Osteopathic ManipulationNCT03250312
The Effects of OMT on the Expression Patterns of Immune Cell Biomarkers
A study testing The Osteopathic Manipulation in people with Osteopathic Manipulation and Low Back Pain, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial summary
This study intends to understand the effects of osteopathic manipulative treatment (OMT) on the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear cells (PBMC) of each participant, before and after intervention - OMT or seated control. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manipulation, Low Back Pain, Biomarkers
- What is being tested?
- The Osteopathic Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2017to 31 Aug 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- experienced at least one or more episodes of LBP in the past two weeks
- BMI (body mass index) < 30 kg/m2
- be able to lie on my back for 30 minutes
- be able to tolerate OMT
Who cannot join
- Have spinal manipulation in the 48 hours prior to the study date
- Have corticosteroids in the 2 weeks prior to the study date
- Have nonsteroidal anti-inflammatory medication in the 48 hours prior to the study data
- Have spinal surgery in the lumbar or low thoracic spine
- Have congenital deformities of the lumbar spine such as spina bifida
Trial locations and contacts
1 site in 1 country.
United States1 site
A. T. Still University of Health Sciences
Kirksville, Missouri, 63501
About this study
Official title: The Effects of Osteopathic Manipulations on the Expression Patterns of Immune Cell Biomarkers
This study intends to understand the effects of osteopathic manipulative treatment (OMT) on the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear cells (PBMC) of each participant, before and after intervention - OMT or seated control. This study will utilize participants with a history of low back pain (LBP), and will identify and validate those immune cell biomarkers that change in most participants after OMT, by using the novel protein subcellular localization (PSL) microarray technology. This study intends to uncover the important immune cells affected by OMT techniques, therefore to uncover the molecular mechanisms of OMT.
Read the detailed description
The study will be conducted over the course of one year. 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 randomly assigned into one of two groups - control or OMT groups. Twenty participants will be assigned to each group. The study will begin recruitment in September 2017. Participants will be recruited from the surrounding Kirksville area. Individuals who cannot tolerate OMT or have coagulation disorders will be excluded. Potential participants will be excluded from the study if they have had nonsteroidal anti-inflammatory medication in the 48 hours prior to the study or if they have had corticosteroids in the 2 weeks prior to the study.
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 receive two blood draws,with 8 ml each draw: first blood draw immediately prior to intervention and second blood draw following the intervention.
The OMT treatment will begin with a brief physical examination to identify somatic dysfunction that the treating physician judges to be relevant to the individual participant's low back pain. OMT will be performed to improve the somatic dysfunctions that the treating physicians finds most relevant. The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping technique. The total treatment time will not to exceed 20 minutes.
The control group will wait in another room for approximately 30 minutes. To encourage participation in the proposed study, participants who are assigned to the control group will have an opportunity to receive OMT after the second blood draw.
The investigators shall determine the expression patterns of 60 immune cell biomarkers in human peripheral blood mononuclear cells (PBMC) of the study participants, and determine the ratio change of those 60 biomarkers, after the OMT treatment. The investigators shall compare the effects of OMT treatment on the ratio change of those 60 biomarkers, with those in the control group.
- Conditions
- Osteopathic Manipulation, Low Back Pain, Biomarkers
- Being tested
- The Osteopathic Manipulation
- Keywords
- Osteopathic manipulation, low back pain, immune cells
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Osteopathic ManipulationOther
The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping
| Study group | Role | What they receive |
|---|---|---|
| The OMT group | Active comparator | This group will be treated by the osteopathic manipulation techniques (OMT). The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping. The total treatment time will not to exceed 20 minutes. Receives: Other: The Osteopathic Manipulation |
| The control group | No intervention | The control group will wait in another room for approximately 30 minutes. To encourage participation in the proposed study, participants who are assigned to the control group will have an opportunity to receive OMT after the second blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of OMT on the amounts of immune cell biomarkers
Measure the ratio change of immune cell biomarkers in the PBMC cell of Low back pain patients after the OMT treatment
Measured: immediate after the 20 minutes OMT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start13 Sep 2017
- Primary completion15 Nov 2017
- Study completion31 Aug 2019
Why it stopped: Study Partner Left. Samples degraded before analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Osteopathic ManipulationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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 Snider, D. O., Principal investigator, A.T. Still University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250312
- Sponsor's protocol ID
- IRB #170804-001
- Status last verified
- Jan 2020
- First submitted
- 11 Aug 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kuchera ML. Lymphatics approach. In: Chila AG, ed. Foundations of Osteopathic Medicine. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:786-808.
Castlio Y, Ferris-Swift L. Effects of splenic stimulation in normal individuals on the active and differential blood cell counts and the opsonotic index. Kansas City Coll Osteopath Surg 1932;16:10-6
Castlio Y, Ferris-Swift L. The effect of direct splenic stimulation on the cells and antibody content of the bloodstream in acute infectious disease. Kansas City Coll Osteopath Surg 1934;18:196-211
Lane MA. On increasing the antibody content of the serum by manipulation of the spleen. J of Osteopath 1920;27:361-4
Mesina J, Hampton D, Evans R, Ziegler T, Mikeska C, Thomas K, Ferretti J. Transient basophilia following the application of lymphatic pump techniques: a pilot study. J Am Osteopath Assoc. 1998 Feb;98(2):91-4.
