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Cranial Laser Reflex Technique for Hamstring Function (CLRTHam)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Hamstring Injury Muscle Tone Increased Muscle Pain Muscle Weakness Device: CLRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Official Title: The Effects of Cranial Laser Reflex Technique on Hamstring Flexibility, Strength, and Pain Pressure Threshold: a Pilot Study
Actual Study Start Date : March 4, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Arm Intervention/treatment
Active Comparator: CLRT, Then Sham
Subjects performed the KEA, HHD, PPT functional tests on their right hamstring before and after the CLRT intervention.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044106


Locations
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United States, North Carolina
UNC- Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
University of North Carolina, Chapel Hill
North Carolina Translational and Clinical Sciences Institute
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Nicholas A Wise, D.C. University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Additional Information:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03044106    
Other Study ID Numbers: 16-0898
First Posted: February 6, 2017    Key Record Dates
Results First Posted: January 29, 2019
Last Update Posted: February 12, 2019
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of North Carolina, Chapel Hill:
hamstrings
flexibility
strength
pain pressure threshold
lllt
photobiomodulation
cranial reflex
cranial laser reflex technique
CLRT
Additional relevant MeSH terms:
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Muscle Weakness
Myalgia
Muscle Hypertonia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Neuromuscular Diseases
Musculoskeletal Pain
Pain