Clinical Trial for High Intensity Laser Therapy (HILT) for Elbow Epicondylosis

Chronic Pain Clinical Trial

— HILT  

Official title:

A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992627
• Other study ID #: CMH-2013-01
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2013
• Last updated: November 19, 2013
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: November 2013
• Source: CM Chungmu Hospital
• Contact: Sang Hoon Lhee, MD, PhD
• Phone: +82(2)2068/4525
• Email: cmirb[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of elbow epicondylosis

Description:

The diagnosed patients with epicondylosis will be treated with HILTERAPIA HIRO 3.O for a total of four sessions during the entire duration of the treatment protocol. Parameters to be evaluated are tenderness, pain upon active resistive motion and DASH scores. After every treatment session of HILTERAPIA HIRO 3.O, these said parameters will be recorded initially on the first treatment, one week after the initial treatment, two weeks after the initial treatment and four weeks after the initial treatment. Patient is advised to follow-up on the 6th and 12 month post initial HILTERAPIA HIRO 3.O treatment for the reevaluation of the parameters. Tenderness is 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 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. And for functional scoring will be using the DASH which is a multidimensional disease specific, brief, self-administered measure of symptoms and functional status among subjects with upper limb disorders. 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." A change in 12.7 DASH score points is considered to represent clinically significant functional improvement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

Inclusion Criteria:

• history of medial and lateral elbow pain for at least three months in duration

• local tenderness for at least three months in duration

• pain on the epicondyle upon active resistive flexion (medial) and extension (lateral) of the wrist

Exclusion Criteria:

• previous elbow conservative managements such as physical therapy and elbow injection-based therapies

• previous surgical management of the elbow

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Elbow Pain Upon Active Resistive Motion
• Elbow Tenderness

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	CM Chungmu Hospital	Seoul	Yeongdeungpo-gu

Sponsors (1)

Lead Sponsor	Collaborator
CM Chungmu Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH as the measure of efficacy for HILT	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.	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	No
Secondary	Tenderness as the measure of efficacy for HILT	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.	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	No
Secondary	Pain upon active resistive motion as the measurement of efficacy for HILT	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.	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	No