Trunk Motor Control Performance Before and After Spinal Manipulation Treatment



Status:Terminated
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:21 - 65
Updated:1/31/2019
Start Date:June 1, 2014
End Date:August 2018

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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.


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.
We found this trial at
3
sites
Lansing, Michigan 48910
Principal Investigator: Norman P Reeves, PhD
Phone: 517-975-3301
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East Lansing, Michigan 48823
Principal Investigator: Norman P Reeves, PhD
Phone: 517-975-3301
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East Lansing, MI
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Lansing, Michigan 48891
Principal Investigator: Norman P Reeves, PhD
Phone: 517-975-3301
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Lansing, MI
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