DysmenorrheaDATNCT00995917
A Pilot Study of Acupoint Injection for Primary Dysmenorrhea
A study testing Vitamin K acupoint injection and Saline Injection in people with Dysmenorrhea and Pain, Menstrual, run by University of California, San Francisco at 1 site in United States.
Trial summary
Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea, Pain, Menstrual
- What is being tested?
- Vitamin K acupoint injection and Saline Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2011
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young women age 18-25
- Severe primary dysmenorrhea (defined as severe, recurrent painful periods for 6 months or more, that are not due to any other diagnosis, and that have not been relieved, or have been only partially relieved by any other treatment)
- Nulliparous
- English speaking
- No acute or chronic conditions diagnosed or suspected
- Not on hormonal contraceptives
- Regular menstrual cycles for at least 6 months
- Has a working phone or pager
Who cannot join
- Use of hormonal contraceptives, or intra-uterine device
- Pregnancy
- Dysmenorrhea due to any other suspected or recognized causes
- History of abdominal surgery
- Participation in other concomitant therapy for acute or chronic pain
- Current treatment with anti-coagulant drugs for any reason
Show all 10Show fewer
- Previous treatment with vitamin K acupoint injection
- Plans to be out of area during next 5 months
- Under age 18
- Known allergy to Vitamin K.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Zion Outpatient Unit
San Francisco, California, 94115
About this study
Official title: A Randomized, Crossover, Pilot Trial of the Feasibility and Safety of Acupoint Injection of Vitamin K for Treatment of Primary Dysmenorrhea
Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K into an acupuncture point has been used as treatment for dysmenorrhea at the Obstetrics \& Gynecology Hospital in Shanghai, China since at least 1985. More research is needed on the effectiveness of this treatment and its acceptability to different women. The objective of this study is to examine the feasibility and effectiveness of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the United States. Twenty participants will be randomized to receive either 1) vitamin K1 injection into an acupuncture point at the start of their menstrual cycle followed by a saline injection in a non-acupuncture point two months later or 2) saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months later. The primary outcome measure will be change in pain intensity measured before and after each treatment. Data on other menstrual symptoms will be collected by telephone or a web-based survey. Three additional participants will be recruited to receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and after injection to determine absorption of vitamin K1. The aims of the study are to collect preliminary data on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S. women; and test the blood absorption of vitamin K1 following acupoint injection treatment.
The investigators hypothesize that:
- Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.
- Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection does.
- The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.
- Vitamin K1 is absorbed into the blood thru acupoint injection.
- Conditions
- Dysmenorrhea, Pain, Menstrual
- Being tested
- Vitamin K acupoint injection, Saline Injection
- Keywords
- acupuncture, menstrual pain, dysmenorrhea, menstrual cramps, vitamin K1
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin K acupoint injectionOther
Vitamin K will be injected into an acupuncture point within 2 days of the onset of painful menstrual cramps. Injections of 5 mg/0.5ml of vitamin K1 will be administered in bilateral acupuncture points. A single shot of vitamin K1 is 10mg/ml. Five mg/0.5ml will be drawn twice from one ampule and injected into each bilateral site, for a total dose of 10mg/ml of vitamin K.
Saline InjectionOther
Injection of .5ml saline bilaterally into both legs within 2 days of the onset of painful menstrual cramps.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin K acupoint injection | Experimental | Participants will receive the vitamin K intervention within 2 days of the onset of painful menstrual cramps. Receives: Other: Vitamin K acupoint injection |
| Saline Injection | Sham comparator | Participants will receive the saline treatment within 2 days of the onset of painful menstrual cramps. Receives: Other: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported pain
Measured: 3-5 months
Secondary outcomes (4)
medications used during menstrual cycle
Measured: 3-5 months
activity restriction
Measured: 3-5 months
vitamin K content in blood
Measured: 1-2 months
Cox retrospective symptom scale
Measured: 3-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Chao, Dr PH, MPA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995917
- Sponsor's protocol ID
- A112809
- Acronym
- DAT
- Status last verified
- Apr 2012
- First submitted
- 14 Oct 2009
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis AR, Westhoff CL. Primary dysmenorrhea in adolescent girls and treatment with oral contraceptives. J Pediatr Adolesc Gynecol. 2001 Feb;14(1):3-8. doi: 10.1016/s1083-3188(00)00076-0.
PubMed 11358700Milsom I, Minic M, Dawood MY, Akin MD, Spann J, Niland NF, Squire RA. Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies. Clin Ther. 2002 Sep;24(9):1384-400. doi: 10.1016/s0149-2918(02)80043-1.
PubMed 12380631Davis AR, Westhoff C, O'Connell K, Gallagher N. Oral contraceptives for dysmenorrhea in adolescent girls: a randomized trial. Obstet Gynecol. 2005 Jul;106(1):97-104. doi: 10.1097/01.AOG.0000165826.03915.65.
PubMed 15994623Yu J. Efficacy of vitamin K3 in the treatment of functional dysmenorrhoea: Clinical and laboratory observations. New Medicine and Clinical Trial. 1985:4
Harlow SD, Park M. A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynaecol. 1996 Nov;103(11):1134-42. doi: 10.1111/j.1471-0528.1996.tb09597.x.
PubMed 8917003
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Crossover, Pilot Trial of the Feasibility and Safety of Acupoint Injection of Vitamin K for Treatment of Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT00995917
- Acronym / sponsor ID
- DAT / A112809
- Conditions
- Dysmenorrhea, Pain, Menstrual
- Keywords
- acupuncture, menstrual pain, dysmenorrhea, menstrual cramps, vitamin K1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 16 Oct 2009 (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.
