Clinical trial NCT04406337: Low Intensity Pulsed Ultrasound Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
Official title: A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis
Rheumatic Diseases
Musculoskeletal Diseases
Keywords: Low intensity pulsed ultrasound (LIPUS)
High intensity continuous ultrasound
Knee pain
Knee stiffness
Randomized controlled trial
Myanmar
Osteotron
Lead sponsor: Ministry of Health and Sports, Myanmar
Sponsor class: OTHER_GOV
Collaborators: name: University of Medicine 1 Yangon
name: Physical Medicine and Rehabilitation, Yangon General Hospital
First posted: 2020-05-28
Enrollment: 86
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of low intensity pulsed ultrasound with high intensity continuous ultrasound in knee osteoarthritis

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 8 weeks
measure: Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)
timeFrame: 8 weeks
measure: Percentage of participants with skin irritation
timeFrame: 8 weeks
measure: Percentage of participants with tingling
timeFrame: 8 weeks
measure: Percentage of participants with oedema
timeFrame: 8 weeks
measure: Percentage of participants with burns
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Department of Physical Medicine and Rehabilitation, Yangon General Hospital
Study officials:
affiliation: Physical Medicine and Rehabilitation Department, Yangon General Hospital
name: Khin Myo Hla, PhD M.B.,B.S
role: STUDY_CHAIR
affiliation: Physical Medicine and Rehabilitation Department, Yangon General Hospital
name: Soe Soe Khaing, PhD M.B.,B.S
role: STUDY_DIRECTOR
References: