Lumbar FusionNCT01703338
Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery
An observational study of Lumbar Fusion and Lumbar Spinal Fusion Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lumbar fusion has been widely used for spinal disorders when conservative treatment has failed. However, a number of studies have reported that the rate of re-operation is high for lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the surgery site can cause weakness and pain. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Fusion, Lumbar Spinal Fusion Surgery
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to 14 Feb 2020
- Phase
- Observational
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All subjects will be recruited from the National Taiwan University Hospital and Far Eastern Memorial Hospital. The study is approved by the Institutional Medical Research Ethics Committees in both National Taiwan University Hospital and Far Eastern Memorial Hospital. Our neurological surgeon will response for subject screening and medical diagnose. According to the power analysis, fifty subjects will be enrolled in this study. The eligible subject will be given the subjects informed consent and sign it before the enrollment.
Who may be able to join
- ages between 20 and 85 years,
- back pain and/or sciatica exceeding 12 weeks for which conservative treatment had failed to improve,
- a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease, and
- the patient selected for lumbar surgery
Who cannot join
- mechanical back pain due to posture changes and cannot maintain an upright posture over 30 minutes;
- segmental instability that includes isthmic spondylolisthesis, degenerative spondylolisthesis over 0.4 cm;
- intervertebral angle reversal on dynamic radiographs; and
- previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Taipei, 10055
About this study
Lumbar fusion has been widely used for spinal disorders when conservative treatment has failed. However, a number of studies have reported that the rate of re-operation is high for lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the surgery site can cause weakness and pain. After fusion, the range of motion is constrained at the fused spine and might facilitate compensative movement of the adjacent levels and increase degeneration rate of the spine.
Evidence has shown that core muscles play an important role to stabilize and support the spine. Whether core stability exercise can enhance spinal stability after lumbar fusion surgery remains unclear. Therefore, the overall goal of this proposed research is to investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators will explore this issue hierarchically and systematically in 3-year duration.
- Conditions
- Lumbar Fusion, Lumbar Spinal Fusion Surgery
- Keywords
- assessment model, biomechanical changes, functional activities, magnetic resonance imaging (MRI), causal relationship, core muscles activation pattern, pathological changes, early rehabilitation, core stability exercise, minimally invasive lumbar spinal fusion surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spinal surgery | The study included participants who were diagnosed by a neurological surgeon and received lumbar surgery according to relevant imaging findings |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2012 (estimated)
- Study startAug 2012
- Primary completion24 Dec 2018
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar FusionStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01703338
- Sponsor's protocol ID
- 201112117RIC
- Status last verified
- Sep 2020
- First submitted
- 5 Oct 2012
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biomechanics Research in Core Muscles After Lumbar Fusion Surgery
- ClinicalTrials.gov ID
- NCT01703338
- Acronym / sponsor ID
- 201112117RIC
- Conditions
- Lumbar Fusion, Lumbar Spinal Fusion Surgery
- Keywords
- assessment model, biomechanical changes, functional activities, magnetic resonance imaging (MRI), causal relationship, core muscles activation pattern, pathological changes, early rehabilitation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 10 Oct 2012 (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.
Lumbar fusion has been widely used for spinal disorders when conservative treatment has failed. However, a number of studies have reported that the rate of re-operation is high for lumbar fusion surgery. Swelling, atrophy or fat infiltration of the paraspinal muscles at the surgery site can cause weakness and pain. After fusion, the range of motion is constrained at the fused spine and might facilitate compensative movement of the adjacent levels and increase degeneration rate of the spine.
Evidence has shown that core muscles play an important role to stabilize and support the spine. Whether core stability exercise can enhance spinal stability after lumbar fusion surgery remains unclear. Therefore, the overall goal of this proposed research is to investigate how core muscles affect outcomes after lumbar spinal fusion. The investigators will explore this issue hierarchically and systematically in 3-year duration.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar spinal surgery | – | –The study included participants who were diagnosed by a neurological surgeon and received lumbar surgery according to relevant imaging findings |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects will be recruited from the National Taiwan University Hospital and Far Eastern Memorial Hospital. The study is approved by the Institutional Medical Research Ethics Committees in both National Taiwan University Hospital and Far Eastern Memorial Hospital. Our neurological surgeon will response for subject screening and medical diagnose. According to the power analysis, fifty subjects will be enrolled in this study. The eligible subject will be given the subjects informed consent and sign it before the enrollment.
Key inclusion criteria (4 listed)
- ages between 20 and 85 years,
- back pain and/or sciatica exceeding 12 weeks for which conservative treatment had failed to improve,
- a primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease, and
- the patient selected for lumbar surgery
Key exclusion criteria (4 listed)
- mechanical back pain due to posture changes and cannot maintain an upright posture over 30 minutes;
- segmental instability that includes isthmic spondylolisthesis, degenerative spondylolisthesis over 0.4 cm;
- intervertebral angle reversal on dynamic radiographs; and
- previous lumbar fusion, rheumatoid arthritis, and ankylosing spondylitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
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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.
Wei-Li Hsu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Fusion and Lumbar Spinal Fusion Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Sep 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 Taiwan. 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 was stopped early. 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.
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 11 Sep 2020.