Osteoarthritis, KneeNCT04406337
Low Intensity Pulsed Ultrasound Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
A study testing Low intensity pulsed ultrasound and High intensity continuous ultrasound in people with Osteoarthritis, Knee and Osteoarthritis, run by Ministry of Health and Sports, Myanmar at 1 site in Burma.
Trial summary
To compare the effects of low intensity pulsed ultrasound with high intensity continuous ultrasound in knee osteoarthritis Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Rheumatic Diseases
- What is being tested?
- Low intensity pulsed ultrasound and High intensity continuous ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteBurma
- Study dates
- 1 Jun 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with knee pain (VAS 3 to 6)
- Kellgren and Lawrence grade 2 and 3 in X' ray knee joint
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Burma1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation, Yangon General Hospital
Yangon
Wunn Lei Thwe, M.B.,B.S, +959786478599, wunnleithwe92@gmail.com
About this study
Official title: A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
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.
- Being tested
- Low intensity pulsed ultrasound, High intensity continuous ultrasound
- Keywords
- Low intensity pulsed ultrasound (LIPUS), High intensity continuous ultrasound, Knee pain, Knee stiffness, Randomized controlled trial, Myanmar, Osteotron
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Rheumatic Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low intensity pulsed ultrasoundDevice
Also called Osteotron IV
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 ultrasoundDevice
Also called US 50 (Medical Italia)
High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity pulsed ultrasound | Experimental | 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. Receives: Device: Low intensity pulsed ultrasound |
| High intensity continuous ultrasound | Active comparator | 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. Receives: Device: High intensity continuous ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Jun 2019
- Primary completion15 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Sports, Myanmar
- Sponsor type
- Other government
- Collaborators
- University of Medicine 1 Yangon, Physical Medicine and Rehabilitation, Yangon General Hospital
- Responsible party
- Principal investigator, Wunn Lei Thwe, Ministry of Health and Sports, Myanmar
- Investigators
- Khin Myo Hla, PhD M.B.,B.S, Study chair, Physical Medicine and Rehabilitation Department, Yangon General HospitalSoe Soe Khaing, PhD M.B.,B.S, Study director, Physical Medicine and Rehabilitation Department, Yangon General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406337
- Sponsor's protocol ID
- PMR
- Status last verified
- Jun 2020
- First submitted
- 23 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04406337
- Acronym / sponsor ID
- PMR
- Keywords
- Low intensity pulsed ultrasound (LIPUS), High intensity continuous ultrasound, Knee pain, Knee stiffness, Randomized controlled trial, Myanmar, Osteotron
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Ministry of Health and Sports, MyanmarOther government
- Collaborators
- University of Medicine 1 Yangon, Physical Medicine and Rehabilitation, Yangon General Hospital
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low intensity pulsed ultrasound | Experimental | Device: Low intensity pulsed ultrasoundParticipants 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. |
| High intensity continuous ultrasound | Active comparator | Device: High intensity continuous ultrasoundParticipants 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with knee pain (VAS 3 to 6)
- Kellgren and Lawrence grade 2 and 3 in X' ray knee joint
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low intensity pulsed ultrasoundAlso: Osteotron IVLow 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. | Device | Low intensity pulsed ultrasound |
| High intensity continuous ultrasoundAlso: US 50 (Medical Italia)High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle. | Device | High intensity continuous ultrasound |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 8 weeks
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".
Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)
Time frame: 8 weeks
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.
Percentage of participants with skin irritation
Time frame: 8 weeks
Skin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with tingling
Time frame: 8 weeks
Tingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with oedema
Time frame: 8 weeks
Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with burns
Time frame: 8 weeks
Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low intensity pulsed ultrasound and High intensity continuous ultrasound in people with Osteoarthritis, Knee and Osteoarthritis, run by Ministry of Health and Sports, Myanmar at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wunn Lei Thwe, M.B.,B.S (+959786478599, wunnleithwe92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.