Back Pain Lower Back ChronicPhase 2NCT01547364
Caudal Epidural Injection of Dextrose For Low Back Pain
A Phase 2 study testing Saline and Dextrose in people with Back Pain Lower Back Chronic, run by Smigel, Liza, M.D. at 1 site in United States.
Trial summary
Objective: The purposes of the study are to 1. Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline. 2. Determine if cumulative benefit results from caudal dextrose injection. 3. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Saline and Dextrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- More than 3 months of back pain
- Some pain below the iliac crest (Either in buttock or in leg)
- At least one conservative (non-injection) modality of treatment to include physical therapy, chiropractic/osteopathic manipulation, exercises, drug therapy, and relative rest.
- Opiate use absent or controlled
- Psychiatric history absent or controlled
- Current medical stability
- Absent steroid use history or no allergy or intolerance to steroid use
Who cannot join
- Unstable neurologic function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blinded Analgesic Effect and 1 Year Outcome of Caudal D5W Injection in All-Comers With Chronic Low Back Pain and Either Buttock or Leg Pain
Objective: The purposes of the study are to
- Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
- Determine if cumulative benefit results from caudal dextrose injection.
- Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.
Read the detailed description
Injection of dextrose into the epidural space as an admixture with various steroids and anesthetic has been utilized for years for purposes of altering the specific gravity of the injectate. No safety issues or concerns have been raised about the dextrose component inclusion but a separate therapeutic effect of dextrose has not heretofore been considered. Recently dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). An analgesic effect of dextrose on chronic pain in the presence of painful sensory nerves has been observed with injection of D5W without anesthetic. That effect begins within seconds clinically. Physicians have empirically trialed D5W for epidural injection in a 10 ml volume and found that marked or complete analgesia of chronic low back and leg pain results in the majority of patients within 15 minutes. An empirical consecutive patient date collection has demonstrated that this initial effect lasts for 2 to 48 hours, and that the effect begins to sustain after 2-3 sessions. For this reason, the current study is designed with the the first two objectives:
- Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
- Determine if cumulative benefit results from caudal dextrose injection.
In addition to determining potential benefit from caudal epidural of dextrose, the accuracy of a simple vertical approach to injection of dextrose is to be evaluated. If this vertical approach is accurate it will allow for
- More comfort with injection.
- Less need for radiographic exposure, in that needle placement is quicker and easier, allowing for less fluoroscopy time.
- Potential for blind injection of solutions that do not include anesthetic or particulate matter, increasing potential applicability of caudal dextrose injection to situations in which fluoroscopy is not available.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Saline, Dextrose
- Keywords
- Caudal, Epidural, Dextrose, Analgesia, TRVP1
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called Normal Saline
Injection of 10 ml of normal saline into the caudal epidural space
DextroseDrug
Also called D5W
Injection of 10 ml or dextrose 5% in water into the caudal epidural space
| Study group | Role | What they receive |
|---|---|---|
| Caudal Saline | Placebo comparator | Not described Receives: Drug: Saline |
| Caudal Dextrose | Active comparator | Not described Receives: Drug: Dextrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain
Caudal epidural injection of D5W will result in more analgesia at 20 minutes than epidural injection of normal saline.
Measured: 20 minutes
Secondary outcomes (2)
Change from Baseline to 1 year in NRS for Pain
Those with consistent analgesia after caudal epidural dextrose will note cumulative benefit on pain and disability that will exceed 1.5 times the MCID for pain and disability in low back pain. (NRS change of 3 or more)
Measured: 1 year
Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method
Blind use of the Rosen technique for vertical short needle caudal epidural injection will produce an epidurogram pattern 80% of the time upon first needle placement.
Measured: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower Back ChronicStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smigel, Liza, M.D.
- Responsible party
- Principal investigator, Liza Smigel, M.D., Smigel, Liza, M.D.
