Lumbar Disc HerniationNCT05403775
Application of 3D Printing Guide Plate in Dorsal Root Ganglion Intervention Treatments
A study testing 3D printing guide plate and Conventional guidance in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study applies 3D-printed customized guide plate in assisting the accurate puncture in transforaminal epidural steroid injection (TFESI) combined with pulsed radiofrequency (PRF) treatment. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- What is being tested?
- 3D printing guide plate and Conventional guidance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2022to 31 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old,
- Chronic lumbosacral radicular pain lasting ≥12 weeks,
- Dominant leg pain with less intense back pain,
- The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
- Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
- Segmental pain of a radicular nature originating from the lumbar segments and with a shooting or lancinating quality corresponding to a dermatome suggestive of the involved nerve root,
- Availability of computed tomography/magnetic resonance imaging findings of pathology concordant with the side and level of their clinical features.
Who cannot join
- Patient refusal to participate in the study,
- Pregnant or nursing
- Progressive motor weakness in the affected leg,
- Allergies to local anesthetics, contrast dyes or steroids
- Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
- Presence of cancer accounting for back pain
Show all 11Show fewer
- Patients with platelet dysfunction, bleeding disorder or continuing anticoagulant treatment
- Steroid injection within the previous 12 weeks,
- Systemic infection,
- Injection site infection,
- Unstable medical or psychiatric condition
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Pain medicine center of Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shuiqing Li, MD, 13581785098, bjfdfx@126.com
About this study
Official title: Application of 3D Printing Guide Plate in Transforaminal Epidural Steroid Injection (TFESI) Combined With Pulsed Radiofrequency (PRF) Treatment
This study applies 3D-printed customized guide plate in assisting the accurate puncture in transforaminal epidural steroid injection (TFESI) combined with pulsed radiofrequency (PRF) treatment. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
Read the detailed description
Lumbar disc herniation (LDH) is a common degenerative spine disease and it can cause low back pain and lumbosacral radicular pain (LSRP). Transforaminal epidural steroid injection (TFESI) is one of the most common minimally invasive interventions for the treatment of LDH. TFESI combined with dorsal root ganglion pulsed radiofrequency (PRF) is an effective procedure for treating LSRP. Needle Puncture is the key technology in this procedure.
In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem is well solved by applying the 3D printing guide plate.
The application procedure for the the 3D printing guide plate: the model of the spine is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Being tested
- 3D printing guide plate, Conventional guidance
- Keywords
- Transforaminal epidural steroid injection, Dorsal root ganglion pulsed radiofrequency, 3D printing guide plate, Lumbosacral radicular pain
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing guide plateOther
3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF to help to reduce intra-operative radiation.
Conventional guidanceOther
The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy.
| Study group | Role | What they receive |
|---|---|---|
| 3D printing guide plate group | Experimental | 3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF. Receives: Other: 3D printing guide plate |
| Conventional guidance group | Active comparator | The surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy. Receives: Other: Conventional guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-arm fluoroscopy times
Numbers of using C-arm fluoroscopy
Measured: Intraoperative
Secondary outcomes (4)
Puncture time
Time from the first puncture to the last puncture
Measured: Intraoperative
Numerical rating scale (NRS)
NRS at One day, 1 month, 3 months after the operation
Measured: Postoperative 1 day, 1 month, 3 months
MacNab
Patient satisfaction using the modified MacNab criteria
Measured: Postoperative 3 months
Complications
Complication like nerve injury, blood, hemotoma, etc.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start8 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403775
- Sponsor's protocol ID
- M2022206
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printing Guide Plate in Transforaminal Epidural Steroid Injection (TFESI) Combined With Pulsed Radiofrequency (PRF) Treatment
- ClinicalTrials.gov ID
- NCT05403775
- Acronym / sponsor ID
- M2022206
- Conditions
- Lumbar Disc Herniation, Lumbar Spinal Stenosis
- Keywords
- Transforaminal epidural steroid injection, Dorsal root ganglion pulsed radiofrequency, 3D printing guide plate, Lumbosacral radicular pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Jun 2022 (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.
This study applies 3D-printed customized guide plate in assisting the accurate puncture in transforaminal epidural steroid injection (TFESI) combined with pulsed radiofrequency (PRF) treatment. This technique can shorten reduce the intra-operative radiation, and do not affect the surgical outcome.
Detailed description
Lumbar disc herniation (LDH) is a common degenerative spine disease and it can cause low back pain and lumbosacral radicular pain (LSRP). Transforaminal epidural steroid injection (TFESI) is one of the most common minimally invasive interventions for the treatment of LDH. TFESI combined with dorsal root ganglion pulsed radiofrequency (PRF) is an effective procedure for treating LSRP. Needle Puncture is the key technology in this procedure.
In the past when there were no customized guides, the surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy or CT. If the position of the needles is not satisfactory, repeated procedure will be performed. This would lead to an increase in the duration of surgery and intra-operative radiation, which is detrimental to both the surgeon and the patient. This problem is well solved by applying the 3D printing guide plate.
The application procedure for the the 3D printing guide plate: the model of the spine is established according to the patient's CT scan data to prepare the customized guide plate, then sterilize them for future use. The final position of needle is confirmed by C-arm fluoroscopy or CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printing guide plate group | Experimental | Other: 3D printing guide plate3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF. |
| Conventional guidance group | Active comparator | Other: Conventional guidanceThe surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years old,
- Chronic lumbosacral radicular pain lasting ≥12 weeks,
- Dominant leg pain with less intense back pain,
- The previous failure of conservative management such as physiotherapy, exercise therapy, or analgesic medications,
- Pain intensity≥4 out of 10 on the numerical rating scale (NRS),
Key exclusion criteria (11 listed)
- Patient refusal to participate in the study,
- Pregnant or nursing
- Progressive motor weakness in the affected leg,
- Allergies to local anesthetics, contrast dyes or steroids
- Significant anatomic deformity (either congenital or acquired) making it difficult to access the foramen as evidenced by computed tomography/magnetic resonance imaging
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 |
|---|---|---|
| 3D printing guide plate3D-printed customized guide plate will be used to guide the puncture in TFESI combined with dorsal root ganglion PRF to help to reduce intra-operative radiation. | Other | 3D printing guide plate group |
| Conventional guidanceThe surgeons would place the needle according to his/her previous experience under the guidance of C-arm fluoroscopy. | Other | Conventional guidance group |
Primary outcome
C-arm fluoroscopy times
Time frame: Intraoperative
Numbers of using C-arm fluoroscopy
4 secondary outcomes
Puncture time
Time frame: Intraoperative
Numerical rating scale (NRS)
Time frame: Postoperative 1 day, 1 month, 3 months
MacNab
Time frame: Postoperative 3 months
Complications
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing guide plate and Conventional guidance in people with Lumbar Disc Herniation and Lumbar Spinal Stenosis, 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 7 inclusion and 11 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 3 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuiqing Li, MD (+86(010)82265026, bjfdfx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-arm fluoroscopy times (time frame: Intraoperative). 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 3 Aug 2022.