Manipulation, OsteopathicNCT02820701
Ultrasound Evaluation of OMT for Sacral Base Asymmetry
A study testing OMT in people with Manipulation, Osteopathic, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial summary
This prospective, randomized, controlled trial is proposed to investigate the effect of OMT on sacral base asymmetry as assessed by ultrasound. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Manipulation, Osteopathic
- What is being tested?
- OMT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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 -
Who cannot join
- Prior spinal surgery Fractures Known congenital anomalies of the lumbar vertebra and sacrum Cannot lie prone for 30 minutes Cannot tolerate OMT
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Manipulation, Osteopathic
- Being tested
- OMT
- Keywords
- Osteopathic Manipulation, Somatic Dysfunction, Musculoskeletal Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTProcedure or surgery
Osteopathic Manipulative Treatment to low back region
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately pre and post treatment - approximately 30 minutes between measurements
Secondary outcomes (1)
Change in Sacral Base Asymmetry without OMT
Determine if ultrasound measurements of sacral landmarks are stable over 30 minutes in untreated (control) participants.
Measured: 30 minutes between measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Manipulation, OsteopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen T Snider, DO, FAAO, Principal investigator, A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820701
- Sponsor's protocol ID
- 160616-001
- Status last verified
- Jan 2019
- First submitted
- 29 Jun 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 26501757Snider 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.
PubMed 29480916
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Evaluation of the Effect of Osteopathic Manipulative Treatment on Sacral Base Asymmetry
- ClinicalTrials.gov ID
- NCT02820701
- Acronym / sponsor ID
- 160616-001
- Conditions
- Manipulation, Osteopathic
- Keywords
- Osteopathic Manipulation, Somatic Dysfunction, Musculoskeletal Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: OMTAll 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 -
Key exclusion criteria (2 listed)
- Prior spinal surgery Fractures Known congenital anomalies of the lumbar vertebra and sacrum Cannot lie prone for 30 minutes Cannot tolerate OMT
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTOsteopathic Manipulative Treatment to low back region | Procedure or surgery | Treatment |
Primary outcome
Change in Sacral Base Asymmetry with OMT
Time frame: 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.
1 secondary outcome
Change in Sacral Base Asymmetry without OMT
Time frame: 30 minutes between measurements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Background: PubMed 26501757Lockwood 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.
- Derived from this study: PubMed 29480916Snider 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen T Snider, DO, FAAO principal investigator
A.T. Still University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT in people with Manipulation, Osteopathic, run by A.T. Still University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sacral Base Asymmetry with OMT (time frame: Immediately pre and post treatment - approximately 30 minutes between measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820701, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.