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

Not Applicable

• Conditions: Rheumatic Diseases; Osteoarthritis, Knee; Osteoarthritis; Musculoskeletal Diseases
• Interventions: Device: Low intensity pulsed ultrasound; Device: High intensity continuous ultrasound

• Registration Number: NCT04406337
• Lead Sponsor: Ministry of Health and Sports, Myanmar

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.

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-05-23
• Study First Submitted QC: 2020-05-23
• Study First Posted: 2020-05-28
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-04
• Primary Completion: 2021-05-15
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low intensity pulsed ultrasound	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.
High intensity continuous ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	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)	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	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 tingling	8 weeks	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	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	8 weeks	Burns, a possible complication of ultrasound therapy, will be recorded as a dichotomous variable (i.e. present or absent).

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Yangon General Hospital; 🇲🇲 Yangon, Myanmar