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| ID | Type | Description | Link |
|---|---|---|---|
| 5U19AT006057-02 | U.S. NIH Grant/Contract | View source |
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Funding for this project ended as of August 31, 2018
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of postural control of the trunk. In order to accomplish this goal, we aim to quantify balance performance in an unstable seated task. Specifically, the investigators will quantify balance performance in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in balance performance after a single session of osteopathic manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and this improvement will be greater than any learning effect.
A secondary objective of this study is to quantify differences in patient-oriented outcome measures (e.g., self-reported pain, disability) in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in these self-reported outcomes following osteopathic manipulative treatment. The association between improvement in postural control parameters and patient-oriented measures will also be explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment | Experimental | This arm receives osteopathic manipulative treatment shortly after enrollment |
|
| Delayed treatment | Experimental | This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic manipulative treatment | Procedure | Up to 4 sessions of osteopathic manipulative treatment (once per week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in postural control | Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees. | Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8. |
| Change in trunk muscle reflex latency | Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds. | Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) | Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). |
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Inclusion Criteria:
All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for LBP participants:
Exclusion Criteria:
All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.
Below is a list of exclusion criteria:
History of:
Unresolved symptoms from:
Current diagnosis of:
Conditions recognized by a physician any time during the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jacek Cholewicki, PhD | Michigan State University | Principal Investigator |
| Norman P Reeves, PhD | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MSU Osteopathic Manipulative Medicine | East Lansing | Michigan | 48823 | United States | ||
| MSU Musculoskeletal Rehabilitation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11295888 | Background | Radebold A, Cholewicki J, Polzhofer GK, Greene HS. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):724-30. doi: 10.1097/00007632-200104010-00004. |
| Label | URL |
|---|---|
| Website for Michigan State University Center for Orthopedic Research | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 25, 2026 | |
| Reset | Apr 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 25, 2026 | Apr 13, 2026 | |||
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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| Change in concomitant medication |
Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire. |
| The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks. |
| Change in Oswestry Disability Index | Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). |
| Change in fear avoidance behavior | Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire. | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). |
| Lansing |
| Michigan |
| 48891 |
| United States |
| Michigan State University Center for Orthopedic Research | Lansing | Michigan | 48910 | United States |
| Website for the National Center for Complementary and Alternative Medicine (Sponsor) | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012046 | Rehabilitation |