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

NCT04406337 | Unknown

• 1 other identifier: PMR
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

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.

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.

Device: High intensity continuous ultrasound

Interventions

Low intensity pulsed ultrasound DEVICE

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.

Also known as: Osteotron IV

Low intensity pulsed ultrasound

High intensity continuous ultrasound DEVICE

High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm\^2 and 100% duty cycle.

Also known as: US 50 (Medical Italia)

High intensity continuous ultrasound

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with knee pain (VAS 3 to 6)
• Kellgren and Lawrence grade 2 and 3 in X' ray knee joint

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health and Sports, Myanmar: lead
• University of Medicine 1 Yangon: collaborator
• Physical Medicine and Rehabilitation, Yangon General Hospital: collaborator

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Yangon General Hospital

Yangon, Burma

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Rheumatic Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Khin Myo Hla, PhD M.B.,B.S

  Physical Medicine and Rehabilitation Department, Yangon General Hospital

  STUDY CHAIR

• Soe Soe Khaing, PhD M.B.,B.S

  Physical Medicine and Rehabilitation Department, Yangon General Hospital

  STUDY DIRECTOR

Central Study Contacts

Wunn Lei Thwe, M.B.,B.S

CONTACT

+959786478599; wunnleithwe92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 28, 2020
• Study Start: June 1, 2019
• Primary Completion: May 15, 2021
• Study Completion: June 30, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)