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

CM Chungmu Hospital

Status: Unknown

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

Treatments: Device: HILTERAPIA HIRO 3.0

Study type: Interventional

Funder types: Other

Identifiers

NCT01992627

CMH-2013-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

High Intensity Laser Therapy

Experimental group

Description:

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.

Treatment:

Device: HILTERAPIA HIRO 3.0