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

High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis Among People Living in Hilly Terrain: A Randomized, Double Blind, Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee
• Intervention / Treatment: Other: High Intensity LASER Therapy; Other: Ibuprofen gel phonophoresis

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vipin Saini, Ph.D; Phone Number: +919729430413; Email: vipinsaini31@rediffmail.com
• Study Contact Backup: Name: Asir J Samuel, Ph.D; Phone Number: +918059930222; Email: asirjohnsamuel@mmumullana.org

Study Locations

• India
  • Himachal Pradesh
    • Solan, Himachal Pradesh, India, 173229
      • Recruiting
      • Dr Vipin Saini
      • Contact: Vipin Saini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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 .	Other: 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.; Initial phase (710 and 810 mJ/cm2 for a total of 500 J); 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); 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.; Other Names: HILT
ACTIVE_COMPARATOR: 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	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.; Other Names: IGP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
36-Item Short Form Health Survey (SF-36)	The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life (QoL). The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).	Changes will be measured at baseline, end of 8-week post-intervention period

Collaborators and Investigators

• Sponsor: Maharishi Markendeswar University (Deemed to be University)
• Collaborators: Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2020
• Primary Completion (ANTICIPATED): May 21, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; laser therapy; Knee osteoarthritis; degeneration; Incline walking
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: MMDU/IEC/140E; U1111-1237-6893 (OTHER: Universal Trial Number (UTN) by WHO ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No