Trial Outcomes & Findings for Cranial Laser Reflex Technique for Hamstring Function (NCT NCT03044106)
NCT ID: NCT03044106
Last Updated: 2019-02-12
Results Overview
Knee Extension Angle (KEA) test is a functional test designed to assess lower extremity flexibility and is considered the gold standard test for assessing hamstring length. Results will be recorded as degrees of knee flexion angle. A clinically significant effect size is an increase of 5 degrees.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
At baseline and immediately after intervention
Results posted on
2019-02-12
Participant Flow
Participant milestones
| Measure |
CLRT, Then SHAM
Subject will perform KEA (knee extension angle), HHD (handheld dynamometry), PPT (pain pressure threshold) functional tests. Investigator will record the mean of 3 attempts for each test. Subject will don protective eyewear. CLRT (Cranial Laser Reflex Technique) will be performed: the aperture of the laser probe will be placed at one end of the reflex (a), turned on and moved to the end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times. After CLRT is completed, the KEA, PPT and HHD tests will be repeated and the mean of 3 attempts for each will be recorded.
|
SHAM, Then CLRT
The identical procedures will be followed as in the other arm. The only difference is the the laser device will be in sham mode: all lights and sounds are operational with no laser emission from the aperture.
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Visit 1
STARTED
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22
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22
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Visit 1
COMPLETED
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22
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22
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Visit 1
NOT COMPLETED
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0
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0
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Washout (1 Week)
STARTED
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22
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22
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Washout (1 Week)
COMPLETED
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22
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20
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Washout (1 Week)
NOT COMPLETED
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0
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2
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Visit 2
STARTED
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22
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20
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Visit 2
COMPLETED
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22
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20
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Visit 2
NOT COMPLETED
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0
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0
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Reasons for withdrawal
| Measure |
CLRT, Then SHAM
Subject will perform KEA (knee extension angle), HHD (handheld dynamometry), PPT (pain pressure threshold) functional tests. Investigator will record the mean of 3 attempts for each test. Subject will don protective eyewear. CLRT (Cranial Laser Reflex Technique) will be performed: the aperture of the laser probe will be placed at one end of the reflex (a), turned on and moved to the end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times. After CLRT is completed, the KEA, PPT and HHD tests will be repeated and the mean of 3 attempts for each will be recorded.
|
SHAM, Then CLRT
The identical procedures will be followed as in the other arm. The only difference is the the laser device will be in sham mode: all lights and sounds are operational with no laser emission from the aperture.
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|---|---|---|
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Washout (1 Week)
Withdrawal by Subject
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0
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2
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Baseline Characteristics
Cranial Laser Reflex Technique for Hamstring Function
Baseline characteristics by cohort
| Measure |
All Participants
n=44 Participants
This is the total of all participants that began the trial and completed at least one visit.
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|---|---|
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Age, Continuous
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24.02 years
STANDARD_DEVIATION 3.14 • n=5 Participants
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Sex: Female, Male
Female
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36 Participants
n=5 Participants
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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3 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Injury, either leg, last 6 months
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4 Participants
n=5 Participants
|
|
surgery to either leg, ever
|
5 participants
n=5 Participants
|
|
Prior hamstring strain history
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8 Participants
n=5 Participants
|
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Subjective hamstring tightness
Very tight
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5 Participants
n=5 Participants
|
|
Subjective hamstring tightness
Somewhat tight
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20 Participants
n=5 Participants
|
|
Subjective hamstring tightness
A little tight
|
11 Participants
n=5 Participants
|
|
Subjective hamstring tightness
Not at all tight
|
4 Participants
n=5 Participants
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Subjective hamstring tightness
Unknown
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4 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At baseline and immediately after interventionPopulation: Analysis was conducted on intention to treat.
Knee Extension Angle (KEA) test is a functional test designed to assess lower extremity flexibility and is considered the gold standard test for assessing hamstring length. Results will be recorded as degrees of knee flexion angle. A clinically significant effect size is an increase of 5 degrees.
