Chronic Low Back PainNCT00887003
Epidural Study of Patients With Chronic Lower Back Pain
A study testing Bupivacaine and Depo-Medrol in people with Chronic Low Back Pain, run by McMaster University at 1 site in Canada.
Trial summary
The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Bupivacaine and Depo-Medrol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Sep 2011
- Phase
- Interventional
- 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
- 18-75 years old
- lower back pains > 6 months
- no lumbar epidural in past 6 months
- no previous back surgery
- written informed consent to participate in study
Who cannot join
- acute lower back pain
- pregnancy
- significant psychiatric disease
- local or systemic infection
- coagulopathy/anticoagulant therapy
- bleeding diathesis
- presently enrolled in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain
The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.
Read the detailed description
To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.
- Conditions
- Chronic Low Back Pain
- Being tested
- Bupivacaine, Depo-Medrol
- Keywords
- epidural, volume, dose, pain relief, steroid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called steroid
Low Volume, Low Dose (5cc, 5mg plain Bupivacaine)
BupivacaineDrug
Also called steroid
Low Volume, High Dose (5cc, 10mg plain Bupivacaine)
BupivacaineDrug
Also called steroid
High Volume, Low Dose (10cc, 5mg plain Bupivacaine)
BupivacaineDrug
Also called steroid
High Volume, High Dose (10cc, 10mg plain Bupivacaine)
Depo-MedrolDrug
Also called methylprednisolone
80mg Depo-Medrol
| Study group | Role | What they receive |
|---|---|---|
| LV/LD 1 | Experimental | Low Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol Receives: Drug: Bupivacaine; Drug: Depo-Medrol |
| LV/HD 2 | Experimental | Low Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol Receives: Drug: Bupivacaine; Drug: Depo-Medrol |
| HV/LD 3 | Experimental | High Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol Receives: Drug: Bupivacaine; Drug: Depo-Medrol |
| HV/HD 4 | Experimental | High Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol Receives: Drug: Bupivacaine; Drug: Depo-Medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.
Measured: Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.
Secondary outcomes (1)
Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.
Measured: Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startMay 2005
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor
- Investigators
- Julian Mulcaster, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887003
- Sponsor's protocol ID
- 04-392
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2009
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Volume and Dose of Local Anaesthetic Solution in Epidural Steroidal Injections for Patients With Chronic Lower Back Pain
- ClinicalTrials.gov ID
- NCT00887003
- Acronym / sponsor ID
- 04-392
- Conditions
- Chronic Low Back Pain
- Keywords
- epidural, volume, dose, pain relief, steroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- May 2005 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Apr 2009 (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.
The purpose of this study is to examine 4 different epidural dosing regimes of local anaesthetic solution in a series of 3 epidural injections over a period of 12 months to determine the optimum dose of anaesthetic solution for pain relief and to determine the nature of any adverse events by measuring anxiety and depression, functionality and any side effects of the medication.
Detailed description
To determine the optimum dose of local anesthetic and the optimum volume of injected solution when used in an epidural steroid injection being given for pain relief to patients with chronic lower back pain, using pain scores as an assessment tool.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LV/LD 1 | Experimental | Drug: Bupivacaine, Drug: Depo-MedrolLow Volume, Low Dose (5cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol |
| LV/HD 2 | Experimental | Drug: Bupivacaine, Drug: Depo-MedrolLow Volume, High Dose (5cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol |
| HV/LD 3 | Experimental | Drug: Bupivacaine, Drug: Depo-MedrolHigh Volume, Low Dose (10cc, 5mg plain Bupivacaine) + 80mg Depo-Medrol |
| HV/HD 4 | Experimental | Drug: Bupivacaine, Drug: Depo-MedrolHigh Volume, High Dose (10cc, 10mg plain Bupivacaine) + 80mg Depo-Medrol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years old
- lower back pains > 6 months
- no lumbar epidural in past 6 months
- no previous back surgery
- written informed consent to participate in study
Key exclusion criteria (7 listed)
- acute lower back pain
- pregnancy
- significant psychiatric disease
- local or systemic infection
- coagulopathy/anticoagulant therapy
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 |
|---|---|---|
| BupivacaineAlso: steroidLow Volume, Low Dose (5cc, 5mg plain Bupivacaine) | Drug | LV/LD 1 |
| BupivacaineAlso: steroidLow Volume, High Dose (5cc, 10mg plain Bupivacaine) | Drug | LV/HD 2 |
| BupivacaineAlso: steroidHigh Volume, Low Dose (10cc, 5mg plain Bupivacaine) | Drug | HV/LD 3 |
| BupivacaineAlso: steroidHigh Volume, High Dose (10cc, 10mg plain Bupivacaine) | Drug | HV/HD 4 |
| Depo-MedrolAlso: methylprednisolone80mg Depo-Medrol | Drug | HV/HD 4, HV/LD 3, LV/HD 2, LV/LD 1 |
Primary outcome
The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief.
Time frame: Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.
1 secondary outcome
Secondary outcomes will be scores on the Oswestry low back pain disability scale and the Hospital anxiety and depression scale correlated with treatment outcomes and adverse events.
Time frame: Oswestry scores and HADS scores will be calculated at 5 time periods throughout the study period, prior to 1st, 2nd, and 3rd injections and at 3 and 6 month post the three month injection.
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 10 Jun 2026.
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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.
Julian Mulcaster, MD principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Depo-Medrol in people with Chronic Low Back Pain, run by McMaster University at 1 site in Canada.
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 5 inclusion and 7 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 10 Jun 2026. 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 Canada. 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.
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?
The volume and dose of local anesthetic injected epidurally, in combination with the steroid, will be measured against the duration and degree of pain relief. (time frame: Pain scores will be measured at 6 time intervals throughout the study period, prior to 1st injection, 30 minutes post 1st injection, prior to 2nd injection and 3rd injections and at 3 and 6 month post the three month injection.). 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 10 Jun 2026.