Clinical trial NCT05091268: Effect of Physical Activity and Pain Education on Endometriosis-associated Pain
Official title: Effect of Physical Activity and Pain Education on Endometriosis-associated Pain A Randomizes Controlled Trial With a Multimodal Interdisciplinary Group Approach
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
women's health
pelvic floor
physical activity
pain education
quality of life
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Fysiofondet
name: Kristiania University College
name: Oslo University Hospital
First posted: 2021-10-25
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endometriosis associated pain
timeFrame: Measured at baseline and after 4 months and 12 months
Secondary outcomes:
measure: Level of physical activity
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Pelvic floor muscle maximal contraction and resting tension
timeFrame: Measured at baseline and after 4 months
measure: Sexual function and sexual pain
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Depression and anxiety
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Pain with urination
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Bowel function
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Health economy and related quality of life
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Fear of movement
timeFrame: Measured at baseline and after 4 months and 12 months
measure: Pain with defecation
timeFrame: Measured at baseline and after 4 months and 12 months
measure: General pain
timeFrame: Measured at baseline and after 4 months and 12 months
Other outcomes:
measure: Body mass index
timeFrame: Measured at baseline
measure: Satisfaction and experience with physical activity and pain management
timeFrame: Measured after 4 months
measure: Satisfaction and experience with physical activity and pain management
timeFrame: Measured after 4 months and 12 months
Locations:
city: Lillestrøm
country: Norway
facility: Akershus University Hospital
state: Nordbyhagen
Study officials:
affiliation: University Hospital, Akershus
name: Merete Kolberg Tennfjord, Phd
role: STUDY_DIRECTOR
References: