Osteopathy in Diseases Classified ElsewhereNCT04374227
The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults
A study testing Osteopathic Manipulative Treatment in people with Osteopathy in Diseases Classified Elsewhere, run by Des Moines University at 1 site in United States.
Trial summary
Participants will be recruited from the Des Moines University community and randomized into treatment and control groups. The treatment group will undergo three treatments one week apart. The control group will have an osteopathic structural exam without treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopathy in Diseases Classified Elsewhere
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 21 Nov 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18-40 years old
- Have the ability to give consent
- Be able to bare weight on both feet
Who cannot join
- had manipulation performed by a D.O., physical therapist, or chiropractor in the last two months,
- had surgery in the six months
- had broken or fractured a bone in the last six months
- have an abnormal neurological exam
- cerebellar dysfunction or ataxia
- has a condition that impairs balance (including orthostatic hypertension,otoneurologic conditions, or arrhythmias)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults: A Pilot Study
Participants will be recruited from the Des Moines University community and randomized into treatment and control groups. The treatment group will undergo three treatments one week apart. The control group will have an osteopathic structural exam without treatment. During the first treatment weeks both groups will undergo balance testing on a force plate pre and post intervention. Additional balance testing will take place one week after last intervention. Six variables will be compared between groups used a linear mixed model analysis.
Read the detailed description
Participants will go through an informed consent process, fill out a screening questionnaire and will undergo neurological testing. If there are any abnormalities in their neurological testing or they meet exclusion criteria, they will not be included in the study. The neurological testing will include reflex testing, sensation testing, strength testing, and coordination and balance tests.
Participants will then be randomized into 2 groups. One control and one treatment.
Each group will have their balance measured using the portable force plate. Participants will be tested on both feet with arms crossed and eyes open for 60 seconds, and both feet with arms crossed and eyes closed for 60 seconds. Then they will be given 15 seconds to practice standing on the force plate on only their right leg with eyes open and arms crossed. The investigators will then test their balance on their right leg with arms crossed and eyes open for 30 seconds. They will be given 15 seconds to practice standing on their right leg with their arms crossed and eyes closed, and then will have their balance tested on their right leg with arms crossed and eyes closed for 30 seconds. The same sequence of events will take place for the left leg as their right leg. This sequence of measurements will take place at the beginning and end of their first treatment visit. For the standing test with eyes closed and all single leg tests someone will be standing beside the force plate with an arm and either side of the participant to prevent the participant from falling and hurting themselves.
The force plate calculates the center of mass of the participant, the area that is covered by the center of mass, the length of the path of center of mass, the velocity of its motion, and the maximum sway in the x and y planes.
During the single leg tests, the investigators will also record the time of when the participant brings the other foot down, touches the two legs together, or if the sternum becomes outside the borders of the pelvis, if they do lose their balance The test duration will be 30 seconds, as stated previously.
Between the two balance tests, the treatment group will receive a full-body osteopathic manipulative treatment according to the Common Compensatory Pattern (CCP). CCP is a treatment approach developed by Dr. Zinc that addresses the transition areas of the body. The treatment will be given by one of the four fellows under supervision by a licensed physician and last 10-20 minutes. The treatment will include the following body regions:
Occipito-atlantal Joint Thoracic Inlet Thoraco-lumbar shift Lumbo-pelvic roll Ribs Sacrum Pelvis Upslip Upper extremity Lower extremity
The fellows will diagnose somatic dysfunctions within these body regions, treat, and reassess to make sure the somatic dysfunctions are resolved. The physician will perform a spinal sweep and side-to-side height assessments before and after treatment to verify there was improvement in somatic dysfunctions.
After the treatment, the treatment group will walk around the perimeter of the lab for 5 minutes before retesting their balance.
The control group will be asked to lay on an OMM (Osteopathic Manual Medicine) treatment for 15 minutes. They will then walk around the perimeter of the lab for 5 minutes before retesting their balance.
