Evidence map›Paper›PMID 32993752›Full record

ArticleTrials2020

Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial.

Lingling Yu, Shiqin Liu, Cuihong Zheng, Wenhua Liu, Hua Wang, Fengxia Liang, Wei Lu, Shabei Xu, Wei Wang

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02783534 (Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02783534 naunknown statusnot on this map

Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea: A Multicenter, Randomized, Controlled, Clinical Trial

TypeinterventionalSponsorHuazhong University of Science and TechnologyRan2016 to 2021Enrolled300ConditionsPrimary DysmenorrheaArmsVerum acupuncture, Sham acupuncture, Usual care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Lingling YuTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
Shiqin LiuTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
Cuihong ZhengTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
Wenhua LiuTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China.
Hua WangAcupuncture 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.
Fengxia LiangAcupuncture 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.
Wei LuAcupuncture 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.
Shabei XuTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China. xushabei@126.com.
Wei WangTongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1095 Jiefang Avenue, Wuhan, 430030, Hubei, China. wwang@vip.126.com.ORCID http://orcid.org/0000-0002-9176-5150
Tongji Hospital · CNHubei University of Chinese Medicine · CN

Funding

National Natural Science Foundation of China 61327902
6 · The paper itself

Abstract

backgroundPrimary 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/

designThis 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 registrationClinical Trials.gov NCT02783534 . Registered on 26 May 2016.

Indexed as

Acupuncture TherapyDysmenorrheaAdolescentFemaleHumansMassachusettsPain MeasurementRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeClinical trialEfficacyManual acupuncturePrimary dysmenorrheaSafetyStudy protocol

Identifiers

PMID32993752
PMCPMC7525957
OpenAlexW3090753947

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.