PubMed 9509835Dons'koi BV, Chernyshov VP, Osypchuk DV, Baksheev SM. Repeated cupping manipulation temporary decreases natural killer lymphocyte frequency, activity and cytotoxicity. J Integr Med. 2016 May;14(3):197-202. doi: 10.1016/S2095-4964(16)60250-9.
PubMed 27181126Walkowski S, Singh M, Puertas J, Pate M, Goodrum K, Benencia F. Osteopathic manipulative therapy induces early plasma cytokine release and mobilization of a population of blood dendritic cells. PLoS One. 2014 Mar 10;9(3):e90132. doi: 10.1371/journal.pone.0090132. eCollection 2014.
PubMed 24614605Licciardone JC, Kearns CM. Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Jul;112(7):420-8.
PubMed 22802542Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.
PubMed 16314677Hodge LM, King HH, Williams AG Jr, Reder SJ, Belavadi T, Simecka JW, Stoll ST, Downey HF. Abdominal lymphatic pump treatment increases leukocyte count and flux in thoracic duct lymph. Lymphat Res Biol. 2007;5(2):127-33. doi: 10.1089/lrb.2007.1001.
PubMed 17935480Hodge LM, Bearden MK, Schander A, Huff JB, Williams A Jr, King HH, Downey HF. Lymphatic pump treatment mobilizes leukocytes from the gut associated lymphoid tissue into lymph. Lymphat Res Biol. 2010 Jun;8(2):103-10. doi: 10.1089/lrb.2009.0011.
PubMed 20583872Schander A, Downey HF, Hodge LM. Lymphatic pump manipulation mobilizes inflammatory mediators into lymphatic circulation. Exp Biol Med (Maywood). 2012 Jan;237(1):58-63. doi: 10.1258/ebm.2011.011220. Epub 2011 Dec 14.
PubMed 22169162Schander A, Padro D, King HH, Downey HF, Hodge LM. Lymphatic pump treatment repeatedly enhances the lymphatic and immune systems. Lymphat Res Biol. 2013 Dec;11(4):219-26. doi: 10.1089/lrb.2012.0021.
PubMed 24364845Major B, Rattazzi L, Brod S, Pilipovic I, Leposavic G, D'Acquisto F. Massage-like stroking boosts the immune system in mice. Sci Rep. 2015 Jun 5;5:10913. doi: 10.1038/srep10913.
PubMed 26046935Hernandez-Reif M, Field T, Ironson G, Beutler J, Vera Y, Hurley J, Fletcher MA, Schanberg S, Kuhn C, Fraser M. Natural killer cells and lymphocytes increase in women with breast cancer following massage therapy. Int J Neurosci. 2005 Apr;115(4):495-510. doi: 10.1080/00207450590523080.
PubMed 15809216
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Osteopathic Manipulations on the Expression Patterns of Immune Cell Biomarkers
- ClinicalTrials.gov ID
- NCT03250312
- Acronym / sponsor ID
- IRB #170804-001
- Conditions
- Osteopathic Manipulation, Low Back Pain, Biomarkers
- Keywords
- Osteopathic manipulation, low back pain, immune cells
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Partner Left. Samples degraded before analysis.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 15 Aug 2017 (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.
This study intends to understand the effects of osteopathic manipulative treatment (OMT) on the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear cells (PBMC) of each participant, before and after intervention - OMT or seated control. This study will utilize participants with a history of low back pain (LBP), and will identify and validate those immune cell biomarkers that change in most participants after OMT, by using the novel protein subcellular localization (PSL) microarray technology. This study intends to uncover the important immune cells affected by OMT techniques, therefore to uncover the molecular mechanisms of OMT.
Detailed description
The study will be conducted over the course of one year. 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 randomly assigned into one of two groups - control or OMT groups. Twenty participants will be assigned to each group. The study will begin recruitment in September 2017. Participants will be recruited from the surrounding Kirksville area. Individuals who cannot tolerate OMT or have coagulation disorders will be excluded. Potential participants will be excluded from the study if they have had nonsteroidal anti-inflammatory medication in the 48 hours prior to the study or if they have had corticosteroids in the 2 weeks prior to the study.
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 receive two blood draws,with 8 ml each draw: first blood draw immediately prior to intervention and second blood draw following the intervention.
The OMT treatment will begin with a brief physical examination to identify somatic dysfunction that the treating physician judges to be relevant to the individual participant's low back pain. OMT will be performed to improve the somatic dysfunctions that the treating physicians finds most relevant. The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping technique. The total treatment time will not to exceed 20 minutes.
The control group will wait in another room for approximately 30 minutes. To encourage participation in the proposed study, participants who are assigned to the control group will have an opportunity to receive OMT after the second blood draw.
The investigators shall determine the expression patterns of 60 immune cell biomarkers in human peripheral blood mononuclear cells (PBMC) of the study participants, and determine the ratio change of those 60 biomarkers, after the OMT treatment. The investigators shall compare the effects of OMT treatment on the ratio change of those 60 biomarkers, with those in the control group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The OMT group | Active comparator | Other: The Osteopathic ManipulationThis group will be treated by the osteopathic manipulation techniques (OMT). The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping. The total treatment time will not to exceed 20 minutes. |
| The control group | No intervention | –The control group will wait in another room for approximately 30 minutes. To encourage participation in the proposed study, participants who are assigned to the control group will have an opportunity to receive OMT after the second blood draw |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- experienced at least one or more episodes of LBP in the past two weeks
- BMI (body mass index) < 30 kg/m2
- be able to lie on my back for 30 minutes
- be able to tolerate OMT
Key exclusion criteria (5 listed)
- Have spinal manipulation in the 48 hours prior to the study date
- Have corticosteroids in the 2 weeks prior to the study date
- Have nonsteroidal anti-inflammatory medication in the 48 hours prior to the study data
- Have spinal surgery in the lumbar or low thoracic spine
- Have congenital deformities of the lumbar spine such as spina bifida
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 |
|---|---|---|
| The Osteopathic ManipulationThe types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping | Other | The OMT group |
Primary outcome
The effects of OMT on the amounts of immune cell biomarkers
Time frame: immediate after the 20 minutes OMT treatment
Measure the ratio change of immune cell biomarkers in the PBMC cell of Low back pain patients after the OMT treatment
Results and safety
The study was stopped early (reason given: Study Partner Left. Samples degraded before analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- BackgroundKuchera ML. Lymphatics approach. In: Chila AG, ed. Foundations of Osteopathic Medicine. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011:786-808.
- BackgroundCastlio Y, Ferris-Swift L. Effects of splenic stimulation in normal individuals on the active and differential blood cell counts and the opsonotic index. Kansas City Coll Osteopath Surg 1932;16:10-6
- BackgroundCastlio Y, Ferris-Swift L. The effect of direct splenic stimulation on the cells and antibody content of the bloodstream in acute infectious disease. Kansas City Coll Osteopath Surg 1934;18:196-211
- BackgroundLane MA. On increasing the antibody content of the serum by manipulation of the spleen. J of Osteopath 1920;27:361-4
- Background: PubMed 9509835Mesina J, Hampton D, Evans R, Ziegler T, Mikeska C, Thomas K, Ferretti J. Transient basophilia following the application of lymphatic pump techniques: a pilot study. J Am Osteopath Assoc. 1998 Feb;98(2):91-4.
- Background: PubMed 27181126Dons'koi BV, Chernyshov VP, Osypchuk DV, Baksheev SM. Repeated cupping manipulation temporary decreases natural killer lymphocyte frequency, activity and cytotoxicity. J Integr Med. 2016 May;14(3):197-202. doi: 10.1016/S2095-4964(16)60250-9.
- Background: PubMed 24614605Walkowski S, Singh M, Puertas J, Pate M, Goodrum K, Benencia F. Osteopathic manipulative therapy induces early plasma cytokine release and mobilization of a population of blood dendritic cells. PLoS One. 2014 Mar 10;9(3):e90132. doi: 10.1371/journal.pone.0090132. eCollection 2014.
- Background: PubMed 22802542Licciardone JC, Kearns CM. Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Jul;112(7):420-8.
- Background: PubMed 16314677Knott EM, Tune JD, Stoll ST, Downey HF. Increased lymphatic flow in the thoracic duct during manipulative intervention. J Am Osteopath Assoc. 2005 Oct;105(10):447-56.
- Background: PubMed 17935480Hodge LM, King HH, Williams AG Jr, Reder SJ, Belavadi T, Simecka JW, Stoll ST, Downey HF. Abdominal lymphatic pump treatment increases leukocyte count and flux in thoracic duct lymph. Lymphat Res Biol. 2007;5(2):127-33. doi: 10.1089/lrb.2007.1001.
- Background: PubMed 20583872Hodge LM, Bearden MK, Schander A, Huff JB, Williams A Jr, King HH, Downey HF. Lymphatic pump treatment mobilizes leukocytes from the gut associated lymphoid tissue into lymph. Lymphat Res Biol. 2010 Jun;8(2):103-10. doi: 10.1089/lrb.2009.0011.
- Background: PubMed 22169162Schander A, Downey HF, Hodge LM. Lymphatic pump manipulation mobilizes inflammatory mediators into lymphatic circulation. Exp Biol Med (Maywood). 2012 Jan;237(1):58-63. doi: 10.1258/ebm.2011.011220. Epub 2011 Dec 14.
- 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 Snider, D. O. principal investigator
A.T. Still University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Osteopathic Manipulation in people with Osteopathic Manipulation and Low Back Pain, 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 13 Jan 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 was stopped early (reason given: Study Partner Left. Samples degraded before analysis.). Results are not available in the source record.
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?
The effects of OMT on the amounts of immune cell biomarkers (time frame: immediate after the 20 minutes OMT treatment). 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 NCT03250312, which also lists 30 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 13 Jan 2020.