The treatment group will come for five visits. The first visit will include the informed consent and neurological exam. The second visit will include a balance measurement, a treatment, and a follow-up balance measurement immediately after the treatment. The next two visits will consist only of osteopathic treatments. Each visit will be spaced one week apart. The participant will come back a week after their last treatment and complete follow-up balance testing.
The control group will have a total of five visits. They will have the same initial visit as the treatment group with informed consent and neurological exam. Their second visit will consist of a balance measurement, have somatic dysfunctions be diagnosed, yet not be treated and have an immediate follow-up measurement. The third and fourth visits will consist of diagnosing somatic dysfunctions without any treatment. The last visit will consist of a follow-up balance testing. Each of these visits will be one week apart.
The data from the force that will be used includes area that the center of mass covers, length of pathway of center of mass, velocity of the center of mass, medial-lateral sway, and anterior-posterior sway. The investigators will also use the length of time participants were able to stand on one leg without losing their balance (without moving their knee or chest outside of their midline, their foot leaving the platform, touching their opposite foot to the ground, or letting their legs touch).
Summary descriptive statistics will be first obtained for the selected variables and demographics covariates as appropriate. For a particular variable, the change between pre- (or baseline) and post- treatment during the first week reflects the immediate treatment effect while the difference between the pre-treatment baseline and the last measurement during week 4 represents the long-term lasting accumulative effect. The data bear the characteristics of repeated measurements on the same study participants since more than one measurements are taken on the same study participant over time. Thus, it is usually plausible to assume the measurements on the same individual subjects are correlated. Ignoring the covariance between such measurements may result in erroneous statistical inference, and avoiding it by data transformation may result in inefficient statistical inference. The statistical technique of linear mixed model allows the covariance structure to be integrated into the modeling while accounting for the randomness of the study subjects. Thus, the data will be analyzed separately for each variable with a linear mixed-effect model with repeated measures design to assess the OMT effects on the balance measurement metrics over time. In the model fitting process, several candidate covariance structures will be selected and evaluated according to the experimental design (i.e., unequal spacing of the time points but with the same time points across the study participants, within-subject correlation over time and convergence of model fitting), out of which one optimal covariance structure will be selected by the Akaike information criterion (AIC) criteria. On the basis of the chosen models for the respective variables, statistical contrasts will be set up to compare the mean values of variable measurements between time points to assess the immediate and long-term effects of OMT treatment. Tukey procedure for the multiple testing adjustment will be used to compute the adjusted p-value in case of need.
- Being tested
- Osteopathic Manipulative Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
Body regions that were treated included head, cervical, thoracic, ribs, lumbar, pelvis, sacrum, lower extremity, and upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The treatment group received three osteopathic manipulative treatments once a week for three weeks. The osteopathic manipulative treatment was a full body treatment based upon Dr. Zink's model of a common compensatory pattern. Receives: Procedure: Osteopathic Manipulative Treatment |
| Control Group | No intervention | This group received an osteopathic structural exam once a week for three weeks without any treatment performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of pathway of center of mass
the center of mass of the participant is tracked on the force plate and the overall length it travels will be recorded
Measured: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
area covered by center of mass
the center of mass of the participant is tracked on the force plate and its total area covered was measured
Measured: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
velocity of center of mass
the center of mass of the participant is tracked on the force plate and the velocity at which that point moved was measured
Measured: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
medial-lateral sway
the center of mass of the participant is tracked on the force plate and the amount of lateral movement the point had was measured
Measured: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
anterior-posterior sway
the center of mass of the participant is tracked on the force plate and the amount of front-to-back movement the point had was measured
Measured: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
Time
we measured the amount of time participants were able to stand upright without touching the ground or having one leg touch the other in the single-leg tests
Measured: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start16 Oct 2019
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopathy in Diseases Classified ElsewhereStudies 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
- Model description
- The subjects were randomized into treatment or control groups. The treatment group for week 1 completed two measurements (before and after) and one treatment. Week 2 the treatment group received a treatment. Week 3 the treatment group received a treatment. Week 2 they completed one measurement. The control group completed two measurements and an assessment during week 1. They completed an assessment during weeks 2 and 3, and then completed a measurement during week 4.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Des Moines University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374227
- Sponsor's protocol ID
- IRB-2019-26
- Status last verified
- May 2020
- First submitted
- 29 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT04374227
- Acronym / sponsor ID
- IRB-2019-26
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Des Moines UniversityUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 5 May 2020 (actual)
- 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.
