Primary DysmenorrheaNCT02783534
Manual Acupuncture for Primary Dysmenorrhea
A study testing Verum acupuncture in people with Primary Dysmenorrhea, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about serious adverse events. Complementary therapies, including acupuncture, are commonly used for PD. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Verum acupuncture
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2016to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with PD according to the primary dysmenorrhea established by Canadian Institute of Obstetrics and gynecology in 2005;
- Aged from 15 to 40 years, have not given birth, and have a history of regular menstrual cycles (28 days±7 days);
- Pain of intensity is moderate varying from 40 to 80 on the visual analogue scale (VAS), and lasting at least 6 months;
- Able to complete the baseline dysmenorrhea diary;
- Able to sign an informed consent
Who cannot join
- Secondary dysmenorrhea caused by endometriosis, pelvic inflammation, myomas of uterus or other gynecological problems confirmed by type-B ultrasound exam by gynecologists;
- Have a history of pelvic or abdominal surgery, or applying oral contraceptives or intrauterine devices;
- Combined with uncontrolled diagnosed psychiatric disorders such as severe anxiety and depression, or severe systemic diseases affecting the implementation of treatment programs;
- Taking analgesics such as NSAIDs or having received any other treatment for PD three months prior to enrollment;
- Women in lactation, pregnant women, or those with plans to get pregnant during any period of the trial;
- Have experience of acupuncture;
- Illiterate, or patients unable to read and understand scales.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei
Wei Wang, Doctor, 86-027-8366-3648, tianyalinghu@126.com
Shabei Xu, Doctor, 86-13554178768, xushabei@126.com
About this study
Official title: Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea: A Multicenter, Randomized, Controlled, Clinical Trial
Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about serious adverse events. Complementary therapies, including acupuncture, are commonly used for PD. Acupuncture has a low risk of adverse effects, while the evidence for the effectiveness of acupuncture in treating PD is inconclusive. Deqi and psychological factors are core concepts in acupuncture theory, but they have been largely neglected in primary dysmenorrhea clinical reports. The objective of this trail is to assess the clinical efficacy of acupuncture in the prevention of PD and investigate what factors will affect the efficacy of acupuncture.The results of this trial will significantly add to the current body of evidence on the role of acupuncture for PD. If found to be effective and safe, acupuncture will be a valuable treatment option in the prevention of PD. In additional, results from this trial will identify what factors will affect the efficacy of acupuncture.
Read the detailed description
This is a multicenter, single blind, randomized controlled, three-arm, large-scale clinical trial. We will recruit 300 PD women who meet diagnostic criteria for PD established in 2005 from Canada gynaecology and obstetrics association. Exclusion criteria include illiteracy, breast feeding women, pregnancy women, serious systemic disease, mental patient, and acupuncture experience. Eligible women will be randomly assigned to verum acupuncture group, sham acupuncture group and usual care group. Participants in the verum acupuncture group will receive traditional acupuncture treatment and will be treated with ture needles, While Participants in the sham acupuncture group will be treated with sham acupuncture with non-insertive needles at non-acupuncture points. Acupuncture treatment will start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days (a treatment course), totally for 15 sessions and 3 treatment courses. Participants in the usual care group will not receive treatment besides health education as a control group. This trail will be composed of a one-menstrual cycle baseline, three-menstrual cycle treatment (cycle 1 to 3), and three-menstrual cycle follow-up period (cycle 4-6). The primary outcome measure is the change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline. Secondary outcome measures include Visual Analogue Scale (VAS), McGill pain questionnaire (SF-MPQ), Pittsburgh sleep quality index (PSQI), and intake of acute medication. Psychological outcome measures are Beck Depression Rating Scale (BDI), Beck Anxiety Inventory (BAI), NEO Five-Factor Inventory (NEO-FFI), the Doctor-Patient Relationship Scale (PDRQ), the Difficult Doctor-Patient Relationship Questionnaire (DDPRQ), and Expectations for interventions assessed by acupuncture expectancy scale (AES). Deqi sensation will be measured by MGH Acupuncture Sensation Scale (MASS).
- Conditions
- Primary Dysmenorrhea
- Being tested
- Verum acupuncture, Sham acupuncture, Usual care
- Keywords
- Acupuncture, Primary Dysmenorrhea, Randomized Controlled Trial, Placebo Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum acupunctureDevice
Participants allocated to VA group will receive traditional acupuncture treatment on the "Guanyuan"(RN 4), bilateral "Sanyinjiao"(SP 6), bilateral "Zigong"(EX-CA1), bilateral "Xuehai"(SP 10). Additional points will be chosen according to TCM syndrome differentiation constitution of patients. If patients with deficient syndrome, bilateral "Zusanli" (ST 36) will be included. If patients with sufficiency syndrome, bilateral "Diji" (SP 8) will be included. The NO.16 special type of acupuncture needle (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
Sham acupunctureDevice
We use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) 5 inch lateral to the seventh thoracic spine; 2) 5 inch lateral to the eighth thoracic spine; 3) 5 inch lateral to the ninth thoracic spine; and 4) 5 inch lateral to the tenth thoracic spine.
