Hamstring Injury, Muscle Pain, Muscle Tone Increased, Muscle Weakness
Conditions
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
CLRT is a novel method of laser stimulation on specific cranial reflex points that modulate muscle tone.
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 90-90 Knee Extension Angle Test | At baseline and immediately after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handheld Dynamometry | At baseline and immediately after intervention | 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. |
| Pain Pressure Threshold | At baseline and immediately after intervention | 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. |
| Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | At baseline and immediately after intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants This is the total of all participants that began the trial and completed at least one visit. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout (1 Week) | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 24.02 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 months | 4 Participants |
| Prior hamstring strain history | 8 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, ever | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 1 / 44 | 2 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLRT | 90-90 Knee Extension Angle Test | KEA at baseline/pre-intervention | 167.3 degrees | Standard Deviation 8.4 |
| CLRT | 90-90 Knee Extension Angle Test | KEA immediately post-intervention | 168.5 degrees | Standard Deviation 9.3 |
| SHAM | 90-90 Knee Extension Angle Test | KEA at baseline/pre-intervention | 166.4 degrees | Standard Deviation 8.8 |
| SHAM | 90-90 Knee Extension Angle Test | KEA immediately post-intervention | 168.8 degrees | Standard Deviation 7.5 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLRT | Handheld Dynamometry | HHD at baseline/pre-intervention | 17.2 Kilograms | Standard Deviation 4.7 |
| CLRT | Handheld Dynamometry | HHD immediately post-intervention | 16.9 Kilograms | Standard Deviation 4.5 |
| SHAM | Handheld Dynamometry | HHD immediately post-intervention | 17.0 Kilograms | Standard Deviation 4.7 |
| SHAM | Handheld Dynamometry | HHD at baseline/pre-intervention | 17.4 Kilograms | Standard Deviation 4.6 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLRT | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | PRE KEA | 167.825 degrees | Standard Deviation 7.925141 |
| CLRT | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | POST KEA | 171.65 degrees | Standard Deviation 6.762501 |
| SHAM | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | POST KEA | 169.4875 degrees | Standard Deviation 8.092225 |
| SHAM | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | PRE KEA | 168.4875 degrees | Standard Deviation 8.898384 |
| Active CLRT With no Prior Hamstring Strain | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | PRE KEA | 167.1778 degrees | Standard Deviation 8.58657 |
| Active CLRT With no Prior Hamstring Strain | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | POST KEA | 167.8417 degrees | Standard Deviation 9.658316 |
| Sham CLRT With no History of Hamstring Strain | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | PRE KEA | 165.9235 degrees | Standard Deviation 8.778143 |
| Sham CLRT With no History of Hamstring Strain | Mean Difference Pre/Post KEA, Stratified by History of Prior Hamstring Strain | POST KEA | 168.6118 degrees | Standard Deviation 7.420887 |
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CLRT | Pain Pressure Threshold | PPT at baseline/pre-intervention | 10.6 kgf | Standard Deviation 3.6 |
| CLRT | Pain Pressure Threshold | PPT immediately post-intervention | 11.3 kgf | Standard Deviation 4.6 |
| SHAM | Pain Pressure Threshold | PPT at baseline/pre-intervention | 11.0 kgf | Standard Deviation 3.9 |
| SHAM | Pain Pressure Threshold | PPT immediately post-intervention | 11.5 kgf | Standard Deviation 4.5 |