Participants will be recruited from the Des Moines University community and randomized into treatment and control groups. The treatment group will undergo three treatments one week apart. The control group will have an osteopathic structural exam without treatment. During the first treatment weeks both groups will undergo balance testing on a force plate pre and post intervention. Additional balance testing will take place one week after last intervention. Six variables will be compared between groups used a linear mixed model analysis.
Detailed description
Participants will go through an informed consent process, fill out a screening questionnaire and will undergo neurological testing. If there are any abnormalities in their neurological testing or they meet exclusion criteria, they will not be included in the study. The neurological testing will include reflex testing, sensation testing, strength testing, and coordination and balance tests.
Participants will then be randomized into 2 groups. One control and one treatment.
Each group will have their balance measured using the portable force plate. Participants will be tested on both feet with arms crossed and eyes open for 60 seconds, and both feet with arms crossed and eyes closed for 60 seconds. Then they will be given 15 seconds to practice standing on the force plate on only their right leg with eyes open and arms crossed. The investigators will then test their balance on their right leg with arms crossed and eyes open for 30 seconds. They will be given 15 seconds to practice standing on their right leg with their arms crossed and eyes closed, and then will have their balance tested on their right leg with arms crossed and eyes closed for 30 seconds. The same sequence of events will take place for the left leg as their right leg. This sequence of measurements will take place at the beginning and end of their first treatment visit. For the standing test with eyes closed and all single leg tests someone will be standing beside the force plate with an arm and either side of the participant to prevent the participant from falling and hurting themselves.
The force plate calculates the center of mass of the participant, the area that is covered by the center of mass, the length of the path of center of mass, the velocity of its motion, and the maximum sway in the x and y planes.
During the single leg tests, the investigators will also record the time of when the participant brings the other foot down, touches the two legs together, or if the sternum becomes outside the borders of the pelvis, if they do lose their balance The test duration will be 30 seconds, as stated previously.
Between the two balance tests, the treatment group will receive a full-body osteopathic manipulative treatment according to the Common Compensatory Pattern (CCP). CCP is a treatment approach developed by Dr. Zinc that addresses the transition areas of the body. The treatment will be given by one of the four fellows under supervision by a licensed physician and last 10-20 minutes. The treatment will include the following body regions:
Occipito-atlantal Joint Thoracic Inlet Thoraco-lumbar shift Lumbo-pelvic roll Ribs Sacrum Pelvis Upslip Upper extremity Lower extremity
The fellows will diagnose somatic dysfunctions within these body regions, treat, and reassess to make sure the somatic dysfunctions are resolved. The physician will perform a spinal sweep and side-to-side height assessments before and after treatment to verify there was improvement in somatic dysfunctions.
After the treatment, the treatment group will walk around the perimeter of the lab for 5 minutes before retesting their balance.
The control group will be asked to lay on an OMM (Osteopathic Manual Medicine) treatment for 15 minutes. They will then walk around the perimeter of the lab for 5 minutes before retesting their balance.
The treatment group will come for five visits. The first visit will include the informed consent and neurological exam. The second visit will include a balance measurement, a treatment, and a follow-up balance measurement immediately after the treatment. The next two visits will consist only of osteopathic treatments. Each visit will be spaced one week apart. The participant will come back a week after their last treatment and complete follow-up balance testing.
The control group will have a total of five visits. They will have the same initial visit as the treatment group with informed consent and neurological exam. Their second visit will consist of a balance measurement, have somatic dysfunctions be diagnosed, yet not be treated and have an immediate follow-up measurement. The third and fourth visits will consist of diagnosing somatic dysfunctions without any treatment. The last visit will consist of a follow-up balance testing. Each of these visits will be one week apart.
