Trunk Motor Control Performance Before and After Spinal Manipulation Treatment (TMCSMT)

Michigan State University

Status: Terminated

Conditions: Low Back Pain

Treatments: Procedure: Spinal manipulation treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02261246

NCCAM U19 AT006057 Project 2

5U19AT006057-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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80 participants in 3 patient groups

Immediate treatment

Experimental group

Description:

This arm receives spinal manipulation treatment shortly after enrollment

Treatment:

Procedure: Spinal manipulation treatment

Delayed treatment

Experimental group

Description:

This arm receives spinal manipulation treatment approximately 4 weeks after enrollment

Treatment:

Procedure: Spinal manipulation treatment

Healthy control (no low back pain)

No Intervention group

Description:

In this arm, healthy controls are tested at baseline.