To Investigate the Effect of PEMF for Knee OA Patients

NCT ID: NCT05442697

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2024-08-31

Brief 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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mild-to-moderate Knee OA PEMF Treatment

Patients with Mild-to-moderate Knee OA will accept PEMF treatment

Group Type: EXPERIMENTAL

PEMF treatment

Intervention Type: DEVICE

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.

Mild-to-moderate Knee OA Placebo Treatment

Patients with Mild-to-moderate Knee OA will accept placebo treatment

Group Type: PLACEBO_COMPARATOR

Placebo treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Pauline Lui

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Countries

Hong Kong

Other Identifiers

2022.242

Identifier Type: -

Identifier Source: org_study_id