Ultrasound Evaluation of OMT for Sacral Base Asymmetry

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

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

Study Overview

• Status: Completed
• Conditions: Manipulation, Osteopathic
• Intervention / Treatment: Procedure: OMT

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kirksville, Missouri, United States, 63501
      • A.T. Still University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; All participants will 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.
EXPERIMENTAL: Treatment; All participants will receive an initial palpatory assessment of the sacral base asymmetry and then an initial ultrasound evaluation of sacral base asymmetry. Participants in the Treatment group will receive OMT to address sacral base asymmetry after the initial ultrasound assessment.	Procedure: OMT; Osteopathic Manipulative Treatment to low back region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sacral Base Asymmetry with OMT	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.	Immediately pre and post treatment - approximately 30 minutes between measurements

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sacral Base Asymmetry without OMT	Determine if ultrasound measurements of sacral landmarks are stable over 30 minutes in untreated (control) participants.	30 minutes between measurements

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between palpatory and ultrasound measurements	Determine if ultrasound measurements of sacral base asymmetry agree with palpatory assessment.	Approximately 10 mins between palpatory and ultrasound measurements

Collaborators and Investigators

• Sponsor: A.T. Still University of Health Sciences
• Investigators: Principal Investigator: Karen T Snider, DO, FAAO, A.T. Still University

Publications and helpful links

General Publications

• Lockwood MD, Kondrashova T, Johnson JC. Feasibility of Using Ultrasonography to Establish Relationships Among Sacral Base Position, Sacral Sulcus Depth, Body Mass Index, and Sex. J Am Osteopath Assoc. 2015 Nov;115(11):648-53. doi: 10.7556/jaoa.2015.135.
• Snider KT, Redman CL, Edwards CR, Bhatia S, Kondrashova T. Ultrasonographic Evaluation of the Effect of Osteopathic Manipulative Treatment on Sacral Base Asymmetry. J Am Osteopath Assoc. 2018 Mar 1;118(3):159-169. doi: 10.7556/jaoa.2018.035.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: June 29, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (ESTIMATE): July 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Musculoskeletal Ultrasound; Osteopathic Manipulation; Somatic Dysfunction
• Other Study ID Numbers: 160616-001

Plan for Individual participant data (IPD)

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