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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

4 weeks

Results posted on

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

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

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 weeks

Numeric 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 915-742-3245

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place