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High Intensity Laser and Exercises in Knee OA

Primary Purpose

Chronic Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity Laser Therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Knee Osteoarthritis focused on measuring knee, osteoarthritis, HILT, exercise, pain, function

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957).
  2. Aged between 50- 70 years
  3. Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees.
  4. Body mass index (BMI) ≤30 kg/m2.
  5. Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
  6. All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university

Exclusion Criteria:

Patients will be excluded if they have the following conditions:

  • History of joint replacement.
  • Symptoms or signs suggestive of another cause of knee pain.
  • Rheumatoid arthritis.
  • Steroid injection or knee surgery (previous six months).
  • acute inflammation around knee joint.
  • Underlying disease such as malignancy.
  • Infection or systemic disease of musculoskeletal system

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    1500 J + exercises

    3000 J + exercises

    exercises + sham LASER

    Arm Description

    consist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises.

    consist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises.

    consist of 17 patients, they will apply exercises plus sham LASER.

    Outcomes

    Primary Outcome Measures

    visual analogue scale
    pain intensity
    The functional disability assessment
    The Western Ontario and McMaster Universities Osteoarthritis Index

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2021
    Last Updated
    February 10, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04751253
    Brief Title
    High Intensity Laser and Exercises in Knee OA
    Official Title
    The Combined Effect Of Different Doses Of High-Intensity Laser And Traditional Exercise On Pain And Function In Patients With Chronic Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to compare the effect of different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
    Detailed Description
    Adding HILT to the traditional physical therapy program may reduce pain and improve the functional status of the affected joints. This may provide clinicians with an understanding of the different treatment modalities that may improve the quality of life of patients suffering from chronic knee OA. Which may benefit a wide range of individuals affected by this chronic and widespread disease all over the world. Although little is known about the efficacy or mechanism of action of what has been termed ''high-intensity laser therapy'' using Nd: YAG lasers it has become commercially available in veterinary practice and is being marketed for the treatment of musculoskeletal disease. clinical research specific to Nd: YAG high-intensity laser therapy is required, as it is being used with little supporting evidence. As there was no evidence about the best protocol for the treatment of knee OA as each study was using different doses, different sites of application, different number of phases, frequency of sessions, and the interval between sessions that make it difficult to have the best results. Specifically, the dosage range in literature was ranged from 1250 to 3000 J as total energy transmitted during one treatment session. The current study is an attempt to answer the question of which dosage of the energy of high-intensity LASER is more effective on pain and functional activities in patients with chronic knee OA at the third degree of osteoarthritis as determined by (Kellgren/Lawrence grading system) as it was recommended that LASER is an ideal treatment for subjects in the later stages of OA .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Knee Osteoarthritis
    Keywords
    knee, osteoarthritis, HILT, exercise, pain, function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    51 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1500 J + exercises
    Arm Type
    Active Comparator
    Arm Description
    consist of 17 patients, they will receive the application of HILT with intensity 1500 J plus exercises.
    Arm Title
    3000 J + exercises
    Arm Type
    Active Comparator
    Arm Description
    consist of 17 patients, they will receive the application of HILT with intensity 3000 J plus exercises.
    Arm Title
    exercises + sham LASER
    Arm Type
    Sham Comparator
    Arm Description
    consist of 17 patients, they will apply exercises plus sham LASER.
    Intervention Type
    Device
    Intervention Name(s)
    High Intensity Laser Therapy
    Intervention Description
    different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
    Primary Outcome Measure Information:
    Title
    visual analogue scale
    Description
    pain intensity
    Time Frame
    8 weeks
    Title
    The functional disability assessment
    Description
    The Western Ontario and McMaster Universities Osteoarthritis Index
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All subjects diagnosed as third degree chronic knee OA as determined by (Kellgren/Lawrence grading system) (Kellgren and Lawrence, 1957). Aged between 50- 70 years Persistent pain ≥4 on the visual analog scale (VAS) for more than 3 months in one or both knees. Body mass index (BMI) ≤30 kg/m2. Self-reported disability due to knee pain with a score of at least 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). All subjects who will participate in this study will read, sign and date an informed consent form which required by ethical committee of faculty of physical therapy, Cairo university Exclusion Criteria: Patients will be excluded if they have the following conditions: History of joint replacement. Symptoms or signs suggestive of another cause of knee pain. Rheumatoid arthritis. Steroid injection or knee surgery (previous six months). acute inflammation around knee joint. Underlying disease such as malignancy. Infection or systemic disease of musculoskeletal system
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mona M ibrahim, professor
    Phone
    +201002992613
    Email
    mona.ibrahiem@cu.edu.eg

    12. IPD Sharing Statement

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    High Intensity Laser and Exercises in Knee OA

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