Head PainNCT01009385
Cervical Epidural Pressure Measurement
A study testing cervical epidural steroid injection and epidural pressure measurement in people with Head Pain and Neck Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Cervical epidural steroid injections The hanging drop (HD) technique is commonly used for identifying the cervical epidural space. The hanging drop (HD) technique is using the negative pressure in the epidural space. The subject of debate whether the epidural space exhibits negative pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Pain, Neck Pain, Upper Extremity Pain
- What is being tested?
- cervical epidural steroid injection and epidural pressure measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Nov 2009
- 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
- cervical radicular pain caused by herniated nucleus pulpous and spinal stenosis
- other conditions including herpes zoster-associated pain and sprain.
Who cannot join
- contraindications for CESIs, such as coagulopathy, patient refusal or infection at the proposed insertion site
- previous cervical spinal surgery
- pregnancy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Kumi, Kyonggi-do, 463-707
About this study
Official title: Cervical Epidural Pressure Measurement: Comparison in the Prone and Sitting Positions
Cervical epidural steroid injections
- The hanging drop (HD) technique is commonly used for identifying the cervical epidural space.
- The hanging drop (HD) technique is using the negative pressure in the epidural space.
- The subject of debate whether the epidural space exhibits negative pressure.
- In a previous study, EP might be influenced by body position
- No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.
Read more
The hypothesis of this study
- There is a difference in the cervical epidural pressure between in the prone and sitting positions
- To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
- Using a closed pressure measurement system
- Under fluoroscopic guidance.
Read the detailed description
Cervical epidural steroid injections (CESIs)
- For the conservative management of head, neck, and upper extremity pain
- Important to identify the epidural space for minimizing the chance of a dural puncture injection
- Dural puncture injection makes CESIs prone to rare but catastrophic complication like permanent spinal cord injury
The hanging drop (HD) technique
- Commonly used for identifying the cervical epidural space
- Using the negative pressure in the epidural space
- The subject of debate whether the epidural space exhibits negative pressure
In previous studies using a closed pressure measurement systems
- The epidural pressure (EP) was commonly positive at the thoracic level in the lateral decubitus position.
- EP was consistently negative only in the sitting position.
- EP might be influenced by body position.
- The patient should be sitting for using the HD technique.
No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.
The hypothesis of this study
- There is a difference in the cervical epidural pressure between in the prone and sitting positions
- To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
- Using a closed pressure measurement system
- Under fluoroscopic guidance.
- Conditions
- Head Pain, Neck Pain, Upper Extremity Pain
- Being tested
- cervical epidural steroid injection, epidural pressure measurement
- Keywords
- cervical, epidural, epidural pressure, monitoring
- Medical subject headings
- Headache, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical epidural steroid injectionProcedure or surgery
Also called cervical interlaminar epidural injection
- After aseptic preparation and skin infiltration with 1% lidocaine
- 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level
- identification of the epidural space confirmed by injection of contrast medium under fluoroscope
- injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl).
- Post-procedure, patients were observed for any adverse effects and followed with a neurological examination
epidural pressure measurementProcedure or surgery
Also called a closed pressure measurement system
- The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view.
- Identification of the epidural space and measurement of EP was performed with a closed measurement system.
| Study group | Role | What they receive |
|---|---|---|
| prone position | Active comparator | Not described Receives: Procedure: cervical epidural steroid injection; Procedure: epidural pressure measurement |
| sitting position | Active comparator | Not described Receives: Procedure: cervical epidural steroid injection; Procedure: epidural pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical epidural pressure
Measured: on interventional procedure (cervical epidural steroid injetion)
Secondary outcomes (1)
the angle of the neck flexion
Measured: on interventional procedure (cervical epidural steroid injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009 (estimated)
- Study completionNov 2009 (estimated)
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 Head 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jeeyoun Moon, Principal investigator, Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009385
- Sponsor's protocol ID
- snu23802
- Status last verified
- Nov 2009
- First submitted
- 4 Nov 2009
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Joo Y, Moon JY, Kim YC, Lee SC, Kim HY, Park SY. A pressure comparison between midline and paramedian approaches to the cervical epidural space. Pain Physician. 2014 Mar-Apr;17(2):155-62.
PubMed 24658476Moon JY, Lee PB, Nahm FS, Kim YC, Choi JB. Cervical epidural pressure measurement: comparison in the prone and sitting positions. Anesthesiology. 2010 Sep;113(3):666-71. doi: 10.1097/ALN.0b013e3181e898e8.