The data from the force that will be used includes area that the center of mass covers, length of pathway of center of mass, velocity of the center of mass, medial-lateral sway, and anterior-posterior sway. The investigators will also use the length of time participants were able to stand on one leg without losing their balance (without moving their knee or chest outside of their midline, their foot leaving the platform, touching their opposite foot to the ground, or letting their legs touch).
Summary descriptive statistics will be first obtained for the selected variables and demographics covariates as appropriate. For a particular variable, the change between pre- (or baseline) and post- treatment during the first week reflects the immediate treatment effect while the difference between the pre-treatment baseline and the last measurement during week 4 represents the long-term lasting accumulative effect. The data bear the characteristics of repeated measurements on the same study participants since more than one measurements are taken on the same study participant over time. Thus, it is usually plausible to assume the measurements on the same individual subjects are correlated. Ignoring the covariance between such measurements may result in erroneous statistical inference, and avoiding it by data transformation may result in inefficient statistical inference. The statistical technique of linear mixed model allows the covariance structure to be integrated into the modeling while accounting for the randomness of the study subjects. Thus, the data will be analyzed separately for each variable with a linear mixed-effect model with repeated measures design to assess the OMT effects on the balance measurement metrics over time. In the model fitting process, several candidate covariance structures will be selected and evaluated according to the experimental design (i.e., unequal spacing of the time points but with the same time points across the study participants, within-subject correlation over time and convergence of model fitting), out of which one optimal covariance structure will be selected by the Akaike information criterion (AIC) criteria. On the basis of the chosen models for the respective variables, statistical contrasts will be set up to compare the mean values of variable measurements between time points to assess the immediate and long-term effects of OMT treatment. Tukey procedure for the multiple testing adjustment will be used to compute the adjusted p-value in case of need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The subjects were randomized into treatment or control groups. The treatment group for week 1 completed two measurements (before and after) and one treatment. Week 2 the treatment group received a treatment. Week 3 the treatment group received a treatment. Week 2 they completed one measurement. The control group completed two measurements and an assessment during week 1. They completed an assessment during weeks 2 and 3, and then completed a measurement during week 4.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Osteopathic Manipulative TreatmentThe treatment group received three osteopathic manipulative treatments once a week for three weeks. The osteopathic manipulative treatment was a full body treatment based upon Dr. Zink's model of a common compensatory pattern. |
| Control Group | No intervention | –This group received an osteopathic structural exam once a week for three weeks without any treatment performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be 18-40 years old
- Have the ability to give consent
- Be able to bare weight on both feet
Key exclusion criteria (6 listed)
- had manipulation performed by a D.O., physical therapist, or chiropractor in the last two months,
- had surgery in the six months
- had broken or fractured a bone in the last six months
- have an abnormal neurological exam
- cerebellar dysfunction or ataxia
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 |
|---|---|---|
| Osteopathic Manipulative TreatmentBody regions that were treated included head, cervical, thoracic, ribs, lumbar, pelvis, sacrum, lower extremity, and upper extremity. | Procedure or surgery | Treatment Group |
Primary outcome
Length of pathway of center of mass
Time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
the center of mass of the participant is tracked on the force plate and the overall length it travels will be recorded
area covered by center of mass
Time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
the center of mass of the participant is tracked on the force plate and its total area covered was measured
velocity of center of mass
Time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
the center of mass of the participant is tracked on the force plate and the velocity at which that point moved was measured
medial-lateral sway
Time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
the center of mass of the participant is tracked on the force plate and the amount of lateral movement the point had was measured
anterior-posterior sway
Time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
the center of mass of the participant is tracked on the force plate and the amount of front-to-back movement the point had was measured
Time
Time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell
we measured the amount of time participants were able to stand upright without touching the ground or having one leg touch the other in the single-leg tests
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 5 May 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Osteopathy in Diseases Classified Elsewhere, run by Des Moines University 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 3 inclusion and 6 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 5 May 2020. 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?
Length of pathway of center of mass (time frame: 60 seconds for two leg testing, 30 seconds for single leg testing, timing may de different if participant fell). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2020.