High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT04320914|
Recruitment Status : Not yet recruiting
First Posted : March 25, 2020
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteo Arthritis Knee||Other: High Intensity LASER Therapy Other: Ibuprofen gel phonophoresis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
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
- 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
- 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).
- 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).
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
|Contact: Dr Vipin Saini, Ph.Dfirstname.lastname@example.org|
|Contact: Dr Asir J Samuel, Ph.Demail@example.com|
|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|