Clinical Trial: Cranial Laser Reflex Technique for Hamstring Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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: In a single, blinded crossover fashion, subjects will complete three functional hamstring tests after CLRT and after sham laser treatment. Subjects will also complete questionnaires to assess their expectations and perceptions of the interventions.


Detailed Summary:

First Visit. The research staff will schedule all study visits in the Neurophysiology Lab or other appropriate site in the UNC Healthcare system or medical school. The baseline phase of the first visit will include review of inclusion/exclusion criteria and the components of the study. Those who wish to sign the consent will complete a brief questionnaire on their activity level, history of hamstring injuries, and perceived hamstring tightness.

Randomization/Random Allocation. Subjects who meet the inclusion criteria and give consent will be 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 will enter the subject's assigned ID into an online computer program (selected by study biostatistician) to determine assignment to one of the two periods. The study biostatistician will use computer-generated random numbers to generate the allocation sequence using random blocks of random sizes. The program documents treatment assignment in an un-editable form including a date stamp.

Post Randomization. After randomization, subjects will be asked to complete the three functional hamstring tests: KEA, HHD, and PPT. Subjects will have direct contact with the investigator and research assistant at each visit to facilitate adverse event reporting.

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 will be in the supine position on a treatment table. The tested extremity (the right leg in each subject) will be placed in a 90° hip and 90° knee position with the contralateral lower extremity placed flat on the table. A digital inc
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: February 2, 2017
Date Started: March 4, 2017
Date Completion: January 22, 2018
Last Updated: April 17, 2017
Last Verified: April 2017