Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

Michigan State University

Status: Terminated

Conditions: Low Back Pain

Treatments: Procedure: Osteopathic manipulative treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02261233

NCCAM U19 AT006057 Project 1

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 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.

Enrollment: 63 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No 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 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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63 participants in 2 patient groups

Immediate treatment

Experimental group

Description:

This arm receives osteopathic manipulative treatment shortly after enrollment

Treatment:

Procedure: Osteopathic manipulative treatment

Delayed treatment

Experimental group

Description:

This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment

Treatment:

Procedure: Osteopathic manipulative treatment