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

Primary Purpose

Osteoarthritis, Knee, Osteoarthritis, Rheumatic Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Myanmar
Study Type
Interventional
Intervention
Low intensity pulsed ultrasound
High intensity continuous ultrasound
Sponsored by
Ministry of Health and Sports, Myanmar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Low intensity pulsed ultrasound (LIPUS), High intensity continuous ultrasound, Knee pain, Knee stiffness, Randomized controlled trial, Myanmar, Osteotron

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Yangon General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low intensity pulsed ultrasound

High intensity continuous ultrasound

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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".
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.
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).
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).
Percentage of participants with oedema
Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Percentage of participants with burns
Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).

Secondary Outcome Measures

Full Information

First Posted
May 23, 2020
Last Updated
June 1, 2020
Sponsor
Ministry of Health and Sports, Myanmar
Collaborators
University of Medicine (1), Yangon, Physical Medicine and Rehabilitation, Yangon General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04406337
Brief Title
Low Intensity Pulsed Ultrasound Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
Official Title
A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 15, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health and Sports, Myanmar
Collaborators
University of Medicine (1), Yangon, Physical Medicine and Rehabilitation, Yangon General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low intensity pulsed ultrasound
Arm Type
Experimental
Arm Description
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.
Arm Title
High intensity continuous ultrasound
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low intensity pulsed ultrasound
Other Intervention Name(s)
Osteotron IV
Intervention Description
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
Intervention Name(s)
High intensity continuous ultrasound
Other Intervention Name(s)
US 50 (Medical Italia)
Intervention Description
High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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
Title
Western Ontario McMaster University Osteoarthritis Index Inventory (WOMAC)
Description
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
Title
Percentage of participants with skin irritation
Description
Skin irritation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Time Frame
8 weeks
Title
Percentage of participants with tingling
Description
Tingling sensation, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Time Frame
8 weeks
Title
Percentage of participants with oedema
Description
Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Time Frame
8 weeks
Title
Percentage of participants with burns
Description
Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wunn Lei Thwe, M.B.,B.S
Phone
+959786478599
Email
wunnleithwe92@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khin Myo Hla, PhD M.B.,B.S
Organizational Affiliation
Physical Medicine and Rehabilitation Department, Yangon General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Soe Soe Khaing, PhD M.B.,B.S
Organizational Affiliation
Physical Medicine and Rehabilitation Department, Yangon General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Yangon General Hospital
City
Yangon
Country
Myanmar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wunn Lei Thwe, M.B.,B.S
Phone
+959786478599
Email
wunnleithwe92@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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