- Investigators
- Liza Smigel, M.D., Principal investigator, Liza Smigel, M.D., P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547364
- Sponsor's protocol ID
- SweetCaudal
- Status last verified
- Apr 2018
- First submitted
- 27 Feb 2012
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinded Analgesic Effect and 1 Year Outcome of Caudal D5W Injection in All-Comers With Chronic Low Back Pain and Either Buttock or Leg Pain
- ClinicalTrials.gov ID
- NCT01547364
- Acronym / sponsor ID
- SweetCaudal
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Caudal, Epidural, Dextrose, Analgesia, TRVP1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Smigel, Liza, M.D.
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Mar 2012 (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.
Objective: The purposes of the study are to
- Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
- Determine if cumulative benefit results from caudal dextrose injection.
- Evaluate accuracy of a small needle vertical approach caudal injection that will allow for blind injection of D5W.
Detailed description
Injection of dextrose into the epidural space as an admixture with various steroids and anesthetic has been utilized for years for purposes of altering the specific gravity of the injectate. No safety issues or concerns have been raised about the dextrose component inclusion but a separate therapeutic effect of dextrose has not heretofore been considered. Recently dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1 receptor on peptidergic nerves). An analgesic effect of dextrose on chronic pain in the presence of painful sensory nerves has been observed with injection of D5W without anesthetic. That effect begins within seconds clinically. Physicians have empirically trialed D5W for epidural injection in a 10 ml volume and found that marked or complete analgesia of chronic low back and leg pain results in the majority of patients within 15 minutes. An empirical consecutive patient date collection has demonstrated that this initial effect lasts for 2 to 48 hours, and that the effect begins to sustain after 2-3 sessions. For this reason, the current study is designed with the the first two objectives:
- Explore the immediate and short term (to 48 hour) analgesic potential of epidural D5W in comparison to normal saline.
- Determine if cumulative benefit results from caudal dextrose injection.
In addition to determining potential benefit from caudal epidural of dextrose, the accuracy of a simple vertical approach to injection of dextrose is to be evaluated. If this vertical approach is accurate it will allow for
- More comfort with injection.
- Less need for radiographic exposure, in that needle placement is quicker and easier, allowing for less fluoroscopy time.
- Potential for blind injection of solutions that do not include anesthetic or particulate matter, increasing potential applicability of caudal dextrose injection to situations in which fluoroscopy is not available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caudal Saline | Placebo comparator | Drug: Saline |
| Caudal Dextrose | Active comparator | Drug: Dextrose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- More than 3 months of back pain
- Some pain below the iliac crest (Either in buttock or in leg)
- At least one conservative (non-injection) modality of treatment to include physical therapy, chiropractic/osteopathic manipulation, exercises, drug therapy, and relative rest.
- Opiate use absent or controlled
- Psychiatric history absent or controlled
Key exclusion criteria (1 listed)
- Unstable neurologic function
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 |
|---|---|---|
| SalineAlso: Normal SalineInjection of 10 ml of normal saline into the caudal epidural space | Drug | Caudal Saline |
| DextroseAlso: D5WInjection of 10 ml or dextrose 5% in water into the caudal epidural space | Drug | Caudal Dextrose |
Primary outcome
Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain
Time frame: 20 minutes
Caudal epidural injection of D5W will result in more analgesia at 20 minutes than epidural injection of normal saline.
2 secondary outcomes
Change from Baseline to 1 year in NRS for Pain
Time frame: 1 year
Percentage Success of Epidurogram Pattern Production with a Blind Needle Placement Using a Vertical Caudal Epidural Method
Time frame: Dye instillation immediately after needle placement with observation of dye pattern fluoroscopically.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
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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.
Liza Smigel, M.D. principal investigator
Liza Smigel, M.D., P.A.
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 Saline and Dextrose in people with Back Pain Lower Back Chronic, run by Smigel, Liza, M.D. 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 1 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: finished, as of the sponsor's last update on 30 Apr 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to 20 minutes in Numerical Rating Scale(NRS) for Pain (time frame: 20 minutes). 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 30 Apr 2018.