To Investigate the Effect of PEMF for Knee OA Patients

Knee Osteoarthritis Clinical Trial

Official title:

Pulsed Electromagnetic Fields (PEMF) in Knee Osteoarthritis: a Double-blind, Placebo-controlled, Randomised Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05442697
• Other study ID #: 2022.242
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Patrick Shu-hang YUNG
• Phone: +852 3505 2728
• Email: patrickyung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (>40% in the elderly suffered from knee OA). Knee osteoarthritis (OA) is the most common form of arthritis, and around 2 million population worldwide suffer from this disorder. OA is a debilitating progressive disease with typical pathological progress such as cartilage degeneration, inflammation, joint width narrowing and developing osteophytes. The main system of knee OA is acute pain leading to loss of mobility. There is no effective treatment to cure or stop the progression of OA. For now, the main method is to alleviate the pain and symptoms, including control weight, exercise, physical treatment and intake of NSAIDs/ paracetamol. Pulsed electromagnetic field (PEMF) treatment has shown to enhance cell activity related to tissue healing, delay bone and cartilage degeneration and give beneficial effects such as relief in pain, anti-inflammation and reduce swelling. In clinic, PEMF treatment has been reported to be safe, and has been proved to reduce the usage of NSAIDs and pain in patients with knee OA. This study aims to investigate the effectiveness of PEMF therapy on for patients with knee OA, including delay the degeneration of articular cartilage, restore the subchondral bone, reduce knee pain and symptoms as well as improve the muscle strength and functions, and even improving the quality of life. Based on the aim of this study, older adult patients (aged 50 or above) with a unilateral knee OA with Kellgren-Lawrence (KL) grade 2-3 by X-ray, visual analogue scale (VAS) >4, no acute knee injuries and muscle strain in past 3 months, and no alleviation of symptoms after ≥ 3 months of nonsurgical treatment. To estimate the improvement of patients the following assessments will be performed, including patient-reported outcomes, muscle strength and physical function assessments, serum evaluation, and imaging examination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Primary osteoarthritis of knee
• VAS score = 4
• Grade 2 and 3 osteoarthritis (Kellgren-Lawrence criteria)
• No alleviation of symptoms after = 3 months of nonsurgical treatment
• No acute knee injuries in both limbs in the past 3 months
• No muscle strain in both limbs in the past 3 months
• Voluntarily agreed to participate and signed the informed consent form

Exclusion Criteria:

• Skin diseases around the target knee joint
• Severe pain in other areas affects the diagnosis of function and symptoms of knee joints
• Injection in target knee within 3 months of enrolment
• Inflammatory joint disease (e.g., rheumatic inflammation)
• Infectious joint disease (e.g., septic arthritis)
• Pregnant or breastfeeding
• Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
• Physical inability to undertake testing procedures
• Inability to give informed consent

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• PEMF treatment
Patient will receive a PEMF treatment. The involved leg will be exposed to PEMF for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of PEMF exposure in total.
• Placebo treatment
Patient will receive a placebo treatment. The involved leg will be exposed to placebo treatment for 30 minutes per session, and the treatment regime will run three times a week for eight weeks, summing up 24 sessions of placebo exposure in total.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type II collagen-specific biomarker change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type II collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 8 weeks
Primary	Type II collagen-specific biomarker change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type II collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 6 months
Primary	Type II collagen-specific biomarker change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type II collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 12 months
Primary	Type VI collagen-specific biomarker change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type VI collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 8 weeks
Primary	Type VI collagen-specific biomarker change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type VI collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 6 months
Primary	Type VI collagen-specific biomarker change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, type VI collagen-specific biomarker, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 12 months
Primary	Cartilage oligomeric matrix protein change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, cartilage oligomeric matrix protein, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 8 weeks
Primary	Cartilage oligomeric matrix protein change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, cartilage oligomeric matrix protein, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 6 months
Primary	Cartilage oligomeric matrix protein change	The serum will be prepared by centrifugation of blood (10ml), aliquoted and kept in a -80° freezer until use. Biomarkers of cartilage breakdown, cartilage oligomeric matrix protein, will be measured by enzyme-linked immunosorbent assays (ELISA).	Change from baseline cartilage turnover at 12 months
Primary	Cartilage thickness change-US	Ultrasound (US) offers an alternative quantitative measurement of cartilage thickness which is more available and more cost-effective compared to MRI. The US will be performed on both knees, the L18-5 MHz linear transducer will be positioned in the axial plane on the suprapatellar region. In order to image the femoral cartilage, all subjects will be placed in the supine position with maximum knee flexion. In this study, the US will be used to assess cartilage thickness of the tibiofemoral joint.	Change from baseline cartilage thickness at 8 weeks
Primary	Cartilage thickness change-US	Ultrasound (US) offers an alternative quantitative measurement of cartilage thickness which is more available and more cost-effective compared to MRI. The US will be performed on both knees, the L18-5 MHz linear transducer will be positioned in the axial plane on the suprapatellar region. In order to image the femoral cartilage, all subjects will be placed in the supine position with maximum knee flexion. In this study, the US will be used to assess cartilage thickness of the tibiofemoral joint.	Change from baseline cartilage thickness at 6 months
Primary	Cartilage thickness change-US	Ultrasound (US) offers an alternative quantitative measurement of cartilage thickness which is more available and more cost-effective compared to MRI. The US will be performed on both knees, the L18-5 MHz linear transducer will be positioned in the axial plane on the suprapatellar region. In order to image the femoral cartilage, all subjects will be placed in the supine position with maximum knee flexion. In this study, the US will be used to assess cartilage thickness of the tibiofemoral joint.	Change from baseline cartilage thickness at 12 months