Caudal Epidural Steroid Injection Ultrasound Guided in LDP
Condition: Refractory Lumbar Disc Prolapse
MeSH terms: Intervertebral Disc Displacement; Prolapse
Study type: Interventional

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
    

Intervention name(s): ultrasound guided caudal epidural injection
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): fluoroscopy guided caudal epidural injection
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