Trial Outcomes & Findings for Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk (NCT NCT03101033)
NCT ID: NCT03101033
Last Updated: 2018-09-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
before treatment
Results posted on
2018-09-04
Participant Flow
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.
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.
Participant milestones
| Measure |
Epidural Neuroplasty Group
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
60
|
|
Overall Study
COMPLETED
|
27
|
51
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk
Baseline characteristics by cohort
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.04 years
STANDARD_DEVIATION 14.56 • n=5 Participants
|
47.67 years
STANDARD_DEVIATION 15.34 • n=7 Participants
|
48.83 years
STANDARD_DEVIATION 15.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
BMI
|
22.50 kg/mʌ2
STANDARD_DEVIATION 2.24 • n=5 Participants
|
23.37 kg/mʌ2
STANDARD_DEVIATION 1.66 • n=7 Participants
|
23.17 kg/mʌ2
STANDARD_DEVIATION 1.60 • n=5 Participants
|
|
Duration of pain
|
9.52 months
STANDARD_DEVIATION 5.65 • n=5 Participants
|
8.84 months
STANDARD_DEVIATION 4.61 • n=7 Participants
|
9.08 months
STANDARD_DEVIATION 4.97 • n=5 Participants
|
PRIMARY outcome
Timeframe: before treatmentVAS (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Pain Assessed by Visual Analogue Scale
|
5.63 units on a scale
Standard Deviation 1.24
|
5.92 units on a scale
Standard Deviation 1.20
|
PRIMARY outcome
Timeframe: at one-month post-treatmentVAS (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Pain Assessed by Visual Analogue Scale
|
2.37 units on a scale
Standard Deviation 1.45
|
2.35 units on a scale
Standard Deviation 1.40
|
PRIMARY outcome
Timeframe: at three-month post-treatmentVAS (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Pain Assessed by Visual Analogue Scale
|
2.19 units on a scale
Standard Deviation 1.04
|
3.25 units on a scale
Standard Deviation 1.57
|
PRIMARY outcome
Timeframe: at six-month post-treatmentVAS (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Pain Assessed by Visual Analogue Scale
|
2.81 units on a scale
Standard Deviation 1.47
|
4.06 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: before treatmentODI (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Functional Status Assessed by Oswestry Disability Index
|
53.85 units on a scale
Standard Deviation 10.29
|
57.84 units on a scale
Standard Deviation 9.63
|
SECONDARY outcome
Timeframe: at one-month post-treatmentODI (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Functional Status Assessed by Oswestry Disability Index
|
29.11 units on a scale
Standard Deviation 11.31
|
35.02 units on a scale
Standard Deviation 13.04
|
SECONDARY outcome
Timeframe: at three-month post-treatmentODI (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Functional Status Assessed by Oswestry Disability Index
|
28.93 units on a scale
Standard Deviation 10.36
|
39.82 units on a scale
Standard Deviation 14.59
|
SECONDARY outcome
Timeframe: at six-month post-treatmentODI (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.
Outcome measures
| Measure |
Epidural Neuroplasty Group
n=27 Participants
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.
|
Transforaminal Steroid Injection Group
n=51 Participants
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.
|
|---|---|---|
|
Functional Status Assessed by Oswestry Disability Index
|
30.52 units on a scale
Standard Deviation 13.23
|
46.39 units on a scale
Standard Deviation 15.58
|
Adverse Events
Transforaminal Steroid Injection Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epidural Neuroplasty Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transforaminal Steroid Injection Group
n=60 participants at risk
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.
|
Epidural Neuroplasty Group
n=32 participants at risk
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.
|
|---|---|---|
|
Surgical and medical procedures
severe pain induced by the NP procedures in two participants
|
0.00%
0/60 • October 2015 and December 2015
|
6.2%
2/32 • Number of events 2 • October 2015 and December 2015
|
Additional Information
Dr yan lu
Xijing Hospital, the Fourth Military Medical University
Phone: 029-84775337
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place