Menstrual PainAKUDNCT01582724
Effectiveness of Additional Self-care Acupressure for Women With Menstrual Pain Compared to Usual Care Alone
A study testing Self-care acupressure at three predefined points in people with Menstrual Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Menstrual Pain
- What is being tested?
- Self-care acupressure at three predefined points
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to Mar 2015
- 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 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with dysmenorrhea as defined as cramping pain during every menstrual cycle
- Age: 18 to 25 years
- Up to now no prior history of a gynecological disease that could be a reason for dysmenorrhea
- Women with menstruation in the last six weeks and a duration of menstruation cycles between 3 and 6 weeks
- Women with moderate and severe pain defined as a score equal or higher than 6 on the numeric rating scale for the worst pain intensity during the last menstruation.
- Written and oral informed consent
- Women must be able to complete the baseline questionnaire in paper form, the electronic questionnaire via App and a electronic diary via App.
- Presence of a Smartphone and agreement to do data entry through the App
Who cannot join
- Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in the next 8 months
- Known or planned pregnancy in the next 8 months.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institue for Social medicine, Epidemiology and Health Economics, Charité University Medical Center
Berlin
About this study
Official title: Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone
The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone.
Read the detailed description
Menstrual pain is a common problem in young women and one of the the main reasons of short term absence from school or work. There is some evidence that acupuncture and acupressure might be successful in treating of menstrual pain. Compared with acupuncture, acupressure offers the possibility for women with menstrual pain to do self-care treatment at home. However, studies have been small and self-care acupressure had been only investigated in one study from Taiwan.
- Conditions
- Menstrual Pain
- Being tested
- Self-care acupressure at three predefined points
- Keywords
- Menstrual pain, Primary dysmenorrhea, Self-care acupressure
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-care acupressure at three predefined pointsProcedure or surgery
Self-care acupressure, one minute for each point, starting 5 days before menstruation, once up to twice daily; when pain is present: twice daily up to five times
| Study group | Role | What they receive |
|---|---|---|
| Self-care acupressure | Experimental | 1 Receives: Procedure: Self-care acupressure at three predefined points |
| Usual care | No intervention | 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)
Measured: 3rd menstruation after therapy start
Secondary outcomes (8)
Worst pain intensity (NRS)
Measured: Baseline, after the 1., 2., 3. and 6. menstruation
Duration of pain
Measured: Baseline, after the 1., 2., 3. and 6. menstruation
Responder rate defined as 50% pain reduction at the days of pain
Measured: Baseline, after the 1., 2., 3. and 6. menstruation
Sick leave days
Measured: Baseline, after the 1., 2., 3. and 6. menstruation
Adverse effects
Measured: After 1., 2., 3. and 6. menstruation
Days with medication intake
Measured: Baseline, after the 1., 2., 3. and 6. menstruation
Bodily self-efficacy
Measured: Baseline, after 1.,2.,3. and 6. menstruation
Credibility of the intervention
Measured: After 3. menstruation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startDec 2012
- Primary completionSep 2014
- Study completionMar 2015
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 Menstrual PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, MD, Principal investigator, Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582724
- Sponsor's protocol ID
- AKUD-12
- Acronym
- AKUD
- Status last verified
- Aug 2015
- First submitted
- 18 Apr 2012
- Last updated
- 4 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Blodt S, Schutzler L, Huang W, Pach D, Brinkhaus B, Hummelsberger J, Kirschbaum B, Kuhlmann K, Lao L, Liang F, Mietzner A, Mittring N, Muller S, Paul A, Pimpao-Niederle C, Roll S, Wu H, Zhu J, Witt CM. Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol. Trials. 2013 Apr 11;14:99. doi: 10.1186/1745-6215-14-99.
PubMed 24499425
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pragmatic Trial for Women With Menstrual Pain Comparing Additional Self-care Acupressure to Usual Care Alone
- ClinicalTrials.gov ID
- NCT01582724
- Acronym / sponsor ID
- AKUD / AKUD-12
- Conditions
- Menstrual Pain
- Keywords
- Menstrual pain, Primary dysmenorrhea, Self-care acupressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- Dec 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Apr 2012 (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.
The aim of the study is to evaluate the effectiveness of additional self-care acupressure in women with menstrual pain compared to usual care alone.
Detailed description
Menstrual pain is a common problem in young women and one of the the main reasons of short term absence from school or work. There is some evidence that acupuncture and acupressure might be successful in treating of menstrual pain. Compared with acupuncture, acupressure offers the possibility for women with menstrual pain to do self-care treatment at home. However, studies have been small and self-care acupressure had been only investigated in one study from Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-care acupressure | Experimental | Procedure: Self-care acupressure at three predefined points1 |
| Usual care | No intervention | –2 |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women with dysmenorrhea as defined as cramping pain during every menstrual cycle
- Age: 18 to 25 years
- Up to now no prior history of a gynecological disease that could be a reason for dysmenorrhea
- Women with menstruation in the last six weeks and a duration of menstruation cycles between 3 and 6 weeks
- Women with moderate and severe pain defined as a score equal or higher than 6 on the numeric rating scale for the worst pain intensity during the last menstruation.
Key exclusion criteria (2 listed)
- Acupressure, acupuncture, shiatsu- or/and tuina massage at the moment or planned in the next 8 months
- Known or planned pregnancy in the next 8 months.
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 |
|---|---|---|
| Self-care acupressure at three predefined pointsSelf-care acupressure, one minute for each point, starting 5 days before menstruation, once up to twice daily; when pain is present: twice daily up to five times | Procedure or surgery | Self-care acupressure |
Primary outcome
Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS)
Time frame: 3rd menstruation after therapy start
8 secondary outcomes
Worst pain intensity (NRS)
Time frame: Baseline, after the 1., 2., 3. and 6. menstruation
Duration of pain
Time frame: Baseline, after the 1., 2., 3. and 6. menstruation
Responder rate defined as 50% pain reduction at the days of pain
Time frame: Baseline, after the 1., 2., 3. and 6. menstruation
Sick leave days
Time frame: Baseline, after the 1., 2., 3. and 6. menstruation
Adverse effects
Time frame: After 1., 2., 3. and 6. menstruation
Days with medication intake
Time frame: Baseline, after the 1., 2., 3. and 6. menstruation
Bodily self-efficacy
Time frame: Baseline, after 1.,2.,3. and 6. menstruation
Credibility of the intervention
Time frame: After 3. menstruation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2015.
- Derived from this study: PubMed 24499425Blodt S, Schutzler L, Huang W, Pach D, Brinkhaus B, Hummelsberger J, Kirschbaum B, Kuhlmann K, Lao L, Liang F, Mietzner A, Mittring N, Muller S, Paul A, Pimpao-Niederle C, Roll S, Wu H, Zhu J, Witt CM. Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol. Trials. 2013 Apr 11;14:99. doi: 10.1186/1745-6215-14-99.
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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.
Claudia M Witt, MD principal investigator
Institue of Social Science, Epidemiology and Health Economics, Charité University Medical Center Berlin Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-care acupressure at three predefined points in people with Menstrual Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 4 Aug 2015. 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 Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean pain intensity at the days of pain during the 3rd cycle after therapy start (Numeric Rating Scale, NRS) (time frame: 3rd menstruation after therapy start). 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 NCT01582724, 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 4 Aug 2015.