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

Osteoarthritis Clinical Trial

Official title:

A Comparative Study of Low Intensity Pulsed Ultrasound (Osteotron IV) Versus High Intensity Continuous Ultrasound Therapy in Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04406337
• Other study ID #: PMR
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Ministry of Health and Sports, Myanmar
• Contact: Wunn Lei Thwe, M.B.,B.S
• Phone: +959786478599
• Email: wunnleithwe92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 30, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• Musculoskeletal Diseases
• Osteoarthritis
• Osteoarthritis, Knee
• Rheumatic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
Myanmar	Department of Physical Medicine and Rehabilitation, Yangon General Hospital	Yangon

Sponsors (3)

Lead Sponsor	Collaborator
Ministry of Health and Sports, Myanmar	Physical Medicine and Rehabilitation, Yangon General Hospital, University of Medicine (1), Yangon

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	8 weeks
Primary	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.	8 weeks
Primary	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).	8 weeks
Primary	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).	8 weeks
Primary	Percentage of participants with oedema	Oedema, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).	8 weeks
Primary	Percentage of participants with burns	Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).	8 weeks