊（3 个自

由站立和 1 个医院门诊）。平均 VAS 疼痛评分从开始治

疗的 6.05（1-10 级）下降到治疗完成的 0.89。在第二项

研究中也报告了类似的结果，一项前瞻性，多中心，非随

机 II 期临床研究，以评估 DRX9000 治疗慢性腰背痛的安

全性和有效性。对 18 例可评价的病人，在 2007 年 1 月到

2007 年 4 月间，6 周内使用 DRX9000 进行 20 次治疗。通

过测验、问卷调查和病人日志，以收集疼痛的评定，镇痛

剂的使用，功能性，安全性，满意度以及日常的活动。平

均 VAS 疼痛评分开始治疗时为 6.4，在两个星期（10 次治

疗后）减少了 50％以上，在治疗结束时平均为 0.8。18 例

中的 16 例患者报告有更好的功能。在满意度调查中，（0-10

范围内）病人对 DRX9000 的满意度为 8.1。没有任何不

良反应事件，所有病人都认为不再需要微创疗法。

最近，三个有关 DRX9000 有效性的病例报告已经发

表 [14-16]。在第一个病例报告中，介绍一名 33 岁男性，最

初疼痛等级 6（0-10 级），接受 6 星期 20 次 DRX9000 治

疗，报告在治疗结束后疼痛减少为 0。DRX9000 治疗前后

的 MRI 比较表明：L2/3，L3/4，L4/5 和 L5/S1 处 T2 加权

像上椎间盘内信号明显增加，这表明 DRX9000 对椎间盘

内水合作用有积极的效果。第二个病例报告中，69 岁的

男性慢性下腰痛，放射到双下肢。在 7 周 22 次的治疗后，

疼痛等级从 10 下降到 1（0-10 级）。治疗前后的 MRI 对

比表明：椎间盘的高度明显增加，多个阶段的椎间盘突出

的尺寸明显减小。第三个病例报告，一名 31 岁男性，下

腰痛病史为期一个月，疼痛放射到左臀部，通过 7 周 27

次 DRX9000 的治疗后，疼痛等级从 8.5 降到 3（0-10 级），

在 DRX9000 治疗后的 MRI 表明：左侧 S1 神经根处椎间

盘突出的尺寸和压迫的位置有显著减少。

这些先前的病例报告结果，与通过 DRX9000 治疗前

后的 CT 对比的数据回顾性研究的结果一致 [17]。16 例慢

性肌肉性，机械性或椎间盘源性慢性下腰痛，在通过 6 星

期DRX9000的治疗后，触诊疼痛分数从5.7下降至0.8（0-10

级）和 ROM 疼痛等级从 5.6 下降到 0.7。此外，腰椎间盘

高度平均增加了 1.6 毫米。另外，椎间盘高度增加 1 毫米，

可以使触诊疼痛和 ROM 疼痛等级减少 3.4（0-10 级）。

结 论

这个案例报告继续证明 DRX9000 对椎间盘形态方面

表现出的积极效应。这个 35 岁的妇女在治疗 5.5 周 20 次

治疗过程中，经历了疼痛的缓解和椎间盘突出尺寸的减少。

这些研究结果与往年通过 DRX9000 治疗成功的病例报告

结果及 CT 回顾性研究结果一致的情况。这些案例报告和

回顾性研究的结果表明，更多的前瞻性临床试验是必要的。

Non-surgical Spinal Decompression(DRX9000(TM)) for the

Treatment of Chronic Low-back Pain – A Case Report

As published in:US Musculoskeletal Review,Vol. 3 Issue 2 European

临床报告8.indd 3 2010-6-29 14:34:40

参考文献：

1. Guo HR, Working hours spent on repeated activities andprevalence of back pain, Occup Envi ron Med, 2002;59(10): 680–88.

2. Guo HR, Tanaka S, Cameron LL, et al., Back pain among workers in the United States: national estimates and workers at high risk, Am J Ind Med, 1995;28(5):591–602.

3. Gilcreest EL, Lumbosacral and sacro-iliac strain causing low back pain: a review of one hundred fifty cases, Ann Surg, 1938;107(6):988–95.

4. Deyo RA, Mirza SK, Martin BI, Back pain prevalence and visit rates: estimate from US national surveys, 2002, Spine, 2006;31: 2724–7.

5. Krishnaney AA, Park J, Benzel EC, Surgical management of neck and low back pain, Neurol Clin, 2007;25:507–22.

6. Jarvik JG, Deyo RA, Diagnostic evaluation of low back pain with emphasis on imaging, Ann Intern Med, 2002;137:586–97.

7. Chou R, Qaseem A, Snow V, et al., Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society, Ann Intern Med, 2007; 147: 478–91.

