Comparison of Electronic Calipers to Conventional Calipers and X-ray Measurement of Spinal Tilt

NCT ID: NCT02920255

Last Updated: 2016-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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

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Lower Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Electronic Caliper Measurements

This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with electronic calipers.

Diagnostic

Intervention Type OTHER

Measurement of spinal tilt

Conventional Caliper Measurements

This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with conventional calipers.

Diagnostic

Intervention Type OTHER

Measurement of spinal tilt

X-ray Measurements

This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with x-rays.

Diagnostic

Intervention Type OTHER

Measurement of spinal tilt

Interventions

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Diagnostic

Measurement of spinal tilt

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Must be able to have shoulder and hip measurements for spinal tilt

Exclusion Criteria

Not able to have shoulder and and hip measurements for spinal tilt.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KKT Orthopedic Spine Center

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aslam Khan, DC

Role: PRINCIPAL_INVESTIGATOR

KKT Orthopedic Spine Center

Locations

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KKT Orthopedic Spine Center

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Aslam Khan, DC

Role: CONTACT

1-905-285-0005

Malcolm Barth, Ph.D.

Role: CONTACT

301-358-3395

Facility Contacts

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Aslam Khan, DC

Role: primary

1-905-285-0005

References

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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.

Reference Type BACKGROUND
PMID: 18027001 (View on PubMed)

Other Identifiers

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Caliper 1001

Identifier Type: -

Identifier Source: org_study_id

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