NCT02169726

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

2 years

First QC Date

June 13, 2014

Last Update Submit

October 28, 2022

Conditions

Injury; Muscle, Back, Lower

Outcome Measures

Primary Outcomes (1)

  • 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

    4 weeks

Study Arms (1)

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

Device: Diffuse Optical Spectroscopy

Interventions

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

Musculoskeletal injuries

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population will be selected from Univesity of California Irvine Medical Center

You may qualify if:

  • 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

You may not qualify if:

  • Minors
  • Obese
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beckman Laser Institute

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Bruce Tromberg, PhD

    Beckman Laser Institute, UCI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bruce Tromberg,Ph.D.,Director, Beckman Laser Institute and Medical Clinic and Professor, Departments of Biomedical Engineering and Surgery

Study Record Dates

First Submitted

June 13, 2014

First Posted

June 23, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 1, 2022

Record last verified: 2022-10

Locations

US(1)