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Cranial Laser Reflex Technique for Hamstring Function

The Effects of Cranial Laser Reflex Technique on Hamstring Flexibility, Strength, and Pain Pressure Threshold: a Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03044106
Acronym
CLRTHam
Enrollment
44
Registered
2017-02-06
Start date
2017-03-04
Completion date
2017-07-31
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hamstring Injury, Muscle Pain, Muscle Tone Increased, Muscle Weakness

Keywords

hamstrings, flexibility, strength, pain pressure threshold, lllt, photobiomodulation, cranial reflex, cranial laser reflex technique, CLRT

Brief summary

Purpose: To conduct a pilot study of the effect of Cranial Laser Reflex Technique (CLRT) compared with sham laser on hamstring muscle flexibility, strength, and pain pressure threshold. Participants: Active, young adults ages 18 to 35. Procedures: A two-visit, assessor and participant-blinded crossover study with 1-week washout. Subjects will complete three functional hamstring tests before and after CLRT and sham laser treatment. Subjects will also complete questionnaires to assess their expectations and perceptions of the interventions.

Detailed description

First Visit: Subjects who met the inclusion criteria and gave consent completed a brief questionnaire on their activity level, history of hamstring injuries, and perceived hamstring tightness and were randomized to one of the following for the first treatment period: 1) active CLRT; or 2) sham laser. After randomization, subjects were asked to complete the three functional hamstring tests: 90-90 Knee Extension Angle (KEA) to assess flexibility, handheld dynamometry (HHD) for strength, and pain pressure threshold (PPT). Assessments. KEA: The 90-90 Knee Extension Angle test is a functional assessment designed to assess lower extremity flexibility and is considered the gold standard for hamstring length. The participant began in the supine position on a treatment table. The tested extremity (the right leg in each subject) was placed in a 90° hip and 90° knee position with the contralateral lower extremity placed flat on the table. A digital inclinometer was consistently placed at the level of the medial malleoli and the superior pole of the patella. The examiner maintained 90° of hip flexion. Pelvic position was monitored by palpation of the anterior superior iliac spine and lumbar spinous processes to maintain a neutral pelvic position. The examiner passively extended the knee to the point of a ''strong, but tolerable stretch, as reported by the subject. The examiner read the angle of the inclinometer and recorded the mean value of three attempts. A greater angle indicates greater degree of flexibility. Hand held Dynamometry (HHD) is currently considered a reliable and valid measurement of peak muscle contraction. The subject began prone on the table with right leg bent to 90°. The tester placed the dynamometer (microFET2; Hoggan Health Industries, Salt Lake City, UT) at the heel of the participant and applied force to the heel, gradually increasing in 3 to 5 seconds. Participants was instructed to resist the applied force and maximally contract the hamstring muscle against the HHD device. The test ended once they are no longer able to resist the force and the leg begins to move (break point). The investigator recorded the mean value of three attempts. Pain Pressure Threshold (PPT) is a reliable, accurate and valid method for measuring muscle pain sensitivity and response to treatment. The digital algometer (FDX, Wagner Instruments, Greenwich, CT) is a hand-held muscle tester with a range of 0-100 lbf that consists of a padded disc with a diameter of 0.5 attached to a microprocessor-control unit that measures peak force (pounds or kilograms). The unit has a digital readout for peak-applied pressure and provides a built-in calibration routine that verifies a valid calibration. In order to determine PPT, the researcher applied the tip of the algometer to a tender spot in the participant's hamstrings and increased the amount of pressure until the participant verbally informed the researcher when the sensation of pressure became pain. At this point the algometer was removed and the peak force recorded. The mean of three repeated measures was reported. Intervention: Cranial Laser Reflex Technique (CLRT) is a novel complementary and alternative (CAM) medicine intervention for musculoskeletal conditions that incorporates principles of laser acupuncture with chiropractic cranial reflexology. Subjects wore protective eyewear. The hamstring reflexes are two lines on the posterior portion of the top of the head, approximately 2 cm long and 2 cm apart, running parallel to the sagittal suture. The posterior end of the reflexes can be located by finding the vertex, or CZ point in the standardized 10-20 EEG system, and moving laterally approximately 1 cm. The aperture of the laser probe was placed at the posterior end of the reflex (b), turned on and moved anteriorly to point (a) at a speed of approximately 2 cm/s. The laser was turned off and quickly returned to the starting point, turned on and moved again. This was repeated for a total of 30 times. The probe skimmed the surface of the scalp, moving aside as much hair as possible. Device: The treatment device used in this study is a Class IIIB 810nm 200 milliwatts (mW) near-infrared diode laser (THOR Photomedicine Ltd, Great Britain) that is currently marketed in the US. The laser probe is FDA-cleared and classified as a non-significant risk device. The spot size is 0.0364 cm\^2, and the treatment time is 30 seconds. Current best-practice recommendations for laser acupuncture recommend a dosage between 1-4 J/cm\^2 per point. Since the CRP is a line of 2 cm, for the purposes of calculating dosage, it was treated 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 received 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/cm\^2. There was a one-week washout and the subject will return for the second treatment period. Primary Outcome: Hamstring flexibility (90-90 Knee Extension Angle, KEA) A clinically significant effect size is an increase of 5 degrees. The investigator recorded the mean value of three attempts. Hypothesis: CLRT will increase hamstring flexibility. Secondary Outcomes: 1. Hamstring Strength as assessed by Handheld Dynamometry. HHD . The investigator recorded the mean value of three attempts. Hypothesis: CLRT will have a neutral to positive effect on hamstring strength. 2. Pain Pressure Threshold. The mean of three repeated measures was reported. An increase in PPT signifies an increase in pain tolerance. Hypothesis: CLRT will increase pain tolerance. 3. Age, gender, activity level, perceived hamstring tightness, perceived hamstring flexibility and perceived hamstring strength were assessed at baseline and subsequent follow up visit. Results were stratified by these variables to assess interaction with treatment. Sample Size and Power: Based on previously published results, a mean increase of 5º on the KEA (e.g., from 135º to 140º) is considered to be clinically meaningful, assuming a common standard deviation of 15º. It is also assumed that correlation between repeated measurements from the same individual will be at least 0.75 (likely a conservative assumption). Under these assumptions, enrolling 38 participants would provide at least 80% power using a two-sided test at the 0.05 level.

