Low Intensity Pulsed Ultrasound Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis

Study Overview
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Brief Summary
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To compare the effects of low intensity pulsed ultrasound with high intensity continuous ultrasound in knee osteoarthritis

Detailed Description
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Knee osteoarthritis is a common disorder affecting elderly and obese. Currently, there are 3 types of treatment; pharmacological, non-pharmacological and surgery. Though ultrasound, a non-pharmacological treatment, is increasingly used in knee osteoarthritis, the advantages and disadvantages of low intensity pulsed ultrasound (LIPUS) and high intensity continuous ultrasound (HICUS) are yet to be clarified. Therefore, a randomized control trial will be done to compare LIPUS and HICUS in participants with knee osteoarthritis presenting to Department of Physical Medicine and Rehabilitation, Yangon General Hospital, Myanmar.

Official Title
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A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Rheumatic Diseases, Musculoskeletal Diseases

Intervention / Treatment
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* Device: Low intensity pulsed ultrasound
* Device: High intensity continuous ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with knee pain (VAS 3 to 6) Kellgren and Lawrence grade 2 and 3 in X' ray knee joint Exclusion Criteria: Rheumatoid arthritis, Gouty arthritis, Spondyloarthropathies, Metabolic arthropathies Infection of knee joint Tumor of knee joint History of hypersensitivity to heat Previous knee surgery in affected side Intra-articular injection within previous 3 months Participants taking treatment with other physical modalities such as low-level laser therapy and Trans Cutaneous Electrical Nerve Stimulation

Ages Eligible for Study
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Minimum Age: 40 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: Low intensity pulsed ultrasound<br>Participants in this arm will receive low intensity pulsed ultrasound therapy on the affected knees for 20 minutes per day, 5 days a week for 4 weeks. Conventional physiotherapy of quadriceps muscle exercise and health education about life style will also be given. | Device: Low intensity pulsed ultrasound<br>* Low intensity pulsed ultrasound therapy will use ultrasound with frequency of 1.5 MHz, power intensity of 30 mW/cm^2 (0.03 W/cm^2 ) and 20% duty cycle.<br>* Other names: Osteotron IV;|
| Active Comparator: High intensity continuous ultrasound<br>Participants in this arm will receive high intensity continuous ultrasound therapy on the affected knees for 10 minutes per day, 5 days a week for 4 weeks. Conventional physiotherapy of quadriceps muscle exercise and health education about life style will also be given. | Device: High intensity continuous ultrasound<br>* High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.<br>* Other names: US 50 (Medical Italia);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) | It is one of the most commonly used measures of pain intensity and it is divided into 10 ordinal ratings with 0 being no pain and 10 being pain as bad as it could be. | 8 weeks | 
| Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC) | This index measures clinically important symptoms of pain, stiffness and function. It consists of 23 questions (5 pain, 2 stiffness and 16 physical function) and the maximum score is 100, indicating the worst outcome while the minimum score is 0, indicating the best outcome. | 8 weeks | 
| Percentage of participants with skin irritation | Skin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent). | 8 weeks | 
| Percentage of participants with tingling | Tingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent). | 8 weeks | 
| Percentage of participants with oedema | Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent). | 8 weeks | 
| Percentage of participants with burns | Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee pain, Low intensity pulsed ultrasound (LIPUS), High intensity continuous ultrasound, Knee stiffness, Randomized controlled trial, Myanmar, Osteotron