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Completed

NCT Number: NCT02820701

Ultrasound Evaluation of OMT for Sacral Base Asymmetry

This prospective, randomized, controlled trial is proposed to investigate the effect of OMT on sacral base asymmetry as assessed by ultrasound.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.T. Still University

Kirksville, Missouri, 63501, United States

About this study

The proposed prospective, randomized, controlled trial will investigate the effect of osteopathic manipulative treatment (OMT) on sacral base asymmetry as assessed by ultrasound. The study will be conducted between July 2016 - June 2017 with data collection planned for August and September 2016. Forty men and women ages 20 to 55 years with at least one or more episodes of LBP in the past two weeks will be recruited from the Kirksville area. Participants will be randomly assigned into two groups, control or OMT using a random number generator. Males and females will be randomized separately to ensure equal distribution into the two study groups. Demographics including sex, age, and body mass index (BMI) will be collected on all participants. All participants will complete a brief medical history questionnaire, receive an initial palpatory assessment of the sacral base asymmetry, and then an initial ultrasound evaluation of sacral base asymmetry. After the ultrasound assessment, the control group will wait in another room for approximately 30 minutes. Participants in the OMT group will receive OMT to address sacral base asymmetry after the initial ultrasound assessment. Following the treatment period for the OMT group, all participants will receive a second ultrasound assessment of sacral base asymmetry. The ultrasonographer will be blinded on whether the subject received an OMT or not. After the second ultrasound measurement, the participants in the control group will be offered an OMT treatment consistent with that of the OMT group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Must have experienced at least one or more episodes of LBP in the past two weeks Must be able to lie prone for 30 minutes Must be able to tolerate OMT -

Exclusion criteria

Prior spinal surgery Fractures Known congenital anomalies of the lumbar vertebra and sacrum Cannot lie prone for 30 minutes Cannot tolerate OMT

-

Treatment and study plan

OMT

Procedure

Osteopathic Manipulative Treatment to low back region

Primary outcomes

  1. Change in Sacral Base Asymmetry with OMT

    Time frame: Immediately pre and post treatment - approximately 30 minutes between measurements

    Determine the extent to which OMT affects the relative asymmetry between the pelvic and sacral landmarks as measured by ultrasonography when compared to control group.

Secondary outcomes

  1. Change in Sacral Base Asymmetry without OMT

    Time frame: 30 minutes between measurements

    Determine if ultrasound measurements of sacral landmarks are stable over 30 minutes in untreated (control) participants.

Other outcomes

  1. Agreement between palpatory and ultrasound measurements

    Time frame: Approximately 10 mins between palpatory and ultrasound measurements

    Determine if ultrasound measurements of sacral base asymmetry agree with palpatory assessment.

Sponsors and collaborators

Lead sponsor

A.T. Still University of Health Sciences

Other

Registry information

Official study title

Ultrasound Evaluation of the Effect of Osteopathic Manipulative Treatment on Sacral Base Asymmetry

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 1, 2016
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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