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

NCT ID: NCT01992627

Last Updated: 2013-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-12-31

Brief Summary

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

Detailed 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.

Conditions

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

Keywords

High Intensity Laser Therapy; elbow epicondylosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HILTERAPIA HIRO 3.0

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CM Chungmu Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang-Hoon Lhee

Director of CM Chungmu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Alan B. Tabar, MD

Role: PRINCIPAL_INVESTIGATOR

CM Chungmu Hospital

Locations

CM Chungmu Hospital

Seoul, Yeongdeungpo-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Hoon Lhee, MD, PhD

Role: CONTACT

Phone: +82(2)2068/4525

Email: cmirb@naver.com

Facility Contacts

Sang Hoon Lhee, MD, PhD

Role: primary

Other Identifiers

CMH-2013-01

Identifier Type: -

Identifier Source: org_study_id