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

NCT01992627 | Unknown DMC

• 1 other identifier: CMH-2013-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

High Intensity Laser Therapy; elbow epicondylosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Tenderness as the measure of efficacy for HILT

  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 upon active resistive motion as the measurement of efficacy for HILT

  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

Study Arms (1)

High Intensity Laser Therapy

EXPERIMENTAL

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

Interventions

HILTERAPIA HIRO 3.0 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.

High Intensity Laser Therapy

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous elbow conservative managements such as physical therapy and elbow injection-based therapies
• previous surgical management of the elbow

Sponsors & Collaborators

• CM Chungmu Hospital: lead

Study Sites (1)

CM Chungmu Hospital

Seoul, Yeongdeungpo-gu, 150-034, South Korea

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paolo Alan B. Tabar, MD

  CM Chungmu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Hoon Lhee, MD, PhD

CONTACT

+82(2)2068/4525; cmirb@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of CM Chungmu Hospital

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

KR (1)