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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Refractory Lumbar Disc Prolapse | Device: ultrasound guided caudal epidural injection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention 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) |
Primary Purpose: | Health Services Research |
Official Title: | Caudal Epidural Steroid Injection Ultrasound Guided Versus Fluoroscopy Guided in Treatment of Refractory Lumbar Disc Prolapse With Radiculopathy |
Actual Study Start Date : | June 1, 2019 |
Actual Primary Completion Date : | November 1, 2019 |
Actual Study Completion Date : | December 1, 2019 |
Arm | Intervention/treatment |
---|---|
ultrasoun guided caudal epidural injection
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.
|
Device: ultrasound guided caudal epidural injection
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 Other Name: fluoroscopy guided caudal epidural injection
|
fluoroscopy guided caudal epidural injection
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
|
Device: ultrasound guided caudal epidural injection
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 Other Name: fluoroscopy guided caudal epidural injection
|
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
Ages Eligible for Study: | 22 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI,
Exclusion Criteria:
Egypt | |
Faculty of medicine Mansoura University | |
Mansoura, Dakahlia Provence, Egypt, 050 |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 24, 2019 | ||||
First Posted Date ICMJE | May 1, 2019 | ||||
Last Update Posted Date | March 23, 2020 | ||||
Actual Study Start Date ICMJE | June 1, 2019 | ||||
Actual Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: assessed immediately before injection,1 month after injection,3 month after injection ] 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
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Caudal Epidural Steroid Injection Ultrasound Guided in LDP | ||||
Official Title ICMJE | Caudal Epidural Steroid Injection Ultrasound Guided Versus Fluoroscopy Guided in Treatment of Refractory Lumbar Disc Prolapse With Radiculopathy | ||||
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:
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
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 |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Sequential Assignment Intervention 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. Primary Purpose: Health Services Research |
||||
Condition ICMJE | Refractory Lumbar Disc Prolapse | ||||
Intervention ICMJE | Device: ultrasound guided caudal epidural injection
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 Other Name: fluoroscopy guided caudal epidural injection
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
120 | ||||
Original Estimated Enrollment ICMJE |
228 | ||||
Actual Study Completion Date ICMJE | December 1, 2019 | ||||
Actual Primary Completion Date | November 1, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria: - Patients with LDP with unilateral radiculopathy diagnosed by routine clinical examination and MRI, Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 22 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03933150 | ||||
Other Study ID Numbers ICMJE | code: MS/16.06.46. | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Mansoura University | ||||
Study Sponsor ICMJE | Mansoura University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Mansoura University | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |