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

NCT04320914 | Unknown DMC

• 2 other identifiers: MMDU/IEC/140EU1111-1237-6893
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteo Arthritis Knee

Keywords

Knee osteoarthritis; Incline walking; degeneration; Ultrasound; laser therapy

Outcome Measures

Primary Outcomes (2)

• Digitalized pain pressure algometer (ALGO-DS-01)

  Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain, which is a reliable and valid tool

  Changes will be measured at baseline, end of 8-week post-intervention period

• Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)

  The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be used to evaluate the disease-specific self-reported symptoms of OA. This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions).

  Changes will be measured at baseline, end of 8-week post-intervention period

Secondary Outcomes (1)

• 36-Item Short Form Health Survey (SF-36)

  Changes will be measured at baseline, end of 8-week post-intervention period

Study Arms (2)

High Intensity LASER Therapy group (HILT)

EXPERIMENTAL

Fourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW .

Other: High Intensity LASER Therapy

Ibuprofen gel phonophoresis (IGP) group

ACTIVE COMPARATOR

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

Other: Ibuprofen gel phonophoresis

Interventions

High Intensity LASER Therapy 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.

Also known as: HILT

High Intensity LASER Therapy group (HILT)

Ibuprofen gel phonophoresis 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.

Also known as: IGP

Ibuprofen gel phonophoresis (IGP) group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maharishi Markendeswar University (Deemed to be University): lead
• Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE): collaborator

Study Sites (1)

Dr Vipin Saini

Solan, Himachal Pradesh, 173229, India

RECRUITING

Related Publications (6)

• 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.

  PMID: 22488283 RESULT

• 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.

  PMID: 30324827 RESULT

• 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.

  PMID: 3741515 RESULT

• 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.

  PMID: 22200383 RESULT

• 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.

  PMID: 18843657 RESULT

• 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.

  PMID: 41114869 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Vipin Saini, Ph.D

  Maharishi Markandeshwar Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Asir J Samuel

  Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Adarsh K Srivastav, MPT

  Maharishi Markandeshwar Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Deeksha Sharma, MPT

  Maharishi Markandeshwar Medical College and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vipin Saini, Ph.D

CONTACT

+919729430413; vipinsaini31@rediffmail.com

Asir J Samuel, Ph.D

CONTACT

+918059930222; asirjohnsamuel@mmumullana.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: September 28, 2020
• Primary Completion: May 21, 2023
• Study Completion: June 30, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)