Chronic Pain Syndrome
Conditions
Keywords
caudal epidural, prolotherapy, steroids, failed back surgery
Brief summary
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
Detailed description
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
Interventions
DRUGmedthylprednisolone
a type of steroids injected in epidural space
DRUGprolotherapy
a type of hypertonic glucose
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) double blinded
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. patients diagnosed with failed back surgery syndrome, having chronic pain for more than 3 months by a detailed assessment including medical history and examination 2. patients having positive radiological (MRI) findings of spinal nerve roots being irritated or compressed after having surgery for one of many conditions including: lumbar disc herniation, spinal canal stenosis, osteophytes, spodylolithesis or foramen stenosis 3. patients whom another surgery is not indicated
Exclusion criteria
1. patient refusal 2. pregnancy 3. systemic infection or infection at the site of injection 4. patients on anticoagulation 5. immunocompromised patients as uncontrolled diabetes, osteoporosis as a contraindication for steroid injection 6. patients with renal impairment or on dialysis 7. acute disc prolapse as it requires immediate surgery 8. opioid use 9. concurrent significant depressive illness, inflammatory of joint disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain | 2 weeks | A decrease in VAS score after 2 weeks by 50 percent or more from pre-injection level is considered successful |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the level reached by the injectate | at time of injection | by using fluoroscopy guidance |
| 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 | 6 months | assess the satisfaction of the patients |
| further change in visual analogue scale | 2 weeks till 6 months | in the next follow up periods |
| recording the number of patients who encountered any complications and treating them accordingly | 6 months | such as pain, allergy, swelling at the site of injection, nerve injury, elevated blood sugar level, nausea and vomiting |
Countries
Egypt
Outcome results
None listed