8. McCamey K, Evans P, Low back pain, Prim Care, 2007; 3:71–82.

9. Marcus A, APS guidelines on low back pain dismiss some interventions, Pain Med RSS, 2008;34:07.

10. Leslie J, Richmond C, Macario A, et al., Pilot: Effect iveness and safety of non-surgical spinal decompression, Paper presented at the 18th Annual Meeting of the American Academy of Pain Management, Las Vegas, NV, 27–30 September 2007.

11. Gan TJ, Leslie J, Pergolizzi J, Nonsurgical Spinal Decompression to treat chronic low back pain, Special Report supplement featured in Anesthesiology News, December 2007.

12. Macario A, Pergolizzi J, Systematic literature review of spinal decompression via motorized traction for chronic discogenic low back pain, Pain Pract, 2006;6:171–8.

13. Macario A, Richmond C, Auster M, Pergolizzi JV, Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective char review, Pain Pract, 2008;8:11–17.

14. Richmond C, F lor io F, Wi lhelm JM, et a l . , MagneticResonance Imaging Findings after Treatment with a Nonsurgical Spinal Decompression System (DRX9000™)—Case Report, US Musculoskeletal Review, 2007;50–52.

15. Pergolizzi J, Florio F, Martin W, et al., Management of low-back pain with a non-surgical spinal decompression system (DRX9000™) – case repor t , European Musculoskeletal Review, 2008;59–60.

16. Pergolizzi J, Yocum T, Florio F, et al., Management ofd iscogen ic low-back pa in w i th a non-surg ica l decompression system (DRX9000™)—Case Report, US Musculoskeletal Review, 2008;14–15.

17. Apfel C, Cakmakkaya S, Martin W, et al., Decreased lower back pain after non-invasive spinal decompression may be due to restored disc height, Abstract presented at the American Conference on Pain Medicine 3rd Annual conference, April 2008.

Non-surgical Spinal Decompression(DRX9000(TM)) for the

Treatment of Chronic Low-back Pain – A Case Report

03

临床报告8.indd 4 2010-6-29 14:34:40

Non-surgical Spinal Decompression (DRX9000TM) for theTreatment of Chronic Low-back Pain – A Case Report

Back pain affects millions of workers worldwide. The prevalence of back pain is associated with the number of hours spent on repeated activities at work1 and in high-risk occupations2. In 1938, it was believed that there was no one condition that produced more disability and economic loss than low-back pain (LBP)3. This statement is just as true today as it was 70 years ago.4–6

Currently, there are abundant options for treatment, with new, often innovative, treatments emerging. However, there is little agreement on which treatment is appropriate or preferable:surgical, non-surgical or pharmacological.Results from back surgery are unpredictable and are associated with surgical risks. Conservative treatment for at least two months, and often much longer, before a surgical option is considered has been recommended in the current evidence-based guidelines7,8.The American Pain Society’s guidelines on LBP have dismissed some interventions such as invasive diagnostic testing, various spinal injections and fusion surgery for non-radicular pain9.Results from a pilot study using non-surgical spinal decompression, specifically the DRX9000(TM) (Axiom Worldwide, Tampa,Florida) 10,are promising and offer another option for treatment of chronic LBP. Therefore, a case of chronic LBP successfully treated with non-surgical spinal decompression via the DRX9000 is reported here.

Presentation of CaseA 35-year-old female presented at an outpatient clinic in

July 2006 complaining of LBP.The back pain was associated

with numbness and recurrent right leg pain. The treating

physician noted that the patient’s condition had been

chronic since December 2004. These symptoms affected

her ability to lift clients – a required part of her occupational

duties – and were aggravated by sitting and prolonged

standing. The patient weighed 291lb and was 5’ 8” tall. Her

history was signifi cant, with two motor vehicle accidents (in

1994 and 2002). Magnetic resonance imaging(MRI) of the

lumbar spine performed on 19 July 2006 revealed a mild to

moderate disc protrusion at L5/S1, eccentric to the right,

impinging on the right S1 nerve root (see Figure 1). Mild

degenerative changes with minimal bulging were also noted

at L2/L3 and L3/L4. Upon initial examination, the patient

presented limited lumbar range of motion (ROM), with pain

in all planes, positive nerve root tension tests and decreased

sensory and motor function of the right lower extremity.

a report by

Joseph Pergolizzi1, Charlotte Richmond2, Martin Auster3, Frank Florio4 and Jonathan Wilhelm5

