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Low Back PainNCT02261233

Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

A study testing Osteopathic manipulative treatment in people with Low Back Pain, run by Michigan State University at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Low Back Pain
What is being tested?
Osteopathic manipulative treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
3 sitesUnited States
Study dates
1 Apr 2014to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 35Show fewer
  • 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 locations and contacts

3 sites in 1 country.

United States3 sites

  • MSU Osteopathic Manipulative Medicine

    East Lansing, Michigan, 48823

  • MSU Musculoskeletal Rehabilitation

    Lansing, Michigan, 48891

  • Michigan State University Center for Orthopedic Research

    Lansing, Michigan, 48910

Other trials in United States

About this study

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.

Conditions
Low Back Pain
Being tested
Osteopathic manipulative treatment
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteopathic manipulative treatmentProcedure or surgery

    Up to 4 sessions of osteopathic manipulative treatment (once per week)

Study groups in NCT02261233
Study groupRoleWhat they receive
Immediate treatmentExperimentalThis arm receives osteopathic manipulative treatment shortly after enrollment
Receives: Procedure: Osteopathic manipulative treatment
Delayed treatmentExperimentalThis arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment
Receives: Procedure: Osteopathic manipulative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postural control

    Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees.

    Measured: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.

  2. Change in trunk muscle reflex latency

    Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds.

    Measured: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.

Secondary outcomes (4)

  1. Change in Patient Reported Outcomes Measurement Information System (PROMIS)

    Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.

    Measured: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  2. Change in concomitant medication

    Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.

    Measured: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks.

  3. Change in Oswestry Disability Index

    Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.

    Measured: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  4. Change in fear avoidance behavior

    Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.

    Measured: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2014 (estimated)
  2. Study start1 Apr 2014
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Why it stopped: Funding for this project ended as of August 31, 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02261233
Sponsor's protocol ID
NCCAM U19 AT006057 Project 1
Other IDs
5U19AT006057-02
Status last verified
Jan 2019
First submitted
19 Sep 2014
Last updated
4 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Radebold A, Cholewicki J, Polzhofer GK, Greene HS. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):724-30. doi: 10.1097/00007632-200104010-00004.

    PubMed 11295888

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic manipulative treatment in people with Low Back Pain, run by Michigan State University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Funding for this project ended as of August 31, 2018). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in postural control (time frame: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02261233, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.

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Clinical Trial NCT02261233 | AzTrials