Tibial FracturesMilCAMNCT00253981
Light Therapy in the Treatment of Leg Pain
A study testing Monochromatic Near-Infrared Light Energy (MIRE) in people with Tibial Fractures and Leg Injuries, run by Samueli Institute for Information Biology at 1 site in United States.
Trial summary
The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tibial Fractures, Leg Injuries
- What is being tested?
- Monochromatic Near-Infrared Light Energy (MIRE)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult
Who may be able to join
- Active duty soldier
- Exertional leg pain of greater than 3 months duration
- Documented bone scintigraphic evidence for tibial stress reaction or fracture
Who cannot join
- Known leg Pathology other than stress reaction or fracture
- Service members known to be leaving area within next 6 months
- Pregnant females
- High risk cardiopulmonary patients
- Patients with assisted walking devices
- Patients with two or more cardiac risk factors
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Army Medical Center
El Paso, Texas, 79920
About this study
Official title: Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction
The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.
Read the detailed description
Tibial stress reactions and fractures are often difficult to treat, and therefore, many soldiers proceed to a medical disability/discharge. It is felt that with the use of the MIRE technology, active duty soldiers with tibial stress reactions and fractures will heal more quickly and completely. All soldiers will have a documented bone scintigraph as evidence for tibial stress reaction or fracture prior to enrollment. In addition, pain-pressure goniometric measures and time to complete the Balke protocol will also be used to assess healing with the MIRE technology.
Comparison: Soldiers with Active MIRE technology, compared to soldiers with Placebo MIRE technology.
- Conditions
- Tibial Fractures, Leg Injuries
- Being tested
- Monochromatic Near-Infrared Light Energy (MIRE)
- Keywords
- Pain, Intractable, Infrared Rays, Leg
- Medical subject headings
- Tibial Fractures, Leg Injuries, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monochromatic Near-Infrared Light Energy (MIRE)Device
Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Infrared Light Therapy | Experimental | Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks. Receives: Device: Monochromatic Near-Infrared Light Energy (MIRE) |
| Standard of Care | Placebo comparator | Standard of care was characterized by the use of standard medical treatment to include medication. Receives: Device: Monochromatic Near-Infrared Light Energy (MIRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
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 posted15 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2008
- Study completionNov 2008
Why it stopped: Enrollment not achieved succesfully
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- William Beaumont Army Medical Center
- Responsible party
- Sponsor
- Investigators
- LTC Richard P Petri, MD, Principal investigator, Department of the Army
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253981
- Sponsor's protocol ID
- WBAMC #05/13
- Other IDs
- CIRO #2005705, NCT00253981
- Acronym
- MilCAM
- Status last verified
- May 2016
- First submitted
- 10 Nov 2005
- Last updated
- 13 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monochromatic Near-Infrared Light Energy (MIRE) in the Treatment of Tibial Stress Reaction
- ClinicalTrials.gov ID
- NCT00253981
- Acronym / sponsor ID
- MilCAM / WBAMC #05/13
- Conditions
- Tibial Fractures, Leg Injuries
- Keywords
- Pain, Intractable, Infrared Rays, Leg
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment not achieved succesfully
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- William Beaumont Army Medical Center
- Study start
- Nov 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Posted 19 Jun 2014
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 apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.
Detailed description
Tibial stress reactions and fractures are often difficult to treat, and therefore, many soldiers proceed to a medical disability/discharge. It is felt that with the use of the MIRE technology, active duty soldiers with tibial stress reactions and fractures will heal more quickly and completely. All soldiers will have a documented bone scintigraph as evidence for tibial stress reaction or fracture prior to enrollment. In addition, pain-pressure goniometric measures and time to complete the Balke protocol will also be used to assess healing with the MIRE technology.
Comparison: Soldiers with Active MIRE technology, compared to soldiers with Placebo MIRE technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrared Light Therapy | Experimental | Device: Monochromatic Near-Infrared Light Energy (MIRE)Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks. |
| Standard of Care | Placebo comparator | Device: Monochromatic Near-Infrared Light Energy (MIRE)Standard of care was characterized by the use of standard medical treatment to include medication. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active duty soldier
- Exertional leg pain of greater than 3 months duration
- Documented bone scintigraphic evidence for tibial stress reaction or fracture
Key exclusion criteria (6 listed)
- Known leg Pathology other than stress reaction or fracture
- Service members known to be leaving area within next 6 months
- Pregnant females
- High risk cardiopulmonary patients
- Patients with assisted walking devices
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 |
|---|---|---|
| Monochromatic Near-Infrared Light Energy (MIRE)Subjects randomized to the intervention group (Monochromatic Near-Infrared Light Energy), received treatment three times a week for a total of four weeks. | Device | Infrared Light Therapy, Standard of Care |
Primary outcome
Visual Analog Scale
Time frame: 4 weeks
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
LTC Richard P Petri, MD principal investigator
Department of the Army
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monochromatic Near-Infrared Light Energy (MIRE) in people with Tibial Fractures and Leg Injuries, run by Samueli Institute for Information Biology 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 6 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: stopped early, as of the sponsor's last update on 13 Jun 2016. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analog Scale (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 13 Jun 2016.