search
Back to results

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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HILTERAPIA HIRO 3.0
Sponsored by
CM Chungmu Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring High Intensity Laser Therapy, elbow epicondylosis

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CM Chungmu HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Intensity Laser Therapy

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 12, 2013
Last Updated
November 19, 2013
Sponsor
CM Chungmu Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01992627
Brief Title
Clinical Trial for High Intensity Laser Therapy (HILT) for Elbow Epicondylosis
Acronym
HILT
Official Title
A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CM Chungmu Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Elbow Tenderness, Elbow Pain Upon Active Resistive Motion
Keywords
High Intensity Laser Therapy, elbow epicondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Laser Therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
HILTERAPIA HIRO 3.0
Intervention Description
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.
Primary Outcome Measure Information:
Title
DASH as the measure of efficacy for HILT
Description
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.
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
Secondary Outcome Measure Information:
Title
Tenderness as the measure of efficacy for HILT
Description
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.
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
Title
Pain upon active resistive motion as the measurement of efficacy for HILT
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Hoon Lhee, MD, PhD
Phone
+82(2)2068/4525
Email
cmirb@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Alan B. Tabar, MD
Organizational Affiliation
CM Chungmu Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CM Chungmu Hospital
City
Seoul
State/Province
Yeongdeungpo-gu
ZIP/Postal Code
150-034
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Hoon Lhee, MD, PhD
Phone
+82(2)2068/4525
Email
cmirb@naver.com
First Name & Middle Initial & Last Name & Degree
Paolo Alan B. Tabar, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs