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

June 1, 2020 updated by: Wunn Lei Thwe, Ministry of Health and Sports, Myanmar

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Myanmar
      • Yangon, Myanmar
        • Recruiting
        • Department of Physical Medicine and Rehabilitation, Yangon General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Osteotron IV
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
High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.
Other Names:
  • US 50 (Medical Italia)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
8 weeks
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.
8 weeks
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).
8 weeks
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).
8 weeks
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).
8 weeks
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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ministry of Health and Sports, Myanmar

Collaborators

University of Medicine (1), Yangon
Physical Medicine and Rehabilitation, Yangon General Hospital

Investigators

  • Study Chair: Khin Myo Hla, PhD M.B.,B.S, Physical Medicine and Rehabilitation Department, Yangon General Hospital
  • Study Director: Soe Soe Khaing, PhD M.B.,B.S, Physical Medicine and Rehabilitation Department, Yangon General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

May 15, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

May 23, 2020

First Submitted That Met QC Criteria

May 23, 2020

First Posted (Actual)

May 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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