High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis

NCT ID: NCT04320914

Last Updated: 2022-09-14

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2023-06-30

Brief Summary

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A total of 80 patients with knee osteoarthritis (KOA) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. Recruited patients will be randomly divided in to two groups high intensity-laser therapy (HILT) group and ibuprofen gel phonophoresis (IGP) group. Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.The pain and quality of life will be assessed at the baseline and at the end of 8-week post-intervention period.

Detailed Description

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Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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 .

Group Type EXPERIMENTAL

High Intensity LASER Therapy

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

Ibuprofen gel phonophoresis

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Other Intervention Names

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HILT IGP

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study

Exclusion Criteria

* Unwillingness to participate in the study
* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)

UNKNOWN

Sponsor Role collaborator

Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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India

Central Contacts

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Vipin Saini, Ph.D

Role: CONTACT

+919729430413

Asir J Samuel, Ph.D

Role: CONTACT

+918059930222

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.

Reference Type RESULT
PMID: 22488283 (View on PubMed)

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.

Reference Type RESULT
PMID: 30324827 (View on PubMed)

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.

Reference Type RESULT
PMID: 3741515 (View on PubMed)

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.

Reference Type RESULT
PMID: 22200383 (View on PubMed)

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.

Reference Type RESULT
PMID: 18843657 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41114869 (View on PubMed)

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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