Low Back PainNCT00373724
A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
A study testing radiofrequency denervation in people with Low Back Pain, run by Johns Hopkins University at 2 sites in United States.
Trial summary
In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study. 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?
- radiofrequency denervation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Aug 2007
- 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
- Sacroiliac joint pain
- Age > 18
Who cannot join
- No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
About this study
In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.
Read the detailed description
30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.
- Conditions
- Low Back Pain
- Being tested
- radiofrequency denervation
- Keywords
- sacroiliac joint, low back pain, radiofrequency
- 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.
radiofrequency denervationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale pain score, Oswestry Disability Index
Measured: 1, 3 and 6 months postprocedure
Secondary outcomes (1)
Medication reduction, global perceived effect, work status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startNov 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Crossover
- Masking
- Single blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Steven P Cohen, MD, Principal investigator, Johns Hopkins School of MedicineSrinivasa N Raja, MD, Study director, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373724
- Sponsor's protocol ID
- 05-03-23-05
- Status last verified
- May 2008
- First submitted
- 7 Sep 2006
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cohen SP, Abdi S. Lateral branch blocks as a treatment for sacroiliac joint pain: A pilot study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):113-9. doi: 10.1053/rapm.2003.50029.
PubMed 12677621Yin W, Willard F, Carreiro J, Dreyfuss P. Sensory stimulation-guided sacroiliac joint radiofrequency neurotomy: technique based on neuroanatomy of the dorsal sacral plexus. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2419-25. doi: 10.1097/01.BRS.0000085360.03758.C3.
PubMed 14560094Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.
PubMed 16244008Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.
PubMed 18648237
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
- ClinicalTrials.gov ID
- NCT00373724
- Acronym / sponsor ID
- 05-03-23-05
- Conditions
- Low Back Pain
- Keywords
- sacroiliac joint, low back pain, radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Sep 2006 (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.
In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.
Detailed description
30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Sacroiliac joint pain
- Age > 18
Key exclusion criteria (1 listed)
- No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
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 |
|---|---|---|
| radiofrequency denervation | Procedure or surgery | – |
Primary outcome
visual analogue scale pain score, Oswestry Disability Index
Time frame: 1, 3 and 6 months postprocedure
1 secondary outcome
Medication reduction, global perceived effect, work status
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 9 May 2008.
- Background: PubMed 12677621Cohen SP, Abdi S. Lateral branch blocks as a treatment for sacroiliac joint pain: A pilot study. Reg Anesth Pain Med. 2003 Mar-Apr;28(2):113-9. doi: 10.1053/rapm.2003.50029.
- Background: PubMed 14560094Yin W, Willard F, Carreiro J, Dreyfuss P. Sensory stimulation-guided sacroiliac joint radiofrequency neurotomy: technique based on neuroanatomy of the dorsal sacral plexus. Spine (Phila Pa 1976). 2003 Oct 15;28(20):2419-25. doi: 10.1097/01.BRS.0000085360.03758.C3.
- Background: PubMed 16244008Cohen SP. Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesth Analg. 2005 Nov;101(5):1440-1453. doi: 10.1213/01.ANE.0000180831.60169.EA.
- Derived from this study: PubMed 18648237Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando B, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-88. doi: 10.1097/ALN.0b013e31817f4c7c.
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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.
Steven P Cohen, MD principal investigator
Johns Hopkins School of Medicine
Srinivasa N Raja, MD study director
Johns Hopkins School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiofrequency denervation in people with Low Back Pain, run by Johns Hopkins University at 2 sites 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 2 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 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
visual analogue scale pain score, Oswestry Disability Index (time frame: 1, 3 and 6 months postprocedure). 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 NCT00373724, which also lists 4 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 9 May 2008.