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

Sponsor

University Hospital, Akershus (Other)

Overall Status

Recruiting

CT.gov ID

NCT05091268

Collaborator

Fysiofondet (Other), Kristiania University College (Other), Oslo University Hospital (Other)

Enrollment

Location

Arms

46.5

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Endometriosis	Behavioral: Exercise	N/A

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

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Effect of Physical Activity and Pain Education on Endometriosis-associated Pain A Randomizes Controlled Trial With a Multimodal Interdisciplinary Group Approach

Actual Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise group 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.	Behavioral: Exercise 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
No Intervention: Pain education group No further follow-up

Arm

Intervention/Treatment

Experimental: Exercise group

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.

Behavioral: Exercise

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

No Intervention: Pain education group

No further follow-up

Outcome Measures

Primary Outcome Measures

Endometriosis associated pain [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported genito-pelvic 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 Outcome Measures

Level of physical activity [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported physical activity level will be measured using the International physical activity questionnaire-short form (IPAQ-SF).
Pelvic floor muscle maximal contraction and resting tension [Measured at baseline and after 4 months]
Pelvic floor muscle maximal contraction and muscular endurance will be measured with manometer using a vaginal balloon catheter Camtech Sandvika Norge AS (cmH2O) will be assessed. This method has demonstrated good validity and reliability, by our research group. Resting tension and the ability to contract using surface electromyography (EMG) will be used with a vaginal probe (Quintet). We will also perform vaginal palpation to assess pain/tenderness and tone. (All women will be instructed on how to correctly perform a pelvic floor muscle contraction prior to assessment).
Sexual function and sexual pain [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported assessment using the Female Sexual Function Index (FSFI). We will also use questions adapted from Sahlgrenska University Hospital related to sexual pain.
Depression and anxiety [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported assessment using Hopkins Symptom Check List (SCL-5)
Pain with urination [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported assessment of pain prior to, during or after urination (developed by urologists at Akershus University Hospital)
Bowel function [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported assessment of bowel function including pain and constipation using the Knowles-Eccersley-Scott-Symptom (KESS)
Health economy and related quality of life [Measured at baseline and after 4 months and 12 months]
Electronically patient-reported assessment using health-related quality of life questionnaire (EQ5D)

Other Outcome Measures

Body mass index [Measured at baseline]
Weight and height will be combined to report BMI in kg/m^2. Weight will be measures wearing underwear and height will be measured against a wall wearing no shoes or heavy clothing.
Satisfaction and experience with physical activity and pain management [Measured after 4 months]
A qualitative interview with open ended questions to participants in both the intervention and control group that include satisfaction with participating and experience with physical exercise and pain management.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.