Facet Joint PainNCT00896688
Ultrasound Guided Diagnostic Cervical Medial Branch Block
An observational study of Facet Joint Pain and Neck Pain, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Facet Joint Pain, Neck Pain
- What is being tested?
- cervical medial branch blocks using the Quincke spinal needle
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Dec 2017
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- healthy volunteers
- patients who have headache, neck pain, and shoulder pain due to possible facet joint disease
Who cannot join
- patients/volunteers with BMI > 35
- patients/volunteers with short thick neck
- coagulopathy
- allergy to local anesthetic, ultrasound gel
- patient unable to fill out post procedure pain diary
Trial locations and contacts
1 site in 1 country.
About this study
The diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.
- Conditions
- Facet Joint Pain, Neck Pain
- Being tested
- cervical medial branch blocks using the Quincke spinal needle
- Keywords
- cervical branch block, fluoroscopic guidance, ultrasound guidance
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical medial branch blocks using the Quincke spinal needleProcedure or surgery
#25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | It will involve 5 volunteers and they will undergo C arm fluoroscopic guided cervical medial branch blocks (C2-C7) on unilateral position and then followed by the 3D ultrasound machine for visualization of needle position. Receives: Procedure: cervical medial branch blocks using the Quincke spinal needle | |
| Candidates for upper and lower cervial medical branch blocks | This will involve 25 patients and they will follow the same procedures as the healthy volunteers. Receives: Procedure: cervical medial branch blocks using the Quincke spinal needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain.
Measured: At time of procedure
Secondary outcomes (1)
Interventional pain procedure studies on chronic pain patients
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: The PI has been unable to continue with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Facet Joint 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Joseph Park, MD, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896688
- Sponsor's protocol ID
- 08-575-D
- Status last verified
- Dec 2018
- First submitted
- 30 Apr 2009
- Last updated
- 14 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fishman SM, Smith H, Meleger A, Seibert JA. Radiation safety in pain medicine. Reg Anesth Pain Med. 2002 May-Jun;27(3):296-305. doi: 10.1053/rapm.2002.32578. No abstract available.
PubMed 12016604Greher M, Scharbert G, Kamolz LP, Beck H, Gustorff B, Kirchmair L, Kapral S. Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Anesthesiology. 2004 May;100(5):1242-8. doi: 10.1097/00000542-200405000-00028.
PubMed 15114223
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Diagnostic Cervical Medial Branch Block
- ClinicalTrials.gov ID
- NCT00896688
- Acronym / sponsor ID
- 08-575-D
- Conditions
- Facet Joint Pain, Neck Pain
- Keywords
- cervical branch block, fluoroscopic guidance, ultrasound guidance
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The PI has been unable to continue with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 12 May 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 diagnostic cervical branch block for neck pain due to cervical facet joint pain has been traditionally done under fluoroscopic guidance. Its diagnostic value and technique have been well established. However, recently some studies have shown that the diagnostic cervical and lumbar medial branch block can be done under ultrasound guidance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Procedure: cervical medial branch blocks using the Quincke spinal needleIt will involve 5 volunteers and they will undergo C arm fluoroscopic guided cervical medial branch blocks (C2-C7) on unilateral position and then followed by the 3D ultrasound machine for visualization of needle position. |
| Candidates for upper and lower cervial medical branch blocks | – | Procedure: cervical medial branch blocks using the Quincke spinal needleThis will involve 25 patients and they will follow the same procedures as the healthy volunteers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (2 listed)
- healthy volunteers
- patients who have headache, neck pain, and shoulder pain due to possible facet joint disease
Key exclusion criteria (5 listed)
- patients/volunteers with BMI > 35
- patients/volunteers with short thick neck
- coagulopathy
- allergy to local anesthetic, ultrasound gel
- patient unable to fill out post procedure pain diary
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 |
|---|---|---|
| cervical medial branch blocks using the Quincke spinal needle#25 gauge 1 and 1/2 inch long needle and #25 gauge 10cm long Quincke spinal needle will be used for placement. | Procedure or surgery | Candidates for upper and lower cervial medical branch blocks, Healthy Volunteers |
Primary outcome
To determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain.
Time frame: At time of procedure
1 secondary outcome
Interventional pain procedure studies on chronic pain patients
Time frame: At time of procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Background: PubMed 12016604Fishman SM, Smith H, Meleger A, Seibert JA. Radiation safety in pain medicine. Reg Anesth Pain Med. 2002 May-Jun;27(3):296-305. doi: 10.1053/rapm.2002.32578. No abstract available.
- Background: PubMed 15114223Greher M, Scharbert G, Kamolz LP, Beck H, Gustorff B, Kirchmair L, Kapral S. Ultrasound-guided lumbar facet nerve block: a sonoanatomic study of a new methodologic approach. Anesthesiology. 2004 May;100(5):1242-8. doi: 10.1097/00000542-200405000-00028.
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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.
Joseph Park, 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?
An observational study of Facet Joint Pain and Neck Pain, run by Hamilton Health Sciences Corporation 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Dec 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 determine the efficacy of the use of ultrasound for diagnostic cervical medial branch block on pain patients who have developed neck pain, cervicogenic headache, or shoulder pain. (time frame: At time of procedure). 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 NCT00896688, which also lists 2 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 14 Dec 2018.