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Caudal Epidural Steroid Injection Ultrasound Guided in LDP

Primary Purpose

Refractory Lumbar Disc Prolapse

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided caudal epidural injection
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Refractory Lumbar Disc Prolapse

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI,

Exclusion Criteria:

  • Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients.

Sites / Locations

  • Faculty of medicine Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ultrasoun guided caudal epidural injection

fluoroscopy guided caudal epidural injection

Arm Description

A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.

B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor

Outcomes

Primary Outcome Measures

change of degree of pain from base line Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
Visual analog scale for pain is a measurement tool that measures a characteristic or attitude that is believed to range across a continuum of values.It is usually a horizontal line, 100 mm in length, anchored by verbal descriptors at each end: 'no pain' and 'worst pain possible'. The patients place a mark on the line that represented their level of pain intensity. The distance from the left-hand side was measured in millimeters. This distance quantifies pain level. The following cut points on has been suggested: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100mm) (Smeets, et al., 2011; Elfving, et al., 2016).
change of Straight leg raising test (SLRT) (Lasègue's sign from base line
One of the most common clinical diagnostic tests (Iversen, et al., 2013). The patient lies on a table in supine position. With one hand set over the knee of the leg being examined, the examiner applies enough firm pressureto keep the knee in full extension. With the alternate hand cupped under the heel, the examiner raises the straight limb gradually. Sciatic nerve compression is indicated if pain is agonized or worsened on raising the leg to a level more than 25° but lower than 75º. The ankle is dorsiflexed as the leg is held at the limit of straight-leg raising (onset). Symptoms are exaggerated in persons who have nerve root compression as the reason (De Luigi and Fitzpatrick, 2011).
change of Femoral stretch test from base line
While patient lies prone, the knee is inactively flexed to the thigh and the hip is pas extended; thetest ispositive if the patient encounters pain in front of the thigh (Magee, 2013).
change of Modified Schober's test from base line
While the patient is standing erect, marks are made 5 cm below and 10 cm above the lumbosacral junction (dimples of Venus) and the distance between the two marks is measured. Then measurement is repeated with the patient in full forward flexion (Fig. 9). In general, the measure should increase by at least 5 cm to 21 cm. An increase of less than 5 cm advocates decreased lumbar spinal mobility.

Secondary Outcome Measures

change of pain and function from base line: Oswestry Disability Index Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI.
Oswestry Disability Index (Fairbank and Pynsent, 2000) It is a self-administered questionnaire compromised of 10 sections; each section is scored on a 0-5 scale, 5 representing the greatest disability (see the Appendix). It is composed of 10 short-termsectors. The index is calculated by dividing the summed score by the total possible score, after that it is multiplied by 100 and expressed as a percentage. Thus, for the not answered questions, the denominator is reduced by 5 for each. Interpretation of scores: 0% to 20%:minimal disability:The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability:The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative

Full Information

First Posted
April 24, 2019
Last Updated
March 20, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT03933150
Brief Title
Caudal Epidural Steroid Injection Ultrasound Guided in LDP
Official Title
Caudal Epidural Steroid Injection Ultrasound Guided Versus Fluoroscopy Guided in Treatment of Refractory Lumbar Disc Prolapse With Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients. All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
Detailed Description
228 patients suffering from LDP with radiculopathy,recruited from the outpatient Clinic of Rheumatology and Rehabilitation department at Mansoura University Hospital were assessed for eligibility to participate in this study. Those who met the inclusion criteria wereselected. Conversely, those who did not meet inclusion criteria or met the exclusion criteria were excluded.Accordingly, 136 patients who met the inclusion criteria were divided into two groups: Group 1: included 68 patients who received US-guided CESI. They were 39 females and 29 males. Their age ranged from 23 to 65. Group 2: included 68 patients who received FL-guided CESI. They were 38 females and 30 males. Their age ranged from 22 to 62. A written consent was obtained from each participant sharing in this study. The institutional research board of faculty of medicine, Mansoura University, approved this study, code: MS/16.06.46. Inclusion Criteria: Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, in whom conservative treatment (medical treatment and physiotherapy) failed for more than 6 weeks and refuse surgery or were unfit for surgery Exclusion Criteria: Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients. Study design: Randomized controlled clinical trial. Type of randomization: Patients were randomly divided into 2 treatment groups. For allotting, bunches bits of paper were set up in a similar number of patients. The name of treatment strategies was composed on the bits of paper. At that point, patients were made a request to take one paper and this is the treatment sort for every individual was determined. I. Clinical Evaluation: 1. History Taking:including Personal history o Name, age, sex, occupation, marital status, offspring and smoking. Present History Pain: onset, course, duration, site, nature, radiation and modifying factors. Associated symptoms: fever, unexplained weight loss, night pain, chronic cough, stiffness, pain in other joints, skin lesions, diarrhea, urogenital diseases, eye lesions, anxiety, depression, fatigue or sleep disturbance. Neurological symptoms: numbness, paresthesia, muscle weakness, claudication, or sphincteric disturbance. Articular symptoms : of other joints including cervical, hips and knees Symptoms related to other systems: respiratory, cardiovascular, gastrointestinal, urinary, and gynecological systems. Work related conditions Past History III. Assessment of pain Patients were assessed before treatment, 1 month and 3 months after the injection using VAS. IV. Assessment of pain and function Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI. All the eligible patients were treated with either US-guided or FL-guided CESI, were administered a mixture of 20 cc (0.5% lidocaine 18.0 mL &2ml of triamcinolone acetonide 40 mg/1ml) (Bicket, et al., 2015; Manchikanti, et al., 2015b). A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients. B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Lumbar Disc Prolapse

