None listed
Conditions
Brief summary
Chronic pelvic pain (CPP) is pain in the pelvis of greater than 6 months duration, and is severe enough to cause functional disability or require medical intervention. Endometriosis, the presence of endometrial tissue outside the uterus, is a common cause of CPP. Worldwide, endometriosis is as common as lower back pain. Endometriosis related CPP includes a variety of pain symptoms including dysmenorrhea (period pain), dyspareunia (pain during sexual intercourse), dyschezia (pain on bowel motions) and dysuria (pain on urination). Current treatments tend to be expensive, invasive or have significant side effects. Acupuncture shows promise in treating endometriosis related chronic pelvic pain however no studies have examined the feasibility of undertaking a fully powered trial in Australia or the effect of acupuncture on a number of objective biomarkers that are altered in women with endometriosis, such as IL-6, an inflammatory marker, or changes in functional connectivity in the brain. The aim of this study is to assess the feasibility and acceptability of acupuncture and to investigate any changes in neurological or biomarkers when using acupuncture to treat endometriosis-related chronic pelvic pain.We are partnering with Endometriosis Australia, a leading not-for-profit in Australia, to recruit women for this study. We will recruit 30 women to either acupuncture plus usual care or usual care alone. We will measure daily pain ratings as well as pain measured during the period and will take blood samples before and at the end of treatment to determine any changes in levels of IL-6. Women will also have an EEG taken to determine if there is any change in the way their brains are processing pain. This data will help provide the important information necessary to help design a larger trial to test if acupuncture is an effective adjunct to current treatments.
Interventions
Manual traditional Chinese medicine (TCM) style acupuncture + usual care:
TCM style acupuncture at fixed acupuncture points will be delivered twice per week for 8 weeks, 16 sessions in total.
Treatments will be delivered in Sydney, in private acupuncture practice clinics and at NICM on Western Sydney Universities Campbelltown Campus. Treatment sessions cannot be less than 48 hours apart and no more than 6 days apart. Acupuncture points will be needled bilaterally and needles retained for 25-3
Manual traditional Chinese medicine (TCM) style acupuncture + usual care: TCM style acupuncture at fixed acupuncture points will be delivered twice per week for 8 weeks, 16 sessions in total. Treatments will be delivered in Sydney, in private acupuncture practice clinics and at NICM on Western Sydney Universities Campbelltown Campus. Treatment sessions cannot be less than 48 hours apart and no more than 6 days apart. Acupuncture points will be needled bilaterally and needles retained for 25-30 minutes. Sessions will last a total of 45 minutes. Point location and needling depth will be as specified in A Manual of Acupuncture. Single use, stainless steel needles of varying gauge (.20 x 30mm or .25 x 40mm), dependent on body shape, will be used. Acupuncture points used will include Spleen 6, Spleen 8, Spleen 10, Stomach 29, Stomach 36, Ren 3, Ren 4 and Liver 3. No other TCM interventions (such as moxibustion, or cupping therapy) will be permitted during the treatment. All study acupuncturists will be experienced, with a minimum of a Bachelors level qualification in Acupuncture and will hold current Chinese Medicine practitioner registration with AHPRA. Practitioners will be observed at least once during the treatment period to ensure protocol compliance. Treatment session attendance will be recorded in case report forms. Usual care consists of the current treatment as advised by the participants medical practitioner. It varies from person to person but usually includes either analgesic medication (such as non-steroidal anti-inflammatories) or hormonal treatments such as the oral contraceptive pill. Subjects will continue with all prescribed medication and can use analgesics as needed for pain relief.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 18-45 * have a laparoscopic diagnosis of endometriosis in the last 5 years * having regular menstruation * the presence of at least one of the following: dysmenorrhea, dyspareunia, dyschezia or dysuria rated >= 4/10 on a numeric rating scale.
Exclusion criteria
* endometriosis surgery within the past 6 months, * started oral or injectable contraceptive pill, GnRH-a or danazol within the last 6 months.
Outcome results
None listed