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Clinical Trials/NCT04406337
NCT04406337
Unknown
N/A

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

Ministry of Health and Sports, Myanmar1 site in 1 country86 target enrollmentJune 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis
Sponsor
Ministry of Health and Sports, Myanmar
Enrollment
86
Locations
1
Primary Endpoint
Percentage of participants with tingling
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ministry of Health and Sports, Myanmar
Responsible Party
Principal Investigator
Principal Investigator

Wunn Lei Thwe

Principal Investigator

Ministry of Health and Sports, Myanmar

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

Outcomes

Primary Outcomes

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).

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 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).

Study Sites (1)

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