Ultrasound Evaluation of OMT for Sacral Base Asymmetry

NCT02820701 | Completed

• 1 other identifier: 160616-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Manipulation, Osteopathic

Keywords

Osteopathic Manipulation; Somatic Dysfunction; Musculoskeletal Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Sacral Base Asymmetry without OMT

  30 minutes between measurements

Other Outcomes (1)

• Agreement between palpatory and ultrasound measurements

  Approximately 10 mins between palpatory and ultrasound measurements

Study Arms (2)

Control

NO INTERVENTION

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.

Treatment

EXPERIMENTAL

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

Interventions

OMT PROCEDURE

Osteopathic Manipulative Treatment to low back region

Treatment

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -

You may not qualify if:

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

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

A.T. Still University

Kirksville, Missouri, 63501, United States

Location

Related Publications (2)

• 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.

  PMID: 26501757 BACKGROUND

• 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.

  PMID: 29480916 DERIVED

Study Officials

• Karen T Snider, DO, FAAO

  A.T. Still University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 1, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)