High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis
NCT ID: NCT04320914
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2020-09-28
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High Intensity LASER Therapy group (HILT)
Fourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW .
High Intensity LASER Therapy
The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.
1. Initial phase (710 and 810 mJ/cm2 for a total of 500 J)
2. Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
3. Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.
Ibuprofen gel phonophoresis (IGP) group
Patients with chronic KOA in IGP group will administered with continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis
Ibuprofen gel phonophoresis
Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. Each treatment session will last for 8 min with one session each day for 3 days/week for 8 weeks.
Interventions
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High Intensity LASER Therapy
The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.
1. Initial phase (710 and 810 mJ/cm2 for a total of 500 J)
2. Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
3. Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.
Ibuprofen gel phonophoresis
Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. Each treatment session will last for 8 min with one session each day for 3 days/week for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Recent history (within the last 3 months) of physical therapy to the same joint
* Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
* History of knee surgery/fracture
* Acute synovitis/arthritis including the infectious conditions
* Presence of malignancy
* Pregnancy
* Taking pain relief medications
45 Years
70 Years
ALL
No
Sponsors
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Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
UNKNOWN
Maharishi Markendeswar University (Deemed to be University)
OTHER
Responsible Party
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Asir John Samuel
Associate Professor
Principal Investigators
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Vipin Saini, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Maharishi Markandeshwar Medical College and Hospital
Asir J Samuel
Role: PRINCIPAL_INVESTIGATOR
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Adarsh K Srivastav, MPT
Role: PRINCIPAL_INVESTIGATOR
Maharishi Markandeshwar Medical College and Hospital
Deeksha Sharma, MPT
Role: PRINCIPAL_INVESTIGATOR
Maharishi Markandeshwar Medical College and Hospital
Locations
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Dr Vipin Saini
Solan, Himachal Pradesh, India
Countries
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Central Contacts
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Facility Contacts
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Vipin Saini
Role: primary
References
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Larkin KA, Martin JS, Zeanah EH, True JM, Braith RW, Borsa PA. Limb blood flow after class 4 laser therapy. J Athl Train. 2012 Mar-Apr;47(2):178-83. doi: 10.4085/1062-6050-47.2.178.
de Matos Brunelli Braghin R, Libardi EC, Junqueira C, Rodrigues NC, Nogueira-Barbosa MH, Renno ACM, Carvalho de Abreu DC. The effect of low-level laser therapy and physical exercise on pain, stiffness, function, and spatiotemporal gait variables in subjects with bilateral knee osteoarthritis: a blind randomized clinical trial. Disabil Rehabil. 2019 Dec;41(26):3165-3172. doi: 10.1080/09638288.2018.1493160. Epub 2018 Oct 16.
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
Loyola-Sanchez A, Richardson J, Beattie KA, Otero-Fuentes C, Adachi JD, MacIntyre NJ. Effect of low-intensity pulsed ultrasound on the cartilage repair in people with mild to moderate knee osteoarthritis: a double-blinded, randomized, placebo-controlled pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):35-42. doi: 10.1016/j.apmr.2011.07.196.
Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
Sharma D, Saini V, Srivastav AK, Samuel AJ. Comparative efficacy of high intensity laser therapy (Class IV) and ibuprofen gel phonophoresis in the treatment of knee osteoarthritis among people living in hilly terrain: A randomized controlled study. Lasers Med Sci. 2025 Oct 20;40(1):440. doi: 10.1007/s10103-025-04613-6.
Other Identifiers
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U1111-1237-6893
Identifier Type: OTHER
Identifier Source: secondary_id
MMDU/IEC/140E
Identifier Type: -
Identifier Source: org_study_id
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