Evaluering af effekten af pulserende elektromagnetisk felt på inflammatorisk knæartrose
Dobbeltblind, randomiseret kontrolleret pilotundersøgelse for at vurdere effekten af pulserende elektromagnetisk felt på inflammatorisk knæartrose
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Knee osteoarthritis (KOA) is a leading cause of pain and disability, posing a significant socioeconomic burden. Current treatments often focus on pain relief with safety concerns, and no disease-modifying drugs are available. Pulsed electromagnetic field (PEMF) therapy is a non-invasive and safe physical modality with potential anti-inflammatory and analgesic effects. However, existing evidence for its efficacy in KOA is inconsistent, likely because KOA is a heterogeneous disease, and previous studies have not targeted specific subtypes. The inflammatory KOA subtype, identifiable via MRI, is the most prevalent and represents a critical target for precise intervention.
Methods This study is a double-blind, randomized, placebo-controlled pilot trial. Fifty patients with inflammatory KOA, confirmed by the presence of effusion-synovitis on MRI will be recruited. Participants will be randomly assigned to receive either active PEMF therapy at a specific, optimized parameter or sham treatment twice a week for 8 weeks. The primary outcome is the change in the WOMAC pain score at 3 months after treatment. Secondary outcomes include knee function and stiffness (WOMAC), quality of life (SF-12), and quantitatively assessed structural changes on MRI (e.g., effusion synovitis volume).
Expected Results The investigators anticipate that the group receiving active PEMF therapy will show a statistically significant and clinically important greater reduction in WOMAC pain scores compared to the sham treatment group.The investigators also expect to observe improvements in secondary outcomes, including better knee function and reduced signs of inflammation on MRI in the treatment group.
Conclusion This will be the first clinical trial to evaluate PEMF therapy specifically for the inflammatory subtype of KOA. Positive findings will provide crucial evidence for a novel, non-invasive, and precise therapeutic strategy for KOA management. This has the potential to improve patient care, alleviate the disease burden, and reduce healthcare costs.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ye LI
- Telefonnummer: +85227664842
- E-mail: ye-julie.li@polyu.edu.hk
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: PEMF Therapy Intervention Patients with inflammatory KOA receive active PEMF therapy with optimized
Active Pulsed Electromagnetic Field (PEMF) Therapy Active PEMF therapy at specific optimized parameters, administered twice a week for 8 weeks |
Assigned Interventions |
|
Placebo komparator: : Sham PEMF Treatment Patients with inflammatory KOA receive sham PEMF treatment (no effective elect
Sham Pulsed Electromagnetic Field (PEMF) Treatments treatment (matching device without active electromagnetic field) administered twice a week for 8 weeks |
Matching device without active electromagnetic field) administered twice a week for 8 weeks |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility outcome：adherence
Tidsramme: 3 months after treatment
|
Adherence will be calculated as the actual number of completed exercise days relative to the prescribed total. |
3 months after treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Serum Levels of Inflammatory Markers and Adipokines
Tidsramme: Baseline; 3 months after treatment
|
The serum concentrations of the following biomarker: Interleukin-6 (picograms per milliliter, pg/mL). |
Baseline; 3 months after treatment
|
|
Western Ontario and McMaster Universities (WOMAC) pain score
Tidsramme: Baseline; 3 months after treatment
|
The primary outcome will be the Western Ontario and McMaster Universities (WOMAC) pain score. This scale consists of 5 questions assessing knee joint pain, each scored on a 5-point Likert scale (0 = no pain, 4 = extreme pain). The total score of the pain subscale ranges from 0 to 20, with higher scores indicating a more severe degree of pain. |
Baseline; 3 months after treatment
|
|
Measurement of biomarkers on MRI images of the knee
Tidsramme: Baseline; 3 months after treatment
|
Cartilage defects (grades 0-4). A higher score indicates more severe pathology. |
Baseline; 3 months after treatment
|
|
Ultrousound measurement
Tidsramme: Baseline, 1and 3 months after treatment
|
The severity of the following pathologies will be assessed via ultrasonography using semi-quantitative scoring systems: Synovitis(0-3), Osteophytes(0-3), Cartilage damage(0-3). A higher score indicates more severe pathology. |
Baseline, 1and 3 months after treatment
|
|
Six-Minute Walk Distance
Tidsramme: Baseline;3 months after treatment
|
The total distance walked during the Six-Minute Walk Test, measured in meters (m). |
Baseline;3 months after treatment
|
|
30-Second Chair Stand Test Repetitions
Tidsramme: Baseline; 3 months after treatment]
|
The maximum number of repetitions of rising fully from a standard-height chair without using arms, sitting back down, and fully rising again, completed within 30 seconds. |
Baseline; 3 months after treatment]
|
|
Timed Up and Go Test Time
Tidsramme: Baseline; 3 months after treatment
|
The time required to complete the Timed Up and Go Test (rising from a chair, walking 3 meters, turning around, walking back, and sitting down), measured in seconds (s). |
Baseline; 3 months after treatment
|
|
12-Item Short Form Health Survey Score
Tidsramme: Baseline; 3 months after treatment
|
Assesses overall health-related quality of life. This scale comprises 12 items, which are aggregated into summary scores for physical and mental health. The scores are transformed to a range of 0 to 100, with higher scores indicating better health status. |
Baseline; 3 months after treatment
|
|
Patient Health Questionnaire-9 (PHQ-9) Score
Tidsramme: Baseline; 3 months after treatment
|
Assesses the severity of depressive symptoms. This scale consists of 9 items, each scored from 0 to 3. The total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms. |
Baseline; 3 months after treatment
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score
Tidsramme: Baseline; 3 months after treatment
|
Assesses the severity of knee stiffness. This subscale contains 2 items, each rated on a 5-point Likert scale (0 = none, 4 = extreme). The total subscale score ranges from 0 to 8, with higher scores indicating worse stiffness. |
Baseline; 3 months after treatment
|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score
Tidsramme: Baseline; 3 months after treatment
|
Assesses knee-related difficulty in performing daily activities. This subscale contains 17 items, each rated on a 5-point Likert scale (0 = none, 4 = extreme). The total subscale score ranges from 0 to 68, with higher scores indicating worse physical function. |
Baseline; 3 months after treatment
|
|
Serum Levels of Interleukin-6
Tidsramme: Baseline; 3 months after treatment
|
The serum concentrations of the following biomarkers will be measured: Interleukin-6 (picograms per milliliter, pg/mL) |
Baseline; 3 months after treatment
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HESEARS20231113002
- 12231596 (Andet bevillings-/finansieringsnummer: Health and Medical Research Fund)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .