EndometriosisNCT01259180
Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis
A study testing acupuncture treatment in people with Endometriosis and Adenomyosis, run by East West Neo Medical Center at 1 site in South Korea.
Trial summary
The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain in women with endometriosis or adenomyosis. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Endometriosis, Adenomyosis, Pelvic Pain
- What is being tested?
- acupuncture treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Sep 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 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had undergone laparoscopic surgery due to pelvic pain
- Patients who have been on GnRH agonist treatment for 6 months after being diagnosed Endometriosis or Adenomyosis
- Patients who agreed a written consent by their own will
- Patients' compliance and geographical adjacency appropriate for proper follow up survey
- continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks of surgery) (0='no pain', '10=most severe')
Who cannot join
- Those who had taken hormones or drugs that can affect diagnosis of endometriosis or adenomyosis for past 1 year
- Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during surgery
- Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy, epilepsy)
- Unable to participate in clinical trial by doctor's judgment
- irritable bowel syndrome
Trial locations and contacts
1 site in 1 country.
South Korea1 site
East-West Neo Medical Center
Seoul, Seoul, 134-727
Ji Yung Lee, OMD, 82-2-440-7128, bromtom@naver.com
About this study
Official title: Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study
The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain in women with endometriosis or adenomyosis.
Read the detailed description
Chronic pelvic pain(CPP) is a common disease among women, and its prevalence ranges from 4 to 25 percent. There are various conditions associated with CPP, including gynecologic, urologic and gastointestinal problems. Endometriosis is the most common diagnosis made at the time of gynecological laparoscopy performed to evaluate CPP. Treatments of CPP with endometriosis include medical(analgesics, oral contraceptive pills, gonadotropin releasing hormone(GnRH) agonist, etc.), surgical and combined treatment. Progestins, danazol, estrogen-progestin pills, or GnRH agonists are commonly used as a concurrent treatment along with surgery. However, a systematic review on the comparison of postsurgical hormonal suppression to surgery alone concluded that, while postoperative medical therapy decreased recurrence rates, there was no significant benefit on the outcomes of pain and pregnancy rates. Therefore there is a need for postoperaive medical therapy for pain relief. In this study, the investigators propose a randomized, sham-controlled trial to investigate the efficacy of acupuncture as a pain control for the patients dignosed endometriosis during laparoscopic surgery due to CPP, and have been on 6 month-scheduled GnRH agonist treatment as a postoperative treatment.
- Conditions
- Endometriosis, Adenomyosis, Pelvic Pain
- Being tested
- acupuncture treatment, Sham acupunture
- Keywords
- acupuncture
- Medical subject headings
- Endometriosis, Adenomyosis, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture treatmentProcedure or surgery
twice a week, 6 weeks, 12sessions penetrating skin with stailess steel acupuncture device(diameter: 0.25-0.3mm,legth: 30-70mm) points: BL 23,BL31,BL32, BL40, BL53, GB30, SP 6 bilaterally plus Ashi. with
Sham acupuntureProcedure or surgery
twice a week, 6 weeks, 12 sessions not penetrating skin with dull acupuncture device(Park Sham device :Acuprime Co. Ltd, UK) point: 1~2inches away from real acupuncture point
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | twice a week, 6 weeks real acupuncture treatment, 12 sessions Receives: Procedure: acupuncture treatment |
| Sham acupuncture group | Sham comparator | twice a week, 6 weeks real acupuncture treatment, 12 sessions Receives: Procedure: Sham acupunture |
| Control group | No intervention | observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chages in Visual Analogue Scale of subjective Pelvic Pain
Measured: 7wks
Secondary outcomes (1)
Health-related Quality of Life
1.36-item Short-Form Health Survey Version 2.0 2.Beck's Depression Index 3.Social Readjustment Rating Scale 4. Heart Rate Variability 5. Digital Infrared Thermographic Image 6. Assessment of Voice
Measured: 7wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East West Neo Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jin-Moo Lee, OMD, Study director, East West Neo Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259180
- Sponsor's protocol ID
- KUIMS-pp-10
- Status last verified
- Oct 2010
- First submitted
- 13 Dec 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study
- ClinicalTrials.gov ID
- NCT01259180
- Acronym / sponsor ID
- KUIMS-pp-10
- Conditions
- Endometriosis, Adenomyosis, Pelvic Pain
- Keywords
- acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- East West Neo Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 14 Dec 2010 (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 purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain in women with endometriosis or adenomyosis.
Detailed description
Chronic pelvic pain(CPP) is a common disease among women, and its prevalence ranges from 4 to 25 percent. There are various conditions associated with CPP, including gynecologic, urologic and gastointestinal problems. Endometriosis is the most common diagnosis made at the time of gynecological laparoscopy performed to evaluate CPP. Treatments of CPP with endometriosis include medical(analgesics, oral contraceptive pills, gonadotropin releasing hormone(GnRH) agonist, etc.), surgical and combined treatment. Progestins, danazol, estrogen-progestin pills, or GnRH agonists are commonly used as a concurrent treatment along with surgery. However, a systematic review on the comparison of postsurgical hormonal suppression to surgery alone concluded that, while postoperative medical therapy decreased recurrence rates, there was no significant benefit on the outcomes of pain and pregnancy rates. Therefore there is a need for postoperaive medical therapy for pain relief. In this study, the investigators propose a randomized, sham-controlled trial to investigate the efficacy of acupuncture as a pain control for the patients dignosed endometriosis during laparoscopic surgery due to CPP, and have been on 6 month-scheduled GnRH agonist treatment as a postoperative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Procedure: acupuncture treatmenttwice a week, 6 weeks real acupuncture treatment, 12 sessions |
| Sham acupuncture group | Sham comparator | Procedure: Sham acupunturetwice a week, 6 weeks real acupuncture treatment, 12 sessions |
| Control group | No intervention | –observation. |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had undergone laparoscopic surgery due to pelvic pain
- Patients who have been on GnRH agonist treatment for 6 months after being diagnosed Endometriosis or Adenomyosis
- Patients who agreed a written consent by their own will
- Patients' compliance and geographical adjacency appropriate for proper follow up survey
- continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks of surgery) (0='no pain', '10=most severe')
Key exclusion criteria (5 listed)
- Those who had taken hormones or drugs that can affect diagnosis of endometriosis or adenomyosis for past 1 year
- Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during surgery
- Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy, epilepsy)
- Unable to participate in clinical trial by doctor's judgment
- irritable bowel syndrome
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 |
|---|---|---|
| acupuncture treatmenttwice a week, 6 weeks, 12sessions penetrating skin with stailess steel acupuncture device(diameter: 0.25-0.3mm,legth: 30-70mm) points: BL 23,BL31,BL32, BL40, BL53, GB30, SP 6 bilaterally plus Ashi. with | Procedure or surgery | Acupuncture group |
| Sham acupunturetwice a week, 6 weeks, 12 sessions not penetrating skin with dull acupuncture device(Park Sham device :Acuprime Co. Ltd, UK) point: 1~2inches away from real acupuncture point | Procedure or surgery | Sham acupuncture group |
Primary outcome
Chages in Visual Analogue Scale of subjective Pelvic Pain
Time frame: 7wks
1 secondary outcome
Health-related Quality of Life
Time frame: 7wks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2010.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Jin-Moo Lee, OMD study director
East West Neo Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture treatment in people with Endometriosis and Adenomyosis, run by East West Neo Medical Center at 1 site in South Korea.
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 5 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 14 Dec 2010. 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 South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chages in Visual Analogue Scale of subjective Pelvic Pain (time frame: 7wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2010.