Lower Back PainNCT02920255
Comparison of Electronic Calipers to Conventional Calipers and X-ray Measurement of Spinal Tilt
An observational study of Lower Back Pain, run by KKT Orthopedic Spine Center at 1 site in Canada.
Trial summary
The objective is to compare the accuracy and reproducibility of measurements taken with electronic calipers and conventional calipers. Using both calipers, reproducibility will be determined by comparing results from a number of practitioners and accuracy will be determined by comparing results with those obtained… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- Diagnostic
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Nov 2017
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient Population and Normal Volunteers at KKT Orthopedic Spinal Center
Who may be able to join
- Must be able to have shoulder and hip measurements for spinal tilt
Who cannot join
- Not able to have shoulder and and hip measurements for spinal tilt.
Trial locations and contacts
1 site in 1 country.
Canada1 site
KKT Orthopedic Spine Center
Mississauga, Ontario, L5M1M2
Aslam Khan, DC, 1-905-285-0005, drkhan@kktspinetreatment.com
Malcolm Barth, Ph.D.
About this study
Official title: Comparison of Electronic Caliper Measurements of Spinal Tilt to Conventional Caliper and X-ray Measurements of Spinal Tilt
The objective is to compare the accuracy and reproducibility of measurements taken with electronic calipers and conventional calipers. Using both calipers, reproducibility will be determined by comparing results from a number of practitioners and accuracy will be determined by comparing results with those obtained from X-rays.
Read the detailed description
Participants will have 2 spinal measurements, one at the shoulder and one at the hip, taken by electronic calipers and conventional calipers with different individual research staff. Up to 5 individual research staff will take the 2 spinal measurements on each participant. This will be done to compare variation of measurements between individual operators.
The accuracy of the spinal measurements, obtained with electronic and conventional calipers will be compared to the results obtained from x-rays taken of shoulder and hip areas. Only one x-ray of the shoulder and one x-ray of the hip will be taken of each participant. X-rays represent the clinically accepted standard of obtaining spinal measurements.
The data will analyzed statistically to determine sources of variation among the methods of spinal measurement described above.
- Conditions
- Lower Back Pain
- Being tested
- Diagnostic
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiagnosticOther
Measurement of spinal tilt
| Study group | Role | What they receive |
|---|---|---|
| Electronic Caliper Measurements | This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with electronic calipers. Receives: Other: Diagnostic | |
| Conventional Caliper Measurements | This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with conventional calipers. Receives: Other: Diagnostic | |
| X-ray Measurements | This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with x-rays. Receives: Other: Diagnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Electronic Caliper Spinal Measurements
All measurements will recorded in degrees of spinal tilt.
Measured: Through study completion, an average of 13 months
Secondary outcomes (5)
Accuracy of Conventional Caliper Spinal Measurements
All measurements will recorded in degrees of spinal tilt.
Measured: Through study completion, an average of 13 months
Accuracy of X-ray Spinal Measurements
All measurements will recorded in degrees of spinal tilt.
Measured: Through study completion, an average of 13 months
Reproducibility of Electronic Caliper Measurements
All measurements will recorded in degrees of spinal tilt.
Measured: Through study completion, an average of 13 months
Reproducibility of Conventional Caliper Measurements
All measurements will recorded in degrees of spinal tilt.
Measured: Through study completion, an average of 13 months
Reproducibility of X-ray Measurements
All measurements will recorded in degrees of spinal tilt.
Measured: Through study completion, an average of 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
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 Lower Back PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KKT Orthopedic Spine Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aslam Khan, DC, Principal investigator, KKT Orthopedic Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920255
- Sponsor's protocol ID
- Caliper 1001
- Status last verified
- Oct 2016
- First submitted
- 22 Sep 2016
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Akel I, Pekmezci M, Hayran M, Genc Y, Kocak O, Derman O, Erdogan I, Yazici M. Evaluation of shoulder balance in the normal adolescent population and its correlation with radiological parameters. Eur Spine J. 2008 Mar;17(3):348-354. doi: 10.1007/s00586-007-0546-0. Epub 2007 Nov 20.
PubMed 18027001
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Electronic Caliper Measurements of Spinal Tilt to Conventional Caliper and X-ray Measurements of Spinal Tilt
- ClinicalTrials.gov ID
- NCT02920255
- Acronym / sponsor ID
- Caliper 1001
- Conditions
- Lower Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KKT Orthopedic Spine CenterIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 30 Sep 2016 (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.
The objective is to compare the accuracy and reproducibility of measurements taken with electronic calipers and conventional calipers. Using both calipers, reproducibility will be determined by comparing results from a number of practitioners and accuracy will be determined by comparing results with those obtained from X-rays.
Detailed description
Participants will have 2 spinal measurements, one at the shoulder and one at the hip, taken by electronic calipers and conventional calipers with different individual research staff. Up to 5 individual research staff will take the 2 spinal measurements on each participant. This will be done to compare variation of measurements between individual operators.
The accuracy of the spinal measurements, obtained with electronic and conventional calipers will be compared to the results obtained from x-rays taken of shoulder and hip areas. Only one x-ray of the shoulder and one x-ray of the hip will be taken of each participant. X-rays represent the clinically accepted standard of obtaining spinal measurements.
The data will analyzed statistically to determine sources of variation among the methods of spinal measurement described above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electronic Caliper Measurements | – | Other: DiagnosticThis arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with electronic calipers. |
| Conventional Caliper Measurements | – | Other: DiagnosticThis arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with conventional calipers. |
| X-ray Measurements | – | Other: DiagnosticThis arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with x-rays. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient Population and Normal Volunteers at KKT Orthopedic Spinal Center
Key inclusion criteria (1 listed)
- Must be able to have shoulder and hip measurements for spinal tilt
Key exclusion criteria (1 listed)
- Not able to have shoulder and and hip measurements for spinal tilt.
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 |
|---|---|---|
| DiagnosticMeasurement of spinal tilt | Other | Conventional Caliper Measurements, Electronic Caliper Measurements, X-ray Measurements |
Primary outcome
Accuracy of Electronic Caliper Spinal Measurements
Time frame: Through study completion, an average of 13 months
All measurements will recorded in degrees of spinal tilt.
5 secondary outcomes
Accuracy of Conventional Caliper Spinal Measurements
Time frame: Through study completion, an average of 13 months
Accuracy of X-ray Spinal Measurements
Time frame: Through study completion, an average of 13 months
Reproducibility of Electronic Caliper Measurements
Time frame: Through study completion, an average of 13 months
Reproducibility of Conventional Caliper Measurements
Time frame: Through study completion, an average of 13 months
Reproducibility of X-ray Measurements
Time frame: Through study completion, an average of 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Background: PubMed 18027001Akel I, Pekmezci M, Hayran M, Genc Y, Kocak O, Derman O, Erdogan I, Yazici M. Evaluation of shoulder balance in the normal adolescent population and its correlation with radiological parameters. Eur Spine J. 2008 Mar;17(3):348-354. doi: 10.1007/s00586-007-0546-0. Epub 2007 Nov 20.
- 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.
Aslam Khan, DC principal investigator
KKT Orthopedic Spine Center
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 Lower Back Pain, run by KKT Orthopedic Spine Center at 1 site in Canada.
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 1 inclusion and 1 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 4 Oct 2016. 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 Canada. 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 Aslam Khan, DC (1-905-285-0005, drkhan@kktspinetreatment.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Electronic Caliper Spinal Measurements (time frame: Through study completion, an average of 13 months). 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 NCT02920255, 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 4 Oct 2016.