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Status unknownNCT04406337Updated Jun 4, 2020

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

An interventional study of Low intensity pulsed ultrasound and High intensity continuous ultrasound in Osteoarthritis, Knee, Osteoarthritis and Rheumatic Diseases, sponsored by Ministry of Health and Sports, Myanmar. Status unknown at 1 site in Myanmar. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-04.

Sponsored by Ministry of Health and Sports, Myanmar · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jun 2019, registered May 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 86 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Ministry of Health and Sports, Myanmar is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with knee pain (VAS 3 to 6)
  • Kellgren and Lawrence grade 2 and 3 in X' ray knee joint

Exclusion criteria

Exclusion Criteria:

  • Rheumatoid arthritis, Gouty arthritis, Spondyloarthropathies, Metabolic arthropathies
  • Infection of knee joint
  • Tumor of knee joint
  • History of 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
86 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Low intensity pulsed ultrasound

  • Active comparator
    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.

    Device: High intensity continuous ultrasound

Interventions

  • DeviceLow 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.

    Also known as: Osteotron IV

  • 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.

    Also known as: US 50 (Medical Italia)

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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).

    Time frame: 8 weeks

  4. 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).

    Time frame: 8 weeks

  5. Percentage of participants with oedema

    Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).

    Time frame: 8 weeks

  6. Percentage of participants with burns

    Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).

    Time frame: 8 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Physical Medicine and Rehabilitation, Yangon General Hospital
    Yangon, Myanmar
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04406337
Lead sponsor
Ministry of Health and Sports, Myanmar
Collaborators
University of Medicine 1 Yangon, Physical Medicine and Rehabilitation, Yangon General Hospital
Responsible party
Wunn Lei Thwe (Principal Investigator, Ministry of Health and Sports, Myanmar) — Principal investigator
First posted
May 28, 2020
Start date
Jun 1, 2019
Primary completion
May 15, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Jun 4, 2020

Study contacts

Wunn Lei Thwe, M.B.,B.S
Contact
wunnleithwe92@gmail.com
+959786478599
Khin Myo Hla, PhD M.B.,B.S
study chair · Physical Medicine and Rehabilitation Department, Yangon General Hospital
Soe Soe Khaing, PhD M.B.,B.S
study director · Physical Medicine and Rehabilitation Department, Yangon General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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