Clinical trial NCT02261246: Trunk Motor Control Performance Before and After Spinal Manipulation Treatment
Official title: Trunk Motor Control Performance Before and After Spinal Manipulation Treatment
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: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 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.


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 ALL 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.

Below is an additional list of inclusion criteria for low back pain participants:

* Willing to be randomized to either immediate or delayed treatment group.
* Musculoskeletal pain - primarily in the lumbar region
* Pain rating greater or equal to 3 out of 10 as indicated on the Numeric Rating Scale for Pain
* Back Disability greater or equal to 26% as indicated on the Oswestry Disability Index

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:

* 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
* Extreme obesity (BMI\>36)
* 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

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.

Primary outcomes:
measure: Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in trunk force tracking accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in trunk position stabilization accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in trunk force stabilization accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in push stabilization accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in pull stabilization accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 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 of week 8
measure: Change in concomitant medication
timeFrame: The expected average is weekly for this outcome measure until the end of week 8
measure: Change in back-related disability
timeFrame: The expected average is weekly for this outcome measure until the end of week 8
measure: Change in fear avoidance behavior
timeFrame: The expected average is weekly for this outcome measure until the end of week 8
measure: Treatment effectiveness belief
timeFrame: This outcome measure will be assessed at baseline
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: MSU Osteopathic Manual 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: Sumaq Life LLC
name: Norman P Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Jacek Cholewicki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.