PMID- 32993752
OWN - NLM
STAT- MEDLINE
DCOM- 20210617
LR  - 20210617
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 21
IP  - 1
DP  - 2020 Sep 29
TI  - Manual acupuncture versus sham acupuncture and usual care for the prevention of 
      primary dysmenorrhea (PD): study protocol for a randomized controlled trial.
PG  - 818
LID - 10.1186/s13063-020-04720-5 [doi]
LID - 818
AB  - BACKGROUND: Primary dysmenorrhea (PD) is a leading cause of dysmenorrhea among 
      adolescent girls. Manual acupuncture may be considered as an effective treatment 
      for PD, but high-quality evidence remains limited. This trial aims to evaluate 
      the efficacy and safety of acupuncture for the prevention of PD as compared with 
      sham acupuncture and usual care. METHODS/DESIGN: This is a three-arm, randomized, 
      controlled clinical trial in which the patients, assessors, and statisticians 
      will be blinded. A total of 300 acupuncture-naive patients who were diagnosed as 
      PD will be randomly allocated to the verum acupuncture, sham acupuncture, or 
      usual care groups in a 2:2:1 ratio. Patients in the verum acupuncture group will 
      receive manual acupuncture at specific acupuncture points with penetrating 
      needling, while those in the sham acupuncture group will receive non-penetrating 
      needling at non-acupuncture points. They will be given five sessions over a 
      menstrual cycle for 3 menstrual cycles. Patients in the usual care group will 
      receive health education and informed to receive manual acupuncture for free 
      after waiting for 7 menstrual cycles. The primary outcome will be the change from 
      baseline in the Cox Menstrual Symptom Scale Score (CMSS). The secondary outcomes 
      will be the changes in Massachusetts General Hospital Acupuncture Sensation Scale 
      (MASS), visual analog scale (VAS), Short-Form McGill Pain Questionnaire 2 
      (SF-MPQ-2), Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), 
      Beck Depression Inventory II (BDI- II), Acupuncture Expectancy Scale (AES), 
      60-item NEO Personality Inventory-Short Form (NEO-FFI), and acute medication 
      intake. The adverse events will be recorded at every visit. The analyses will be 
      performed base on a full analysis set (FAS) and a per-protocol set (PPS). 
      DISCUSSION: This study may provide high-quality evidence regarding the efficacy 
      and safety of manual acupuncture for PD. In addition, the results of this study 
      will help to identify the efficacy of acupuncture due to the specific effects of 
      acupuncture or placebo effects of acupuncture ritual. TRIAL REGISTRATION: 
      Clinical Trials.gov NCT02783534 . Registered on 26 May 2016.
FAU - Yu, Lingling
AU  - Yu L
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
FAU - Liu, Shiqin
AU  - Liu S
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
FAU - Zheng, Cuihong
AU  - Zheng C
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
FAU - Liu, Wenhua
AU  - Liu W
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
FAU - Wang, Hua
AU  - Wang H
AD  - Acupuncture and Moxibustion Institution, College of Acupuncture and Moxibustion, 
      Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation 
      Center of Preventive Treatment by Acupuncture and Moxibustion, 1 Tanhualin Road, 
      Wuhan, 430030, Hubei, China.
FAU - Liang, Fengxia
AU  - Liang F
AD  - Acupuncture and Moxibustion Institution, College of Acupuncture and Moxibustion, 
      Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation 
      Center of Preventive Treatment by Acupuncture and Moxibustion, 1 Tanhualin Road, 
      Wuhan, 430030, Hubei, China.
FAU - Lu, Wei
AU  - Lu W
AD  - Acupuncture and Moxibustion Institution, College of Acupuncture and Moxibustion, 
      Hubei University of Chinese Medicine/Hubei Provincial Collaborative Innovation 
      Center of Preventive Treatment by Acupuncture and Moxibustion, 1 Tanhualin Road, 
      Wuhan, 430030, Hubei, China.
FAU - Xu, Shabei
AU  - Xu S
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China. xushabei@126.com.
FAU - Wang, Wei
AU  - Wang W
AUID- ORCID: 0000-0002-9176-5150
AD  - Tongji Hospital, Tongji Medical College, Huazhong University of Science and 
      Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China. wwang@vip.126.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT02783534
GR  - 61327902/National Natural Science Foundation of China/
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20200929
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
SB  - IM
MH  - *Acupuncture Therapy/adverse effects
MH  - Adolescent
MH  - *Dysmenorrhea/diagnosis/therapy
MH  - Female
MH  - Humans
MH  - Massachusetts
MH  - Pain Measurement
MH  - Randomized Controlled Trials as Topic
MH  - Time Factors
MH  - Treatment Outcome
PMC - PMC7525957
OTO - NOTNLM
OT  - Clinical trial
OT  - Efficacy
OT  - Manual acupuncture
OT  - Primary dysmenorrhea
OT  - Safety
OT  - Study protocol
COIS- The authors declare that they have no competing interests.
EDAT- 2020/10/01 06:00
MHDA- 2021/06/22 06:00
PMCR- 2020/09/29
CRDT- 2020/09/30 05:48
PHST- 2020/02/06 00:00 [received]
PHST- 2020/09/02 00:00 [accepted]
PHST- 2020/09/30 05:48 [entrez]
PHST- 2020/10/01 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/09/29 00:00 [pmc-release]
AID - 10.1186/s13063-020-04720-5 [pii]
AID - 4720 [pii]
AID - 10.1186/s13063-020-04720-5 [doi]
PST - epublish
SO  - Trials. 2020 Sep 29;21(1):818. doi: 10.1186/s13063-020-04720-5.