Cranial Laser Reflex Technique for Hamstring Function

NCT03044106 | Completed Results FDA Device

• 1 other identifier: 16-0898
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Hamstring Injury; Muscle Tone Increased; Muscle Pain; Muscle Weakness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and immediately after intervention

Secondary Outcomes (3)

• Handheld Dynamometry

  At baseline and immediately after intervention

• Pain Pressure Threshold

  At baseline and immediately after intervention

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

  At baseline and immediately after intervention

Study Arms (2)

CLRT, Then Sham

ACTIVE COMPARATOR

Subjects performed the KEA, HHD, PPT functional tests on their right hamstring before and after the CLRT intervention.

Device: CLRT

Sham, Then CLRT

SHAM COMPARATOR

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

Interventions

CLRT DEVICE

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

Also known as: Cranial Laser Reflex Technique

CLRT, Then Sham; Sham, Then CLRT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

UNC- Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Links

• Study website

MeSH Terms

Conditions

Muscle Hypertonia; Myalgia; Muscle Weakness

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Pain; Pathologic Processes

Limitations and Caveats

The high baseline flexibility of the population may have a ceiling effect on the intervention. Further examination of the effects of CLRT in a clinical population is warranted.

Results Point of Contact

• Title: Nicholas Wise, DC
• Organization: University of North Carolina at Chapel Hill

nicholas_wise@med.unc.edu

(864) 494-1001

Study Officials

• Nicholas A Wise, D.C.

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 6, 2017
• Study Start: March 4, 2017
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2017
• Last Updated: February 12, 2019
• Results First Posted: January 29, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)