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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

Tracking Information
First Submitted Date  ICMJE February 2, 2017
First Posted Date  ICMJE February 6, 2017
Results First Submitted Date  ICMJE October 3, 2018
Results First Posted Date  ICMJE January 29, 2019
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE March 4, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
90-90 Knee Extension Angle Test [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
90-90 Knee Extension Angle Test [ Time Frame: Immediate post intervention ]
KEA is a functional test designed to assess lower extremity flexibility and is considered the gold standard test for assessing hamstring length (53). Results will be recorded as degrees of knee flexion angle. A clinically significant effect size is an increase of 5 degrees.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2019)
  • Handheld Dynamometry [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2017)
  • Handheld Dynamometry [ Time Frame: Immediate post intervention ]
    HHD is currently considered a reliable and valid measurement of peak muscle contraction. 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.
  • Pain Pressure Threshold [ Time Frame: Immediate post intervention ]
    PPT is a reliable, accurate and valid method for measuring muscle pain sensitivity and response to treatment(54). 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranial Laser Reflex Technique for Hamstring Function
Official Title  ICMJE The Effects of Cranial Laser Reflex Technique on Hamstring Flexibility, Strength, and Pain Pressure Threshold: a Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, 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.

Primary Purpose: Treatment
Condition  ICMJE
  • Hamstring Injury
  • Muscle Tone Increased
  • Muscle Pain
  • Muscle Weakness
Intervention  ICMJE Device: CLRT
CLRT is a novel method of laser stimulation on specific cranial reflex points that modulate muscle tone.
Other Name: Cranial Laser Reflex Technique
Study Arms  ICMJE
  • Active Comparator: CLRT, Then Sham
    Subjects performed the KEA, HHD, PPT functional tests on their right hamstring before and after the CLRT intervention.
    Intervention: Device: CLRT
  • Sham Comparator: Sham, Then CLRT
    The Sham procedure was identical to CLRT except the laser device was placed in placebo mode: all device indicator lights and sounds will be functional but no laser light will be emitted from probe aperture.
    Intervention: Device: CLRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2017)
44
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03044106
Other Study ID Numbers  ICMJE 16-0898
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • North Carolina Translational and Clinical Sciences Institute
  • National Institutes of Health (NIH)
Investigators  ICMJE
Principal Investigator: Nicholas A Wise, D.C. University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP