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

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.

Study Overview

• Status: Unknown
• Conditions: Lower Back Pain
• Intervention / Treatment: Other: Diagnostic

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga,, Ontario, Canada, L5M1M2
      • KKT Orthopedic Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patient Population and Normal Volunteers at KKT Orthopedic Spinal Center

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Electronic Caliper Measurements; This arm would be the spinal diagnostic measurements taken at the hips and shoulders of participants with electronic calipers.	Other: Diagnostic; 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.	Other: Diagnostic; 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.	Other: Diagnostic; Measurement of spinal tilt

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KKT Orthopedic Spine Center
• Investigators: Principal Investigator: Aslam Khan, DC, KKT Orthopedic Spine Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: September 22, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 30, 2016

Study Record Updates

• Last Update Posted (Estimate): October 4, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Caliper 1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO