Manipulation, Osteopathic
Conditions
Keywords
Osteopathic Manipulation, Somatic Dysfunction, Musculoskeletal Ultrasound
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.
Interventions
PROCEDUREOMT
Osteopathic Manipulative Treatment to low back region
Sponsors
A.T. Still University of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sacral Base Asymmetry with OMT | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Sacral Base Asymmetry without OMT | 30 minutes between measurements | Determine if ultrasound measurements of sacral landmarks are stable over 30 minutes in untreated (control) participants. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Agreement between palpatory and ultrasound measurements | Approximately 10 mins between palpatory and ultrasound measurements | Determine if ultrasound measurements of sacral base asymmetry agree with palpatory assessment. |
Countries
United States
Outcome results
None listed