Injury; Muscle, Back, LowerNCT02169726
A Pilot Study Non-Invasive Guidance for Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries
An observational study of Injury; Muscle, Back, Lower, run by University of California, Irvine at 1 site in United States.
Trial summary
Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injury; Muscle, Back, Lower
- What is being tested?
- Diffuse Optical Spectroscopy
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be selected from Univesity of California Irvine Medical Center
Who may be able to join
- Male or Female over 18 years of age,
- No back injuries, No plan treatment
- Currently diagnose with back injuries, with plan treatment of therapeutic ultrasound
Who cannot join
- Minors
- Obese
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate Non-Invasive Metabolic Guidance for Improving Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries
Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing.
Read the detailed description
Researchers at Beckman Laser institute, using a technology developed at University of California, Irvine. The device call Diffuse Optical Spectroscopy, this device developed with harmless light that can measures and detect the change of blood flow, oxygen level, temperature and muscle tissue in lower back during therapeutic ultrasound therapy treatment.
The researchers can provide information in real-time tissue change before, during, and after treatments that can determine the effectiveness of the treatment and speed up recovery time.
- Conditions
- Injury; Muscle, Back, Lower
- Being tested
- Diffuse Optical Spectroscopy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffuse Optical SpectroscopyDevice
Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal injuries | Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment Receives: Device: Diffuse Optical Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal lower back muscle
Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury; Muscle, Back, LowerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Responsible party
- Principal investigator, Beckman Laser Institute and Medical Center, University of California, Irvine
- Investigators
- Bruce Tromberg, PhD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169726
- Sponsor's protocol ID
- 20139473
- Status last verified
- Oct 2022
- First submitted
- 13 Jun 2014
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Non-Invasive Metabolic Guidance for Improving Therapeutic Ultrasound Treatment of Lower Back Muscle Injuries
- ClinicalTrials.gov ID
- NCT02169726
- Acronym / sponsor ID
- 20139473
- Conditions
- Injury; Muscle, Back, Lower
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Beckman Laser Institute University of California Irvine
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Jun 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.
Back injuries are the most common reason people seeking for effective treatment. One of the most common treatments in sports medicine for muscular injuries is therapeutic ultrasound, which is designed to heat the injured tissue and increase the flow of blood to promote healing.
Detailed description
Researchers at Beckman Laser institute, using a technology developed at University of California, Irvine. The device call Diffuse Optical Spectroscopy, this device developed with harmless light that can measures and detect the change of blood flow, oxygen level, temperature and muscle tissue in lower back during therapeutic ultrasound therapy treatment.
The researchers can provide information in real-time tissue change before, during, and after treatments that can determine the effectiveness of the treatment and speed up recovery time.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal injuries | – | Device: Diffuse Optical SpectroscopyDiffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from Univesity of California Irvine Medical Center
Key inclusion criteria (3 listed)
- Male or Female over 18 years of age,
- No back injuries, No plan treatment
- Currently diagnose with back injuries, with plan treatment of therapeutic ultrasound
Key exclusion criteria (3 listed)
- Minors
- Obese
- 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 |
|---|---|---|
| Diffuse Optical SpectroscopyDiffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment | Device | Musculoskeletal injuries |
Primary outcome
Normal lower back muscle
Time frame: 4 weeks
Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment
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 1 Nov 2022.
Related trials for Injury; Muscle, Back, Lower
Active, not recruiting
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Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injury
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.
Bruce Tromberg, PhD principal investigator
Beckman Laser Institute, UCI
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 Injury; Muscle, Back, Lower, run by University of California, Irvine 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 3 inclusion and 3 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 1 Nov 2022. 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?
Normal lower back muscle (time frame: 4 weeks). 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 1 Nov 2022.