Back PainNCT03483714
Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants
An observational study of Back Pain, run by University of Denver at 1 site in United States.
Trial summary
To characterize muscle activity through electromyography (EMG) of the lumbar spine during high velocity, low amplitude (HVLA) spinal manipulation according to parameters of practitioner contact (location, applied force) in healthy participants and two categories of low back pain participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Spinal Manipulation
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2011to 5 Nov 2015
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: community sample
Who may be able to join
- male and female participants ages 18 to 55 years old
Who cannot join
- Active Worker's Compensation claim related to low back pain episode Active personal injury case related to low back pain episode Currently taking muscle relaxers, steroids, or narcotics
- Body mass index > 30 kg/m2
- Active cancer process
- Active infection
- Pregnancy
- High risk of osteoporosis assessed using the World Health Organization Fracture Risk Assessment Tool (included in submission)
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- Osteogenic conditions (see screening questionnaire)
- Premature menopause
- Latex Allergies
- Lumbar spine or pelvic surgery
- Past spinal trauma producing spinal fracture
Trial locations and contacts
1 site in 1 country.
About this study
To characterize muscle activity through electromyography (EMG) of the lumbar spine during high velocity, low amplitude (HVLA) spinal manipulation according to parameters of practitioner contact (location, applied force) in healthy participants and two categories of low back pain participants.
- Conditions
- Back Pain
- Being tested
- Spinal Manipulation
- Keywords
- Manipulation, Spinal, electromyography, kinetics, kinematic
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal ManipulationProcedure or surgery
HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Spinal manipulation Receives: Procedure: Spinal Manipulation | |
| Acute Low back pain participants | Spinal Manipulation Receives: Procedure: Spinal Manipulation | |
| Chronic low back pain participants | Spinal Manipulation Receives: Procedure: Spinal Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Response
Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Total response expressed as a percentage of muscles "on".
Measured: During spinal manipulation at the time of testing
Muscle Activity Onset Delay
Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Time delay between the manipulation force and the muscle activity
Measured: During spinal manipulation at the time of testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Feb 2011
- Primary completion5 Nov 2015
- Study completion5 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuart Currie, University of Denver
- Investigators
- Bradley S Davidson, PhD, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483714
- Sponsor's protocol ID
- LSM
- Status last verified
- Mar 2018
- First submitted
- 11 Mar 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Currie SJ, Myers CA, Krishnamurthy A, Enebo BA, Davidson BS. Methods of Muscle Activation Onset Timing Recorded During Spinal Manipulation. J Manipulative Physiol Ther. 2016 May;39(4):279-87. doi: 10.1016/j.jmpt.2016.03.001. Epub 2016 Apr 9.
PubMed 27072513Currie SJ, Myers CA, Durso C, Enebo BA, Davidson BS. The Neuromuscular Response to Spinal Manipulation in the Presence of Pain. J Manipulative Physiol Ther. 2016 May;39(4):288-93. doi: 10.1016/j.jmpt.2016.02.011. Epub 2016 Apr 6.
PubMed 27059250Myers CA, Enebo BA, Davidson BS. Optimized prediction of contact force application during side-lying lumbar manipulation. J Manipulative Physiol Ther. 2012 Nov-Dec;35(9):669-77. doi: 10.1016/j.jmpt.2012.10.010.
PubMed 23206961
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants
- ClinicalTrials.gov ID
- NCT03483714
- Acronym / sponsor ID
- LSM
- Conditions
- Back Pain
- Keywords
- Manipulation, Spinal, electromyography, kinetics, kinematic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 30 Mar 2018 (actual)
- 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.
To characterize muscle activity through electromyography (EMG) of the lumbar spine during high velocity, low amplitude (HVLA) spinal manipulation according to parameters of practitioner contact (location, applied force) in healthy participants and two categories of low back pain participants.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | – | Procedure: Spinal ManipulationSpinal manipulation |
| Acute Low back pain participants | – | Procedure: Spinal ManipulationSpinal Manipulation |
| Chronic low back pain participants | – | Procedure: Spinal ManipulationSpinal Manipulation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (1 listed)
- male and female participants ages 18 to 55 years old
Key exclusion criteria (11 listed)
- Active Worker's Compensation claim related to low back pain episode Active personal injury case related to low back pain episode Currently taking muscle relaxers, steroids, or narcotics
- Body mass index > 30 kg/m2
- Active cancer process
- Active infection
- Pregnancy
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 ManipulationHVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints | Procedure or surgery | Acute Low back pain participants, Chronic low back pain participants, Healthy Participants |
Primary outcome
Muscle Response
Time frame: During spinal manipulation at the time of testing
Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Total response expressed as a percentage of muscles "on".
Muscle Activity Onset Delay
Time frame: During spinal manipulation at the time of testing
Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Time delay between the manipulation force and the muscle activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Results publication: PubMed 27072513Currie SJ, Myers CA, Krishnamurthy A, Enebo BA, Davidson BS. Methods of Muscle Activation Onset Timing Recorded During Spinal Manipulation. J Manipulative Physiol Ther. 2016 May;39(4):279-87. doi: 10.1016/j.jmpt.2016.03.001. Epub 2016 Apr 9.
- Results publication: PubMed 27059250Currie SJ, Myers CA, Durso C, Enebo BA, Davidson BS. The Neuromuscular Response to Spinal Manipulation in the Presence of Pain. J Manipulative Physiol Ther. 2016 May;39(4):288-93. doi: 10.1016/j.jmpt.2016.02.011. Epub 2016 Apr 6.
- Results publication: PubMed 23206961Myers CA, Enebo BA, Davidson BS. Optimized prediction of contact force application during side-lying lumbar manipulation. J Manipulative Physiol Ther. 2012 Nov-Dec;35(9):669-77. doi: 10.1016/j.jmpt.2012.10.010.
- Individual participant dataSharing planned: No
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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.
Bradley S Davidson, PhD principal investigator
University of Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by University of Denver at 1 site 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Muscle Response (time frame: During spinal manipulation at the time of testing). 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 NCT03483714, which also lists 3 linked publications.
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 30 Mar 2018.