Clinical Trial for High Intensity Laser Therapy (HILT) for Elbow Epicondylosis (HILT)
|ClinicalTrials.gov Identifier: NCT01992627|
Recruitment Status : Unknown
Verified November 2013 by Sang-Hoon Lhee, CM Chungmu Hospital.
Recruitment status was: Recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
|Condition or disease||Intervention/treatment|
|Chronic Pain Elbow Tenderness Elbow Pain Upon Active Resistive Motion||Device: HILTERAPIA HIRO 3.0|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Experimental: High Intensity Laser Therapy
High Intensity Laser Therapy (HILTERAPIA HIRO 3.O)will be used among diagnosed patients with elbow epicondylosis. A five minutes duration of HILTERAPIA HIRO 3.0 along the epicondyle area in a targeted manner will be use on the initial treatment, one week after the initial treatment, two weeks after the initial treatment and four weeks after the initial treatment thereafter.
Device: HILTERAPIA HIRO 3.0
High-intensity laser therapy (HILT), which involves higher-intensity laser radiation and which causes minor and slow light absorption by chromophores. This absorption is obtained not with concentrated light but with diffuse light in all directions (the scattering phenomenon), increasing the mitochondrial oxidative reaction and adenosine triphosphate, RNA, or DNA production (photochemistry effects) and resulting in the phenomenon of tissue stimulation called photobiology.
- DASH as the measure of efficacy for HILT [ Time Frame: On the initial treatment, one week after the initial treatment, two weeks after the initial treatment, four weeks after the initial treatment, 6th and 12 month post initial treatment ]The DASH is intended to measure how much difficulty a subject has when performing common functional tasks and activities. The DASH consists of a 30-item questionnaire with 5 response options for each item with a scale ranging from 0, which indicates "least disability," to 100, which indicates "most disability." It incorporates questions related to functional limitations, symptoms, and psychosocial problems. The DASH has been well validated and has a smaller standard error of measurement and a validity comparable to that of joint-specific measures. A change in 12.7 DASH score points is considered to represent clinically significant functional improvement.
- Tenderness as the measure of efficacy for HILT [ Time Frame: On the initial treatment, one week after the initial treatment, two weeks after the initial treatment, four weeks after the initial treatment, 6th and 12 month post initial treatment ]Tenderness described as pain upon palpation and is further categorized into, 0= no tenderness, 1 = mild tenderness, 2 = tenderness evident on facial expression and 3 = patient screams upon palpation.
- Pain upon active resistive motion as the measurement of efficacy for HILT [ Time Frame: On the initial treatment, one week after the initial treatment, two weeks after the initial treatment, four weeks after the initial treatment, 6th and 12 month post initial treatment ]Pain is also noted upon active resistive motion of extension/flexion, supination/pronation. Classification includes; 0 = no pain and 1 = mild pain with full power, 2 = severe pain with full power, and 3 = muscle weakness with pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992627
|Contact: Sang Hoon Lhee, MD, PhD||+82(2)firstname.lastname@example.org|
|Korea, Republic of|
|CM Chungmu Hospital||Recruiting|
|Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-034|
|Contact: Sang Hoon Lhee, MD, PhD +82(2)2068/4525 email@example.com|
|Principal Investigator: Paolo Alan B. Tabar, MD|
|Principal Investigator:||Paolo Alan B. Tabar, MD||CM Chungmu Hospital|