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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05403931
Other study ID # Admin/GDEC/276/20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 30, 2022
Est. completion date September 30, 2023

Study information

Verified date May 2023
Source Universiti Teknologi Malaysia
Contact Adnan Afzal, PhD*
Phone + 92 3085389670
Email adnanafzal@Hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility - 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Pakistan Central Park Teaching Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Universiti Teknologi Malaysia

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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