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

NCT06419569 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/003450
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Conditions

Knee Osteoarthritis

Keywords

High Power Laser; Low Level Laser; Ultrasonographic changes; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• osteophyte diameter

  ultrasonographe device will be used to assess the osteophyte diameter

  up to eight weeks

• hyaline cartilage thickness assessment

  utrasonographe device will be used to assess hyaline cartilage thickness

  up to eight weeks

Secondary Outcomes (4)

• knee function

  up to eight weeks

• pain intensity

  up to eight weeks

• knee range of motion

  up to eight weeks

• pressure pain threshold

  up to eight weeks

Study Arms (3)

high power laser

EXPERIMENTAL

thirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks

Other: high power laser; Other: conventional physical therapy

low level laser

EXPERIMENTAL

thirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks

Other: low level laser; Other: conventional physical therapy

conventional physical therapy

ACTIVE COMPARATOR

thirty patients will receive conventional physical therapy three times a week for eight weeks

Other: conventional physical therapy

Interventions

high power laser OTHER

Sessions will performed with scanning in longitudinal and perpendicular direction on the medial and lateral sides of the knee with Laser scanner machine. handpiece was positioned in contact and perpendicularly while the patient in a supine lying position with the knee flexed at 30° to open the joint surfaces to the laser beam (optical windows). The scanning was performed transversely and longitudinally in the anterior, medial, and lateral aspects of the knee joint with emphasis on the application on the joint line between the tibial and femoral epicondyles. The total energy delivered to the patient during one session was 1,250 J through three phases of treatment. The initial phase is performed with fast manual scanning with a total of 500 J. In the initial phase, the laser fluency is set to two successive subphases of 710 and 810 mJ/cm2 for a total of 500 J.

high power laser

low level laser OTHER

patients will receive laser with 0.5 W to gain energy density of 6 J/cm2, and total energy of 240 J during one session. LASER apparatus that will be used is Chattanoga Intelect Laser with 850nm wavelength and 200mW power Lasers. Same three phases like HPL with different energy dose. First phase: Fast manual scan 100 J. Second 10 point joint line phase with evey point 14 seconds and 4J to deliver a total of 40 J in this phase. Third phase: Slow manual scan 100 J.

low level laser

conventional physical therapy OTHER

the patients will receive conventiobal physical therapy in the form of Exercise therapy program (1) Warm-up exercises: Walking at the usual speed on a flat surface for 10 min with hamstring and calf gentle stretches.(2) Major exercises for knee OA: Straight leg raise, quadriceps setting, heel raise, one leg balance, step ups, and quadriceps strengthening exercises. The US protocol consists of continuous ultrasonic waves of 1 MHz frequency and 1 W/cm2 intensity applied with a 5-cm diameter applicator. The patients will be placed in a supine position, and the US applied to the medial and lateral parts (5 min on each side) of the knee in circular movements with the probe at right angles to ensure maximum absorption of the energy.

conventional physical therapy; high power laser; low level laser

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

mohamed H abdo, doctoral

CONTACT

01007433819; theorymtc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelop
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator nabil mahmoud ismail abdel-aal

Model Details: high power laser and low level laser

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: May 30, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05