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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Low level laser therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Adnan Afzal, PhD*; Phone Number: + 92 3085389670; Email: adnanafzal@Hotmail.com
• Study Contact Backup: Name: Muhammad Hanif Ramlee, PhD; Phone Number: +60 75558480; Email: muhammad.hanif.ramlee@biomedical.utm.my

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Central Park Teaching Hospital
      • Contact: Maryam, MBBS; Phone Number: +92 3014789648

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Particular joint point group; This group will receive laser irradiation on 6-7 particular points including 4-5 on tibiofemoral and 2 on patellofemoral joint.	Device: Low level laser therapy; Omega XP is the particular device producing low level laser therapy and has been in use for therapeutic purposes to treat different musculoskeletal conditions.; Other Names: Cold laser therapy
Experimental: Acupuncture points group; 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.	Device: Low level laser therapy; Omega XP is the particular device producing low level laser therapy and has been in use for therapeutic purposes to treat different musculoskeletal conditions.; Other Names: Cold laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	2nd week
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.	3rd week
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.	4th week
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.	16th week
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.	Baseline
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.	2nd week
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.	3rd week
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.	4th week
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.	16th week
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.	Baseline
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.	2nd week
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.	3rd week
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.	4th week
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.	16th week

Collaborators and Investigators

• Sponsor: Universiti Teknologi Malaysia
• Investigators: Principal Investigator: Adnan Afzal, PhD, University of Technology Malaysia

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: May 6, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Admin/GDEC/276/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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