Back PainPhase 4NCT01071369
Treatment of Chronic Thoracic and Neck and Upper Extremity Pain
A Phase 4 study testing Xylocaine and Xylocaine and Celestone in people with Back Pain and Neck Pain, run by Pain Management Center of Paducah at 1 site in United States.
Trial summary
To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Xylocaine and Xylocaine and Celestone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2012
- Phase
- Phase 4
- 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
- Subjects of at least 18 years of age
- Subjects with a history of chronic, function-limiting thoracic or cervical pain with or without upper extremity pain of at least 6 months in duration
- Subjects who are able to give voluntary, written informed consent to participate in this investigation
- Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
- Subjects have not had recent surgical procedures within the last 3 months.
Who cannot join
- Compressive radiculopathy
- Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
- Uncontrolled major depression or uncontrolled psychiatric disorders
- Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease
- Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
- Women who are pregnant or lactating
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- Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
- Patients with multiple complaints involving concomitant shoulder osteoarthritis, due to the overlap of pain complaints
- Inability to achieve appropriate positioning and inability to understand informed consent and protocol
- History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome
To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.
Read the detailed description
This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.
Patients are studied in 2 groups in each region.
- Group I-local anesthetic only.
- Group II-local anesthetic with 6 mg of non-particulate Celestone.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
- Being tested
- Xylocaine, Xylocaine and Celestone
- Medical subject headings
- Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylocaineDrug
0.5% Xylocaine
Xylocaine and CelestoneDrug
Also called Celestone
non-particulate Celestone
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine | Active comparator | 0.5% Xylocaine Receives: Drug: Xylocaine |
| Xylocaine and Celestone | Active comparator | 0.5% Xylocaine with 6 mg of non-particulate Celestone. Receives: Drug: Xylocaine; Drug: Xylocaine and Celestone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids
examined improvements between those who received and did not receive steroids
Measured: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Secondary outcomes (2)
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
examined differences between those who received and did not receive steroids
Measured: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate and compare the adverse event profile in all patients.
examined adverse event differences between those who received and did not receive steroids
Measured: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2008
- Primary completionFeb 2008
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pain Management Center of Paducah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laxmaiah Manchikanti, MD, Pain Management Center of Paducah
- Investigators
- Laxmaiah Manchikanti, MD, Principal investigator, Ambulatory Surgery Center, Paducah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01071369
- Sponsor's protocol ID
- protocol 16
- Status last verified
- Apr 2017
- First submitted
- 14 Feb 2008
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):465-78.
PubMed 24077193Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic epidural injections in cervical spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):E59-70.
PubMed 22270749Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic cervical interlaminar epidural injections in managing chronic pain of cervical postsurgery syndrome: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):13-25.
PubMed 22270734Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A preliminary report of a randomized double-blind, active controlled trial of fluoroscopic thoracic interlaminar epidural injections in managing chronic thoracic pain. Pain Physician. 2010 Nov-Dec;13(6):E357-69.
PubMed 21102973Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):E265-78.
PubMed 20648213Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 May-Jun;13(3):223-36.
PubMed 20495586
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Cervical and Thoracic Interlaminar Epidural Injections in Thoracic and Cervical Disc Herniation, Discogenic Pain, and Post-Cervical Laminectomy Syndrome
- ClinicalTrials.gov ID
- NCT01071369
- Acronym / sponsor ID
- protocol 16
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Pain Management Center of PaducahUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- Feb 2008 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Feb 2010 (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.
To study improvements or lack thereof with the interlaminar epidural patients with or without steroids experiences mid back, upper back or neck pain with or without chest wall and upper extremity pain of at least 6-months duration non-responsive to conservative management.
Detailed description
This is a Single-center, prospective, controlled, double-blind, randomized study in thoracic and cervical regions.
Patients are studied in 2 groups in each region.
- Group I-local anesthetic only.
- Group II-local anesthetic with 6 mg of non-particulate Celestone.
All patients will be unblinded at 12 or 24 months. Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group, if patient consents. Non-responsive patients may be unblinded and withdrawn from the study at any time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine | Active comparator | Drug: Xylocaine0.5% Xylocaine |
| Xylocaine and Celestone | Active comparator | Drug: Xylocaine, Drug: Xylocaine and Celestone0.5% Xylocaine with 6 mg of non-particulate Celestone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects of at least 18 years of age
- Subjects with a history of chronic, function-limiting thoracic or cervical pain with or without upper extremity pain of at least 6 months in duration
- Subjects who are able to give voluntary, written informed consent to participate in this investigation
- Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
- Subjects have not had recent surgical procedures within the last 3 months.
Key exclusion criteria (10 listed)
- Compressive radiculopathy
- Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
- Uncontrolled major depression or uncontrolled psychiatric disorders
- Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease
- Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily 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 |
|---|---|---|
| Xylocaine0.5% Xylocaine | Drug | Xylocaine, Xylocaine and Celestone |
| Xylocaine and CelestoneAlso: Celestonenon-particulate Celestone | Drug | Xylocaine and Celestone |
Primary outcome
To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
examined improvements between those who received and did not receive steroids
2 secondary outcomes
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate and compare the adverse event profile in all patients.
Time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
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 27 Apr 2017.
- Derived from this study: PubMed 24077193Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. A randomized, double-blind, active control trial of fluoroscopic cervical interlaminar epidural injections in chronic pain of cervical disc herniation: results of a 2-year follow-up. Pain Physician. 2013 Sep-Oct;16(5):465-78.
- Derived from this study: PubMed 22270749Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic epidural injections in cervical spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):E59-70.
- Derived from this study: PubMed 22270734Manchikanti L, Malla Y, Cash KA, McManus CD, Pampati V. Fluoroscopic cervical interlaminar epidural injections in managing chronic pain of cervical postsurgery syndrome: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):13-25.
- Derived from this study: PubMed 21102973Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. A preliminary report of a randomized double-blind, active controlled trial of fluoroscopic thoracic interlaminar epidural injections in managing chronic thoracic pain. Pain Physician. 2010 Nov-Dec;13(6):E357-69.
- Derived from this study: PubMed 20648213Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. Cervical epidural injections in chronic discogenic neck pain without disc herniation or radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul-Aug;13(4):E265-78.
- Derived from this study: PubMed 20495586Manchikanti L, Cash KA, Pampati V, Wargo BW, Malla Y. The effectiveness of fluoroscopic cervical interlaminar epidural injections in managing chronic cervical disc herniation and radiculitis: preliminary results of a randomized, double-blind, controlled trial. Pain Physician. 2010 May-Jun;13(3):223-36.
- Individual participant dataSharing planned: No
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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.
Laxmaiah Manchikanti, MD principal investigator
Ambulatory Surgery Center, Paducah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xylocaine and Xylocaine and Celestone in people with Back Pain and Neck Pain, run by Pain Management Center of Paducah 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 5 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: finished, as of the sponsor's last update on 27 Apr 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To demonstrate clinically significant improvements or lack thereof with the interlaminar epidural patients with or without steroids (time frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01071369, which also lists 6 linked publications.
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 27 Apr 2017.