Effect of Physical Activity and Pain Education on Endometriosis-associated Pain

University Hospital, Akershus

Status: Active, not recruiting

Conditions: Endometriosis

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05091268

2019/28494(REK)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 83 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 2 patient groups

Exercise group

Experimental group

Description:

All participants will attend a four-hour pain education session including gynecologist, psychologist, sexologist, and physiotherapist at Akershus University Hospital. The education will be held twice, with half of the participants at the time. The training group will then attend a 60 minutes weekly group training session led by a physiotherapist with specialist training in women's health, over a period of four months. In addition, participants will perform a progressive home exercise program performed daily over the same period. The focus will be general strength training using own body weight and cardiovascular fitness (walking, low-impact aerobic exercise), stretching, and relaxation.

Treatment:

Behavioral: Exercise

Pain education group

No Intervention group

Description:

No further follow-up