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

Lower Back Pain Clinical Trial

Official title:

Comparison of Electronic Caliper Measurements of Spinal Tilt to Conventional Caliper and X-ray Measurements of Spinal Tilt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02920255
• Other study ID #: Caliper 1001
• Status: Not yet recruiting
• Phase: N/A
• First received: September 22, 2016
• Last updated: October 3, 2016
• Start date: October 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: KKT Orthopedic Spine Center
• Contact: Aslam Khan, DC
• Phone: 1-905-285-0005
• Email: drkhan[@]kktspinetreatment.com
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical 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 from X-rays.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lower Back Pain

Intervention

Other:
• Diagnostic
Measurement of spinal tilt

Locations

Country	Name	City	State
Canada	KKT Orthopedic Spine Center	Mississauga,	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
KKT Orthopedic Spine Center

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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):348-54. Epub 2007 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Electronic Caliper Spinal Measurements	All measurements will recorded in degrees of spinal tilt.	Through study completion, an average of 13 months	No
Secondary	Accuracy of Conventional Caliper Spinal Measurements	All measurements will recorded in degrees of spinal tilt.	Through study completion, an average of 13 months	No
Secondary	Accuracy of X-ray Spinal Measurements	All measurements will recorded in degrees of spinal tilt.	Through study completion, an average of 13 months	No
Secondary	Reproducibility of Electronic Caliper Measurements	All measurements will recorded in degrees of spinal tilt.	Through study completion, an average of 13 months	No
Secondary	Reproducibility of Conventional Caliper Measurements	All measurements will recorded in degrees of spinal tilt.	Through study completion, an average of 13 months	No
Secondary	Reproducibility of X-ray Measurements	All measurements will recorded in degrees of spinal tilt.	Through study completion, an average of 13 months	No