PubMed 20693880
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Epidural Pressure Measurement: Comparison in the Prone and Sitting Positions
- ClinicalTrials.gov ID
- NCT01009385
- Acronym / sponsor ID
- snu23802
- Conditions
- Head Pain, Neck Pain, Upper Extremity Pain
- Keywords
- cervical, epidural, epidural pressure, monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 6 Nov 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.
Cervical epidural steroid injections
- The hanging drop (HD) technique is commonly used for identifying the cervical epidural space.
- The hanging drop (HD) technique is using the negative pressure in the epidural space.
- The subject of debate whether the epidural space exhibits negative pressure.
- In a previous study, EP might be influenced by body position
- No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.
The hypothesis of this study
- There is a difference in the cervical epidural pressure between in the prone and sitting positions
- To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
- Using a closed pressure measurement system
- Under fluoroscopic guidance.
Detailed description
Cervical epidural steroid injections (CESIs)
- For the conservative management of head, neck, and upper extremity pain
- Important to identify the epidural space for minimizing the chance of a dural puncture injection
- Dural puncture injection makes CESIs prone to rare but catastrophic complication like permanent spinal cord injury
The hanging drop (HD) technique
- Commonly used for identifying the cervical epidural space
- Using the negative pressure in the epidural space
- The subject of debate whether the epidural space exhibits negative pressure
In previous studies using a closed pressure measurement systems
- The epidural pressure (EP) was commonly positive at the thoracic level in the lateral decubitus position.
- EP was consistently negative only in the sitting position.
- EP might be influenced by body position.
- The patient should be sitting for using the HD technique.
No report or peer-reviewed literature to demonstrate the cervical epidural pressure (CEP) now.
The hypothesis of this study
- There is a difference in the cervical epidural pressure between in the prone and sitting positions
- To evaluate this hypothesis, CEPs in the prone and sitting groups were measured and compared in the two groups.
- Using a closed pressure measurement system
- Under fluoroscopic guidance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prone position | Active comparator | Procedure: cervical epidural steroid injection, Procedure: epidural pressure measurement |
| sitting position | Active comparator | Procedure: cervical epidural steroid injection, Procedure: epidural pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- cervical radicular pain caused by herniated nucleus pulpous and spinal stenosis
- other conditions including herpes zoster-associated pain and sprain.
Key exclusion criteria (3 listed)
- contraindications for CESIs, such as coagulopathy, patient refusal or infection at the proposed insertion site
- previous cervical spinal surgery
- pregnancy.
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 epidural steroid injectionAlso: cervical interlaminar epidural injection* After aseptic preparation and skin infiltration with 1% lidocaine * 20-gauge Tuohy needle (Tae-Chang Industrial Co., Kongju, Korea) was inserted in the midline at the C6 - C7 level * identification of the epidural space confirmed by injection of contrast medium under fluoroscope * injection of 5 mL of solution containing 10 mg of triamcinolone acetonide suspension and 1.5 mL of 0.75% levobupivacaine hydrochloride, and 3.5 mL of physiologic saline (0.9% NaCl). * Post-procedure, patients were observed for any adverse effects and followed with a neurological examination | Procedure or surgery | prone position, sitting position |
| epidural pressure measurementAlso: a closed pressure measurement system* The stylet within the Tuohy needle is removed when the needle was placed in C6-7 ligamentum flavum under fluoroscopic true lateral view. * Identification of the epidural space and measurement of EP was performed with a closed measurement system. | Procedure or surgery | prone position, sitting position |
Primary outcome
cervical epidural pressure
Time frame: on interventional procedure (cervical epidural steroid injetion)
1 secondary outcome
the angle of the neck flexion
Time frame: on interventional procedure (cervical epidural steroid injection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2009.
- Derived from this study: PubMed 24658476Joo Y, Moon JY, Kim YC, Lee SC, Kim HY, Park SY. A pressure comparison between midline and paramedian approaches to the cervical epidural space. Pain Physician. 2014 Mar-Apr;17(2):155-62.
- Derived from this study: PubMed 20693880Moon JY, Lee PB, Nahm FS, Kim YC, Choi JB. Cervical epidural pressure measurement: comparison in the prone and sitting positions. Anesthesiology. 2010 Sep;113(3):666-71. doi: 10.1097/ALN.0b013e3181e898e8.
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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.
Jeeyoun Moon principal investigator
Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical epidural steroid injection and epidural pressure measurement in people with Head Pain and Neck Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 3 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: status not confirmed, as of the sponsor's last update on 6 Nov 2009. 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 South Korea. 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?
Results are not available in the source record.
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?
cervical epidural pressure (time frame: on interventional procedure (cervical epidural steroid injetion)). 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 NCT01009385, 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 6 Nov 2009.