Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial

Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample...
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Autor*in:	Zheng, Cui Hong [verfasserIn] Huang, Guang Ying Xu, Xiao Hu Wang, Ying Zhang, Ming Min Wang, Wei Jing, Xiang Hong Zhu, Bing

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2013

Schlagwörter:	Acupuncture Functional constipation Study protocol

Anmerkung:	© Zheng et al.; licensee BioMed Central Ltd. 2013

Übergeordnetes Werk:	Enthalten in: Trials - London : BioMed Central, 2000, 14(2013), 1 vom: 22. Okt.
Übergeordnetes Werk:	volume:14 ; year:2013 ; number:1 ; day:22 ; month:10

Links:	Volltext

DOI / URN:	10.1186/1745-6215-14-344

Katalog-ID:	SPR030064821

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520			\|a Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793.
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allfields	10.1186/1745-6215-14-344 doi (DE-627)SPR030064821 (SPR)1745-6215-14-344-e DE-627 ger DE-627 rakwb eng Zheng, Cui Hong verfasserin aut Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Zheng et al.; licensee BioMed Central Ltd. 2013 Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. Acupuncture (dpeaa)DE-He213 Functional constipation (dpeaa)DE-He213 Study protocol (dpeaa)DE-He213 Huang, Guang Ying aut Xu, Xiao Hu aut Wang, Ying aut Zhang, Ming Min aut Wang, Wei aut Jing, Xiang Hong aut Zhu, Bing aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 22. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:22 month:10 https://dx.doi.org/10.1186/1745-6215-14-344 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 14 2013 1 22 10
spelling	10.1186/1745-6215-14-344 doi (DE-627)SPR030064821 (SPR)1745-6215-14-344-e DE-627 ger DE-627 rakwb eng Zheng, Cui Hong verfasserin aut Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Zheng et al.; licensee BioMed Central Ltd. 2013 Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. Acupuncture (dpeaa)DE-He213 Functional constipation (dpeaa)DE-He213 Study protocol (dpeaa)DE-He213 Huang, Guang Ying aut Xu, Xiao Hu aut Wang, Ying aut Zhang, Ming Min aut Wang, Wei aut Jing, Xiang Hong aut Zhu, Bing aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 22. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:22 month:10 https://dx.doi.org/10.1186/1745-6215-14-344 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 14 2013 1 22 10
allfields_unstemmed	10.1186/1745-6215-14-344 doi (DE-627)SPR030064821 (SPR)1745-6215-14-344-e DE-627 ger DE-627 rakwb eng Zheng, Cui Hong verfasserin aut Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Zheng et al.; licensee BioMed Central Ltd. 2013 Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. Acupuncture (dpeaa)DE-He213 Functional constipation (dpeaa)DE-He213 Study protocol (dpeaa)DE-He213 Huang, Guang Ying aut Xu, Xiao Hu aut Wang, Ying aut Zhang, Ming Min aut Wang, Wei aut Jing, Xiang Hong aut Zhu, Bing aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 22. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:22 month:10 https://dx.doi.org/10.1186/1745-6215-14-344 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 14 2013 1 22 10
allfieldsGer	10.1186/1745-6215-14-344 doi (DE-627)SPR030064821 (SPR)1745-6215-14-344-e DE-627 ger DE-627 rakwb eng Zheng, Cui Hong verfasserin aut Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Zheng et al.; licensee BioMed Central Ltd. 2013 Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. Acupuncture (dpeaa)DE-He213 Functional constipation (dpeaa)DE-He213 Study protocol (dpeaa)DE-He213 Huang, Guang Ying aut Xu, Xiao Hu aut Wang, Ying aut Zhang, Ming Min aut Wang, Wei aut Jing, Xiang Hong aut Zhu, Bing aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 22. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:22 month:10 https://dx.doi.org/10.1186/1745-6215-14-344 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 14 2013 1 22 10
allfieldsSound	10.1186/1745-6215-14-344 doi (DE-627)SPR030064821 (SPR)1745-6215-14-344-e DE-627 ger DE-627 rakwb eng Zheng, Cui Hong verfasserin aut Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Zheng et al.; licensee BioMed Central Ltd. 2013 Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. Acupuncture (dpeaa)DE-He213 Functional constipation (dpeaa)DE-He213 Study protocol (dpeaa)DE-He213 Huang, Guang Ying aut Xu, Xiao Hu aut Wang, Ying aut Zhang, Ming Min aut Wang, Wei aut Jing, Xiang Hong aut Zhu, Bing aut Enthalten in Trials London : BioMed Central, 2000 14(2013), 1 vom: 22. Okt. (DE-627)326173552 (DE-600)2040523-6 1745-6215 nnns volume:14 year:2013 number:1 day:22 month:10 https://dx.doi.org/10.1186/1745-6215-14-344 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 14 2013 1 22 10
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author	Zheng, Cui Hong
spellingShingle	Zheng, Cui Hong misc Acupuncture misc Functional constipation misc Study protocol Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
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topic_title	Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial Acupuncture (dpeaa)DE-He213 Functional constipation (dpeaa)DE-He213 Study protocol (dpeaa)DE-He213
topic	misc Acupuncture misc Functional constipation misc Study protocol
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title	Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
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title_full	Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
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title_sort	electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
title_auth	Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
abstract	Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. © Zheng et al.; licensee BioMed Central Ltd. 2013
abstractGer	Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. © Zheng et al.; licensee BioMed Central Ltd. 2013
abstract_unstemmed	Background Functional constipation (FC) is highly prevalent in the general population of the world and has a substantial negative impact on the health-related quality of life of individuals. Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. Trial registration ClinicalTrials.gov ID: NCT01274793. © Zheng et al.; licensee BioMed Central Ltd. 2013
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title_short	Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
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Many clinical trials have indicated that acupuncture is effective in the treatment of FC. However, the sample sizes of these previous studies were too small. Furthermore, there are no reports investigating the relationship between the stimulation parameter and the therapeutic effect. We therefore designed a multicenter randomized controlled trial to address these problems and hopefully provide a more conclusive answer to these questions. Methods Participants will be included if they meet all of the following conditions: (1) diagnosed with functional constipation according to the Roman III standard; (2) aged between 18 and 65 years; (3) not taking any drugs that promote gastrointestinal movements at least during the 1 week prior to randomization; (3) willing to sign an informed consent form; (4) willing to return to the study site for their study visits. The participants will be randomly assigned to three groups in a 1:1:1 ratio: high current intensity group, low current intensity group, and mosapride citrate control group. The total study period is 9 weeks for each patient, 1 week for baseline, 4 weeks for treatment, and 4 weeks for follow-up. The primary outcome in this trial is the number of defecating events per week. The secondary outcomes will include the shape and properties of the stool, intensity of defecating difficulty, Patient Assessment of Constipation Quality of Life (PAC-QOL), MOS item Short Form health survey (SF-36), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS). Discussion This study will provide significant evidence for the application of acupuncture in FC and will identify a suitable stimulation parameter for treatment. 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Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial

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