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

A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01992627
Acronym
HILT
Enrollment
40
Registered
2013-11-25
Start date
2013-10-31
Completion date
2013-12-31
Last updated
2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

High Intensity Laser Therapy, elbow epicondylosis

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.

Interventions

DEVICEHILTERAPIA 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.

Sponsors

CM Chungmu Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
DASH as the measure of efficacy for HILTOn 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 treatmentThe 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

MeasureTime frameDescription
Tenderness as the measure of efficacy for HILTOn 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 treatmentTenderness 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 HILTOn 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 treatmentPain 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.

Countries

South Korea

Contacts

Primary ContactSang Hoon Lhee, MD, PhD
cmirb@naver.com+82(2)2068/4525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026