Herniated Lumbar DiscNCT03101033

Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

A study testing Mechanical epidural neuroplasty, Transforaminal epidural compound betamethasone injection and Caudal epidural compound betamethasone injection in people with Herniated Lumbar Disc, run by yan lu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Herniated Lumbar Disc
What is being tested?: Mechanical epidural neuroplasty, Transforaminal epidural compound betamethasone injection and Caudal epidural compound betamethasone injection
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteChina
Study dates: May 2015to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

clinical diagnosis of herniated lumbar disc
written informed consent obtained

Who cannot join

Lumbar instability
Piriformis syndrome
Diabetes mellitus with uncontrolled blood glucose
Severe osteoporosis
Impaired function of cauda equina
Severe sacral hiatus variation

Show all 9Show fewer

Interspinous ligament inflammation
Myofascitis on lumbar and legs
The third lumbar transverse process syndrome

Trial locations and contacts

1 site in 1 country.

China1 site

Fourth Military Medical University china
Xi'an, Shaanxi, 710132

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Herniated Lumbar Disc
Being tested: Mechanical epidural neuroplasty, Transforaminal epidural compound betamethasone injection, Caudal epidural compound betamethasone injection, Epidural hyaluronidase injection
Keywords: Herniated lumbar disc, Epidural neuroplasty, Epidural injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mechanical epidural neuroplastyDevice
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.
Transforaminal epidural compound betamethasone injectionDrug
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.
Caudal epidural compound betamethasone injectionDrug
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 injectionDrug
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.

Study groups in NCT03101033
Study group	Role	What they receive
Epidural neuroplasty group	Experimental	This group will be given epidural neuroplasty once enrolled. Receives: Device: Mechanical epidural neuroplasty; Drug: Caudal epidural compound betamethasone injection; Drug: Epidural hyaluronidase injection
Transforaminal steroid injection group	Active comparator	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. Receives: Drug: Transforaminal epidural compound betamethasone injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain Assessed by Visual Analogue Scale
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.
Measured: before treatment
Pain Assessed by Visual Analogue Scale
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.
Measured: at one-month post-treatment
Pain Assessed by Visual Analogue Scale
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.
Measured: at three-month post-treatment
Pain Assessed by Visual Analogue Scale
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.
Measured: at six-month post-treatment

Secondary outcomes (4)

Functional Status Assessed by Oswestry Disability Index
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.
Measured: before treatment
Functional Status Assessed by Oswestry Disability Index
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.
Measured: at one-month post-treatment
Functional Status Assessed by Oswestry Disability Index
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.
Measured: at three-month post-treatment
Functional Status Assessed by Oswestry Disability Index
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.
Measured: at six-month post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Jun 2016

First posted4 Apr 2017
Study startMay 2015
Primary completionFeb 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Herniated Lumbar DiscStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03101033
Sponsor's protocol ID: 20150401
Status last verified: Nov 2017
First submitted: 14 Mar 2017
Last updated: 4 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch Phys Med Rehabil. 1998 Nov;79(11):1362-6. doi: 10.1016/s0003-9993(98)90228-3.
PubMed 9821894
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. doi: 10.1007/s00776-006-1032-y.
PubMed 16897200
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.
PubMed 16902688
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.
PubMed 16868590
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. doi: 10.1097/00007632-200201010-00005.
PubMed 11805628
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. doi: 10.1097/00007632-198710000-00009.
PubMed 2961088
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.
PubMed 24466517

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Herniated Lumbar Disc trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03101033
Acronym / sponsor ID: 20150401
Conditions: Herniated Lumbar Disc
Keywords: Herniated lumbar disc, Epidural neuroplasty, Epidural injection
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: yan luUniversity, hospital or other
Study start: May 2015
Primary completion: Feb 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 4 Apr 2017 (actual)
Results: Posted 4 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Epidural neuroplasty group	Experimental	Device: Mechanical epidural neuroplasty, Drug: Caudal epidural compound betamethasone injection, Drug: Epidural hyaluronidase injectionThis group will be given epidural neuroplasty once enrolled.
Transforaminal steroid injection group	Active comparator	Drug: Transforaminal epidural compound betamethasone injectionThis 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

clinical diagnosis of herniated lumbar disc
written informed consent obtained

Key exclusion criteria (9 listed)

