Spinal StenosisNCT04062474
Epidural Intervention of Spinal Nerves With Tumor Necrosis Factor-Alpha Inhibitor
A study testing Epidural Intervention with TNF-α inhibitor in people with Spinal Stenosis, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Epidural Intervention with TNF-α inhibitor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2016to 1 May 2017
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of spinal stenosis with radicular pain at least 5 scores of VAS(ranging from 0 to 10).
- Failed to improve symptom significantly through conservative treatment, including physiotherapy, chiropractic therapy, exercise, medication and bed rest.
Who cannot join
- lumbar surgery history,
- spinal stenosis without radicular pain,
- uncontrollable or unstable use of opioids,
- uncontrolled mental illness,
- pregnant or lactating women,
- patients with a history of adverse reactions or possible adverse reactions to local anesthetics, etanercept or Steroids.
About this study
Official title: Treatment of Pain in Patients With Lumbar Spinal Stenosis By Epidural Intervention of Spinal Nerves With Local Anesthetic, Steroids and Tumor Necrosis Factor-Alpha Inhibitor Respectively：a Prospective Randomized Study
This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.
Read the detailed description
This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated by VAS and ODI, and received 6 months' follow-up.
- Conditions
- Spinal Stenosis
- Being tested
- Epidural Intervention with TNF-α inhibitor
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Intervention with TNF-α inhibitorProcedure or surgery
Epidural administration with TNF-α inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Epidural Intervention with Steroids | Experimental | Epidural Intervention with Steroids Receives: Procedure: Epidural Intervention with TNF-α inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Measured: 6 months
Oswestry Disability Index
Oswestry Disability Index is for movement function, Questionnaire examines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start15 May 2016
- Primary completion15 Dec 2016
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062474
- Sponsor's protocol ID
- KY20151014-01
- Status last verified
- May 2019
- First submitted
- 19 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wei P, Xu Y, Yao Q, Wang L. Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-alpha inhibitor in treatment of lumbar stenosis. Br J Neurosurg. 2020 Apr;34(2):168-171. doi: 10.1080/02688697.2020.1713990. Epub 2020 Jan 20.
PubMed 31955619
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Pain in Patients With Lumbar Spinal Stenosis By Epidural Intervention of Spinal Nerves With Local Anesthetic, Steroids and Tumor Necrosis Factor-Alpha Inhibitor Respectively：a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04062474
- Acronym / sponsor ID
- KY20151014-01
- Conditions
- Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2016 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 20 Aug 2019 (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 is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.
Detailed description
This study is to assess the clinical efficacy of epidural injections with Tumor Necrosis Factor-Alpha(TNF-α) Inhibitor in patients with chronic radicular pain caused by lumbar spinal stenosis.Ninety patients were diagnosed with lumbar spinal stenosis and were randomly assigned to 3 groups, for each group 30 cases. Patients in Group A received epidural injection of spinal nerve with 2.0 ml of lidocaine and 10 mg of Tumor Necrosis Factor-Alpha Inhibitor (etanercept) onto the affected spinal nerve, Group B patients received epidural injection with lidocaine 2ml mixed with 2ml of steroid(Diprospan), and group C patients received epidural injections with 4.0 ml of lidocaine only. All the 3 groups were evaluated by VAS and ODI, and received 6 months' follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural Intervention with Steroids | Experimental | Procedure: Epidural Intervention with TNF-α inhibitorEpidural Intervention with Steroids |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of spinal stenosis with radicular pain at least 5 scores of VAS(ranging from 0 to 10).
- Failed to improve symptom significantly through conservative treatment, including physiotherapy, chiropractic therapy, exercise, medication and bed rest.
Key exclusion criteria (6 listed)
- lumbar surgery history,
- spinal stenosis without radicular pain,
- uncontrollable or unstable use of opioids,
- uncontrolled mental illness,
- pregnant or lactating women,
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 |
|---|---|---|
| Epidural Intervention with TNF-α inhibitorEpidural administration with TNF-α inhibitor | Procedure or surgery | Epidural Intervention with Steroids |
Primary outcome
visual analog scale
Time frame: 6 months
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Oswestry Disability Index
Time frame: 6 months
Oswestry Disability Index is for movement function, Questionnaire examines
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 20 Aug 2019.
- Derived from this study: PubMed 31955619Wei P, Xu Y, Yao Q, Wang L. Randomized trial of 3-drug combination for lumbar nerve root epidural injections with a TNF-alpha inhibitor in treatment of lumbar stenosis. Br J Neurosurg. 2020 Apr;34(2):168-171. doi: 10.1080/02688697.2020.1713990. Epub 2020 Jan 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Intervention with TNF-α inhibitor in people with Spinal Stenosis, run by Nanjing First Hospital, Nanjing Medical University.
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 6 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 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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 analog scale (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT04062474, which also lists 1 linked publication.
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 20 Aug 2019.