NCT07443462

Brief Summary

This study will assess the efficacy of pulsed electromagnetic field therapy in patients with inflammatory knee osteoarthritis confirmed by MRI-detected effusion-synovitis. Fifty participants will be randomly allocated into two groups. One group will receive active PEMF therapy at a specific optimized parameter twice a week for 8 weeks, while the other group will receive sham treatment using the same device without PEMF signal. The primary outcome is the change in WOMAC pain score, and secondary outcomes include knee function, stiffness, quality of life, and MRI-quantified structural changes.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
31mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

December 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 2, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

December 10, 2025

Last Update Submit

February 27, 2026

Conditions

Knee Osteoarthritis (Knee OA)

Keywords

Pulsed electromagnetic field therapyKnee osteoarthritisInflammatory subtype

Outcome Measures

Primary Outcomes (1)

  • Feasibility outcome：adherence

    Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total.

    3 months after treatment

Secondary Outcomes (12)

  • Serum Levels of Inflammatory Markers and Adipokines

    Baseline; 3 months after treatment

  • Western Ontario and McMaster Universities (WOMAC) pain score

    Baseline; 3 months after treatment

  • Measurement of biomarkers on MRI images of the knee

    Baseline; 3 months after treatment

  • Ultrousound measurement

    Baseline, 1and 3 months after treatment

  • Six-Minute Walk Distance

    Baseline;3 months after treatment

  • +7 more secondary outcomes

Study Arms (2)

PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized

EXPERIMENTAL

Active Pulsed Electromagnetic Field (PEMF) Therapy Active PEMF therapy at specific optimized parameters, administered twice a week for 8 weeks

Device: Pulsed Electromagnetic Field (PEMF) Therapy

: Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect

PLACEBO COMPARATOR

Sham Pulsed Electromagnetic Field (PEMF) Treatments treatment (matching device without active electromagnetic field) administered twice a week for 8 weeks

Device: Sham Pulsed Electromagnetic Field (PEMF) Treatments

Interventions

Pulsed Electromagnetic Field (PEMF) TherapyDEVICE

Assigned Interventions

PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized
Sham Pulsed Electromagnetic Field (PEMF) TreatmentsDEVICE

Matching device without active electromagnetic field) administered twice a week for 8 weeks

: Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Knee visual analogue scale (VAS) pain of \<40 mm (0-100 mm)
  • Effusion-synovitis or Hoffa synovitis MRI semi-quantitative score of ≥2 (used to determine inflammatory subtype KOA);
  • Kellgren-Lawrence (KL) grade II and III
  • Patients can listen, speak, read, and understand Chinese; understand the pilot study's requirements and are willing to cooperate with the investigator in conducting the pilot study
  • Willing and able to provide written informed consent

You may not qualify if:

  • Other inflammatory arthritis (e.g., gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, and seronegative spondyloarthropathy) and systemic lupus erythematosus.
  • Participants with usual KOA interventions/ treatments
  • History of knee trauma
  • Contraindications to MRI
  • Administration of intra-articular, intramuscular, and oral glucocorticoids within the last 4
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Ye LI

CONTACT

+85227664842ye-julie.li@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2025

First Posted

March 2, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share