Back PainNCT02239627
Epidural Clonidine Versus Corticosteroid for Low Back Pain
A study testing Epidural steroid and Clonidine in people with Back Pain, run by West Virginia University at 1 site in United States.
Trial summary
Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Epidural steroid and Clonidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal stenosis or herniated disc
- Subject has average pain score (VAS) at least 5
- Subject has persistent pain despite conservative care
- Subjects has experienced pain for at least 1 month
- 18 years of age or older when written informed consent is obtained
- Signed Institutional Review Board (IRB) approved informed consent form
Who cannot join
- Allergy to clonidine, dexamethasone, ropivicaine or lidocaine
- Coagulopathy
- Active Infection
- Serious neurologic deficit
- Subject is pregnant or planning on becoming pregnant during the course of the study
- Subject is member of a vulnerable population
Show all 10Show fewer
- Investigator suspects substance abuse that might confound the study results
- Subject has unresolved major issues of secondary gain (as determined by the investigator)
- Subject exhibits major psychiatric morbidity, untreated or refractory to treatment as determined by the investigator
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University Hospitals
Morgantown, West Virginia, 26505
About this study
Official title: Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain
Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain.
For those suffering from continued or recurrent low back pain, numerous treatment options exist. One such option is an epidural injection, particularly when other non-surgical treatment options have failed. An epidural injection is the placement of a needle into the space around the spinal cord with the aid of a live X-Ray machine, followed by an injection of various medications. Typically, the medication that is injected is a steroid, commonly with the combination of local anesthetic medication. Epidural steroid injections, with or without local anesthetic is part of the established standard of care in the United States for those with continued or recurrent low back pain. The steroid is believed to reduce inflammation and edema of the injured or irritated nerves. However, despite the routine use of epidural steroids, the steroid itself is not without risks or side effects. Though rare, the steroids have been associated with complications including osteoporosis, steroid induced myopathy, cataracts and many others. In order to minimize the side effects associated with epidural steroids, limiting the dose and frequency have been outlined.
Read more
Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and Drug Administration approved the medication for epidural use for cancer pain but studies have shown effectiveness in non-cancer pain was well and is routinely used for various conditions. There is growing evidence on the use of epidural clonidine for treatment of pain, including low back pain.
This research will study and compare the effectiveness, if any, of clonidine compared to steroid in an epidural injection for low back pain.
- Conditions
- Back Pain
- Being tested
- Epidural steroid, Clonidine
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural steroidDrug
ClonidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Steroid | Active comparator | Epidural steroid injection Receives: Drug: Epidural steroid |
| Clonidine | Experimental | Epidural clonidine injection Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Measured on Visual Analog Scale (VAS)
Measured: 3 months
Secondary outcomes (3)
Percentage of Pain Relief
Measured: Day 0, 3 weeks, 3 months
Level of Disability (Oswestry Back Scale)
Measured: 3 weeks, 3 months
Adverse Events
Measured: Day 0, 3 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: based on interim anaylsis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by West Virginia 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239627
- Sponsor's protocol ID
- 1407358518
- Status last verified
- Dec 2020
- First submitted
- 10 Sep 2014
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double Blinded Comparison of the Analgesic Efficacy of Epidural Clonidine Versus Corticosteroid for Low Back Pain
- ClinicalTrials.gov ID
- NCT02239627
- Acronym / sponsor ID
- 1407358518
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: based on interim anaylsis
- Enrolment
- 16 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low back pain is a common condition, affecting majority of the adults in the United States at some point in their lives. Fortunately, most resolve, even without treatment. However, some suffer from continued or recurrent pain.
For those suffering from continued or recurrent low back pain, numerous treatment options exist. One such option is an epidural injection, particularly when other non-surgical treatment options have failed. An epidural injection is the placement of a needle into the space around the spinal cord with the aid of a live X-Ray machine, followed by an injection of various medications. Typically, the medication that is injected is a steroid, commonly with the combination of local anesthetic medication. Epidural steroid injections, with or without local anesthetic is part of the established standard of care in the United States for those with continued or recurrent low back pain. The steroid is believed to reduce inflammation and edema of the injured or irritated nerves. However, despite the routine use of epidural steroids, the steroid itself is not without risks or side effects. Though rare, the steroids have been associated with complications including osteoporosis, steroid induced myopathy, cataracts and many others. In order to minimize the side effects associated with epidural steroids, limiting the dose and frequency have been outlined.
Clonidine is another medication, commonly used in numerous clinical settings. U. S. Food and Drug Administration approved the medication for epidural use for cancer pain but studies have shown effectiveness in non-cancer pain was well and is routinely used for various conditions. There is growing evidence on the use of epidural clonidine for treatment of pain, including low back pain.
This research will study and compare the effectiveness, if any, of clonidine compared to steroid in an epidural injection for low back pain.
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 |
|---|---|---|
| Steroid | Active comparator | Drug: Epidural steroidEpidural steroid injection |
| Clonidine | Experimental | Drug: ClonidineEpidural clonidine injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has clinical diagnosis of low back due to intervertebral disc disease, spinal stenosis or herniated disc
- Subject has average pain score (VAS) at least 5
- Subject has persistent pain despite conservative care
- Subjects has experienced pain for at least 1 month
- 18 years of age or older when written informed consent is obtained
Key exclusion criteria (10 listed)
- Allergy to clonidine, dexamethasone, ropivicaine or lidocaine
- Coagulopathy
- Active Infection
- Serious neurologic deficit
- Subject is pregnant or planning on becoming pregnant during the course of the study
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 steroid | Drug | Steroid |
| Clonidine | Drug | Clonidine |
Primary outcome
Pain Intensity Measured on Visual Analog Scale (VAS)
Time frame: 3 months
3 secondary outcomes
Percentage of Pain Relief
Time frame: Day 0, 3 weeks, 3 months
Level of Disability (Oswestry Back Scale)
Time frame: 3 weeks, 3 months
Adverse Events
Time frame: Day 0, 3 weeks, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural steroid and Clonidine in people with Back Pain, run by West Virginia University 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 6 inclusion and 10 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: stopped early, as of the sponsor's last update on 20 Jan 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Intensity Measured on Visual Analog Scale (VAS) (time frame: 3 months). 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 20 Jan 2021.