Back to resultsEffect of Physical Activity and Pain Education on Endometriosis-associated Pain
Primary Purpose
Endometriosis
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis focused on measuring endometriosis, women's health, pelvic floor, physical activity, pain education, quality of life
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.
Sites / Locations
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Pain education group
Arm 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.
No further follow-up
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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).
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
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
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
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
Health economy and related quality of life
Electronically patient-reported assessment using health-related quality of life questionnaire (EQ5D)
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).
Full Information
NCT ID
NCT05091268
First Posted
September 23, 2021
Last Updated
August 30, 2023
Sponsor
University Hospital, Akershus
Collaborators
Fysiofondet, Kristiania University College, Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05091268
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Fysiofondet, Kristiania University College, Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
Keywords
endometriosis, women's health, pelvic floor, physical activity, pain education, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm 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.
Arm Title
Pain education group
Arm Type
No Intervention
Arm Description
No further follow-up
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention 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
Primary Outcome Measure Information:
Title
Endometriosis associated pain
Description
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.
Time Frame
Measured at baseline and after 4 months and 12 months
Secondary Outcome Measure Information:
Title
Level of physical activity
Description
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
Time Frame
Measured at baseline and after 4 months and 12 months
Title
Pelvic floor muscle maximal contraction and resting tension
Description
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).
Time Frame
Measured at baseline and after 4 months
Title
Sexual function and sexual pain
Description
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
Time Frame
Measured at baseline and after 4 months and 12 months
Title
Depression and anxiety
Description
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
Time Frame
Measured at baseline and after 4 months and 12 months
Title
Pain with urination
Description
Electronically patient-reported assessment of pain prior to, during or after urination (developed by urologists at Akershus University Hospital). Categories of answers
Time Frame
Measured at baseline and after 4 months and 12 months
Title
Bowel function
Description
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
Time Frame
Measured at baseline and after 4 months and 12 months
Title
Health economy and related quality of life
Description
Electronically patient-reported assessment using health-related quality of life questionnaire (EQ5D)
Time Frame
Measured at baseline and after 4 months and 12 months
Title
Fear of movement
Description
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).
Time Frame
Measured at baseline and after 4 months and 12 months
Other Pre-specified Outcome Measures:
Title
Body mass index
Description
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.
Time Frame
Measured at baseline
Title
Satisfaction and experience with physical activity and pain management
Description
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.
Time Frame
Measured after 4 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
The study is on endometriosis which only affect women in fertile age
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Kolberg Tennfjord, Phd
Organizational Affiliation
University Hospital, Akershus
Official's Role
Study Director
Facility Information:
Facility Name
Akershus University Hospital
City
Lillestrøm
State/Province
Nordbyhagen
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Within reasonable request, anonymised data could be shared with other researchers. Data from training diaries and transcripts from qualitative interviews will not be shared.
IPD Sharing Time Frame
The data will be available from 2024 until 2031
IPD Sharing Access Criteria
Researchers in the field of endometriosis
Learn more about this trial
Effect of Physical Activity and Pain Education on Endometriosis-associated Pain
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