Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial

Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Kang, Ha-Ra [verfasserIn] Jung, Chan-Yung Lee, Seung-Deok Kim, Kyung-Ho Kim, Kap-Sung Kim, Eun-Jung

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	Knee osteoarthritis Electrical moxibustion Moxibustion Randomized controlled trial

Anmerkung:	© The Author(s). 2018

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 19(2018), 1 vom: 05. März
Übergeordnetes Werk:	volume:19 ; year:2018 ; number:1 ; day:05 ; month:03

Links:	Volltext

DOI / URN:	10.1186/s13063-018-2514-x

Katalog-ID:	SPR030101328

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520			\|a Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017.
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allfields	10.1186/s13063-018-2514-x doi (DE-627)SPR030101328 (SPR)s13063-018-2514-x-e DE-627 ger DE-627 rakwb eng Kang, Ha-Ra verfasserin aut Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. Knee osteoarthritis (dpeaa)DE-He213 Electrical moxibustion (dpeaa)DE-He213 Moxibustion (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Jung, Chan-Yung aut Lee, Seung-Deok aut Kim, Kyung-Ho aut Kim, Kap-Sung aut Kim, Eun-Jung aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 05. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:05 month:03 https://dx.doi.org/10.1186/s13063-018-2514-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 05 03
spelling	10.1186/s13063-018-2514-x doi (DE-627)SPR030101328 (SPR)s13063-018-2514-x-e DE-627 ger DE-627 rakwb eng Kang, Ha-Ra verfasserin aut Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. Knee osteoarthritis (dpeaa)DE-He213 Electrical moxibustion (dpeaa)DE-He213 Moxibustion (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Jung, Chan-Yung aut Lee, Seung-Deok aut Kim, Kyung-Ho aut Kim, Kap-Sung aut Kim, Eun-Jung aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 05. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:05 month:03 https://dx.doi.org/10.1186/s13063-018-2514-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 05 03
allfields_unstemmed	10.1186/s13063-018-2514-x doi (DE-627)SPR030101328 (SPR)s13063-018-2514-x-e DE-627 ger DE-627 rakwb eng Kang, Ha-Ra verfasserin aut Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. Knee osteoarthritis (dpeaa)DE-He213 Electrical moxibustion (dpeaa)DE-He213 Moxibustion (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Jung, Chan-Yung aut Lee, Seung-Deok aut Kim, Kyung-Ho aut Kim, Kap-Sung aut Kim, Eun-Jung aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 05. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:05 month:03 https://dx.doi.org/10.1186/s13063-018-2514-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 05 03
allfieldsGer	10.1186/s13063-018-2514-x doi (DE-627)SPR030101328 (SPR)s13063-018-2514-x-e DE-627 ger DE-627 rakwb eng Kang, Ha-Ra verfasserin aut Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. Knee osteoarthritis (dpeaa)DE-He213 Electrical moxibustion (dpeaa)DE-He213 Moxibustion (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Jung, Chan-Yung aut Lee, Seung-Deok aut Kim, Kyung-Ho aut Kim, Kap-Sung aut Kim, Eun-Jung aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 05. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:05 month:03 https://dx.doi.org/10.1186/s13063-018-2514-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 05 03
allfieldsSound	10.1186/s13063-018-2514-x doi (DE-627)SPR030101328 (SPR)s13063-018-2514-x-e DE-627 ger DE-627 rakwb eng Kang, Ha-Ra verfasserin aut Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial 2018 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © The Author(s). 2018 Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. Knee osteoarthritis (dpeaa)DE-He213 Electrical moxibustion (dpeaa)DE-He213 Moxibustion (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213 Jung, Chan-Yung aut Lee, Seung-Deok aut Kim, Kyung-Ho aut Kim, Kap-Sung aut Kim, Eun-Jung aut Enthalten in Trials London : BioMed Central, 2000 19(2018), 1 vom: 05. März (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:19 year:2018 number:1 day:05 month:03 https://dx.doi.org/10.1186/s13063-018-2514-x kostenfrei Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2009 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2055 GBV_ILN_2111 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 19 2018 1 05 03
language	English
source	Enthalten in Trials 19(2018), 1 vom: 05. März volume:19 year:2018 number:1 day:05 month:03
sourceStr	Enthalten in Trials 19(2018), 1 vom: 05. März volume:19 year:2018 number:1 day:05 month:03
