Ultrasound Evaluation of OMT for Sacral Base Asymmetry

Manipulation, Osteopathic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820701
• Other study ID #: 160616-001
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2019
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Manipulation, Osteopathic

Intervention

Procedure:
• OMT
Osteopathic Manipulative Treatment to low back region

Locations

Country	Name	City	State
United States	A.T. Still University	Kirksville	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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