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

• Conditions: Lower Back Pain
• Interventions: Other: Diagnostic

• Registration Number: NCT02920255
• Lead Sponsor: KKT Orthopedic Spine Center

Brief 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.

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 Timeline

• Study First Submitted: 2016-09-22
• Study First Submitted QC: 2016-09-28
• Study First Posted: 2016-09-30
• Status Verified: 2016-10
• Study Start: 2016-10
• Last Update Submitted: 2016-10-03
• Last Update Posted: 2016-10-04
• Primary Completion: 2017-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Electronic Caliper Measurements	Diagnostic	This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with electronic calipers.
Conventional Caliper Measurements	Diagnostic	This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with conventional calipers.
X-ray Measurements	Diagnostic	This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with x-rays.

Primary Outcome Measures

Name	Time	Method
Accuracy of Electronic Caliper Spinal Measurements	Through study completion, an average of 13 months	All measurements will recorded in degrees of spinal tilt.

Secondary Outcome Measures

Name	Time	Method
Reproducibility of X-ray Measurements	Through study completion, an average of 13 months	All measurements will recorded in degrees of spinal tilt.
Accuracy of Conventional Caliper Spinal Measurements	Through study completion, an average of 13 months	All measurements will recorded in degrees of spinal tilt.
Reproducibility of Conventional Caliper Measurements	Through study completion, an average of 13 months	All measurements will recorded in degrees of spinal tilt.
Accuracy of X-ray Spinal Measurements	Through study completion, an average of 13 months	All measurements will recorded in degrees of spinal tilt.
Reproducibility of Electronic Caliper Measurements	Through study completion, an average of 13 months	All measurements will recorded in degrees of spinal tilt.

Trial Locations

Locations (1)

KKT Orthopedic Spine Center; 🇨🇦 Mississauga,, Ontario, Canada