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

NCT05403931 | Unknown

• 1 other identifier: Admin/GDEC/276/20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (15)

• 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

Study Arms (2)

Particular joint point group

EXPERIMENTAL

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

Acupuncture points group

EXPERIMENTAL

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

Interventions

Low level laser therapy DEVICE

Omega XP is the particular device producing low level laser therapy and has been in use for therapeutic purposes to treat different musculoskeletal conditions.

Also known as: Cold laser therapy

Acupuncture points group; Particular joint point group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Knee OA grade other than III.
• Any contraindication of LLLT including;
• pregnancy
• carcinoma involving knee area
• Steroids and NSAIDS use

Sponsors & Collaborators

• Universiti Teknologi Malaysia: lead

Study Sites (1)

Central Park Teaching Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 19530911 BACKGROUND

• 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.

  PMID: 12775206 BACKGROUND

• 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.

  PMID: 24418801 BACKGROUND

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

Study Officials

• Adnan Afzal, PhD

  University of Technology Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Afzal, PhD*

CONTACT

+ 92 3085389670; adnanafzal@Hotmail.com

Muhammad Hanif Ramlee, PhD

CONTACT

+60 75558480; muhammad.hanif.ramlee@biomedical.utm.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Person assessing the outcomes will have no knowledge that patient received laser therapy on which points of knee area.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: June 3, 2022
• Study Start: April 30, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)