Clinical trial NCT01992627: Clinical Trial for High Intensity Laser Therapy (HILT) for Elbow Epicondylosis
Official title: A Prospective Randomized Clinical Trial of High Intensity Laser Therapy for Elbow Epicondylosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Elbow Tenderness
Elbow Pain Upon Active Resistive Motion
Keywords: High Intensity Laser Therapy
elbow epicondylosis
Lead sponsor: CM Chungmu Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: DASH as the measure of efficacy for HILT
timeFrame: 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:
measure: Tenderness as the measure of efficacy for HILT
timeFrame: 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
measure: Pain upon active resistive motion as the measurement of efficacy for HILT
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CM Chungmu Hospital
state: Yeongdeungpo-gu
Study officials:
affiliation: CM Chungmu Hospital
name: Paolo Alan B. Tabar, MD
role: PRINCIPAL_INVESTIGATOR
References: