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The Effectiveness of Low Level Laser Therapy on Particular Joint Points and Acupuncture Points on Knee Joints in Grade III Knee Osteoarthritis (LLLT OA)

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Low level laser therapy
Sponsored by
Universiti Teknologi Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Inclusion Criteria:

    • Pain in the knee joint ( minimum 30/100 on VAS )
    • Kellgren-Lawrence Grade III knee OA
    • ACR criteria for knee OA with radiological findings including ;

      • age 35 and above
      • joint crepitus
      • less than 30 minutes of morning stiffness
  • Exclusion Criteria:

    • Knee OA grade other than III.
    • Any contraindication of LLLT including;

      • pregnancy
      • carcinoma involving knee area
    • Steroids and NSAIDS use

Sites / Locations

  • Central Park Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Particular joint point group

Acupuncture points group

Arm Description

This group will receive laser irradiation on 6-7 particular points including 4-5 on tibiofemoral and 2 on patellofemoral joint.

This group will receive laser irradiation on 6-7 particular acupuncture points which have been previously used in another study and or identified in literature.

Outcomes

Primary Outcome Measures

Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Timed Up and Go test ( TUG )
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Timed Up and Go test ( TUG )
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Timed Up and Go test ( TUG )
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Timed Up and Go test ( TUG )
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means better performance and longer the time means poor performance.
Timed Up and Go test ( TUG )
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Visual Analog Scale ( VAS )
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Visual Analog Scale ( VAS )
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Visual Analog Scale ( VAS )
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Visual Analog Scale ( VAS )
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Visual Analog Scale ( VAS )
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2022
Last Updated
May 16, 2023
Sponsor
Universiti Teknologi Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05403931
Brief Title
The Effectiveness of Low Level Laser Therapy on Particular Joint Points and Acupuncture Points on Knee Joints in Grade III Knee Osteoarthritis
Acronym
LLLT OA
Official Title
The Effectiveness of Low Level Laser Therapy on Particular Joint Points and Acupuncture Points on Knee Joints in Grade III Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Teknologi Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
LLLT is in use to treat different musculoskeletal condition. Osteoarthritis is one of the conditions needing LLLT for therapeutic effects. LLLT has been used in different previous studies using different points on joint and also on acupuncture points. This study is going to compare the effectiveness of LLLT on both points. Omega xp device is going to be used in this study.
Detailed Description
LLLT is a non-invasive modality to treat variety of musculoskeletal conditions. Photobiomodulation has been studies for last two decades in different perspectives and on different musculoskeletal condition. Studies suggest profound results due to effect of LLLT at the cellular level. Osteoarthritis is one of the most common debilitating musculoskeletal condition affecting people worldwide. Statistics indicate an increase in this debilitating condition in future. Knee OA is more common amongst other OA of the body. LLLT has been used in previous studies to see the impact on pain and functional performance in knee OA. LLLT has been used on different points on knee joint and also applied on acupuncture points of the knee joints. Different outcomes were used to assess LLLT effectiveness including pain, ROM and even different biomarkers. This study is going to use LLLT on different particular joint points of knee and also acupuncture points of the knee joint and compare the outcomes. This study will present evidence for the clinicians to use LLLT on either the particular joint points or acupuncture points for better clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional study to compare the effectiveness of low level laser therapy on two groups of points of irradiation in knee OA grade III. One group of points involves 6-7 particular points on tibiofemoral and patellofemoral joints. Other group involves the 6-7 particular acupuncture points which have been previously used in a study. Outcomes will indicate that which group irradiation will produce better therapeutic results.
Masking
Outcomes Assessor
Masking Description
Person assessing the outcomes will have no knowledge that patient received laser therapy on which points of knee area.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Particular joint point group
Arm Type
Experimental
Arm Description
This group will receive laser irradiation on 6-7 particular points including 4-5 on tibiofemoral and 2 on patellofemoral joint.
Arm Title
Acupuncture points group
Arm Type
Experimental
Arm Description
This group will receive laser irradiation on 6-7 particular acupuncture points which have been previously used in another study and or identified in literature.
Intervention Type
Device
Intervention Name(s)
Low level laser therapy
Other Intervention Name(s)
Cold laser therapy
Intervention Description
Omega XP is the particular device producing low level laser therapy and has been in use for therapeutic purposes to treat different musculoskeletal conditions.
Primary Outcome Measure Information:
Title
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Description
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Time Frame
Baseline
Title
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Description
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Time Frame
2nd week
Title
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Description
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Time Frame
3rd week
Title
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Description
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Time Frame
4th week
Title
Western Ontario and McMaster University Osteoarthritis Index ( WOMAC )
Description
Western Ontario and McMaster University Osteoarthritis Index is a standard questionnaire used in knee OA to assess the outcome of an intervention. It's 24 items scale which covers pain, stiffness and function. The score ranges from 0-96. 0 means the best health or best performance and 96 is the worst health status or performance.
Time Frame
16th week
Title
Timed Up and Go test ( TUG )
Description
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Time Frame
Baseline
Title
Timed Up and Go test ( TUG )
Description
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Time Frame
2nd week
Title
Timed Up and Go test ( TUG )
Description
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Time Frame
3rd week
Title
Timed Up and Go test ( TUG )
Description
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means better performance and longer the time means poor performance.
Time Frame
4th week
Title
Timed Up and Go test ( TUG )
Description
Timed Up and Go test assesses the balance and is widely used in the clinical outcomes assessment. It's measured in seconds. Lesser the time means good balance and longer the time means poor balance.
Time Frame
16th week
Title
Visual Analog Scale ( VAS )
Description
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Time Frame
Baseline
Title
Visual Analog Scale ( VAS )
Description
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Time Frame
2nd week
Title
Visual Analog Scale ( VAS )
Description
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Time Frame
3rd week
Title
Visual Analog Scale ( VAS )
Description
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Time Frame
4th week
Title
Visual Analog Scale ( VAS )
Description
Visual Analog Scale is a widely used tool to assess pain in knee OA. The score ranges from 0-100. 0 means no pain and 100 means the worst pain.
Time Frame
16th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain in the knee joint ( minimum 30/100 on VAS ) Kellgren-Lawrence Grade III knee OA ACR criteria for knee OA with radiological findings including ; age 35 and above joint crepitus less than 30 minutes of morning stiffness Exclusion Criteria: Knee OA grade other than III. Any contraindication of LLLT including; pregnancy carcinoma involving knee area Steroids and NSAIDS use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adnan Afzal, PhD*
Phone
+ 92 3085389670
Email
adnanafzal@Hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Hanif Ramlee, PhD
Phone
+60 75558480
Email
muhammad.hanif.ramlee@biomedical.utm.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adnan Afzal, PhD
Organizational Affiliation
University of Technology Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Park Teaching Hospital
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maryam, MBBS
Phone
+92 3014789648

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19530911
Citation
Hegedus B, Viharos L, Gervain M, Galfi M. The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial. Photomed Laser Surg. 2009 Aug;27(4):577-84. doi: 10.1089/pho.2008.2297.
Results Reference
background
PubMed Identifier
12775206
Citation
Bjordal JM, Couppe C, Chow RT, Tuner J, Ljunggren EA. A systematic review of low level laser therapy with location-specific doses for pain from chronic joint disorders. Aust J Physiother. 2003;49(2):107-16. doi: 10.1016/s0004-9514(14)60127-6.
Results Reference
background
PubMed Identifier
24418801
Citation
Al Rashoud AS, Abboud RJ, Wang W, Wigderowitz C. Efficacy of low-level laser therapy applied at acupuncture points in knee osteoarthritis: a randomised double-blind comparative trial. Physiotherapy. 2014 Sep;100(3):242-8. doi: 10.1016/j.physio.2013.09.007. Epub 2013 Nov 15.
Results Reference
background

Learn more about this trial

The Effectiveness of Low Level Laser Therapy on Particular Joint Points and Acupuncture Points on Knee Joints in Grade III Knee Osteoarthritis

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