Low Back PainNCT00355914

Effectiveness of Lumbar Facet Joint Nerve Blocks

A study testing Lumbar Facet Joint Nerve Block in people with Low Back Pain, run by Pain Management Center of Paducah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. To demonstrate whether: i. Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect. ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar facet joint pain when used with facet joint nerve blocks. 2. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Lumbar Facet Joint Nerve Block
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: Aug 2003to Jul 2006
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Positive for facet joint pain with comparative local anesthetic blocks
Candidates are over 18 years of age
Subjects with a history of chronic, function limiting low back pain of at least six 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 Investigator, 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 The subject has not had recent surgical procedures within the last three months.

Who cannot join

Negative or false-positive response to controlled comparative local anesthetic blocks
Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 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 intercranial pressure, pseudotumor cerebri, intercranial 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

Show all 9Show fewer

Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
Patients with multiple complaints involving concomitant hip osteoarthritis, will not be amenable to study 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

Trial locations and contacts

1 site in 1 country.

United States1 site

Ambulatory Surgery Center
Paducah, Kentucky, 42003

Other trials in United States

About this study

Official title: A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Facet Joint Nerve Blocks

To demonstrate whether:
Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect. ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar facet joint pain when used with facet joint nerve blocks.
To demonstrate whether or not there are clinically significant improvements in function of patients who receive lumbar facet joint nerve block with or without Sarapin and Depo-steroids (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
To determine the adverse event profile in both groups.

Read the detailed description

Primary Outcome Measure(s) To demonstrate a clinically significant difference between the patients treated with adjuvants and those patients randomized to Group I in the pain status, physical, and psychological status and pain at 3, 6, 12, 18and 24 months post treatment.

Conditions: Low Back Pain
Being tested: Lumbar Facet Joint Nerve Block
Keywords: Lumbar Facet Joint Nerve Block
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lumbar Facet Joint Nerve BlockProcedure or surgery
Lumbar Facet Joint Nerve Block

Study groups in NCT00355914
Study group	Role	What they receive
Group 1 Without Steroids	Active comparator	Lumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) Receives: Procedure: Lumbar Facet Joint Nerve Block
Group 2 With Steroids	Experimental	Lumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone) Receives: Procedure: Lumbar Facet Joint Nerve Block

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Numeric Rating Scale
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
Measured: Baseline, 3, 6, 12, 18, and 24 months post-treatment
Oswestry Disability Index
Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).
Measured: Baseline, 3, 6, 12, 18, and 24 months post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Jul 2006

First posted25 Jul 2006 (estimated)
Study startAug 2003
Primary completionJul 2006
Study completionJul 2006

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.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Low 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00355914
Sponsor's protocol ID: protocol3
Status last verified: Sep 2013
First submitted: 24 Jul 2006
Last updated: 26 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010 May 28;7(3):124-35. doi: 10.7150/ijms.7.124.
PubMed 20567613
Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.
PubMed 18354721
Manchikanti L, Manchikanti KN, Manchukonda R, Cash KA, Damron KS, Pampati V, McManus CD. Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914. Pain Physician. 2007 May;10(3):425-40.
PubMed 17525777

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2013. 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 Lumbar Facet Joint Nerve Blocks
ClinicalTrials.gov ID: NCT00355914
Acronym / sponsor ID: protocol3
Conditions: Low Back Pain
Keywords: Lumbar Facet Joint Nerve Block
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Pain Management Center of PaducahUniversity, hospital or other
Study start: Aug 2003
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 25 Jul 2006 (estimated)
Results: Posted 26 Nov 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To demonstrate whether:
Facet joint nerve blocks have therapeutic value beyond the duration of local anesthetic effect. ii. Adjuvant medications (Sarapin and Depo-steroids) provide additional relief of lumbar facet joint pain when used with facet joint nerve blocks.
To demonstrate whether or not there are clinically significant improvements in function of patients who receive lumbar facet joint nerve block with or without Sarapin and Depo-steroids (Group II) compared to patients randomized to Group I who receive only local anesthetic blocks.
To determine the adverse event profile in both groups.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1 Without Steroids	Active comparator	Procedure: Lumbar Facet Joint Nerve BlockLumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
Group 2 With Steroids	Experimental	Procedure: Lumbar Facet Joint Nerve BlockLumbar Facet Joint Nerve Block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Positive for facet joint pain with comparative local anesthetic blocks
Candidates are over 18 years of age
Subjects with a history of chronic, function limiting low back pain of at least six 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 Investigator, 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 The subject has not had recent surgical procedures within the last three months.

