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| ID | Type | Description | Link |
|---|---|---|---|
| 5U19AT006057-02 | U.S. NIH Grant/Contract | View source |
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We no longer have the resources to complete enrollment
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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 trunk motor control. In order to accomplish this goal, the investigators aim to quantify changes in trunk motor control before and after spinal manipulation treatment. The investigators hypothesize that trunk motor control will improve in the low back pain participants after 4-weeks of spinal manipulation treatment. Additionally, the investigators will compare position and force trunk motor control between healthy controls and low back pain patients. The investigators hypothesize that baseline tests of position and force trunk motor control will be better in healthy individuals than low back pain patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate treatment | Experimental | This arm receives spinal manipulation treatment shortly after enrollment |
|
| Delayed treatment | Experimental | This arm receives spinal manipulation treatment approximately 4 weeks after enrollment |
|
| Healthy control (no low back pain) | No Intervention | In this arm, healthy controls are tested at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulation treatment | Procedure | Up to 4 sessions of spinal manipulation treatment (once per week). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy | Participants will be in a seated position during the position tracking task and will wear a chest harness with an attached position sensor. The angular position of the trunk will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their trunk. Accuracy will be determined by taking the difference between the target position signal and the actual trunk position (measured in degrees with string potentiometers). | Change from baseline to week 4 and from week 4 to 8 |
| Change from baseline to week 4 and from week 4 to 8 in trunk force tracking accuracy | Participants will be in a seated position and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their trunk. Accuracy will be determined by taking the difference between target force signal and the actual trunk force (measured in Newtons with the load cell). | Change from baseline to week 4 and from week 4 to 8 |
| Change from baseline to week 4 and from week 4 to 8 in trunk position stabilization accuracy | Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will wear a chest harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) their trunk position in the upright posture. Accuracy will be determined by measuring the amount of trunk displacement (measured in degrees with string potentiometers) during the perturbation trial. | Change from baseline to week 4 and from week 4 to 8 |
| Change from baseline to week 4 and from week 4 to 8 in trunk force stabilization accuracy |
| 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 of week 8 |
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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 ALL participants:
Below is an additional list of inclusion criteria for low back pain 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 for ALL participants:
History of:
Unresolved symptoms from:
Current diagnosis of:
Conditions recognized by a physician any time during the study:
Below is an additional exclusion criterion for healthy control participants:
• Based on the minimal clinically important difference of 2 points (Childs et al., 2005), "healthy controls" with 2 points or greater pain on NRS will not be eligible to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Norman P Reeves, PhD | Sumaq Life LLC | Principal Investigator |
| Jacek Cholewicki, PhD | Michigan State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MSU Osteopathic Manual Medicine | East Lansing | Michigan | 48823 | United States | ||
| MSU Musculoskeletal Rehabilitation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24262851 | Background | Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22. |
| Label | URL |
|---|---|
| Website for Michigan State University Center for Orthopedic Research | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their trunk (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial. |
| Change from baseline to week 4 and from week 4 to 8 |
| Change from baseline to week 4 and from week 4 to 8 in push stabilization accuracy | Participants will be standing and will be asked to generate push force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial. | Change from baseline to week 4 and from week 4 to 8 |
| Change from baseline to week 4 and from week 4 to 8 in pull stabilization accuracy | Participants will be standing and will be asked to generate pull force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial. | Change from baseline to week 4 and from week 4 to 8 |
| Change in concomitant medication |
Assesses weekly changes in the use of medication for treating neck 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 of week 8 |
| Change in back-related disability | Assesses weekly changes in functional limitations related to back pain with the Modified Oswestry Disability questionnaire. | The expected average is weekly for this outcome measure until the end of week 8 |
| Change in fear avoidance behavior | Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Belief questionnaire. | The expected average is weekly for this outcome measure until the end of week 8 |
| Treatment effectiveness belief | Assesses the patient's belief in how effective the treatment will be prior to treatment using the Credibility Expectancy questionnaire. | This outcome measure will be assessed at baseline |
| 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 |