Outcome measures
| Measure |
CLRT
n=42 Participants
Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The treatment device to be used in this study is a Class 3B, 810 nanometer (nm), 200 milliwatt (mW) near-infrared diode laser (THOR Photomedicine Ltd, Great Britain) that is currently marketed in the US.The aperture of the laser probe will be placed at the posterior end of the reflex, turned on and moved to the anterior end of the reflex at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
|
SHAM
n=44 Participants
The Sham procedure will be identical to CLRT except the laser device will be in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
|
Active CLRT With no Prior Hamstring Strain
Participants receiving active treatment who reported no prior history of hamstring strain (n=36)
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Sham CLRT With no History of Hamstring Strain
Participants receiving sham CLRT with no history of hamstring strain
|
|---|---|---|---|---|
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90-90 Knee Extension Angle Test
KEA at baseline/pre-intervention
|
167.3 degrees
Standard Deviation 8.4
|
166.4 degrees
Standard Deviation 8.8
|
—
|
—
|
|
90-90 Knee Extension Angle Test
KEA immediately post-intervention
|
168.5 degrees
Standard Deviation 9.3
|
168.8 degrees
Standard Deviation 7.5
|
—
|
—
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SECONDARY outcome
Timeframe: At baseline and immediately after interventionPopulation: Intention to treat.
Handheld Dynamometry (HHD) is measures peak muscle contraction. The measurements will be recorded as kilograms (kg) and higher scores indicate higher muscle strength. The subject will be prone on the table with right leg bent to 90° and will maximally contract the hamstring muscle for 4-5 seconds against the HHD device. The investigator will record the mean value of three attempts. Higher scores indicate greater strength.
Outcome measures
| Measure |
CLRT
n=42 Participants
Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The treatment device to be used in this study is a Class 3B, 810 nanometer (nm), 200 milliwatt (mW) near-infrared diode laser (THOR Photomedicine Ltd, Great Britain) that is currently marketed in the US.The aperture of the laser probe will be placed at the posterior end of the reflex, turned on and moved to the anterior end of the reflex at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
|
SHAM
n=44 Participants
The Sham procedure will be identical to CLRT except the laser device will be in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
|
Active CLRT With no Prior Hamstring Strain
Participants receiving active treatment who reported no prior history of hamstring strain (n=36)
|
Sham CLRT With no History of Hamstring Strain
Participants receiving sham CLRT with no history of hamstring strain
|
|---|---|---|---|---|
|
Handheld Dynamometry
HHD at baseline/pre-intervention
|
17.2 Kilograms
Standard Deviation 4.7
|
17.4 Kilograms
Standard Deviation 4.6
|
—
|
—
|
|
Handheld Dynamometry
HHD immediately post-intervention
|
16.9 Kilograms
Standard Deviation 4.5
|
17.0 Kilograms
Standard Deviation 4.7
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and immediately after interventionPopulation: Intention to treat.
PPT is a reliable, accurate and valid method for measuring muscle pain sensitivity and response to treatment. In order to determine PPT, the researcher will apply the tip of the algometer to a tender spot in the participant's hamstrings and increase the amount of pressure until the participant verbally informs the researcher when the sensation of pressure became pain. At this point the algometer is removed and the peak force recorded. The mean of three repeated measures will be reported. An increase in PPT signifies an increase in pain tolerance and a decrease in pain sensitivity.
