Efficacy of High Power Laser Versus Low Level Laser in Ultrasonographic and Functional Outcomes in Patients With Knee Osteoarthritis

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Other: low level laser; Other: conventional physical therapy; Other: high power laser

• Registration Number: NCT06419569
• Lead Sponsor: Cairo University

Brief Summary

this study will be conducted to compare between high power laser and low-intensity laser on ultrasonographic and functional outcomes in patients with knee osteoarthritis

Detailed Description

Osteoarthritis (OA) is a major source of pain, disability, and socioeconomic cost worldwide. The epidemiology of the disorder is complex and multifactorial, with genetic, biological, and biomechanical components. It is estimated that 63 to 85 percent of Americans over age 65 have radiographic signs of OA and that 35 to 50 percent have symptoms of pain, stiffness or limitation of motion. Between 9 and 12 percent of elderly Americans (approximately 3 million people) have enough impairment from OA that they cannot perform their major activities, and half of these individuals are totally disabled (confined to bed or a wheelchair). High power laser therapy (HPL) that involves higher-intensity laser radiation is a new, painless, and powerful modality that showed significant results in pain reduction. One of the modalities commonly used by clinicians was Low Level Laser Therapy introduced as an alternative, safe and non-invasive treatment for OA about 30 years ago.A more recent systemic review investigated the effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis and concluded that Both LLLT and HPL are beneficial as adjuncts to rehabilitation exercise in the management of knee OA. Based on an indirect comparison, the HPL and exercise seems to have higher efficacy in reducing knee pain and stiffness, and in increasing function. To confirm this finding, a direct comparative investigation of the two types of laser therapy may be necessary. ninety patients with knee osteoarthritis will be assigned randomly to three groups; the first experimental will receive high power laser plus conventional physical therapy, second one will receive low-intensity laser and traditional physical therapy, finally, the third group will receive traditionally therapy only

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Last Update Submitted: 2024-05-14
• Study First Posted: 2024-05-17
• Last Update Posted: 2024-05-17
• Study Start: 2024-05-30
• Primary Completion: 2024-12-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• X-ray stages II and III osteoarthritis
• Age between 45 and 75 years.
• BMI equal to or less than 35.

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Exclusion Criteria

• Unwillingness to participate in the study.
• Uncompleted evaluation/treatment programs.
• Any damage to the knee joint during the study.
• Using any treatment other than prescribed therapeutic protocols.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low level laser	low level laser	thirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks
conventional physical therapy	conventional physical therapy	thirty patients will receive conventional physical therapy three times a week for eight weeks
high power laser	high power laser	thirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks
low level laser	conventional physical therapy	thirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks
high power laser	conventional physical therapy	thirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks

Primary Outcome Measures

Name	Time	Method
hyaline cartilage thickness assessment	up to eight weeks	utrasonographe device will be used to assess hyaline cartilage thickness
osteophyte diameter	up to eight weeks	ultrasonographe device will be used to assess the osteophyte diameter

Secondary Outcome Measures

Name	Time	Method
knee range of motion	up to eight weeks	digital goniometer will be used to assess knee range of motion
pressure pain threshold	up to eight weeks	algometer will be used to assess pressure pain threshold
knee function	up to eight weeks	Knee Injury and Osteoarthritis Outcome Score questionnaire will be used to assess knee function.five patient-relevant subscales of KOOS are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.
pain intensity	up to eight weeks	Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)