Interventions

DEVICECLRT

CLRT is a novel method of laser stimulation on specific cranial reflex points that modulate muscle tone.

Sponsors

North Carolina Translational and Clinical Sciences Institute
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
University of North Carolina, Chapel Hill
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Subjects and assessors were blinded to treatment allocation. The subject was face down, eyes closed, and wearing protective eyewear that blocks the specific wavelength of the laser light during the intervention. After each treatment session, the participants completed a de-blinding questionnaire administrated by the assessor providing a dichotomous 'yes' or 'no' answer as to whether active treatment was received. This response was followed by a second question regarding how certain they were that active treatment was received on a 0-10 numeric rating scale (NRS), where 0 represents absolutely uncertain and 10 represents absolutely certain.

Intervention model description

Subjects who meet the inclusion criteria and give consent were randomized to one of the following for the first treatment period: 1) active CLRT; or 2) sham laser. At the first intervention visit, the research assistant entered the subject's assigned identification into an online computer program (selected by study biostatistician) to determine assignment to one of the two periods. The study biostatistician used computer-generated random numbers to generate the allocation sequence using random blocks of random sizes. A one-week washout period minimized carryover effects.

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

1. Between 18-35 years of age 2. All genders 3. Willing to complete two study visits over 2-3 weeks 4. Able to read and communicate in English

Exclusion criteria

1. Current lower back condition with pain, numbness or tingling that radiates down the legs 2. Active treatment for a major medical illness, such as heart disease, uncontrolled diabetes or hypertension, malignancy, autoimmune, or immune deficiency disorder 3. History of vasculitis, intracranial mass, clotting disorder (including medication-induced, e.g., warfarin) 4. Current skin malignancy on scalp 5. Cognitive dysfunction preventing informed consent 6. Pending or currently receiving benefits from personal injury litigation, including worker's compensation 7. Chronic long-term disability related to lumbosacral injury/symptoms 8. Epilepsy

Design outcomes

Primary

MeasureTime frameDescription
90-90 Knee Extension Angle TestAt baseline and immediately after interventionKnee 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.

Secondary

MeasureTime frameDescription
Handheld DynamometryAt baseline and immediately after interventionHandheld 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.
Pain Pressure ThresholdAt baseline and immediately after interventionPPT 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.
Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainAt baseline and immediately after interventionMean 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
All Participants
This is the total of all participants that began the trial and completed at least one visit.
44
Total44

Withdrawals & dropouts

PeriodReasonFG000FG001
Washout (1 Week)Withdrawal by Subject02

Baseline characteristics

CharacteristicAll Participants
Age, Continuous24.02 years
STANDARD_DEVIATION 3.14
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Injury, either leg, last 6 months4 Participants
Prior hamstring strain history8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
3 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
38 Participants
Sex: Female, Male
Female
36 Participants
Sex: Female, Male
Male
8 Participants
Subjective hamstring tightness
A little tight
11 Participants
Subjective hamstring tightness
Not at all tight
4 Participants
Subjective hamstring tightness
Somewhat tight
20 Participants
Subjective hamstring tightness
Unknown
4 Participants
Subjective hamstring tightness
Very tight
5 Participants
surgery to either leg, ever5 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 440 / 44
other
Total, other adverse events
1 / 442 / 44
serious
Total, serious adverse events
0 / 440 / 44

Outcome results

Primary

90-90 Knee Extension Angle Test

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

Population: Analysis was conducted on intention to treat.

ArmMeasureGroupValue (MEAN)Dispersion
CLRT90-90 Knee Extension Angle TestKEA at baseline/pre-intervention167.3 degreesStandard Deviation 8.4
CLRT90-90 Knee Extension Angle TestKEA immediately post-intervention168.5 degreesStandard Deviation 9.3
SHAM90-90 Knee Extension Angle TestKEA at baseline/pre-intervention166.4 degreesStandard Deviation 8.8
SHAM90-90 Knee Extension Angle TestKEA immediately post-intervention168.8 degreesStandard Deviation 7.5
Secondary

Handheld Dynamometry

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

Population: Intention to treat.

ArmMeasureGroupValue (MEAN)Dispersion
CLRTHandheld DynamometryHHD at baseline/pre-intervention17.2 KilogramsStandard Deviation 4.7
CLRTHandheld DynamometryHHD immediately post-intervention16.9 KilogramsStandard Deviation 4.5
SHAMHandheld DynamometryHHD immediately post-intervention17.0 KilogramsStandard Deviation 4.7
SHAMHandheld DynamometryHHD at baseline/pre-intervention17.4 KilogramsStandard Deviation 4.6
Secondary

Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain

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

Population: Mean difference in pre/post KEA after receiving active CLRT and Sham in hamstring flexibility (KEA), stratified by a history of prior hamstring injury.

ArmMeasureGroupValue (MEAN)Dispersion
CLRTMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPRE KEA167.825 degreesStandard Deviation 7.925141
CLRTMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPOST KEA171.65 degreesStandard Deviation 6.762501
SHAMMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPOST KEA169.4875 degreesStandard Deviation 8.092225
SHAMMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPRE KEA168.4875 degreesStandard Deviation 8.898384
Active CLRT With no Prior Hamstring StrainMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPRE KEA167.1778 degreesStandard Deviation 8.58657
Active CLRT With no Prior Hamstring StrainMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPOST KEA167.8417 degreesStandard Deviation 9.658316
Sham CLRT With no History of Hamstring StrainMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPRE KEA165.9235 degreesStandard Deviation 8.778143
Sham CLRT With no History of Hamstring StrainMean Difference Pre/Post KEA, Stratified by History of Prior Hamstring StrainPOST KEA168.6118 degreesStandard Deviation 7.420887
Comparison: This is the difference between pre and post KEA in those receiving the active treatment with a history of hamstring strain.p-value: 0.006895% CI: [1.058809, 6.591192]t-test, 2 sided
Comparison: This is the difference in pre /post KEA means after receiving the sham treatment in those with a history of hamstring strains.p-value: 0.218595% CI: [-1.869044, 3.869044]t-test, 2 sided
Comparison: This is the difference in pre/post KEA means in those receiving the active treatment with no history of hamstring strain.p-value: 0.128195% CI: [-0.5037233, 1.831504]t-test, 2 sided
Comparison: This is the difference in pre/post KEA means in those receiving the sham treatment who have no history of hamstring strain.p-value: 095% CI: [1.557137, 3.819337]t-test, 2 sided
Comparison: This is the mean difference in effect between active and sham in those with a history of hamstring strainp-value: 0.0995% CI: [-0.4543, 6.0581]Mixed Models Analysis
Comparison: This is the mean difference of effect between active and sham in those without a history of hamstring strain.p-value: 0.01895% CI: [-3.4474, -0.3406]Mixed Models Analysis
Secondary

Pain Pressure Threshold

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

Population: Intention to treat.

ArmMeasureGroupValue (MEAN)Dispersion
CLRTPain Pressure ThresholdPPT at baseline/pre-intervention10.6 kgfStandard Deviation 3.6
CLRTPain Pressure ThresholdPPT immediately post-intervention11.3 kgfStandard Deviation 4.6
SHAMPain Pressure ThresholdPPT at baseline/pre-intervention11.0 kgfStandard Deviation 3.9
SHAMPain Pressure ThresholdPPT immediately post-intervention11.5 kgfStandard Deviation 4.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026