Trial record 2 of 35 for:    Open Studies | "Elbow"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by CM Chungmu Hospital
Sponsor:
Information provided by (Responsible Party):
Sang-Hoon Lhee, CM Chungmu Hospital
ClinicalTrials.gov Identifier:
NCT01992627
First received: November 12, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Chronic Pain
Elbow Tenderness
Elbow Pain Upon Active Resistive Motion
Device: HILTERAPIA HIRO 3.0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis

Resource links provided by NLM:


Further study details as provided by CM Chungmu Hospital:

Primary Outcome Measures:
  • DASH as the measure of efficacy for HILT [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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 [ 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992627

Contacts
Contact: Sang Hoon Lhee, MD, PhD +82(2)2068/4525 cmirb@naver.com

Locations
Korea, Republic of
CM Chungmu Hospital Recruiting
Seoul, Yeongdeungpo-gu, Korea, Republic of, 150-034
Contact: Sang Hoon Lhee, MD, PhD    +82(2)2068/4525    cmirb@naver.com   
Principal Investigator: Paolo Alan B. Tabar, MD         
Sponsors and Collaborators
CM Chungmu Hospital
Investigators
Principal Investigator: Paolo Alan B. Tabar, MD CM Chungmu Hospital
  More Information

No publications provided

Responsible Party: Sang-Hoon Lhee, Director of CM Chungmu Hospital, CM Chungmu Hospital
ClinicalTrials.gov Identifier: NCT01992627     History of Changes
Other Study ID Numbers: CMH-2013-01
Study First Received: November 12, 2013
Last Updated: November 19, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by CM Chungmu Hospital:
High Intensity Laser Therapy
elbow epicondylosis

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014