Clinical trial NCT03933150: 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
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Lumbar Disc Prolapse
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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

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

1. Personal history

   o Name, age, sex, occupation, marital status, offspring and smoking.
2. 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
3. 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

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.

Primary outcomes:
measure: change of degree of pain from base line Patients were assessed before treatment, 1 month and 3 months after the injection using VAS.
timeFrame: assessed immediately before injection,1 month after injection,3 month after injection
measure: change of Straight leg raising test (SLRT) (Lasègue's sign from base line
timeFrame: assessed immediately before injection,1 month after injection,3 month after injection
measure: change of Femoral stretch test from base line
timeFrame: assessed immediately before injection,1 month after injection,3 month after injection
measure: change of Modified Schober's test from base line
timeFrame: assessed immediately before injection,1 month after injection,3 month after injection
Secondary outcomes:
measure: 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.
timeFrame: assessed immediately before injection,1 month after injection,3 month after injection
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of medicine Mansoura University
state: Dakahlia Provence
Study officials:
References: