This study will be held on patients with failed back surgery syndrome, the investigators are comparing prolotherapy and steroids injections in caudal epidural space to relieve the pain
This study is a prospective double blinded randomized controlled study. It will be held on patients with failed back surgery syndrome aged between 20 and 70 years old, one group will receive ultrasound and fluoroscopy-guided injection of prolotherapy in caudal epidural space while the other group will receive ultrasound and fluoroscopy-guided injection of steroids in the caudal epidural space 40 patients will be included in each group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
a type of steroids injected in epidural space
a type of hypertonic glucose
Ahmed S. Shehab
Alexandria, Egypt
Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful
Time frame: 2 weeks
the level reached by the injectate
by using fluoroscopy guidance
Time frame: at time of injection
assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS) from 0 to 28 where 0 is so dissatisfied and 28 means very satisfied
assess the satisfaction of the patients
Time frame: 6 months
further change in visual analogue scale
in the next follow up periods
Time frame: 2 weeks till 6 months
recording the number of patients who encountered any complications and treating them accordingly
such as pain, allergy, swelling at the site of injection, nerve injury, elevated blood sugar level, nausea and vomiting
Time frame: 6 months
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