Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

• Sponsor: yan lu (Other)
• Overall Status: Completed
• CT.gov ID: NCT03101033
• Collaborator: (none)
• Enrollment: 92
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.

Condition or Disease	Intervention/Treatment	Phase
Herniated Lumbar Disc	Device: Mechanical epidural neuroplasty; Drug: Transforaminal epidural compound betamethasone injection; Drug: Caudal epidural compound betamethasone injection; Drug: Epidural hyaluronidase injection	N/A

Detailed Description

One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into two groups. One group will be treated with Transforaminal steroid injection, the other with epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six months post-treatment will be analysed statistically.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficacy Between Transforaminal Steroid Epidural Injection and Epidural Neuroplasty for the Treatment of Herniated Lumbar Disc：A Single Center, Controlled Clinical Trial
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epidural neuroplasty group This group will be given epidural neuroplasty once enrolled.	Device: Mechanical epidural neuroplasty; Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.; Drug: Caudal epidural compound betamethasone injection; steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.; Drug: Epidural hyaluronidase injection; Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.
Active Comparator: Transforaminal steroid injection group This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later.	Drug: Transforaminal epidural compound betamethasone injection; Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.

Outcome Measures

Primary Outcome Measures

1. Pain Assessed by Visual Analogue Scale [before treatment]

   VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.

2. Pain Assessed by Visual Analogue Scale [at one-month post-treatment]

   VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.

3. Pain Assessed by Visual Analogue Scale [at three-month post-treatment]

   VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.

4. Pain Assessed by Visual Analogue Scale [at six-month post-treatment]

   VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.

Secondary Outcome Measures

1. Functional Status Assessed by Oswestry Disability Index [before treatment]

   ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.

2. Functional Status Assessed by Oswestry Disability Index [at one-month post-treatment]

   ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.

3. Functional Status Assessed by Oswestry Disability Index [at three-month post-treatment]

   ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.

4. Functional Status Assessed by Oswestry Disability Index [at six-month post-treatment]

   ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• clinical diagnosis of herniated lumbar disc

• written informed consent obtained

Exclusion Criteria:

• Lumbar instability

• Piriformis syndrome

• Diabetes mellitus with uncontrolled blood glucose

• Severe osteoporosis

• Impaired function of cauda equina

• Severe sacral hiatus variation

• Interspinous ligament inflammation

• Myofascitis on lumbar and legs

• The third lumbar transverse process syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fourth Military Medical University china	Xian	Shaanxi	China	710132

Sponsors and Collaborators

• yan lu

Investigators

• Study Director: Yan Lu, MD,PhD, Fourth Military Medical University China

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kim HJ, Rim BC, Lim JW, Park NK, Kang TW, Sohn MK, Beom J, Kang S. Efficacy of epidural neuroplasty versus transforaminal epidural steroid injection for the radiating pain caused by a herniated lumbar disc. Ann Rehabil Med. 2013 Dec;37(6):824-31. doi: 10.5535/arm.2013.37.6.824. Epub 2013 Dec 23.
• Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch Phys Med Rehabil. 1998 Nov;79(11):1362-6.
• Manchikanti L, Pampati V, Fellows B, Rivera J, Beyer CD, Damron KS. Role of one day epidural adhesiolysis in management of chronic low back pain: a randomized clinical trial. Pain Physician. 2001 Apr;4(2):153-66.
• Manchikanti L, Rivera JJ, Pampati V, Damron KS, McManus CD, Brandon DE, Wilson SR. One day lumbar epidural adhesiolysis and hypertonic saline neurolysis in treatment of chronic low back pain: a randomized, double-blind trial. Pain Physician. 2004 Apr;7(2):177-86.
• McCarron RF, Wimpee MW, Hudkins PG, Laros GS. The inflammatory effect of nucleus pulposus. A possible element in the pathogenesis of low-back pain. Spine (Phila Pa 1976). 1987 Oct;12(8):760-4.
• Vad VB, Bhat AL, Lutz GE, Cammisa F. Transforaminal epidural steroid injections in lumbosacral radiculopathy: a prospective randomized study. Spine (Phila Pa 1976). 2002 Jan 1;27(1):11-6.
• Veihelmann A, Devens C, Trouillier H, Birkenmaier C, Gerdesmeyer L, Refior HJ. Epidural neuroplasty versus physiotherapy to relieve pain in patients with sciatica: a prospective randomized blinded clinical trial. J Orthop Sci. 2006 Jul;11(4):365-9.

