Herniated Lumbar Disc
Conditions
Keywords
Herniated lumbar disc, Epidural neuroplasty, Epidural injection
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.
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.
Interventions
DEVICEMechanical 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.
DRUGTransforaminal 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.
DRUGCaudal 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.
DRUGEpidural 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.
Sponsors
yan lu
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 51 |
| Total | 78 |
Baseline characteristics
| Characteristic | Transforaminal Steroid Injection Group | Total | Epidural Neuroplasty Group |
|---|---|---|---|
| Age, Continuous | 47.67 years STANDARD_DEVIATION 15.34 | 48.83 years STANDARD_DEVIATION 15.07 | 51.04 years STANDARD_DEVIATION 14.56 |
| BMI | 23.37 kg/mʌ2 STANDARD_DEVIATION 1.66 | 23.17 kg/mʌ2 STANDARD_DEVIATION 1.6 | 22.50 kg/mʌ2 STANDARD_DEVIATION 2.24 |
| Duration of pain | 8.84 months STANDARD_DEVIATION 4.61 | 9.08 months STANDARD_DEVIATION 4.97 | 9.52 months STANDARD_DEVIATION 5.65 |
| Sex: Female, Male Female | 28 Participants | 40 Participants | 12 Participants |
| Sex: Female, Male Male | 23 Participants | 38 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 32 |
| other Total, other adverse events | 0 / 60 | 2 / 32 |
| serious Total, serious adverse events | 0 / 60 | 0 / 32 |
Outcome results
Primary
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.
Time frame: at three-month post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Pain Assessed by Visual Analogue Scale | 2.19 units on a scale | Standard Deviation 1.04 |
| Transforaminal Steroid Injection Group | Pain Assessed by Visual Analogue Scale | 3.25 units on a scale | Standard Deviation 1.57 |
Primary
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.
Time frame: at six-month post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Pain Assessed by Visual Analogue Scale | 2.81 units on a scale | Standard Deviation 1.47 |
| Transforaminal Steroid Injection Group | Pain Assessed by Visual Analogue Scale | 4.06 units on a scale | Standard Deviation 1.76 |
Primary
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.
Time frame: before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Pain Assessed by Visual Analogue Scale | 5.63 units on a scale | Standard Deviation 1.24 |
| Transforaminal Steroid Injection Group | Pain Assessed by Visual Analogue Scale | 5.92 units on a scale | Standard Deviation 1.2 |
Primary
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.
Time frame: at one-month post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Pain Assessed by Visual Analogue Scale | 2.37 units on a scale | Standard Deviation 1.45 |
| Transforaminal Steroid Injection Group | Pain Assessed by Visual Analogue Scale | 2.35 units on a scale | Standard Deviation 1.4 |
Secondary
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.
Time frame: before treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Functional Status Assessed by Oswestry Disability Index | 53.85 units on a scale | Standard Deviation 10.29 |
| Transforaminal Steroid Injection Group | Functional Status Assessed by Oswestry Disability Index | 57.84 units on a scale | Standard Deviation 9.63 |
Secondary
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.
Time frame: at one-month post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Functional Status Assessed by Oswestry Disability Index | 29.11 units on a scale | Standard Deviation 11.31 |
| Transforaminal Steroid Injection Group | Functional Status Assessed by Oswestry Disability Index | 35.02 units on a scale | Standard Deviation 13.04 |
Secondary
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.
Time frame: at three-month post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Functional Status Assessed by Oswestry Disability Index | 28.93 units on a scale | Standard Deviation 10.36 |
| Transforaminal Steroid Injection Group | Functional Status Assessed by Oswestry Disability Index | 39.82 units on a scale | Standard Deviation 14.59 |
Secondary
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.
Time frame: at six-month post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Epidural Neuroplasty Group | Functional Status Assessed by Oswestry Disability Index | 30.52 units on a scale | Standard Deviation 13.23 |
| Transforaminal Steroid Injection Group | Functional Status Assessed by Oswestry Disability Index | 46.39 units on a scale | Standard Deviation 15.58 |