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

May 14, 2024 updated by: Nabil Mahmoud Ismail Abdel-Aal, Cairo University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: high power laser
thirty patients will receive high-power laser and conventional physical therapy three times a week for eight weeks
Other: high power laser
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.
Other: conventional physical therapy
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.
Experimental: low level laser
thirty patients will receive low level laser and conventional physical therapy three times a week for eight weeks
Other: conventional physical therapy
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.
Other: low level laser
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.
Active Comparator: conventional physical therapy
thirty patients will receive conventional physical therapy three times a week for eight weeks
Other: conventional physical therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
osteophyte diameter
Time Frame: up to eight weeks
ultrasonographe device will be used to assess the osteophyte diameter
up to eight weeks
hyaline cartilage thickness assessment
Time Frame: up to eight weeks
utrasonographe device will be used to assess hyaline cartilage thickness
up to eight weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
knee function
Time Frame: 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.
up to eight weeks
pain intensity
Time Frame: 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)
up to eight weeks
knee range of motion
Time Frame: up to eight weeks
digital goniometer will be used to assess knee range of motion
up to eight weeks
pressure pain threshold
Time Frame: up to eight weeks
algometer will be used to assess pressure pain threshold
up to eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/003450

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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