Lumbar Intervertebral MotionNCT03737227
Lumbar Intervertebral Motion in Asymptomatic Male Participants
A study testing Cinematographic recording in people with Lumbar Intervertebral Motion, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
The investigators aim to analyze the physiological segmental motion of the lumbar spine during flexion and extension cinematographic recordings of asymptomatic individuals. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lumbar Intervertebral Motion
- What is being tested?
- Cinematographic recording
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jan 2019to 1 Jan 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 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age between 18 and 25 years old.
- BMI under 25
- Participants have to be able to perform flexion and extension over a full range of motion without complaints of pain.
- Participants have no medical history of spinal problems based on anamneses and zero ODI-, and VAS-score.
- Kellgrens' classification on cinematographic recordings is zero or one.
- Informed consent has been signed.
- Ability to read and understand Dutch.
Who cannot join
- Medical history of visiting general practitioners, allied health professionals or specialists for spinal problems.
- Former spine surgery.
- Radiographs of abdomen, pelvis, hips, lumbar spine or sacral spine in last year.
- Degenerative abnormalities of the lumbar spine.
- Active spinal infection.
- Immature bone.
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- Lumbar tumor processes.
- Former lumbar radiotherapy.
- Congenital lumbar spine abnormalities, for example spina bifida.
- Planning pregnancy for the coming year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Lumbar Intervertebral Motion During Flexion and Extension Cinematographic Recordings in Asymptomatic Male Participants.
The investigators aim to analyze the physiological segmental motion of the lumbar spine during flexion and extension cinematographic recordings of asymptomatic individuals.
Read the detailed description
In this study the investigators aim to define the lumbar spines' physiological motion by analyzing sequence of initiation of motion and sequence of maximum contribution in segmental translation and rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants. Participants will undergo two cinematographic recordings with an interval of two weeks. Segmental translation and rotation of each segment will be plotted against total range of motion of the lumbar spine for each individual participant. With these graphs the investigators can analyze if there are specific physiological motion patterns during flexion and extension of the lumbar spine. In the future, the investigators hope to compare these physiological motion patterns to potential abnormal motion patterns in patients suffering from lumbar spinal pathology or after lumbar spine surgery to gain knowledge about complaints and, for example, adjacent level disease.
- Conditions
- Lumbar Intervertebral Motion
- Being tested
- Cinematographic recording
- Keywords
- Lumbar intervertebral motion, Flexion, Extension, Cinematographic recording, Segmental rotations, Segmental translation, lumbar spine, asymptomatic participants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinematographic recordingRadiation
Cinematographic recording during flexion and extension of the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| Cinematographic recording | Other | Cinematographic recordings of the asymptomatic participants during flexion and extension of the lumbar spine.Cinematographic recordings will be performed twice with an interval of two weeks. Receives: Radiation: Cinematographic recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar segmental rotation
Analyzing sequence of initiation of motion and sequence of segmental contribution in rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants.
Measured: 30 minutes
Secondary outcomes (1)
Lumbar segmental translation
Analyzing intervertebral horizontal and vertical translation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants. If mean intra-class correlation coefficient is higher than 0.60, sequence of initiation of motion and sequence of segmental contribution of intervertebral horizontal and vertical translation will be analyzed.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start9 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Intervertebral MotionStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fundamental research with 11 male participants in one study arm, all performingflexion and extension of the lumbar spine during cinematographic recordings twice.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henk Van Santbrink, Dr., Principal investigator, neurosurgeon Zuyderland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737227
- Sponsor's protocol ID
- NL63033.096.18
- Status last verified
- Feb 2019
- First submitted
- 2 Nov 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caelers I, Boselie T, van Hemert W, Rijkers K, De Bie R, van Santbrink H. The Variability of Lumbar Sequential Motion Patterns: Observational Study. JMIR Biomed Eng. 2023 Jun 20;8:e41906. doi: 10.2196/41906.
PubMed 38875682Caelers IJ, Boselie TF, Rijkers K, Van Hemert WL, De Bie RA, Van Santbrink H. Lumbar Intervertebral Motion Analysis During Flexion and Extension Cinematographic Recordings in Healthy Male Participants: Protocol. JMIR Res Protoc. 2020 Feb 24;9(2):e14741. doi: 10.2196/14741.
