Clinical trial NCT02261233: Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Official title: Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-10-10
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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 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:

* Inability or unwillingness of individual to give written informed consent.
* Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment
* Workers' compensation benefits in the past 3 months or ongoing medical legal issues
* Possibly pregnant
* Obesity (BMI\>32)
* Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.)

History of:

* Spinal surgery
* Spinal fracture
* Spinal infection (e.g., osteomyelitis)
* Cancer

Unresolved symptoms from:

* Head trauma
* Inner ear infection with associated balance and coordination problems
* Orthostatic hypotension
* Uncontrolled hypertension
* Vestibular disorder (e.g. vertigo)

Current diagnosis of:

* Significant spinal deformity (e.g., scoliosis \> 20 degrees, torticollis)
* Ankylosing spondylitis
* Spondylolisthesis grades III or IV
* Cauda equine syndrome
* Rheumatoid arthritis
* Osteoporosis
* Angina or congestive heart failure symptoms
* Active bleeding or infection in the back
* Blindness
* Seizures
* Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia)

Conditions recognized by a physician any time during the study:

* Significant or worsening signs of neurologic deficit
* Symptoms are not consistent with mechanical findings
* Other conditions impeding protocol implementation

Primary outcomes:
measure: Change in postural control
timeFrame: 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: Change in trunk muscle reflex latency
timeFrame: 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.
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
measure: Change in concomitant medication
timeFrame: 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.
measure: Change in Oswestry Disability Index
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
measure: Change in fear avoidance behavior
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: MSU Osteopathic Manipulative Medicine
state: Michigan
city: Lansing
country: United States
facility: MSU Musculoskeletal Rehabilitation
state: Michigan
city: Lansing
country: United States
facility: Michigan State University Center for Orthopedic Research
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jacek Cholewicki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Norman P Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.