Muscle Weakness Clinical Trial
— CLRTHamOfficial title:
The Effects of Cranial Laser Reflex Technique on Hamstring Flexibility, Strength, and Pain Pressure Threshold: a Pilot Study
NCT number | NCT03044106 |
Other study ID # | 16-0898 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 4, 2017 |
Est. completion date | July 31, 2017 |
Verified date | October 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | July 31, 2017 |
Est. primary completion date | July 31, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
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 |
Country | Name | City | State |
---|---|---|---|
United States | UNC- Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institutes of Health (NIH), North Carolina Translational and Clinical Sciences Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | At baseline and immediately after intervention | |
Secondary | 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. | At baseline and immediately after intervention | |
Secondary | 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. | At baseline and immediately after intervention |
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