PubMed 32130199
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Lumbar Intervertebral Motion During Flexion and Extension Cinematographic Recordings in Asymptomatic Male Participants.
- ClinicalTrials.gov ID
- NCT03737227
- Acronym / sponsor ID
- NL63033.096.18
- Conditions
- Lumbar Intervertebral Motion
- Keywords
- Lumbar intervertebral motion, Flexion, Extension, Cinematographic recording, Segmental rotations, Segmental translation, lumbar spine, asymptomatic participants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 9 Nov 2018 (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 investigators aim to analyze the physiological segmental motion of the lumbar spine during flexion and extension cinematographic recordings of asymptomatic individuals.
Detailed description
In this study the investigators aim to define the lumbar spines' physiological motion by analyzing sequence of initiation of motion and sequence of maximum contribution in segmental translation and rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants. Participants will undergo two cinematographic recordings with an interval of two weeks. Segmental translation and rotation of each segment will be plotted against total range of motion of the lumbar spine for each individual participant. With these graphs the investigators can analyze if there are specific physiological motion patterns during flexion and extension of the lumbar spine. In the future, the investigators hope to compare these physiological motion patterns to potential abnormal motion patterns in patients suffering from lumbar spinal pathology or after lumbar spine surgery to gain knowledge about complaints and, for example, adjacent level disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fundamental research with 11 male participants in one study arm, all performingflexion and extension of the lumbar spine during cinematographic recordings twice.
| Arm | Type | Receives |
|---|---|---|
| Cinematographic recording | Other | Radiation: Cinematographic recordingCinematographic recordings of the asymptomatic participants during flexion and extension of the lumbar spine.Cinematographic recordings will be performed twice with an interval of two weeks. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male
- Age between 18 and 25 years old.
- BMI under 25
- Participants have to be able to perform flexion and extension over a full range of motion without complaints of pain.
- Participants have no medical history of spinal problems based on anamneses and zero ODI-, and VAS-score.
Key exclusion criteria (10 listed)
- Medical history of visiting general practitioners, allied health professionals or specialists for spinal problems.
- Former spine surgery.
- Radiographs of abdomen, pelvis, hips, lumbar spine or sacral spine in last year.
- Degenerative abnormalities of the lumbar spine.
- Active spinal infection.
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 |
|---|---|---|
| Cinematographic recordingCinematographic recording during flexion and extension of the lumbar spine. | Radiation | Cinematographic recording |
Primary outcome
Lumbar segmental rotation
Time frame: 30 minutes
Analyzing sequence of initiation of motion and sequence of segmental contribution in rotation of each vertebra L1, L2, L3, L4, L5 and S1 by using flexion and extension cinematographic recordings in asymptomatic male participants.
1 secondary outcome
Lumbar segmental translation
Time frame: 30 minutes
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 18 Jan 2020.
- Derived from this study: PubMed 38875682Caelers I, Boselie T, van Hemert W, Rijkers K, De Bie R, van Santbrink H. The Variability of Lumbar Sequential Motion Patterns: Observational Study. JMIR Biomed Eng. 2023 Jun 20;8:e41906. doi: 10.2196/41906.
- Derived from this study: PubMed 32130199Caelers IJ, Boselie TF, Rijkers K, Van Hemert WL, De Bie RA, Van Santbrink H. Lumbar Intervertebral Motion Analysis During Flexion and Extension Cinematographic Recordings in Healthy Male Participants: Protocol. JMIR Res Protoc. 2020 Feb 24;9(2):e14741. doi: 10.2196/14741.
- 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.
Henk Van Santbrink, Dr. principal investigator
neurosurgeon Zuyderland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinematographic recording in people with Lumbar Intervertebral Motion, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 8 inclusion and 10 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 18 Jan 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 Netherlands. 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?
Lumbar segmental rotation (time frame: 30 minutes). 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 NCT03737227, which also lists 2 linked publications.
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 18 Jan 2020.