Connective TissueStromaTorqueNCT01570647
Automated Connective Tissue Torque Sensor
An observational study of Connective Tissue and Musculoskeletal Pain, run by Stromatec, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Connective Tissue, Musculoskeletal Pain
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2013
- 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
- back pain that has disrupted activity for more than half the days in the past 12 months.
- 90/90 test of more than 20 degrees
- physician diagnosis
- Beighton test score of 7 or higher
Who cannot join
- surgery or scars in thighs or low back
- neurological or major psychiatric disorder
- bleeding disorders
- acute systemic infection
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.
Read the detailed description
Chronic musculoskeletal pain is a source of considerable disability, work absenteeism and health care costs. A major obstacle to the treatment of these conditions is the lack of methods to objectively assess connective tissues and measure the effect of treatments. Needle torque test technology under development in this project will potentially enable objective measurement of connective tissue abnormalities associated with musculoskeletal pain and dysfunction. This could help evaluate the efficacy of various treatments and enhance the objective monitoring of patient progress in clinical practice.
- Conditions
- Connective Tissue, Musculoskeletal Pain
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described | |
| Chronic low back pain | Not described | |
| restricted hamstrings | Not described | |
| systemic scleroderma | Not described | |
| joint hyperlaxity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle revolutions to achieve threshold torque
Measured: Time zero, 30 minutes and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Connective TissueStudies 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
- 165 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.
- Investigators
- Robert Davis, Principal investigator, Stromatec, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570647
- Sponsor's protocol ID
- R44AT004379
- Acronym
- StromaTorque
- Status last verified
- Oct 2013
- First submitted
- 1 Apr 2012
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Connective Tissue Torque Sensor
- ClinicalTrials.gov ID
- NCT01570647
- Acronym / sponsor ID
- StromaTorque / R44AT004379
- Conditions
- Connective Tissue, Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Stromatec, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Apr 2012 (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.
The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.
Detailed description
Chronic musculoskeletal pain is a source of considerable disability, work absenteeism and health care costs. A major obstacle to the treatment of these conditions is the lack of methods to objectively assess connective tissues and measure the effect of treatments. Needle torque test technology under development in this project will potentially enable objective measurement of connective tissue abnormalities associated with musculoskeletal pain and dysfunction. This could help evaluate the efficacy of various treatments and enhance the objective monitoring of patient progress in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | – |
| Chronic low back pain | – | – |
| restricted hamstrings | – | – |
| systemic scleroderma | – | – |
| joint hyperlaxity | – | – |
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 (4 listed)
- back pain that has disrupted activity for more than half the days in the past 12 months.
- 90/90 test of more than 20 degrees
- physician diagnosis
- Beighton test score of 7 or higher
Key exclusion criteria (5 listed)
- surgery or scars in thighs or low back
- neurological or major psychiatric disorder
- bleeding disorders
- acute systemic 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.
Primary outcome
Number of needle revolutions to achieve threshold torque
Time frame: Time zero, 30 minutes and 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 9 Oct 2013.
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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.
Robert Davis principal investigator
Stromatec, Inc.
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 Connective Tissue 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 4 inclusion and 5 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 9 Oct 2013. 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?
Number of needle revolutions to achieve threshold torque (time frame: Time zero, 30 minutes and one week). 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 9 Oct 2013.