Cargando…
Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial
Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic ev...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4795538/ https://www.ncbi.nlm.nih.gov/pubmed/26705327 http://dx.doi.org/10.1093/rheumatology/kev426 |
_version_ | 1782421617547149312 |
---|---|
author | Bagnato, Gian Luca Miceli, Giovanni Marino, Natale Sciortino, Davide Bagnato, Gian Filippo |
author_facet | Bagnato, Gian Luca Miceli, Giovanni Marino, Natale Sciortino, Davide Bagnato, Gian Filippo |
author_sort | Bagnato, Gian Luca |
collection | PubMed |
description | Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 |
format | Online Article Text |
id | pubmed-4795538 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-47955382016-03-21 Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial Bagnato, Gian Luca Miceli, Giovanni Marino, Natale Sciortino, Davide Bagnato, Gian Filippo Rheumatology (Oxford) Clinical Science Objectives. This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients. Methods. In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics. Results. Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of −0.73 (95% CI − 1.24 to − 0.19) was seen in VAS score, while the effect size was −0.34 (95% CI − 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected. Conclusion. These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted. Trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT01877278 Oxford University Press 2016-04 2015-12-24 /pmc/articles/PMC4795538/ /pubmed/26705327 http://dx.doi.org/10.1093/rheumatology/kev426 Text en © The Author 2015. Published by Oxford University Press on behalf of the British Society for Rheumatology. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com |
spellingShingle | Clinical Science Bagnato, Gian Luca Miceli, Giovanni Marino, Natale Sciortino, Davide Bagnato, Gian Filippo Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
title | Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
title_full | Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
title_fullStr | Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
title_full_unstemmed | Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
title_short | Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
title_sort | pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial |
topic | Clinical Science |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4795538/ https://www.ncbi.nlm.nih.gov/pubmed/26705327 http://dx.doi.org/10.1093/rheumatology/kev426 |
work_keys_str_mv | AT bagnatogianluca pulsedelectromagneticfieldsinkneeosteoarthritisadoubleblindplacebocontrolledrandomizedclinicaltrial AT miceligiovanni pulsedelectromagneticfieldsinkneeosteoarthritisadoubleblindplacebocontrolledrandomizedclinicaltrial AT marinonatale pulsedelectromagneticfieldsinkneeosteoarthritisadoubleblindplacebocontrolledrandomizedclinicaltrial AT sciortinodavide pulsedelectromagneticfieldsinkneeosteoarthritisadoubleblindplacebocontrolledrandomizedclinicaltrial AT bagnatogianfilippo pulsedelectromagneticfieldsinkneeosteoarthritisadoubleblindplacebocontrolledrandomizedclinicaltrial |