Adenomyosis, Endometriosis, Pelvic Pain
Conditions
Keywords
acupuncture
Brief summary
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.
Interventions
PROCEDUREacupuncture treatment
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
PROCEDURESham acupunture
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
Sponsors
East West Neo Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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')
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chages in Visual Analogue Scale of subjective Pelvic Pain | 7wks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life | 7wks | 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 |
Countries
South Korea
Outcome results
None listed