Low Back PainNCT04953520
Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots
A study testing ultrasound-CT fusion imaging and pure ultrasound guidance in people with Low Back Pain, run by Peking University Third Hospital at 1 site in China.
Trial summary
The study is aimed at patients with low back and leg pain. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Back Pain
- What is being tested?
- ultrasound-CT fusion imaging and pure ultrasound guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2017to 16 Jan 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients who need lumbar nerve root block treatment
Who cannot join
- Tumor patients
- Patients who have had lumbar spine surgery before
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ultrasound Diagnosis, Peking University Third Hospital
Beijing, Beijing Municipality
About this study
The study is aimed at patients with low back and leg pain. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.
Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.
Read the detailed description
A total of 80 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.Follow-up of VAS pain score after lumbar nerve root block treatment. This study aims to establish a standardized operation method and process for lumbosacral nerve ultrasound-CT fusion guided interventional pain treatment.
- Conditions
- Low Back Pain
- Being tested
- ultrasound-CT fusion imaging, pure ultrasound guidance
- 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.
ultrasound-CT fusion imagingProcedure or surgery
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
pure ultrasound guidanceProcedure or surgery
The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-CT fusion imaging guidance | Experimental | The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging Receives: Procedure: ultrasound-CT fusion imaging |
| Pure ultrasound guidance | Active comparator | The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance Receives: Procedure: pure ultrasound guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture
Measured: VAS pain scores were performed 1 month after surgery
3 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
Measured: VAS pain scores were performed 3 month after surgery
6 month VAS pain score
Patients undergo VAS pain score after the sonographer performs selective
Measured: VAS pain scores were performed 6 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start29 Dec 2017
- Primary completion16 Jun 2018
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ligang Cui, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953520
- Sponsor's protocol ID
- M2017318
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-CT Fusion Image-guided Minimally Invasive Interventional Treatment of Lumbosacral Nerve Roots
- ClinicalTrials.gov ID
- NCT04953520
- Acronym / sponsor ID
- M2017318
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 8 Jul 2021 (actual)
- 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 study is aimed at patients with low back and leg pain. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.
Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.
Detailed description
A total of 80 patients with low back and leg pain were randomly divided into two groups, 30 people in each group. The patients in the experimental group were guided by ultrasound-CT fusion imaging to insert the lumbar nerve root puncture needle.Patients in the control group underwent the insertion of the lumbar nerve root puncture needle under the guidance of ultrasound alone.Follow-up of VAS pain score after lumbar nerve root block treatment. This study aims to establish a standardized operation method and process for lumbosacral nerve ultrasound-CT fusion guided interventional pain treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-CT fusion imaging guidance | Experimental | Procedure: ultrasound-CT fusion imagingThe patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging |
| Pure ultrasound guidance | Active comparator | Procedure: pure ultrasound guidanceThe patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients who need lumbar nerve root block treatment
Key exclusion criteria (2 listed)
- Tumor patients
- Patients who have had lumbar spine surgery before
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 |
|---|---|---|
| ultrasound-CT fusion imagingThe patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging | Procedure or surgery | Ultrasound-CT fusion imaging guidance |
| pure ultrasound guidanceThe patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance | Procedure or surgery | Pure ultrasound guidance |
Primary outcome
1 month VAS pain score
Time frame: VAS pain scores were performed 1 month after surgery
Patients undergo VAS pain score after the sonographer performs selective lumbar nerve root block puncture
3 month VAS pain score
Time frame: VAS pain scores were performed 3 month after surgery
Patients undergo VAS pain score after the sonographer performs selective
6 month VAS pain score
Time frame: VAS pain scores were performed 6 month after surgery
Patients undergo VAS pain score after the sonographer performs selective
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 8 Jul 2021.
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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.
Ligang Cui study chair
Peking University Third 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 ultrasound-CT fusion imaging and pure ultrasound guidance in people with Low Back Pain, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 2 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 8 Jul 2021. 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 China. 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?
1 month VAS pain score (time frame: VAS pain scores were performed 1 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2021.