Low Back PainNCT01784094
Connective Tissue Motion Measure 2
An observational study of Low Back Pain and Musculoskeletal Pain, run by Stromatec, Inc. at 1 site in United States.
Trial summary
This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Musculoskeletal Pain
- What is being tested?
- StromaGlide
- Type of treatment
- Medical device
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Oct 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- able to stand and walk without assistance
- able to read and understand English
- able to understand and sign a consent form
- history of recurrent or chronic low back pain
- no history of low back pain or other chronic pain that has limited activities of daily living or work
- numerical chronic pain index of less than 0.5
Who cannot join
- previous severe back or lower extremity injury or surgery
- major structural spinal deformity (scoliosis, kyphosis, stenosis)
- ankylosing spondylitis or rheumatoid arthritis
- neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))
- radicular pain
- neurological or major psychiatric disorder
Show all 13Show fewer
- bleeding disorders
- corticosteroid or anticoagulant medication
- substance abuse
- pregnancy
- active worker's compensation or disability case
- in litigation for a low back pain problem
- acute systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.
- Conditions
- Low Back Pain, Musculoskeletal Pain
- Being tested
- StromaGlide
- Medical subject headings
- Low Back Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StromaGlideDevice
| Study group | Role | What they receive |
|---|---|---|
| Low back pain subjects | Subjects with chronic or recurrent low back pain Receives: Device: StromaGlide | |
| No low back pain subjects | Subjects who are generally healthy with no low back pain Receives: Device: StromaGlide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connective Tissue Shear Strain Motion
Measured: Baseline
Change in Connective Tissue Shear Strain Motion
Measured: Baseline to 1 hour
Change in Connective Tissue Shear Strain Motion
Measured: Baseline to one day
Change in Connective Tissue Shear Strain Motion
Measured: Baseline to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stromatec, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Robert Davis, Stromatec, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784094
- Sponsor's protocol ID
- 2R44AT006085
- Status last verified
- Dec 2014
- First submitted
- 30 Jan 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connective Tissue Motion Measure 2
- ClinicalTrials.gov ID
- NCT01784094
- Acronym / sponsor ID
- 2R44AT006085
- Conditions
- Low Back Pain, Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Stromatec, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Feb 2013 (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.
This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low back pain subjects | – | Device: StromaGlideSubjects with chronic or recurrent low back pain |
| No low back pain subjects | – | Device: StromaGlideSubjects who are generally healthy with no low back pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (6 listed)
- able to stand and walk without assistance
- able to read and understand English
- able to understand and sign a consent form
- history of recurrent or chronic low back pain
- no history of low back pain or other chronic pain that has limited activities of daily living or work
Key exclusion criteria (13 listed)
- previous severe back or lower extremity injury or surgery
- major structural spinal deformity (scoliosis, kyphosis, stenosis)
- ankylosing spondylitis or rheumatoid arthritis
- neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))
- radicular pain
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 |
|---|---|---|
| StromaGlide | Device | Low back pain subjects, No low back pain subjects |
Primary outcome
Connective Tissue Shear Strain Motion
Time frame: Baseline
Change in Connective Tissue Shear Strain Motion
Time frame: Baseline to 1 hour
Change in Connective Tissue Shear Strain Motion
Time frame: Baseline to one day
Change in Connective Tissue Shear Strain Motion
Time frame: Baseline to one week
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 Dec 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Low Back Pain and Musculoskeletal Pain, run by Stromatec, Inc. 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 6 inclusion and 13 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 Dec 2014. 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?
Connective Tissue Shear Strain Motion (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2014.