Many women, particularly adolescent women, suffer from painful menstrual cramps, medically referred to as dysmenorrhea. Common treatments for menstrual cramps are non-steroidal anti-inflammatory drugs and oral contraceptives, but both have side effects that limit their use. Injection of vitamin K into an acupuncture point has been used as treatment for dysmenorrhea at the Obstetrics \& Gynecology Hospital in Shanghai, China since at least 1985. More research is needed on the effectiveness of this treatment and its acceptability to different women. The objective of this study is to examine the feasibility and effectiveness of acupoint injection of vitamin K1 for the treatment of severe primary dysmenorrhea in the United States. Twenty participants will be randomized to receive either 1) vitamin K1 injection into an acupuncture point at the start of their menstrual cycle followed by a saline injection in a non-acupuncture point two months later or 2) saline injection in a non-acupuncture point followed by vitamin K1 injection into an acupuncture point two months later. The primary outcome measure will be change in pain intensity measured before and after each treatment. Data on other menstrual symptoms will be collected by telephone or a web-based survey. Three additional participants will be recruited to receive vitamin K1 injection into an acupuncture point and have blood samples drawn before and after injection to determine absorption of vitamin K1. The aims of the study are to collect preliminary data on the efficacy and safety of vitamin K1 injected in an acupoint for the treatment of severe primary dysmenorrhea; assess the feasibility and acceptability of the treatment among U.S. women; and test the blood absorption of vitamin K1 following acupoint injection treatment.
The investigators hypothesize that:
- Vitamin K1 acupoint injection is a safe treatment for women with menstrual pain.
- Vitamin K1 acupoint injection reduces menstrual pain more than placebo saline injection does.
- The treatment of vitamin K1 acupoint injection is acceptable to U.S. women.
- Vitamin K1 is absorbed into the blood thru acupoint injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin K acupoint injection | Experimental | Other: Vitamin K acupoint injectionParticipants will receive the vitamin K intervention within 2 days of the onset of painful menstrual cramps. |
| Saline Injection | Sham comparator | Other: Saline InjectionParticipants will receive the saline treatment within 2 days of the onset of painful menstrual cramps. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Young women age 18-25
- Severe primary dysmenorrhea (defined as severe, recurrent painful periods for 6 months or more, that are not due to any other diagnosis, and that have not been relieved, or have been only partially relieved by any other treatment)
- Nulliparous
- English speaking
- No acute or chronic conditions diagnosed or suspected
Key exclusion criteria (10 listed)
- Use of hormonal contraceptives, or intra-uterine device
- Pregnancy
- Dysmenorrhea due to any other suspected or recognized causes
- History of abdominal surgery
- Participation in other concomitant therapy for acute or chronic pain
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 |
|---|---|---|
| Vitamin K acupoint injectionVitamin K will be injected into an acupuncture point within 2 days of the onset of painful menstrual cramps. Injections of 5 mg/0.5ml of vitamin K1 will be administered in bilateral acupuncture points. A single shot of vitamin K1 is 10mg/ml. Five mg/0.5ml will be drawn twice from one ampule and injected into each bilateral site, for a total dose of 10mg/ml of vitamin K. | Other | Vitamin K acupoint injection |
| Saline InjectionInjection of .5ml saline bilaterally into both legs within 2 days of the onset of painful menstrual cramps. | Other | Saline Injection |
Primary outcome
self-reported pain
Time frame: 3-5 months
4 secondary outcomes
medications used during menstrual cycle
Time frame: 3-5 months
activity restriction
Time frame: 3-5 months
vitamin K content in blood
Time frame: 1-2 months
Cox retrospective symptom scale
Time frame: 3-5 months
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 20 Apr 2012.
- Background: PubMed 11358700Davis AR, Westhoff CL. Primary dysmenorrhea in adolescent girls and treatment with oral contraceptives. J Pediatr Adolesc Gynecol. 2001 Feb;14(1):3-8. doi: 10.1016/s1083-3188(00)00076-0.
- Background: PubMed 12380631Milsom I, Minic M, Dawood MY, Akin MD, Spann J, Niland NF, Squire RA. Comparison of the efficacy and safety of nonprescription doses of naproxen and naproxen sodium with ibuprofen, acetaminophen, and placebo in the treatment of primary dysmenorrhea: a pooled analysis of five studies. Clin Ther. 2002 Sep;24(9):1384-400. doi: 10.1016/s0149-2918(02)80043-1.
- Background: PubMed 15994623Davis AR, Westhoff C, O'Connell K, Gallagher N. Oral contraceptives for dysmenorrhea in adolescent girls: a randomized trial. Obstet Gynecol. 2005 Jul;106(1):97-104. doi: 10.1097/01.AOG.0000165826.03915.65.
- BackgroundYu J. Efficacy of vitamin K3 in the treatment of functional dysmenorrhoea: Clinical and laboratory observations. New Medicine and Clinical Trial. 1985:4
- Background: PubMed 8917003Harlow SD, Park M. A longitudinal study of risk factors for the occurrence, duration and severity of menstrual cramps in a cohort of college women. Br J Obstet Gynaecol. 1996 Nov;103(11):1134-42. doi: 10.1111/j.1471-0528.1996.tb09597.x.
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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.
Maria Chao, Dr PH, MPA principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K acupoint injection and Saline Injection in people with Dysmenorrhea and Pain, Menstrual, run by University of California, San Francisco at 1 site in United States.
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 10 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 20 Apr 2012. 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 United States. 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?
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?
self-reported pain (time frame: 3-5 months). 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 NCT00995917, which also lists 5 linked publications.
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 20 Apr 2012.