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Type of randomization: Patients were randomly divided into 2 treatment groups. For allotting, bunches bits of paper were set up in a similar number of patients. The name of treatment strategies was composed on the bits of paper. At that point, patients were made a request to take one paper and this is the treatment sort for every individual was determined.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ultrasoun guided caudal epidural injection
Arm Type
Other
Arm Description
A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
Arm Title
fluoroscopy guided caudal epidural injection
Arm Type
Other
Arm Description
B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
Intervention Type
Device
Intervention Name(s)
ultrasound guided caudal epidural injection
Other Intervention Name(s)
fluoroscopy guided caudal epidural injection
Intervention Description
A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients. B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor
Primary Outcome Measure Information:
Title
change of degree of pain from base line Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
Description
Visual analog scale for pain is a measurement tool that measures a characteristic or attitude that is believed to range across a continuum of values.It is usually a horizontal line, 100 mm in length, anchored by verbal descriptors at each end: 'no pain' and 'worst pain possible'. The patients place a mark on the line that represented their level of pain intensity. The distance from the left-hand side was measured in millimeters. This distance quantifies pain level. The following cut points on has been suggested: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100mm) (Smeets, et al., 2011; Elfving, et al., 2016).
Time Frame
assessed immediately before injection,1 month after injection,3 month after injection
Title
change of Straight leg raising test (SLRT) (Lasègue's sign from base line
Description
One of the most common clinical diagnostic tests (Iversen, et al., 2013). The patient lies on a table in supine position. With one hand set over the knee of the leg being examined, the examiner applies enough firm pressureto keep the knee in full extension. With the alternate hand cupped under the heel, the examiner raises the straight limb gradually. Sciatic nerve compression is indicated if pain is agonized or worsened on raising the leg to a level more than 25° but lower than 75º. The ankle is dorsiflexed as the leg is held at the limit of straight-leg raising (onset). Symptoms are exaggerated in persons who have nerve root compression as the reason (De Luigi and Fitzpatrick, 2011).
Time Frame
assessed immediately before injection,1 month after injection,3 month after injection
Title
change of Femoral stretch test from base line
Description
While patient lies prone, the knee is inactively flexed to the thigh and the hip is pas extended; thetest ispositive if the patient encounters pain in front of the thigh (Magee, 2013).
Time Frame
assessed immediately before injection,1 month after injection,3 month after injection
Title
change of Modified Schober's test from base line
Description
While the patient is standing erect, marks are made 5 cm below and 10 cm above the lumbosacral junction (dimples of Venus) and the distance between the two marks is measured. Then measurement is repeated with the patient in full forward flexion (Fig. 9). In general, the measure should increase by at least 5 cm to 21 cm. An increase of less than 5 cm advocates decreased lumbar spinal mobility.
Time Frame
assessed immediately before injection,1 month after injection,3 month after injection
Secondary Outcome Measure Information:
Title
change of pain and function from base line: Oswestry Disability Index Patients were assessed before treatment, 1 month and 3 months after the injection procedure by the ODI.
Description
Oswestry Disability Index (Fairbank and Pynsent, 2000) It is a self-administered questionnaire compromised of 10 sections; each section is scored on a 0-5 scale, 5 representing the greatest disability (see the Appendix). It is composed of 10 short-termsectors. The index is calculated by dividing the summed score by the total possible score, after that it is multiplied by 100 and expressed as a percentage. Thus, for the not answered questions, the denominator is reduced by 5 for each. Interpretation of scores: 0% to 20%:minimal disability:The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability:The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative
Time Frame
assessed immediately before injection,1 month after injection,3 month after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, Exclusion Criteria: Vertebral fractures, direct trauma, spinal inflammatory disease, spinal infection, bleeding tendency, LBP with tumors, bilateral radiculopathy, cauda equina syndrome, spinal canal stenosis, post-laminectomy surgery, diabetic and hypertensive patients.
Facility Information:
Facility Name
Faculty of medicine Mansoura University
City
Mansoura
State/Province
Dakahlia Provence
ZIP/Postal Code
050
Country
Egypt

12. IPD Sharing Statement

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Caudal Epidural Steroid Injection Ultrasound Guided in LDP

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