None listed
Conditions
Brief summary
Endometriosis is a condition where endometrial-like tissue grows outside the uterus. The direct consequences of endometriosis usually include different chronic pain symptoms, but also other symptoms beyond pain, such as fatigue, bloating, and gastrointestinal disturbances. The typically complex range of symptoms affects the quality of life of women with endometriosis. Endometriosis has also been consistently associated with mental health issues such as anxiety and depression. Unfortunately, many of the pharmaceutical medications for endometriosis have bothersome side effects or should only be used for a short period of time due to concerns related to dependence and addiction. Therefore, it is important to define other treatment options that are safe, effective, and associated with minor side effects. Acupuncture has shown promising results in previous research for the management of endometriosis. In addition, it is also considered a safe treatment. Acupuncture is the insertion of fine needles into specific body points. It is part of Traditional Chinese medicine (TCM) and aims to restore the balance, which is believed to be impaired in pathological conditions such as endometriosis. Each needle addresses the entire network, reflecting TCM’s holistic approach. We will test whether two types of acupuncture can improve endometriosis symptoms. We will also examine the safety of the treatment by monitoring any adverse events participants might experience.
Interventions
Arm 1: Verum acupuncture
Endometriosis is a chronic gynecological condition often associated with pain, and acupuncture has been investigated as a potential management option, though current evidence is limited.
Participants in the verum acupuncture group will attend ~45-minute sessions once a week for 12 weeks, during which sterile, single-use acupuncture needles will be inserted into acupuncture points according to traditional Chinese medicine principles. Needles will be retained for approxi
Arm 1: Verum acupuncture Endometriosis is a chronic gynecological condition often associated with pain, and acupuncture has been investigated as a potential management option, though current evidence is limited. Participants in the verum acupuncture group will attend ~45-minute sessions once a week for 12 weeks, during which sterile, single-use acupuncture needles will be inserted into acupuncture points according to traditional Chinese medicine principles. Needles will be retained for approximately 30 minutes per session. Stainless steel acupuncture needles (Seirin J-Type acupuncture needles) of varying gauge (0.20 x 30mm and 0.25 x 30mm), dependent on body shape, will be used. Acupuncture needles will be provided by Acuneeds (https://www.acuneeds.com/), an online distributor for acupuncture supply where acupuncture needles can be purchased. The verum acupuncture will follow a treatment manual developed using co-design by the research team. This treatment manual provides information on point selection according to Traditional Chinese medicine pattern differentiation and stimulation intensity according to acupuncture point. Treatments will be provided face-to-face at NICM Health Research Institute by the PhD candidate Nora Giese. Nora Giese is trained in acupuncture and holds a Master’s Degree in Advanced Oriental Medicine (United Kingdom). She has >10 years of experience in treating people with endometriosis, with at least 15 patients with endometriosis per week. Point location and needling depth will be as specified in A Manual of Acupuncture. No other TCM co-interventions (moxibustion, cupping, or herbal medicine) will be allowed during the trial. Adherence will be assessed through case report forms maintained by Nora Giese, documenting the number of sessions attended, duration of each session, and any missed or incomplete treatments.
Sponsors
Western Sydney University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
• Adults of reproductive age (18-45 years) • Confirmation of endometriosis via laparoscopy, laparotomy with or without histological confirmation, specialized transvaginal ultrasound scans (TVUSS), or ovarian endometrioma detected by imaging (MRI, ultrasound) in the past five years • Pelvic pain significant enough to seek medical attention
Exclusion criteria
• Endometriosis-related surgery in the last three months • Acupuncture treatments within the last three months • No changes in daily endometriosis-specific medication, such as hormonal treatment within the last three months; pro re nata analgesics used for pain are exempted from this criterion. • Phobia of needles. • Intend to become pregnant within the next seven months.
Outcome results
None listed