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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320914
Recruitment Status : Not yet recruiting
First Posted : March 25, 2020
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
Information provided by (Responsible Party):
Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)

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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Other: High Intensity LASER Therapy Other: Ibuprofen gel phonophoresis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.

  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.
Other Name: 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 Name: IGP




Primary Outcome Measures :
  1. Digitalized pain pressure algometer (ALGO-DS-01) [ Time Frame: Changes will be measured at baseline, end of 8-week post-intervention period ]
    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

  2. Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) [ Time Frame: Changes will be measured at baseline, end of 8-week post-intervention period ]
    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).


Secondary Outcome Measures :
  1. 36-Item Short Form Health Survey (SF-36) [ Time Frame: Changes will be measured at baseline, end of 8-week post-intervention period ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320914


Contacts
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Contact: Dr Vipin Saini, Ph.D +919729430413 vipinsaini31@rediffmail.com
Contact: Dr Asir J Samuel, Ph.D +918059930222 asirjohnsamuel@mmumullana.org

Sponsors and Collaborators
Maharishi Markendeswar University (Deemed to be University)
Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan
Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
Investigators
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Principal Investigator: Dr Vipin Saini, Ph.D Maharishi Markandeshwar Medical College and Hospital
Principal Investigator: Dr Asir J Samuel Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Publications of Results:

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Responsible Party: Asir John Samuel, Associate Professor, Maharishi Markendeswar University (Deemed to be University)
ClinicalTrials.gov Identifier: NCT04320914    
Other Study ID Numbers: MMDU/IEC/140E
U1111-1237-6893 ( Other Identifier: Universal Trial Number (UTN) by WHO ICTRP )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asir John Samuel, Maharishi Markendeswar University (Deemed to be University):
Knee osteoarthritis
Incline walking
degeneration
Ultrasound
laser therapy
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action