1. Adjunct Assistant Professor, Johns Hopkins University School of Medicine;2. Director of

Clinical Research, NEMA Research Inc.; 3. Assistant Professor, Department of Radiology,

Johns Hopkins University School of Medicine; 4. Director of Clinical Research, Axiom

Worldwide, LLC; 5. Big Sky Spinal Care Center

The patient underwent 20 treatments on the DRX9000 over

an approximately 5.5-week period. Initial parameters began

at a maximum decompressive force of 90lb with a minimum

force of 45lb. Final treatment parameters were a maximum

of 110lb and a minimum of 55lb. The decompressive force

was raised in increments of 10lb at the discretion of the

healthcare provider. The angle of treatment force (which

allows the physician to make adjustments to treat the

affected lumbar region) ranged from 10 to 20o. Adjunctive

treatment included electric stimulation, ice and therapeutic

exercise.

04

临床报告8.indd 5 2010-6-29 14:34:41

At initial treatment, the patient reported pain at 7 on a 0–10

scale; at the end of the treatment protocol she reported pain

at 1. A reduction in the duration of pain was noted as well:

pain initially occurred 75% of the time, but decreased to 10%

of the time at completion of treatment. At final evaluation,

the examiner noted an improvement in lumbar ROM tests:

flexion increased from 42 to 58o, extension increased from 12

to 26o, left lateral flexion increased from 14 to 25o and right

lateral flexion increased from 12 to 24o. Orthopaedic and

neurological fi ndings were noted as normal. Limited follow-

up MRI of the lumbar spine performed on 22 September

2006 revealed a decrease in the excursion of the disc at L5/

S1 on T2-weighted sagittal images (see Figure 2)

DiscussionThe DRX9000 True Non-surgical Spinal Decompression

SystemTM applies spinal distraction forces by using a sensitive

computerised feedback mechanism to provide relief of LBP

and symptoms associated with herniated discs, bulging or

protruding intervertebral discs, degenerative disc disease,

posterior facet syndrome and sciatica11.In a systematic review

of the peer-reviewed literature12,Macario and Pergolizzi

conclude that there are too little data to determine whether

spinal decompression provides greater benefit than other

non-surgical treatments. However,the results of two new

studies suggest that the DRX9000 is safe and effi cacious in

patients with discogenic LBP10,13.

In the first study, a retrospective study was conducted to

evaluate the efficacy of non-surgical spinal decompression

using the DRX900013.Ninety-four charts were reviewed

from September 2005 to March 2006 at four outpatient

clinics (three free-standing and one hospital-based).

The mean verbal rating score (VRS) decreased from 6.05

(1–10 scale) at the start of treatment to 0.89 at treatment

completion. Similar results were reported in the second

study, a prospective, multicentre, non-randomised phase

II pilot study to evaluate the safety and effectiveness of

the DRX9000 for the treatment of chronic LBP. Eighteen

evaluable patients, followed between January 2007 and April

2007, received a 20-treatment protocol with the DRX9000

over a six-week period. Assessments of pain, analgesic

use, functionality, satisfaction, activities of daily living and

safety were collected through examinations, questionnaires

and patient diaries. The mean VRS at the start of treatment

was 6.4; it decreased by more than 50% at two weeks (10

treatments) and averaged 0.8 at the end of treatment.

Sixteen of the 18 patients reported better function and

patients rated the DRX9000 with an average score of 8.1 on

a 0–10 satisfaction scale. No adverse events were noted and

no subjects required more invasive therapy.

Recently, three case reports addressing the effectiveness

DRX9000TM

05

Figure1: Pre-treatment Magnetic Resonance Image Figure2: Post-treatment Magnetic Resonance Image

临床报告8.indd 6 2010-6-29 14:34:41

of the DRX9000 have been Published14–16.In the fi rst case

report14,a 33-year-old male with an initial VRS of 6 (0–10

scale) received 20 DRX9000 treatments over a sixweek period

and reported a decrease in the VRS to 0 at the time of the

last treatment. Pre- and post-DRX9000 MRIs were compared,

demonstrating an increase in the intradiscal signal on T2-

weighted images at L2/3, L3/4, L4/5 and L5/S1, which

suggests a positive hydrating effect on the intervertebral

disc. The second case report followed a 69-year-old male

with chronic LBP radiating to both legs15.His VRS decreased

from 10 to 1 (0–10 scale) with 22 treatment sessions over

a seven-week treatment period. Comparison of pre- and

post-treatment MRIs demonstrated increased disc height

and decreased herniation size at multiple lumbar levels.

