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Cranial Laser Reflex Technique for Hamstring Function (CLRTHam)

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ClinicalTrials.gov Identifier: NCT03044106
Recruitment Status : Completed
First Posted : February 6, 2017
Results First Posted : January 29, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
North Carolina Translational and Clinical Sciences Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Hamstring Injury
Muscle Tone Increased
Muscle Pain
Muscle Weakness
Intervention Device: CLRT
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CLRT, Then SHAM SHAM, Then CLRT
Hide Arm/Group Description 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. 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.
Period Title: Visit 1
Started 22 22
Completed 22 22
Not Completed 0 0
Period Title: Washout (1 Week)
Started 22 22
Completed 22 20
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Period Title: Visit 2
Started 22 20
Completed 22 20
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description This is the total of all participants that began the trial and completed at least one visit.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants
24.02  (3.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
36
  81.8%
Male
8
  18.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Hispanic or Latino
3
   6.8%
Not Hispanic or Latino
41
  93.2%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
3
   6.8%
White
38
  86.4%
More than one race
2
   4.5%
Unknown or Not Reported
0
   0.0%
Injury, either leg, last 6 months  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
4
   9.1%
surgery to either leg, ever  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 44 participants
5
Prior hamstring strain history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
8
  18.2%
Subjective hamstring tightness  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Very tight
5
  11.4%
Somewhat tight
20
  45.5%
A little tight
11
  25.0%
Not at all tight
4
   9.1%
Unknown
4
   9.1%
1.Primary Outcome
Title 90-90 Knee Extension Angle Test
Hide Description 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.
Time Frame At baseline and immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on intention to treat.
Arm/Group Title CLRT SHAM
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 42 44
Mean (Standard Deviation)
Unit of Measure: degrees
KEA at baseline/pre-intervention 167.3  (8.4) 166.4  (8.8)
KEA immediately post-intervention 168.5  (9.3) 168.8  (7.5)
2.Secondary Outcome
Title Handheld Dynamometry
Hide Description 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.
Time Frame At baseline and immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title CLRT Sham
Hide Arm/Group Description:

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 the 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.

The spot size is 0.0364 cm², and the treatment time is 30 seconds. Since the CRP is a line of 2 cm, for the purposes of calculating dosage, we will treat it as a series of 10 connected points each with a diameter of 2mm. With the scanning rate of 2 cm/s, each "point" on the line will receive 1/10 of each pass, totaling 3s (out of 30s total) exposure time per point. The dose per "point" for this intervention is calculated to be approximately 1.65 J/cm².

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.
Overall Number of Participants Analyzed 42 44
Mean (Standard Deviation)
Unit of Measure: Kilograms
HHD at baseline/pre-intervention 17.2  (4.7) 17.4  (4.6)
HHD immediately post-intervention 16.9  (4.5) 17.0  (4.7)
3.Secondary Outcome
Title Pain Pressure Threshold
Hide Description 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.
Time Frame At baseline and immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat.
Arm/Group Title CLRT Sham
Hide Arm/Group Description:

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 the 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.

The spot size is 0.0364 cm², and the treatment time is 30 seconds. Since the CRP is a line of 2 cm, for the purposes of calculating dosage, we will treat it as a series of 10 connected points each with a diameter of 2mm. With the scanning rate of 2cm/s, each "point" on the line will receive 1/10 of each pass, totaling 3s (out of 30 s total) exposure time per point. The dose per "point" for this intervention is calculated to be approximately 1.65 J/cm².

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.
Overall Number of Participants Analyzed 42 44
Mean (Standard Deviation)
Unit of Measure: kgf
PPT at baseline/pre-intervention 10.6  (3.6) 11.0  (3.9)
PPT immediately post-intervention 11.3  (4.6) 11.5  (4.5)
4.Secondary Outcome
Title Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain
Hide Description 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.
Time Frame At baseline and immediately after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Mean difference in pre/post KEA after receiving active CLRT and Sham in hamstring flexibility (KEA), stratified by a history of prior hamstring injury.
Arm/Group Title Active CLRT, History of Hamstring Strain Sham CLRT With History of Hamstring Strain Active CLRT With no Prior Hamstring Strain Sham CLRT With no History of Hamstring Strain
Hide Arm/Group Description:
Participants receiving active treatment who reported a prior history of hamstring strain (n=8). This group approximates a clinical population.
Participants receiving sham treatment who reported a prior history of hamstring strain (n=8)
Participants receiving active treatment who reported no prior history of hamstring strain (n=36)
Participants receiving sham CLRT with no history of hamstring strain
Overall Number of Participants Analyzed 8 8 36 36
Mean (Standard Deviation)
Unit of Measure: degrees
PRE KEA 167.825  (7.925141) 168.4875  (8.898384) 167.1778  (8.58657) 165.9235  (8.778143)
POST KEA 171.65  (6.762501) 169.4875  (8.092225) 167.8417  (9.658316) 168.6118  (7.420887)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active CLRT, History of Hamstring Strain
Comments This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.825
Confidence Interval (2-Sided) 95%
1.058809 to 6.591192
Parameter Dispersion
Type: Standard Deviation
Value: 3.308759
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham CLRT With History of Hamstring Strain
Comments This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2185
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-1.869044 to 3.869044
Parameter Dispersion
Type: Standard Deviation
Value: 3.431784
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Active CLRT With no Prior Hamstring Strain
Comments This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1281
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .6638904
Confidence Interval (2-Sided) 95%
-.5037233 to 1.831504
Parameter Dispersion
Type: Standard Deviation
Value: 3.450892
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sham CLRT With no History of Hamstring Strain
Comments This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.688237
Confidence Interval (2-Sided) 95%
1.557137 to 3.819337
Parameter Dispersion
Type: Standard Deviation
Value: 3.241751
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Active CLRT, History of Hamstring Strain, Sham CLRT With History of Hamstring Strain
Comments This is the mean difference in effect between active and sham in those with a history of hamstring strain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.825
Confidence Interval (2-Sided) 95%
-0.4543 to 6.0581
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Active CLRT With no Prior Hamstring Strain, Sham CLRT With no History of Hamstring Strain
Comments This is the mean difference of effect between active and sham in those without a history of hamstring strain.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.024
Confidence Interval (2-Sided) 95%
-3.4474 to -0.3406
Estimation Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CLRT SHAM
Hide Arm/Group Description 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. The laser is inactive, all other descriptions are the same as active.
All-Cause Mortality
CLRT SHAM
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)      0/44 (0.00%)    
Hide Serious Adverse Events
CLRT SHAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/44 (0.00%)      0/44 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CLRT SHAM
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/44 (2.27%)      2/44 (4.55%)    
Musculoskeletal and connective tissue disorders     
Mild soreness in Hamstring   0/44 (0.00%)  0 2/44 (4.55%)  2
Mild Headache   1/44 (2.27%)  1 1/44 (2.27%)  1
Indicates events were collected by systematic assessment
The high baseline flexibility of the population may have a ceiling effect on the intervention. Further examination of the effects of CLRT in a clinical population is warranted.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicholas Wise, DC
Organization: University of North Carolina at Chapel Hill
Phone: (864) 494-1001
EMail: nicholas_wise@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03044106    
Other Study ID Numbers: 16-0898
First Submitted: February 2, 2017
First Posted: February 6, 2017
Results First Submitted: October 3, 2018
Results First Posted: January 29, 2019
Last Update Posted: February 12, 2019