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Corticosteroid

Prolotherapy vs. Steroid Injections for Chronic Low Back Pain

Phase 2
Waitlist Available
Research Sponsored by Naveed Natanzi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS
Has received at least 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial found that caudal prolotherapy was more effective than conventional steroid injections for chronic low back pain.

Who is the study for?
This trial is for adults over 18 with chronic low back pain, specifically at the L4 nerve root level or below, confirmed by MRI or X-ray. They should have tried at least two other treatments like physical therapy and must not be heavy drinkers. People can't join if they have respiratory or cardiac issues, trouble understanding the study, a history of cancer, certain medical conditions that could affect participation, are pregnant or might become pregnant.Check my eligibility
What is being tested?
The study is comparing two types of injections for chronic low back pain: caudal prolotherapy (dextrose injection) and conventional epidural steroid injections. It aims to see which treatment provides better relief from pain.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, infection risk from the procedure itself, allergic reactions to injected substances, increased blood sugar levels especially in diabetics due to steroids and temporary increases in pain following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had lower back pain for over 6 months with a current pain level above 6/10.
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I have tried at least 2 different supportive treatments like physical therapy or acupuncture.
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I am 18 years old or older.
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I experience low back pain.
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My lower back pain is confirmed by MRI or X-ray to affect the L4 nerve root or below.
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I have had at least 2 unsuccessful spinal injections for pain relief.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain relief as measured by VAS pain scale.
Secondary outcome measures
Change in the frequency and amount of opioid use.
Disability score as determined by Oswstery questionnaire.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Epidural SteroidExperimental Treatment1 Intervention
80mg depo-medrol 9mL 1% lidocaine
Group II: Epidural ProlotherapyActive Control1 Intervention
10ml of 5% generic dextrose

Find a Location

Who is running the clinical trial?

Naveed NatanziLead Sponsor

Media Library

Epidural Steroid (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02116075 — Phase 2
None Research Study Groups: Epidural Prolotherapy, Epidural Steroid
None Clinical Trial 2023: Epidural Steroid Highlights & Side Effects. Trial Name: NCT02116075 — Phase 2
Epidural Steroid (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02116075 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to volunteer for this research endeavor at the moment?

"The clinicaltrials.gov database shows that this trial, which was initially posted on the 1st of January 2015, is no longer recruiting patients. Nonetheless, another research project has opened up recruitment opportunities at present."

Answered by AI

To what extent could Epidural Prolotherapy put patients at risk?

"The potency of Epidural Prolotherapy is assessed at a level 2 due to the existence of safety-supporting data, though no efficacy evidence has been collected yet."

Answered by AI
~5 spots leftby Mar 2025