Comparable results were reported in the third case report,

in which a 31-year-old male with a onemonth history of LBP

(history of previous episodes of back pain) with radiation

into the left buttock received 27

DRX9000 treatments over a seven-week period. VRS

decreased from 8.5 to 3 (0–10 scale), witha dramatic

decrease in the size of the disc lesionand the compression

placed on the left S1 nerveroot on post-DRX9000 MRI of the

lumbar spine.

The results of these previous case reports,in addition to

the results of the current study, areconsistent with the

results of data retrospectivelycollected from lumbar spine

computedtomography (CT) scans taken prior to andafter

DRX9000 treatments17.Sixteen patientswith chronic

musculoskeletal, mechanical ordiscogenic LBP received

a six-week course ofDRX9000, resulting in a decrease in

palpationpain scores of 5.7 to 0.8 (0–10 scale) and ROM pain

scores from 5.6 to 0.7. Additionally, theaverage lumbar disc

height was increased by1.6mm. Furthermore, an increase

of 1mm in discheight was associated with a decrease of 3.4

(0–10 scale) for both palpation and ROM pain.

ConclusionThis case report continues to demonstrate the positive effects of the

DRX9000 on disc morphology. This 35-year-old woman experienced

pain relief and a decrease in herniation size following 20 treatments

over an approximately 5.5-week period. These findings are

consistent with previous14–16case reports of patients successfully

treated with the DRX9000 and with a retrospective CT review study. 17Results of these case reports and retrospective study suggest that

additional prospective clinical trials are needed.

1. Guo HR, Working hours spent on repeated activities and

prevalence of back pain, Occup Environ Med, 2002;59(10): 680–88.

2. Guo HR, Tanaka S, Cameron LL, et al., Back pain among workers in

the United States: national estimates and workers at high risk, Am J

Ind Med, 1995;28(5):591–602.

3. Gilcreest EL, Lumbosacral and sacro-iliac strain causing

low back pain: a review of one hundred fi fty cases, Ann Surg,

1938;107(6):988–95.

4. Deyo RA, Mirza SK, Martin BI, Back pain prevalence and visit rates:

estimate from US national surveys, 2002, Spine, 2006;31:2724–7.

5. Krishnaney AA, Park J, Benzel EC, Surgical management of neck

and low back pain, Neurol Clin, 2007;25:507–22.

6. Jarvik JG, Deyo RA, Diagnostic evaluation of low back pain with

emphasis on imaging, Ann Intern Med, 2002;137:586–97.

7. Chou R, Qaseem A, Snow V, et al., Diagnosis and treatment of

low back pain: a joint clinical practice guideline from the American

College of Physicians and the American Pain Society, Ann Intern

Med, 2007;147:478–91.

8. McCamey K, Evans P, Low back pain, Prim Care, 2007;3:71–82.

9. Marcus A, APS guidelines on low back pain dismiss some

interventions, Pain Med RSS, 2008;34:07.

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

safety of non-surgical spinal decompression, Paper presented at the

18th

Annual Meeting of the American Academy of Pain Management, Las

Vegas, NV, 27–30 September 2007.

11. Gan TJ, Leslie J, Pergolizzi J, Nonsurgical Spinal Decompression

to treat chronic low back pain, Special Report supplement featured

in Anesthesiology News, December 2007.

12. Macario A, Pergolizzi J, Systematic literature review of spinal

decompression via motorized traction for chronic discogenic low

back pain, Pain Pract, 2006;6:171–8.

Macario A, Richmond C, Auster M, Pergolizzi JV,Treatment of

94 outpatients with chronic discogenic low back pain with the

DRX9000: a retrospective char review, Pain Pract, 2008;8:11–17.

14. Richmond C, Florio F, Wilhelm JM, et al., MagneticResonance

Imaging Findings after Treatment with a Nonsurgical Spinal

Decompression System (DRX9000( TM))—Case Repor t, US

Musculoskeletal Review, 2007;50–52.

15. Pergolizzi J, Florio F, Martin W, et al., Management of low-

back pain with a non-surgical spinal decompression system

(DRX9000(TM)) – case report, European Musculoskeletal Review,

2008;59–60.

16. Pergolizzi J, Yocum T, Florio F, et al., Management of discogenic

low-back pain with a non-surgical decompression system

(DRX9000(TM))—Case Report, US Musculoskeletal Review,

2008;14–15.17. Apfel C, Cakmakkaya S, Martin W, et al., Decreased lower back

pain after non-invasive spinal decompression may be due to

restored disc height, Abstract presented at the American Conference

on Pain Medicine 3rd Annual conference, April 2008.

As published in:US Musculoskeletal Review,Vol. 3 Issue 2 European 06

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临床报告8.indd 8 2010-6-29 14:34:41