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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05091268
• Other study ID #: 2019/28494(REK)
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 83
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

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

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lillestrøm	Nordbyhagen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Akershus	Fysiofondet, Kristiania University College, Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body mass index	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.	Measured at baseline
Other	Satisfaction and experience with physical activity and pain management	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.	Measured after 4 months
Other	Satisfaction and experience with physical activity and pain management	Self-defined questions on satisfaction with participation in the project	Measured after 4 months and 12 months
Primary	Endometriosis associated pain	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.	Measured at baseline and after 4 months and 12 months
Secondary	Level of physical activity	Electronically patient-reported physical activity level will be measured using the International physical activity questionnaire-short form (IPAQ-SF). We will analyse MET values and categories of activity in addition to walking	Measured at baseline and after 4 months and 12 months
Secondary	Pelvic floor muscle maximal contraction and resting tension	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).	Measured at baseline and after 4 months
Secondary	Sexual function and sexual pain	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. Higher scores indicates more problems. range 0-36	Measured at baseline and after 4 months and 12 months
Secondary	Depression and anxiety	Electronically patient-reported assessment using Hopkins Symptom Check List (SCL-5). Hopkins Symptom Checklist (SCL-5) was used to evaluate psychological distress, a higher score (up to 20) indicating greater psychological distress. range 0-20	Measured at baseline and after 4 months and 12 months
Secondary	Pain with urination	Electronically patient-reported assessment of pain prior to, during or after urination (developed by urologists at Akershus University Hospital). Categories of answers	Measured at baseline and after 4 months and 12 months
Secondary	Bowel function	Electronically patient-reported assessment of bowel function including pain and constipation using the Knowles-Eccersley-Scott-Symptom (KESS). Higher scores indicating more problems. range 0-39	Measured at baseline and after 4 months and 12 months
Secondary	Health economy and related quality of life	Electronically patient-reported assessment using health-related quality of life questionnaire (EQ5D)	Measured at baseline and after 4 months and 12 months
Secondary	Fear of movement	Tampa scale measuring fair of movement. Fair avoidance with Tampa Scale for Kinesiophobia (TSK-13), which score ranges from 0 - 52, 4 subcategories, "subclinical" (score 13-22), "mild" (score 23-32) "moderate" (score 33-42) and "severe" (score 43-52).	Measured at baseline and after 4 months and 12 months