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

NCT ID: NCT04406337

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-06-30

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.

Conditions

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Osteoarthritis, Knee Osteoarthritis Rheumatic Diseases Musculoskeletal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low intensity pulsed ultrasound

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.

Group Type EXPERIMENTAL

Low intensity pulsed ultrasound

Intervention Type DEVICE

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.

High intensity continuous ultrasound

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.

Group Type ACTIVE_COMPARATOR

High intensity continuous ultrasound

Intervention Type DEVICE

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

Interventions

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Low intensity pulsed ultrasound

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.

Intervention Type DEVICE

High 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.

Intervention Type DEVICE

Other Intervention Names

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Osteotron IV US 50 (Medical Italia)

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine 1 Yangon

OTHER

Sponsor Role collaborator

Physical Medicine and Rehabilitation, Yangon General Hospital

UNKNOWN

Sponsor Role collaborator

Ministry of Health and Sports, Myanmar

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wunn Lei Thwe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khin Myo Hla, PhD M.B.,B.S

Role: STUDY_CHAIR

Physical Medicine and Rehabilitation Department, Yangon General Hospital

Soe Soe Khaing, PhD M.B.,B.S

Role: STUDY_DIRECTOR

Physical Medicine and Rehabilitation Department, Yangon General Hospital

Locations

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Department of Physical Medicine and Rehabilitation, Yangon General Hospital

Yangon, , Burma

Site Status RECRUITING

Countries

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Burma

Central Contacts

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Wunn Lei Thwe, M.B.,B.S

Role: CONTACT

+959786478599

Facility Contacts

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Wunn Lei Thwe, M.B.,B.S

Role: primary

+959786478599

Other Identifiers

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PMR

Identifier Type: -

Identifier Source: org_study_id

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