Usual careBehavioural
Patients in usual care group will not receive acupuncture treatment but enhance usual care by providing them with detailed information via propaganda booklets or the internet in the form of health education.
| Study group | Role | What they receive |
|---|---|---|
| Verum acupuncture | Experimental | Participants will receive verum acupuncture plus usual care. Participants will receive acupuncture treatment start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days, totally be treated with 15 sessions.Verum needles will be inserted into the skin and manipulated manually until deqi occurs. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and manipulates the needles to maintain the intensity of deqi. Participants will receive the same usual care as those in the usual care group. Receives: Device: Verum acupuncture; Behavioral: Usual care |
| Sham acupuncture | Sham comparator | Participants will receive sham acupuncture plus usual care. The Streitberger placebo needle will be placed at non-acupuncture points which are distant from the meridian parts and not located on the same neuromuscular segments as the prescribed points used in the VA group, so as to minimize any therapeutic and segmental effects. The same acupuncture schedule as that in the verum acupuncture group will be applied. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and pretends to manipulate the needles but deqi is not sought.Participants will receive the same usual care as those in the usual care group. Receives: Device: Sham acupuncture; Behavioral: Usual care |
| Usual care | Placebo comparator | Participants will not receive acupuncture treatment besides health education as a control group. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline.
Measured: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Secondary outcomes (4)
Change of Visual Analogue Scale (VAS) in a menstrual cycle compared to baseline.
Measured: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Change of McGill pain questionnaire (SF-MPQ) in a menstrual cycle compared to baseline.
Measured: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Change of Pittsburgh sleep quality index (PSQI) in a menstrual cycle compared to baseline.
Measured: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Change of the dose of intake of acute medication in a menstrual cycle compared to baseline.
Measured: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start2 Aug 2016
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
- Responsible party
- Principal investigator, Wei Wang, Huazhong University of Science and Technology
- Investigators
- Wei Wang, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783534
- Sponsor's protocol ID
- 201403RCTPD
- Status last verified
- Oct 2019
- First submitted
- 5 May 2016
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yu L, Liu S, Zheng C, Liu W, Wang H, Liang F, Lu W, Xu S, Wang W. Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial. Trials. 2020 Sep 29;21(1):818. doi: 10.1186/s13063-020-04720-5.
PubMed 32993752
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Acupuncture vs Sham Acupuncture and Usual Care for the Prevention of Primary Dysmenorrhea: A Multicenter, Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02783534
- Acronym / sponsor ID
- 201403RCTPD
- Conditions
- Primary Dysmenorrhea
- Keywords
- Acupuncture, Primary Dysmenorrhea, Randomized Controlled Trial, Placebo Effect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary dysmenorrhea (PD) is a common complaint in menstruating women. Although nonsteroidal anti-inflammatory drug is an effective treatment, there are concerns about serious adverse events. Complementary therapies, including acupuncture, are commonly used for PD. Acupuncture has a low risk of adverse effects, while the evidence for the effectiveness of acupuncture in treating PD is inconclusive. Deqi and psychological factors are core concepts in acupuncture theory, but they have been largely neglected in primary dysmenorrhea clinical reports. The objective of this trail is to assess the clinical efficacy of acupuncture in the prevention of PD and investigate what factors will affect the efficacy of acupuncture.The results of this trial will significantly add to the current body of evidence on the role of acupuncture for PD. If found to be effective and safe, acupuncture will be a valuable treatment option in the prevention of PD. In additional, results from this trial will identify what factors will affect the efficacy of acupuncture.
Detailed description
This is a multicenter, single blind, randomized controlled, three-arm, large-scale clinical trial. We will recruit 300 PD women who meet diagnostic criteria for PD established in 2005 from Canada gynaecology and obstetrics association. Exclusion criteria include illiteracy, breast feeding women, pregnancy women, serious systemic disease, mental patient, and acupuncture experience. Eligible women will be randomly assigned to verum acupuncture group, sham acupuncture group and usual care group. Participants in the verum acupuncture group will receive traditional acupuncture treatment and will be treated with ture needles, While Participants in the sham acupuncture group will be treated with sham acupuncture with non-insertive needles at non-acupuncture points. Acupuncture treatment will start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days (a treatment course), totally for 15 sessions and 3 treatment courses. Participants in the usual care group will not receive treatment besides health education as a control group. This trail will be composed of a one-menstrual cycle baseline, three-menstrual cycle treatment (cycle 1 to 3), and three-menstrual cycle follow-up period (cycle 4-6). The primary outcome measure is the change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline. Secondary outcome measures include Visual Analogue Scale (VAS), McGill pain questionnaire (SF-MPQ), Pittsburgh sleep quality index (PSQI), and intake of acute medication. Psychological outcome measures are Beck Depression Rating Scale (BDI), Beck Anxiety Inventory (BAI), NEO Five-Factor Inventory (NEO-FFI), the Doctor-Patient Relationship Scale (PDRQ), the Difficult Doctor-Patient Relationship Questionnaire (DDPRQ), and Expectations for interventions assessed by acupuncture expectancy scale (AES). Deqi sensation will be measured by MGH Acupuncture Sensation Scale (MASS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Verum acupuncture | Experimental | Device: Verum acupuncture, Behavioral: Usual careParticipants will receive verum acupuncture plus usual care. Participants will receive acupuncture treatment start from the 5th or 7th day before the estimated first day of menstrual cycle, and for each cycle, participants will receive one session of treatment each day for 5 consecutive days, totally be treated with 15 sessions.Verum needles will be inserted into the skin and manipulated manually until deqi occurs. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and manipulates the needles to maintain the intensity of deqi. Participants will receive the same usual care as those in the usual care group. |
| Sham acupuncture | Sham comparator | Device: Sham acupuncture, Behavioral: Usual careParticipants will receive sham acupuncture plus usual care. The Streitberger placebo needle will be placed at non-acupuncture points which are distant from the meridian parts and not located on the same neuromuscular segments as the prescribed points used in the VA group, so as to minimize any therapeutic and segmental effects. The same acupuncture schedule as that in the verum acupuncture group will be applied. The needles are retained for 30 min in each session. During the treatment, the acupuncturist inquires the patient about deqi sensations and pretends to manipulate the needles but deqi is not sought.Participants will receive the same usual care as those in the usual care group. |
| Usual care | Placebo comparator | Behavioral: Usual careParticipants will not receive acupuncture treatment besides health education as a control group. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosed with PD according to the primary dysmenorrhea established by Canadian Institute of Obstetrics and gynecology in 2005;
- Aged from 15 to 40 years, have not given birth, and have a history of regular menstrual cycles (28 days±7 days);
- Pain of intensity is moderate varying from 40 to 80 on the visual analogue scale (VAS), and lasting at least 6 months;
- Able to complete the baseline dysmenorrhea diary;
- Able to sign an informed consent
Key exclusion criteria (7 listed)
- Secondary dysmenorrhea caused by endometriosis, pelvic inflammation, myomas of uterus or other gynecological problems confirmed by type-B ultrasound exam by gynecologists;
- Have a history of pelvic or abdominal surgery, or applying oral contraceptives or intrauterine devices;
- Combined with uncontrolled diagnosed psychiatric disorders such as severe anxiety and depression, or severe systemic diseases affecting the implementation of treatment programs;
- Taking analgesics such as NSAIDs or having received any other treatment for PD three months prior to enrollment;
- Women in lactation, pregnant women, or those with plans to get pregnant during any period of the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum acupunctureParticipants allocated to VA group will receive traditional acupuncture treatment on the "Guanyuan"(RN 4), bilateral "Sanyinjiao"(SP 6), bilateral "Zigong"(EX-CA1), bilateral "Xuehai"(SP 10). Additional points will be chosen according to TCM syndrome differentiation constitution of patients. If patients with deficient syndrome, bilateral "Zusanli" (ST 36) will be included. If patients with sufficiency syndrome, bilateral "Diji" (SP 8) will be included. The NO.16 special type of acupuncture needle (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi. | Device | Verum acupuncture |
| Sham acupunctureWe use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) 5 inch lateral to the seventh thoracic spine; 2) 5 inch lateral to the eighth thoracic spine; 3) 5 inch lateral to the ninth thoracic spine; and 4) 5 inch lateral to the tenth thoracic spine. | Device | Sham acupuncture |
| Usual carePatients in usual care group will not receive acupuncture treatment but enhance usual care by providing them with detailed information via propaganda booklets or the internet in the form of health education. | Behavioural | Sham acupuncture, Usual care, Verum acupuncture |
Primary outcome
Change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline.
Time frame: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
4 secondary outcomes
Change of Visual Analogue Scale (VAS) in a menstrual cycle compared to baseline.
Time frame: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Change of McGill pain questionnaire (SF-MPQ) in a menstrual cycle compared to baseline.
Time frame: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Change of Pittsburgh sleep quality index (PSQI) in a menstrual cycle compared to baseline.
Time frame: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Change of the dose of intake of acute medication in a menstrual cycle compared to baseline.
Time frame: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Derived from this study: PubMed 32993752Yu L, Liu S, Zheng C, Liu W, Wang H, Liang F, Lu W, Xu S, Wang W. Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial. Trials. 2020 Sep 29;21(1):818. doi: 10.1186/s13063-020-04720-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Wang, Doctor principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum acupuncture in people with Primary Dysmenorrhea, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shabei Xu, Doctor (86-13554178768, xushabei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Cox Menstrual Symptom Scale (CMSS) in a menstrual cycle compared to baseline. (time frame: At baseline (one menstrual cycle/one month before randomization), the first，second, third, fourth, fifth, and sixth month after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02783534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019.