• Responsible Party: yan lu, Director of the pain clinic of Xijing Hospital, Xijing Hospital
• ClinicalTrials.gov Identifier: NCT03101033
• Other Study ID Numbers: 20150401
• First Posted: Apr 4, 2017
• Last Update Posted: Sep 4, 2018
• Last Verified: Nov 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by yan lu, Director of the pain clinic of Xijing Hospital, Xijing Hospital: Herniated lumbar disc; Epidural neuroplasty; Epidural injection
• Additional relevant MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone sodium phosphate

Study Results

Participant Flow

Recruitment Details	Participants were assessed in the pain clinic of xijing hospital by a separate clinician, their clinical data and phone number were recorded. The total of 186 participants were assessed and 92 of them were enrolled.
Pre-assignment Detail	Ninety-four participants were excluded before assignment. Sixty-three of them did not meet the inclusion criteria. Twenty-four of them refused to participate. Seven participants were excluded as other reasons such as the physician was uncertain about the diagnosis or the participants was difficult to communicate with.

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Period Title: Overall Study
STARTED	32	60
COMPLETED	27	51
NOT COMPLETED	5	9

Baseline Characteristics

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group	Total
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.	Total of all reporting groups
Overall Participants	27	51	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.04 (14.56)	47.67 (15.34)	48.83 (15.07)
Sex: Female, Male (Count of Participants)
Female	12 44.4%	28 54.9%	40 51.3%
Male	15 55.6%	23 45.1%	38 48.7%
BMI (kg/mʌ2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/mʌ2]	22.50 (2.24)	23.37 (1.66)	23.17 (1.60)
Duration of pain (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	9.52 (5.65)	8.84 (4.61)	9.08 (4.97)

Outcome Measures

1. Primary Outcome

Title	Pain Assessed by Visual Analogue Scale
Description	VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
Time Frame	before treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	5.63 (1.24)	5.92 (1.20)

2. Primary Outcome

Title	Pain Assessed by Visual Analogue Scale
Description	VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
Time Frame	at one-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	2.37 (1.45)	2.35 (1.40)

3. Primary Outcome

Title	Pain Assessed by Visual Analogue Scale
Description	VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
Time Frame	at three-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	2.19 (1.04)	3.25 (1.57)

4. Primary Outcome

Title	Pain Assessed by Visual Analogue Scale
Description	VAS (Visual analogue scale), with the highest score of 10, representing the most severe pain one could experience, and the lowest score of 0, representing no pain at all. The higher score means more severe pain.
Time Frame	at six-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	2.81 (1.47)	4.06 (1.76)

5. Secondary Outcome

Title	Functional Status Assessed by Oswestry Disability Index
Description	ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
Time Frame	before treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	53.85 (10.29)	57.84 (9.63)

6. Secondary Outcome

Title	Functional Status Assessed by Oswestry Disability Index
Description	ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
Time Frame	at one-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	29.11 (11.31)	35.02 (13.04)

7. Secondary Outcome

Title	Functional Status Assessed by Oswestry Disability Index
Description	ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
Time Frame	at three-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	28.93 (10.36)	39.82 (14.59)

8. Secondary Outcome

Title	Functional Status Assessed by Oswestry Disability Index
Description	ODI (Oswestry disability index) consists of 10 subscales, which evaluates pain intensity, and functional satus of personal care, lifting, walking, sitting, standing, sleeping, sex, social life, traveling. Each subscales range from 0 to 5, with the higher score indicating more severe functional damage. the ODI score ranges from 0 to 100. it equals the sum of all the subscales and divided by 50. If the patients answers 9 subscale questions, then the total sum should be divided by 45, and by this analogy.
Time Frame	at six-month post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epidural Neuroplasty Group	Transforaminal Steroid Injection Group
Arm/Group Description	This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
Measure Participants	27	51
Mean (Standard Deviation) [units on a scale]	30.52 (13.23)	46.39 (15.58)

Adverse Events

Time Frame	October 2015 and December 2015
Arm/Group Title	Transforaminal Steroid Injection Group		Epidural Neuroplasty Group
Arm/Group Description	This group will be given transforaminal betamethasone injection once enrolled, if no obvious pain relief was reported, another epidural injection will be given one week later. Transforaminal epidural compound betamethasone injection: Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.		This group will be given epidural neuroplasty once enrolled. Mechanical epidural neuroplasty: Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented. Caudal epidural compound betamethasone injection: steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty. Epidural hyaluronidase injection: Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.
All Cause Mortality
	Transforaminal Steroid Injection Group		Epidural Neuroplasty Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/32 (0%)
Serious Adverse Events
	Transforaminal Steroid Injection Group		Epidural Neuroplasty Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Transforaminal Steroid Injection Group		Epidural Neuroplasty Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		2/32 (6.3%)
Surgical and medical procedures
severe pain induced by the NP procedures in two participants	0/60 (0%)	0	2/32 (6.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.