Low Back PainTMCSMTNCT02261246

Trunk Motor Control Performance Before and After Spinal Manipulation Treatment

A study testing Spinal manipulation 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

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: Spinal manipulation treatment
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 3 sitesUnited States
Study dates: 1 Jun 2014to 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
Healthy volunteers accepted
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 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:

Show all 10Show fewer

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

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 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

Show all 37Show fewer

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 locations and contacts

3 sites in 1 country.

United States3 sites

MSU Osteopathic Manual 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 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.

Conditions: Low Back Pain
Being tested: Spinal manipulation 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.

Spinal manipulation treatmentProcedure or surgery
Up to 4 sessions of spinal manipulation treatment (once per week).

Study groups in NCT02261246
Study group	Role	What they receive
Immediate treatment	Experimental	This arm receives spinal manipulation treatment shortly after enrollment Receives: Procedure: Spinal manipulation treatment
Delayed treatment	Experimental	This arm receives spinal manipulation treatment approximately 4 weeks after enrollment Receives: Procedure: Spinal manipulation treatment
Healthy control (no low back pain)	No intervention	In this arm, healthy controls are tested at baseline.

What is being measured

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

Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy
Participants will be in a seated position during the position tracking task and will wear a chest harness with an attached position sensor. The angular position of the trunk will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their trunk. Accuracy will be determined by taking the difference between the target position signal and the actual trunk position (measured in degrees with string potentiometers).
Measured: Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in trunk force tracking accuracy
Participants will be in a seated position and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their trunk. Accuracy will be determined by taking the difference between target force signal and the actual trunk force (measured in Newtons with the load cell).
Measured: Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in trunk position stabilization accuracy
Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will wear a chest harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) their trunk position in the upright posture. Accuracy will be determined by measuring the amount of trunk displacement (measured in degrees with string potentiometers) during the perturbation trial.
Measured: Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in trunk force stabilization accuracy
Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their trunk (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Measured: Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in push stabilization accuracy
Participants will be standing and will be asked to generate push force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Measured: Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in pull stabilization accuracy
Participants will be standing and will be asked to generate pull force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Measured: Change from baseline to week 4 and from week 4 to 8

Secondary outcomes (5)

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 of week 8
Change in concomitant medication
Assesses weekly changes in the use of medication for treating neck 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 of week 8
Change in back-related disability
Assesses weekly changes in functional limitations related to back pain with the Modified Oswestry Disability questionnaire.
Measured: The expected average is weekly for this outcome measure until the end of week 8
Change in fear avoidance behavior
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Belief questionnaire.
Measured: The expected average is weekly for this outcome measure until the end of week 8
Treatment effectiveness belief
Assesses the patient's belief in how effective the treatment will be prior to treatment using the Credibility Expectancy questionnaire.
Measured: This outcome measure will be assessed at baseline

Timeline

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

1 Jun 2014Aug 2018

First posted10 Oct 2014 (estimated)
Study start1 Jun 2014
Primary completionAug 2018
Study completionAug 2018

Why it stopped: We no longer have the resources to complete enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02261246
Sponsor's protocol ID: NCCAM U19 AT006057 Project 2
Other IDs: 5U19AT006057-02
Acronym: TMCSMT
Status last verified: Jan 2019
First submitted: 19 Sep 2014
Last updated: 29 Jan 2019
Results posted: No
Data monitoring committee: Yes

Publications

Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22.
PubMed 24262851

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trunk Motor Control Performance Before and After Spinal Manipulation Treatment
ClinicalTrials.gov ID: NCT02261246
Acronym / sponsor ID: TMCSMT / NCCAM U19 AT006057 Project 2
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: TerminatedReason stopped: We no longer have the resources to complete enrollment
Enrolment: 80 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: 1 Jun 2014 (actual)
Primary completion: Aug 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 10 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Immediate treatment	Experimental	Procedure: Spinal manipulation treatmentThis arm receives spinal manipulation treatment shortly after enrollment
Delayed treatment	Experimental	Procedure: Spinal manipulation treatmentThis arm receives spinal manipulation treatment approximately 4 weeks after enrollment
Healthy control (no low back pain)	No intervention	–In this arm, healthy controls are tested at baseline.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (37 listed)

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.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal manipulation treatmentUp to 4 sessions of spinal manipulation treatment (once per week).	Procedure or surgery	Delayed treatment, Immediate treatment

Primary outcome

Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be in a seated position during the position tracking task and will wear a chest harness with an attached position sensor. The angular position of the trunk will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their trunk. Accuracy will be determined by taking the difference between the target position signal and the actual trunk position (measured in degrees with string potentiometers).
Change from baseline to week 4 and from week 4 to 8 in trunk force tracking accuracy
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be in a seated position and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their trunk. Accuracy will be determined by taking the difference between target force signal and the actual trunk force (measured in Newtons with the load cell).
Change from baseline to week 4 and from week 4 to 8 in trunk position stabilization accuracy
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will wear a chest harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) their trunk position in the upright posture. Accuracy will be determined by measuring the amount of trunk displacement (measured in degrees with string potentiometers) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8 in trunk force stabilization accuracy
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their trunk (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8 in push stabilization accuracy
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be standing and will be asked to generate push force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8 in pull stabilization accuracy
Time frame: Change from baseline to week 4 and from week 4 to 8
Participants will be standing and will be asked to generate pull force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.

5 secondary outcomes

Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Time frame: The expected average is weekly for this outcome measure until the end of week 8
Change in concomitant medication
Time frame: The expected average is weekly for this outcome measure until the end of week 8
Change in back-related disability
Time frame: The expected average is weekly for this outcome measure until the end of week 8
Change in fear avoidance behavior
Time frame: The expected average is weekly for this outcome measure until the end of week 8
Treatment effectiveness belief
Time frame: This outcome measure will be assessed at baseline

Results and safety

The study was stopped early (reason given: We no longer have the resources to complete enrollment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Background: PubMed 24262851Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22.
Website for Michigan State University Center for Orthopedic ResearchLink provided by the sponsor.
Website for the National Center for Complementary and Alternative Medicine (Sponsor)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Norman P Reeves, PhD principal investigator

Sumaq Life LLC

Jacek Cholewicki, PhD principal investigator

Michigan State University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal manipulation 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 10 inclusion and 37 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 29 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: We no longer have the resources to complete enrollment). 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 from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy (time frame: Change from baseline to week 4 and from week 4 to 8). The study lists 6 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 NCT02261246, 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 29 Jan 2019.