Key exclusion criteria (9 listed)

Negative or false-positive response to controlled comparative local anesthetic blocks
Narcotic use of greater than Hydrocodone 100 mg/day, Methadone 80 mg or Morphine 100 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 intercranial pressure, pseudotumor cerebri, intercranial 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
Lumbar Facet Joint Nerve BlockLumbar Facet Joint Nerve Block	Procedure or surgery	Group 1 Without Steroids, Group 2 With Steroids

Primary outcome

Average Numeric Rating Scale
Time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment
Numeric rating scale represented 0 with no pain and 10 with the worst pain imaginable.
Oswestry Disability Index
Time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment.
Oswestry Disability Index 2.0 (ODI): ODI score is ranged from 0 to 50. Total score is converted in to percent disability. ODI Scoring: 0% to 20% (minimal disability), 21%-40% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled) and 81%-100% (may be bed bound or exaggerating their symptoms).

Results and safety

Results posted to the registry on 26 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Without Steroids	60	60
Group II With Steroids	60	60

Primary outcome: Average Numeric Rating Scale

Time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment. Mean (Standard Error). Unit: units on a scale

Measure	Group I n = 60	Group II n = 60
Baseline	8.2 (0.8)	7.9 (1.0)
3 months	3.8 (1.3)	3.5 (1.1)
6 months	3.6 (1.5)	3.3 (0.8)
12 months	3.7 (1.7)	3.5 (1.1)
18 months	3.5 (1.5)	3.3 (1.0)
24 months	3.5 (1.5)	3.2 (0.9)

Group I vs Group II: p >0.05, t-test, 2 sided

Primary outcome: Oswestry Disability Index

Time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment.. Mean (Standard Deviation). Unit: units on a scale

Measure	Group 1 Without Steroids n = 60	Group II With Steroids n = 60
Baseline	26.6 (4.6)	25.9 (5.0)
3 months	12.7 (4.7)	13.5 (5.6)
6 months	12.7 (4.7)	12.2 (5.0)
12 months	12.3 (4.8)	12.0 (5.4)
18 months	12.1 (5.0)	11.2 (4.9)
24 months	12.0 (4.9)	11.0 (4.8)

Group 1 Without Steroids vs Group II With Steroids: p >0.05, t-test, 2 sided

Population analysed: An intent-to-treat-analysis was performed on all patients utilizing the last follow-up data. Initial data were utilized in the patients who dropped out of the study without further follow-up after the first treatment.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 Without Steroids	0 of 60 (0%)	0 of 60 (0%)	Not reported
Group II With Steroids	0 of 60 (0%)	0 of 60 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20567613Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up. Int J Med Sci. 2010 May 28;7(3):124-35. doi: 10.7150/ijms.7.124.
Results publication: PubMed 18354721Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Lumbar facet joint nerve blocks in managing chronic facet joint pain: one-year follow-up of a randomized, double-blind controlled trial: Clinical Trial NCT00355914. Pain Physician. 2008 Mar-Apr;11(2):121-32.
Results publication: PubMed 17525777Manchikanti L, Manchikanti KN, Manchukonda R, Cash KA, Damron KS, Pampati V, McManus CD. Evaluation of lumbar facet joint nerve blocks in the management of chronic low back pain: preliminary report of a randomized, double-blind controlled trial: clinical trial NCT00355914. Pain Physician. 2007 May;10(3):425-40.
Evaluation of lumbar facet joint nerve blocks in managing chronic low back pain: a randomized, double-blind, controlled trial with a 2-year follow-up.Link provided by the sponsor.

Related trials for Low Back Pain

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lumbar Facet Joint Nerve Block in people with Low Back 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 3 inclusion and 9 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 26 Nov 2013. 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 26 Nov 2013). 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?

Average Numeric Rating Scale (time frame: Baseline, 3, 6, 12, 18, and 24 months post-treatment). The study lists 2 primary outcomes in all. 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 NCT00355914, which also lists 3 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 26 Nov 2013.