Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial

Publication Date:
2018-02-28
Publisher:
BMJ Publishing
Electronic ISSN:
2044-6055
Topics:
Medicine
Keywords:
Open access, Complementary medicine
Published by:
_version_ 1836398813423599616
autor Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
beschreibung Introduction Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). Methods and analysis This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. Ethics and dissemination Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. Trial registration number ChiCTR-IOR-16010283; Pre-results.
citation_standardnr 6176839
datenlieferant ipn_articles
feed_id 151627
feed_publisher BMJ Publishing
feed_publisher_url http://group.bmj.com/
insertion_date 2018-02-28
journaleissn 2044-6055
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher BMJ Publishing
quelle BMJ Open
relation http://bmjopen.bmj.com/cgi/content/short/8/2/e017912?rss=1
schlagwort Open access, Complementary medicine
search_space articles
shingle_author_1 Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
shingle_author_2 Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
shingle_author_3 Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
shingle_author_4 Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
shingle_catch_all_1 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
Open access, Complementary medicine
Introduction Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). Methods and analysis This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. Ethics and dissemination Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. Trial registration number ChiCTR-IOR-16010283; Pre-results.
Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_2 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
Open access, Complementary medicine
Introduction Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). Methods and analysis This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. Ethics and dissemination Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. Trial registration number ChiCTR-IOR-16010283; Pre-results.
Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_3 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
Open access, Complementary medicine
Introduction Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). Methods and analysis This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. Ethics and dissemination Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. Trial registration number ChiCTR-IOR-16010283; Pre-results.
Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_4 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
Open access, Complementary medicine
Introduction Spasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC). Methods and analysis This study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored. Ethics and dissemination Ethics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences. Trial registration number ChiCTR-IOR-16010283; Pre-results.
Cai, Y., Zhang, C. S., Ouyang, W., Li, J., Nong, W., Zhang, A. L., Xue, C. C., Wen, Z.
BMJ Publishing
2044-6055
20446055
shingle_title_1 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
shingle_title_2 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
shingle_title_3 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
shingle_title_4 Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
timestamp 2025-06-30T23:33:02.078Z
titel Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
titel_suche Electroacupuncture for poststroke spasticity (EAPSS): protocol for a randomised controlled trial
topic WW-YZ
uid ipn_articles_6176839