Trial Outcomes & Findings for Light Therapy in the Treatment of Leg Pain (NCT NCT00253981)
NCT ID: NCT00253981
Last Updated: 2016-06-13
Results Overview
Numeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
TERMINATED
NA
30 participants
4 weeks
2016-06-13
Participant Flow
The recruitment took place between 2006-2007 at a military treatment facility.
Some participants were excluded due to deployment, military training that required them to leave the post.
Participant milestones
| Measure |
Infrared Light Therapy
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
Standard of care was characterized by the use of standard medical treatment to include medication.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
16
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Light Therapy in the Treatment of Leg Pain
Baseline characteristics by cohort
| Measure |
Experimental
n=16 Participants
The experimental group received the monochromatic light infrared energy treatment (MIRE).
|
Control
n=14 Participants
The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksNumeric scale based on pain level (1-10). The higher the numeric value, the higher the pain level, as perceived by the participant.
Outcome measures
Outcome data not reported
Adverse Events
Experimental
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
COL Richard Petri, Chief Integrative Pain Management
William Beaumont Army Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place