no ConditionsPhase 2NCT02116075
Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
A Phase 2 study testing Epidural Prolotherapy and Epidural Steroid in people with no Conditions, run by Naveed Natanzi at 1 site in United States.
Trial summary
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- no Conditions
- What is being tested?
- Epidural Prolotherapy and Epidural Steroid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings.
- Evidence of low back pain base upon one or more of the following:
- Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS.
- Has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.)
- Men or women age greater than or equal to 18 years.
- No significant alcohol use (7 or fewer drinks per week).
- Patient has a history of at least 2 failed epidural CS injections.
Who cannot join
- Treatment risk factors including one or more of the following:
- Unstable or symptomatic cardiac complaints ii. Unstable or symptomatic respiratory complaints iii. Unable to reliably comprehend the protocol or reliably record data
- Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
- History of Malignancy
- Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veteran'S Affairs Healthy System
Long Beach, California
NAVEED NATANZI, DO, NNATANZI@UCI.EDU
About this study
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
- Conditions
- no Conditions
- Being tested
- Epidural Prolotherapy, Epidural Steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural ProlotherapyProcedure or surgery
caudal injection of 10mL 5% dextrose
Epidural SteroidProcedure or surgery
caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Epidural Steroid | Experimental | 80mg depo-medrol 9mL 1% lidocaine Receives: Procedure: Epidural Prolotherapy |
| Epidural Prolotherapy | Active comparator | 10ml of 5% generic dextrose Receives: Procedure: Epidural Steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief as measured by VAS pain scale.
Measured: 1 year
Secondary outcomes (2)
Change in the frequency and amount of opioid use.
Measured: 1 year
Disability score as determined by Oswstery questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naveed Natanzi
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Naveed Natanzi, VA Long Beach Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116075
- Sponsor's protocol ID
- SC2626
- Status last verified
- Jun 2015
- First submitted
- 9 Apr 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
- ClinicalTrials.gov ID
- NCT02116075
- Acronym / sponsor ID
- SC2626
- Conditions
- no Conditions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Naveed NatanziUS federal agency
- Study start
- Jan 2015
- Primary completion
- Nov 2016 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study comparing caudal prolotherapy to conventional steroid for chronic low back pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Steroid | Experimental | Procedure: Epidural Prolotherapy80mg depo-medrol 9mL 1% lidocaine |
| Epidural Prolotherapy | Active comparator | Procedure: Epidural Steroid10ml of 5% generic dextrose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings.
- Evidence of low back pain base upon one or more of the following:
- Men or women age greater than or equal to 18 years.
- No significant alcohol use (7 or fewer drinks per week).
- Patient has a history of at least 2 failed epidural CS injections.
Key exclusion criteria (5 listed)
- Treatment risk factors including one or more of the following:
- Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
- History of Malignancy
- Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Prolotherapycaudal injection of 10mL 5% dextrose | Procedure or surgery | Epidural Steroid |
| Epidural Steroidcaudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine | Procedure or surgery | Epidural Prolotherapy |
Primary outcome
Pain relief as measured by VAS pain scale.
Time frame: 1 year
2 secondary outcomes
Change in the frequency and amount of opioid use.
Time frame: 1 year
Disability score as determined by Oswstery questionnaire.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epidural Prolotherapy and Epidural Steroid in people with no Conditions, run by Naveed Natanzi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naveed M Natanzi, DO (8186059333, NNATANZI@UCI.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief as measured by VAS pain scale. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.