Refractory Lumbar Disc Prolapse Clinical Trial
Official title:
Caudal Epidural Steroid Injection Ultrasound Guided Versus Fluoroscopy Guided in Treatment of Refractory Lumbar Disc Prolapse With Radiculopathy
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
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
;