Outcome measures
| Measure |
CLRT
n=42 Participants
Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The treatment device to be used in this study is a Class 3B, 810 nanometer (nm), 200 milliwatt (mW) near-infrared diode laser (THOR Photomedicine Ltd, Great Britain) that is currently marketed in the US.The aperture of the laser probe will be placed at the posterior end of the reflex, turned on and moved to the anterior end of the reflex at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
|
SHAM
n=44 Participants
The Sham procedure will be identical to CLRT except the laser device will be in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
|
Active CLRT With no Prior Hamstring Strain
Participants receiving active treatment who reported no prior history of hamstring strain (n=36)
|
Sham CLRT With no History of Hamstring Strain
Participants receiving sham CLRT with no history of hamstring strain
|
|---|---|---|---|---|
|
Pain Pressure Threshold
PPT at baseline/pre-intervention
|
10.6 kgf
Standard Deviation 3.6
|
11.0 kgf
Standard Deviation 3.9
|
—
|
—
|
|
Pain Pressure Threshold
PPT immediately post-intervention
|
11.3 kgf
Standard Deviation 4.6
|
11.5 kgf
Standard Deviation 4.5
|
—
|
—
|
SECONDARY outcome
Timeframe: At baseline and immediately after interventionPopulation: Mean difference in pre/post KEA after receiving active CLRT and Sham in hamstring flexibility (KEA), stratified by a history of prior hamstring injury.
Mean difference between active CLRT and Sham in hamstring flexibility (KEA) stratified by a history of prior hamstring injury. 8 participants reported prior injuries, 36 reported having no prior hamstring strain.
Outcome measures
| Measure |
CLRT
n=8 Participants
Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The treatment device to be used in this study is a Class 3B, 810 nanometer (nm), 200 milliwatt (mW) near-infrared diode laser (THOR Photomedicine Ltd, Great Britain) that is currently marketed in the US.The aperture of the laser probe will be placed at the posterior end of the reflex, turned on and moved to the anterior end of the reflex at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
|
SHAM
n=8 Participants
The Sham procedure will be identical to CLRT except the laser device will be in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
|
Active CLRT With no Prior Hamstring Strain
n=36 Participants
Participants receiving active treatment who reported no prior history of hamstring strain (n=36)
|
Sham CLRT With no History of Hamstring Strain
n=36 Participants
Participants receiving sham CLRT with no history of hamstring strain
|
|---|---|---|---|---|
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Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain
PRE KEA
|
167.825 degrees
Standard Deviation 7.925141
|
168.4875 degrees
Standard Deviation 8.898384
|
167.1778 degrees
Standard Deviation 8.58657
|
165.9235 degrees
Standard Deviation 8.778143
|
|
Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain
POST KEA
|
171.65 degrees
Standard Deviation 6.762501
|
169.4875 degrees
Standard Deviation 8.092225
|
167.8417 degrees
Standard Deviation 9.658316
|
168.6118 degrees
Standard Deviation 7.420887
|
Adverse Events
CLRT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
SHAM
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CLRT
n=44 participants at risk
Subject will don protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head. The aperture of the laser probe will be placed at posterior end of the reflex (a), turned on and moved to the anterior end of the reflex (b) at a speed of approximately 2 cm/s. The laser will be turned off and quickly returned to point (a), turned on and moved to point (b) again. This will be repeated for a total of 30 times.
|
SHAM
n=44 participants at risk
The laser is inactive, all other descriptions are the same as active.
|
|---|---|---|
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Musculoskeletal and connective tissue disorders
Mild soreness in Hamstring
|
0.00%
0/44 • Data was collected on two visits separated by at least 1 week washout period. On the second visit, participants were asked about any adverse events. A survey on adverse events was sent 2 weeks after second visit asking for any information on adverse everts as well.
|
4.5%
2/44 • Number of events 2 • Data was collected on two visits separated by at least 1 week washout period. On the second visit, participants were asked about any adverse events. A survey on adverse events was sent 2 weeks after second visit asking for any information on adverse everts as well.
|
|
Musculoskeletal and connective tissue disorders
Mild Headache
|
2.3%
1/44 • Number of events 1 • Data was collected on two visits separated by at least 1 week washout period. On the second visit, participants were asked about any adverse events. A survey on adverse events was sent 2 weeks after second visit asking for any information on adverse everts as well.
|
2.3%
1/44 • Number of events 1 • Data was collected on two visits separated by at least 1 week washout period. On the second visit, participants were asked about any adverse events. A survey on adverse events was sent 2 weeks after second visit asking for any information on adverse everts as well.
|
Additional Information
Nicholas Wise, DC
University of North Carolina at Chapel Hill
Phone: (864) 494-1001
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place