Trunk Motor Control Performance Before and After Spinal Manipulation Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2018-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Immediate treatment

This arm receives spinal manipulation treatment shortly after enrollment

Group Type EXPERIMENTAL

Spinal manipulation treatment

Intervention Type PROCEDURE

Up to 4 sessions of spinal manipulation treatment (once per week).

Delayed treatment

This arm receives spinal manipulation treatment approximately 4 weeks after enrollment

Group Type EXPERIMENTAL

Spinal manipulation treatment

Intervention Type PROCEDURE

Up to 4 sessions of spinal manipulation treatment (once per week).

Healthy control (no low back pain)

In this arm, healthy controls are tested at baseline.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spinal manipulation treatment

Up to 4 sessions of spinal manipulation treatment (once per week).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 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

* 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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes