Effect of Physical Activity and Pain Education on Endometriosis-associated Pain A Randomizes Controlled Trial With a Multimodal Interdisciplinary Group Approach
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Endometriosis associated pain
Study Overview
Brief Summary
Endometriosis is a benign gynecological condition where the uterine endometrium is located outside the uterus. The condition affects up to 10% of women of fertile age and up to 70% of women with endometriosis have symptoms with severe pain during menstruation (dysmenorrhea), pain during intercourse (dyspareunia), and/or chronic pelvic pain. Current treatments are dictated by the primary symptom: pain and are limited to surgery and hormonal treatments with often short-lived effects. Advances in the understanding of the condition have expanded to focus on less invasive and non-pharmacological treatments. Systematic reviews and meta-analyses of observational studies have focused on the protective role of physical activity and exercise on the risk of developing endometriosis. The results from these studies have been inconclusive. However, the efficacy of physical activity and exercise on pain among women with endometriosis has not been tested in high-quality randomized controlled trials (RCT).
Detailed Description
Due to the complexity of the disease, international clinical guidelines recommend that the treatment of endometriosis-associated pain should come from a multimodal and multidisciplinary perspective. Numerous non-pharmacological treatments have been proposed to alleviate endometriosis-associated pain, such as physical activity. Physical activity was introduced as a factor in the treatment of endometriosis-associated pain over three decades ago, with the possible beneficial effect that physical activity stimulates anti-inflammatory properties that will impede the development of endometriosis and lower the pain. A recent systematic review and meta-analysis found one randomized controlled study that showed no effect of physical activity on endometriosis-associated pain. They concluded that the methodological quality of this study was low, and the need for future randomized controlled studies was warranted. We, therefore, aimed to study the effect of pain education and group-based physical activity versus pain education alone on women with endometriosis-associated pain.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women of age 18-45 with signs of endometriosis on ultrasound and/or MRI and/or confirmed by laparoscopy with histology at Akershus University Hospital and Oslo University Hospital. Women may also be recruited through social media but must present with diagnosis of endometriosis.
- •genital-pelvic pain ≥4/10 as measured on a numeric rating scale.
- •able to understand and speak Norwegian language
- •able to meet at Akershus University Hospital for participation in the study
- •giving signed consent to participate.
Exclusion Criteria
- •Intra-abdominal or vaginal surgery in the last six months
- •Patients who have received Botox over the past four months
- •Severe pathology (malignancy),cardiovascular conditions and immune system diseases diagnosed by specialist; pregnancy, as well as childbirth the last 12 months and breastfeeding; severe psychiatric disorders that demands or has demanded admission to the hospital; personality disorder diagnosed by specialist and recently started or recently adjusted ongoing hormonal therapy.
- •Participants should not have any disease or injury that could prevent them from participating in the intervention.
- •Participants will be encouraged not to start with any new treatment (non-pharmacological or pharmacological) during the four-month intervention period.
- •Participants who have recently undergone surgery and received Botox injections into the pelvic area can be referred but must wait 4-6 months before being included in the study. Women with planned surgery or Botox in the study period will be excluded.
- •Participants recently started or adjusting ongoing hormonal therapy must wait 3-6 months to be included in the study.
Outcomes
Primary Outcomes
Endometriosis associated pain
Time Frame: Measured at baseline and after 4 months and 12 months
Electronically patient-reported pelvic and genital pain will include a pain body map and pain intensity scale (NRS). We will ask for average pain, worst pain, and conditional pain over the course of one month.
Secondary Outcomes
- Bowel function(Measured at baseline and after 4 months and 12 months)
- Fear of movement(Measured at baseline and after 4 months and 12 months)
- Level of physical activity(Measured at baseline and after 4 months and 12 months)
- Pelvic floor muscle maximal contraction and resting tension(Measured at baseline and after 4 months)
- Pain with urination(Measured at baseline and after 4 months and 12 months)
- Health economy and related quality of life(Measured at baseline and after 4 months and 12 months)
- Sexual function and sexual pain(Measured at baseline and after 4 months and 12 months)
- Depression and anxiety(Measured at baseline and after 4 months and 12 months)
- Pain with defecation(Measured at baseline and after 4 months and 12 months)
- General pain(Measured at baseline and after 4 months and 12 months)
Investigators
Merete Kolberg Tennfjord
Phd
University Hospital, Akershus