Clinical trial NCT02820701: Ultrasound Evaluation of OMT for Sacral Base Asymmetry
Official title: Ultrasound Evaluation of the Effect of Osteopathic Manipulative Treatment on Sacral Base Asymmetry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Manipulation, Osteopathic
Keywords: Osteopathic Manipulation
Somatic Dysfunction
Musculoskeletal Ultrasound
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

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Primary outcomes:
measure: Change in Sacral Base Asymmetry with OMT
timeFrame: Immediately pre and post treatment - approximately 30 minutes between measurements
Secondary outcomes:
measure: Change in Sacral Base Asymmetry without OMT
timeFrame: 30 minutes between measurements
Other outcomes:
measure: Agreement between palpatory and ultrasound measurements
timeFrame: Approximately 10 mins between palpatory and ultrasound measurements
Locations:
city: Kirksville
country: United States
facility: A.T. Still University
state: Missouri
Study officials:
affiliation: A.T. Still University
name: Karen T Snider, DO, FAAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.