Lumbar instability
Piriformis syndrome
Diabetes mellitus with uncontrolled blood glucose
Severe osteoporosis
Impaired function of cauda equina

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mechanical epidural neuroplastyGuided 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.	Device	Epidural neuroplasty group
Transforaminal epidural compound betamethasone injectionGuided 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.	Drug	Transforaminal steroid injection group
Caudal epidural compound betamethasone injectionsteroid 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 neuroplasty group
Epidural hyaluronidase injectionHyaluronidase 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.	Drug	Epidural neuroplasty group

Primary outcome

Pain Assessed by Visual Analogue Scale
Time frame: 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.
Pain Assessed by Visual Analogue Scale
Time frame: 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.
Pain Assessed by Visual Analogue Scale
Time frame: 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.
Pain Assessed by Visual Analogue Scale
Time frame: 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.

4 secondary outcomes

Functional Status Assessed by Oswestry Disability Index
Time frame: before treatment
Functional Status Assessed by Oswestry Disability Index
Time frame: at one-month post-treatment
Functional Status Assessed by Oswestry Disability Index
Time frame: at three-month post-treatment
Functional Status Assessed by Oswestry Disability Index
Time frame: at six-month post-treatment

Results and safety

Results posted to the registry on 4 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epidural Neuroplasty Group	32	27
Transforaminal Steroid Injection Group	60	51

Primary outcome: Pain Assessed by Visual Analogue Scale

Time frame: before treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Epidural Neuroplasty Group n = 27	Transforaminal Steroid Injection Group n = 51
Value	5.63 (1.24)	5.92 (1.20)

Primary outcome: Pain Assessed by Visual Analogue Scale

Time frame: at one-month post-treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Epidural Neuroplasty Group n = 27	Transforaminal Steroid Injection Group n = 51
Value	2.37 (1.45)	2.35 (1.40)

Primary outcome: Pain Assessed by Visual Analogue Scale

Time frame: at three-month post-treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Epidural Neuroplasty Group n = 27	Transforaminal Steroid Injection Group n = 51
Value	2.19 (1.04)	3.25 (1.57)

Primary outcome: Pain Assessed by Visual Analogue Scale

Time frame: at six-month post-treatment. Mean (Standard Deviation). Unit: units on a scale

Measure	Epidural Neuroplasty Group n = 27	Transforaminal Steroid Injection Group n = 51
Value	2.81 (1.47)	4.06 (1.76)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: October 2015 and December 2015. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transforaminal Steroid Injection Group	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Epidural Neuroplasty Group	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9821894Lutz GE, Vad VB, Wisneski RJ. Fluoroscopic transforaminal lumbar epidural steroids: an outcome study. Arch Phys Med Rehabil. 1998 Nov;79(11):1362-6. doi: 10.1016/s0003-9993(98)90228-3.
Background: PubMed 16897200Veihelmann 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. doi: 10.1007/s00776-006-1032-y.
Background: PubMed 16902688Manchikanti 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.
Background: PubMed 16868590Manchikanti 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.
Background: PubMed 11805628Vad 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. doi: 10.1097/00007632-200201010-00005.
Background: PubMed 2961088McCarron 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. doi: 10.1097/00007632-198710000-00009.
Background: PubMed 24466517Kim 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.
Individual participant dataSharing planned: Yes

Related trials for Herniated Lumbar Disc

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yan Lu, MD,PhD study director

Fourth Military Medical University China

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assessed by Visual Analogue Scale (time frame: before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03101033, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.