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

Study Overview
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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.

Official Title
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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

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Other: High Intensity LASER Therapy
* Other: Ibuprofen gel phonophoresis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity LASER Therapy group (HILT)<br>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<br>* 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.<br>* Other names: HILT;|
| Active Comparator: Ibuprofen gel phonophoresis (IGP) group<br>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<br>* 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.<br>* Other names: IGP;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incline walking, Knee osteoarthritis, degeneration, Ultrasound, laser therapy