Clinical trial NCT05442697: To Investigate the Effect of PEMF for Knee OA Patients
Official title: Pulsed Electromagnetic Fields (PEMF) in Knee Osteoarthritis: a Double-blind, Placebo-controlled, Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Muscle power
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Secondary outcomes:
measure: Sonography
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
measure: Dual-energy X-ray absorptiometry (DXA)
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
measure: 6-meter timed walking test
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
measure: 30-second chair stand test
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
measure: X-ray Radiography
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), and 14 months (12 months post-treatment)
measure: WOMAC
timeFrame: Baseline (pre-treatment), 2 months (immediate post-treatment), 8 months (6 months post-treatment), and 14 months (12 months post-treatment)
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: