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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand the study's requirements and can accurately report my health data.I have had cancer before.I have had lower back pain for over 6 months with a current pain level above 6/10.I do not have any heart problems causing symptoms or instability.I have tried at least 2 different supportive treatments like physical therapy or acupuncture.I am 18 years old or older.I do not have any health or personal issues that would stop me from following the study's requirements.I experience low back pain.My lower back pain is confirmed by MRI or X-ray to affect the L4 nerve root or below.I have had at least 2 unsuccessful spinal injections for pain relief.I have one or more risk factors related to my treatment.I have breathing problems that are getting worse or causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Epidural Prolotherapy
- Group 2: Epidural Steroid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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