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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04406337
Enrollment
86
Registered
2020-05-28
Start date
2019-06-01
Completion date
2021-06-30
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Musculoskeletal Diseases, Osteoarthritis, Osteoarthritis, Knee, Rheumatic Diseases

Keywords

Low intensity pulsed ultrasound (LIPUS), High intensity continuous ultrasound, Knee pain, Knee stiffness, Randomized controlled trial, Myanmar, Osteotron

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.

Interventions

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.

DEVICEHigh intensity continuous ultrasound

High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm\^2 and 100% duty cycle.

Sponsors

University of Medicine 1 Yangon
CollaboratorOTHER
Physical Medicine and Rehabilitation, Yangon General Hospital
CollaboratorUNKNOWN
Ministry of Health and Sports, Myanmar
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual Analog Scale (VAS)8 weeksIt 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.
Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)8 weeksThis 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.
Percentage of participants with skin irritation8 weeksSkin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with tingling8 weeksTingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with oedema8 weeksOedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with burns8 weeksBurns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).

Countries

Burma

Contacts

Primary ContactWunn Lei Thwe, M.B.,B.S
wunnleithwe92@gmail.com+959786478599

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026