- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05091268
Effect of Physical Activity and Pain Education on Endometriosis-associated Pain
Effect of Physical Activity and Pain Education on Endometriosis-associated Pain A Randomizes Controlled Trial With a Multimodal Interdisciplinary Group Approach
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nordbyhagen
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Lillestrøm, Nordbyhagen, Norway, 1478
- Akershus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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. |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endometriosis associated pain
Time Frame: 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.
|
Measured at baseline and after 4 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pelvic floor muscle maximal contraction and resting tension
Time Frame: 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). |
Measured at baseline and after 4 months
|
Health economy and related quality of life
Time Frame: Measured at baseline and after 4 months and 12 months
|
Electronically patient-reported assessment using health-related quality of life questionnaire (EQ5D)
|
Measured at baseline and after 4 months and 12 months
|
Level of physical activity
Time Frame: 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).
We will analyse MET values and categories of activity in addition to walking
|
Measured at baseline and after 4 months and 12 months
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Pain with urination
Time Frame: 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).
Categories of answers
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Measured at baseline and after 4 months and 12 months
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Fear of movement
Time Frame: Measured at baseline and after 4 months and 12 months
|
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).
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Measured at baseline and after 4 months and 12 months
|
Sexual function and sexual pain
Time Frame: 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.
Higher scores indicates more problems.
range 0-36
|
Measured at baseline and after 4 months and 12 months
|
Depression and anxiety
Time Frame: Measured at baseline and after 4 months and 12 months
|
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
|
Bowel function
Time Frame: 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).
Higher scores indicating more problems.
range 0-39
|
Measured at baseline and after 4 months and 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body mass index
Time Frame: 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.
|
Measured at baseline
|
Satisfaction and experience with physical activity and pain management
Time Frame: Measured after 4 months
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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
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Satisfaction and experience with physical activity and pain management
Time Frame: Measured after 4 months and 12 months
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Self-defined questions on satisfaction with participation in the project
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Measured after 4 months and 12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Merete Kolberg Tennfjord, Phd, University Hospital, Akershus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/28494(REK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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