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Knee osteoarthritis Electrical moxibustion Moxibustion Randomized controlled trial
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container_title	Trials
authorswithroles_txt_mv	Kang, Ha-Ra @@aut@@ Jung, Chan-Yung @@aut@@ Lee, Seung-Deok @@aut@@ Kim, Kyung-Ho @@aut@@ Kim, Kap-Sung @@aut@@ Kim, Eun-Jung @@aut@@
publishDateDaySort_date	2018-03-05T00:00:00Z
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spellingShingle	Kang, Ha-Ra misc Knee osteoarthritis misc Electrical moxibustion misc Moxibustion misc Randomized controlled trial Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
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topic_title	Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial Knee osteoarthritis (dpeaa)DE-He213 Electrical moxibustion (dpeaa)DE-He213 Moxibustion (dpeaa)DE-He213 Randomized controlled trial (dpeaa)DE-He213
topic	misc Knee osteoarthritis misc Electrical moxibustion misc Moxibustion misc Randomized controlled trial
topic_unstemmed	misc Knee osteoarthritis misc Electrical moxibustion misc Moxibustion misc Randomized controlled trial
topic_browse	misc Knee osteoarthritis misc Electrical moxibustion misc Moxibustion misc Randomized controlled trial
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title	Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
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title_full	Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
author_sort	Kang, Ha-Ra
journal	Trials
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author_browse	Kang, Ha-Ra Jung, Chan-Yung Lee, Seung-Deok Kim, Kyung-Ho Kim, Kap-Sung Kim, Eun-Jung
container_volume	19
format_se	Elektronische Aufsätze
author-letter	Kang, Ha-Ra
doi_str_mv	10.1186/s13063-018-2514-x
title_sort	efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
title_auth	Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
abstract	Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. © The Author(s). 2018
abstractGer	Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. © The Author(s). 2018
abstract_unstemmed	Background Knee osteoarthritis (KOA) is a significant health issue because it causes pain and functional limitation. Many studies have reported that moxibustion, a treatment in traditional Korean medicine, is effective in treating KOA. However, conventional moxibustion produces smoke, harmful gases, and odors that can adversely affect the eyes, skin, and throat. It is also difficult to control the intensity of stimulation in conventional moxibustion. An electrical moxibustion device was developed to circumvent these problems, but there are few studies of that device. We will evaluate the efficacy and safety of electrical moxibustion as a treatment for KOA, and compare it with traditional indirect moxibustion and usual care. Methods This is a multicenter, randomized, open, assessor-blinded, parallel-group clinical trial. A total of 138 eligible participants with KOA will be randomly allocated into three groups (electrical moxibustion, traditional indirect moxibustion, or usual care) with a 1:1:1 ratio. Participants in each moxibustion group will receive 12 sessions of moxibustion treatment at 6 acupoints (ST36, ST35, ST34, SP9, EX-LE4, SP10) plus up to 2 points of “ashi”, if needed, over a period of 6 weeks (2 sessions per week). A specifically designed device that provides thermal stimulation using electrical energy will be used for the electrical moxibustion group. Participants in the usual care group will receive usual treatment and self-care. The primary outcome measure is change in pain on a numerical rating scale (NRS) from week 1 to week 6. The secondary outcome measures are pain assessed on a visual analog scale (VAS), the Korean version of the Western Ontario and McMaster osteoarthritis index (K-WOMAC), patient global assessment (PGA), and the European quality of life five dimension five level scale (EQ-5D-5 L). Safety will be assessed by monitoring adverse events at each visit. Follow-up measurements will be performed at 12 weeks after baseline measurements. Discussion This trial will provide evidence on the efficacy and safety of electrical moxibustion as a treatment for KOA. Trial registration ClinicalTrials.gov, NCT03287570. Registered on 19 September 2017. © The Author(s). 2018
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title_short	Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
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author2	Jung, Chan-Yung Lee, Seung-Deok Kim, Kyung-Ho Kim, Kap-Sung Kim, Eun-Jung
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