Caudal Epidural Prolotherapy Versus Steroids in Failed Back Surgery Syndrome

Chronic Pain Syndrome Clinical Trial

Official title:

The Efficacy of Ultrasound and Fluoroscopy Guided Caudal Epidural Prolotherapy Versus Steroids for Chronic Pain Management in Failed Back Surgery Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05548738
• Other study ID #: 0201626
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 20, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Failed Back Surgery Syndrome
• Syndrome

Intervention

Drug:
• medthylprednisolone
a type of steroids injected in epidural space
• prolotherapy
a type of hypertonic glucose

Locations

Country	Name	City	State
Egypt	Ahmed S. Shehab	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 weeks
Secondary	the level reached by the injectate	by using fluoroscopy guidance	at time of injection
Secondary	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	6 months
Secondary	further change in visual analogue scale	in the next follow up periods	2 weeks till 6 months
Secondary	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	6 months