Low Back Pain
Conditions
Brief summary
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.
Interventions
PROCEDUREOsteopathic manipulative treatment
Up to 4 sessions of osteopathic manipulative treatment (once per week)
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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: * Age 21-65 years * Independently ambulatory * Able to speak and read English * Able to understand study procedures and to comply with them for the entire length of the study. * Willing to be randomized to either immediate or delayed treatment group. * Musculoskeletal pain - primarily in the low back region * Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating Scale for Pain * Disability equal to or greater than 26% as indicated on the Oswestry Disability Questionnaire
Exclusion criteria
All candidates meeting any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postural control | 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. | 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 in trunk muscle reflex latency | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcomes Measurement Information System (PROMIS) | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire. |
| Change in concomitant medication | 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. | 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. |
| Change in Oswestry Disability Index | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire. |
| Change in fear avoidance behavior | The expected average is weekly for this outcome measure until the end (expected average of 8 weeks). | Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire. |
Countries
United States
Outcome results
None listed