Osteoporotic FractureNCT04108507
Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
A study testing posterior branch block of spinal nerve in people with Osteoporotic Fracture, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporotic Fracture
- What is being tested?
- posterior branch block of spinal nerve
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 24 Oct 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoporotic fracture
- acute vertebral compression fracture (within 2 weeks)
- fracture level lower thanT6
Who cannot join
- other types of fractures
- patients younger than 60 years of age,
- with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)
Trial locations and contacts
1 site in 1 country.
China1 site
The 2nd Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, feykjkcy@163.com
About this study
The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.
Read the detailed description
Patients older than 60 years old who underwent Percutaneous kyphosis(PKP) surgery for osteoporotic fractures were randomly divided into two groups. The lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during PKP operation, while the lumbar spinal nerve branch block was not performed in the control group during PKP operation. The low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using Visual analogue pain score(VAS)scale.So as to compare the effect of lumbar spinal nerve block on residual pain after PKP.
- Conditions
- Osteoporotic Fracture
- Being tested
- posterior branch block of spinal nerve
- Keywords
- Percutaneous kyphoplasty（PKP）, nerve block, posterior branch of spinal nerve
- Medical subject headings
- Osteoporotic Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior branch block of spinal nerveProcedure or surgery
posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation
| Study group | Role | What they receive |
|---|---|---|
| posterior branch block of spinal nerve | Experimental | posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP)operation Receives: Procedure: posterior branch block of spinal nerve |
| without posterior branch block of spinal nerve | No intervention | without posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual low back pain after operation
Residual low back pain after operation using Visual analogue pain score(VAS) scale, VAS scores range from 0 to 10, more higher score means more severe pain, and residual back pain was defined as a VAS score greater than or equal to 4.
Measured: 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Sep 2019
- Primary completion24 Oct 2020
- Study completion24 Oct 2020
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 Osteoporotic FractureStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WU YAOSEN, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108507
- Sponsor's protocol ID
- SAHoWMU-CR2018-08-109
- Status last verified
- Oct 2020
- First submitted
- 21 Sep 2019
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.
PubMed 20701962
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve
- ClinicalTrials.gov ID
- NCT04108507
- Acronym / sponsor ID
- SAHoWMU-CR2018-08-109
- Conditions
- Osteoporotic Fracture
- Keywords
- Percutaneous kyphoplasty（PKP）, nerve block, posterior branch of spinal nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 24 Oct 2020 (actual)
- Study completion
- 24 Oct 2020 (actual)
- First posted
- 30 Sep 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.
The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.
Detailed description
Patients older than 60 years old who underwent Percutaneous kyphosis(PKP) surgery for osteoporotic fractures were randomly divided into two groups. The lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during PKP operation, while the lumbar spinal nerve branch block was not performed in the control group during PKP operation. The low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using Visual analogue pain score(VAS)scale.So as to compare the effect of lumbar spinal nerve block on residual pain after PKP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior branch block of spinal nerve | Experimental | Procedure: posterior branch block of spinal nerveposterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP)operation |
| without posterior branch block of spinal nerve | No intervention | –without posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- osteoporotic fracture
- acute vertebral compression fracture (within 2 weeks)
- fracture level lower thanT6
Key exclusion criteria (3 listed)
- other types of fractures
- patients younger than 60 years of age,
- with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)
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 |
|---|---|---|
| posterior branch block of spinal nerveposterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation | Procedure or surgery | posterior branch block of spinal nerve |
Primary outcome
Residual low back pain after operation
Time frame: 6 months after operation
Residual low back pain after operation using Visual analogue pain score(VAS) scale, VAS scores range from 0 to 10, more higher score means more severe pain, and residual back pain was defined as a VAS score greater than or equal to 4.
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 27 Oct 2020.
- Results publication: PubMed 20701962Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior branch block of spinal nerve in people with Osteoporotic Fracture, run by Second Affiliated Hospital of Wenzhou Medical University 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 3 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: finished, as of the sponsor's last update on 27 Oct 2020. 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?
Residual low back pain after operation (time frame: 6 months after operation). 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 NCT04108507, 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 27 Oct 2020.