Clinical trial NCT05548738: Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome
Official title: The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Pain Syndrome
Keywords: caudal epidural
prolotherapy
steroids
failed back surgery
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Assessing in both groups the Visual analogue scale from 0-10 where 0 indicates no pain and 10 indicates maximum pain
timeFrame: 2 weeks
Secondary outcomes:
measure: the level reached by the injectate
timeFrame: at time of injection
measure: 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
timeFrame: 6 months
measure: further change in visual analogue scale
timeFrame: 2 weeks till 6 months
measure: recording the number of patients who encountered any complications and treating them accordingly
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Ahmed S. Shehab
Study officials:
affiliation: Alexandria University
name: Ahmed S shehab
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maniquis-Smigel L, Reeves KD, Rosen HJ, Lyftogt J, Graham-Coleman C, Cheng AL, Rabago D. Analgesic Effect and Potential Cumulative Benefit from Caudal Epidural D5W in Consecutive Participants with Chronic Low-Back and Buttock/Leg Pain. J Altern Complement Med. 2018 Dec;24(12):1189-1196. doi: 10.1089/acm.2018.0085. Epub 2018 Jun 8.