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| Name | Class |
|---|---|
| Fysiofondet | OTHER |
| Kristiania University College | OTHER |
| Oslo University Hospital | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise group | Experimental | 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. |
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| Pain education group | No Intervention | No further follow-up |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Endometriosis associated pain | Electronically patient-reported pelvic and genital 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Satisfaction and experience with physical activity and pain management |
Inclusion Criteria:
Exclusion Criteria:
The study is on endometriosis which only affect women in fertile age
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| Name | Affiliation | Role |
|---|---|---|
| Merete Kolberg Tennfjord, Phd | University Hospital, Akershus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lillestrøm | Nordbyhagen | 1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41006088 | Derived | Gabrielsen R, Tellum T, Bo K, Engh ME, Frawley H, Nedregard Tveito S, Tennfjord MK. Supervised exercise and pelvic floor muscle training eases current pelvic and genital pain but not worst pelvic and genital pain in women with endometriosis: a randomised trial. J Physiother. 2025 Oct;71(4):246-253. doi: 10.1016/j.jphys.2025.09.012. Epub 2025 Sep 25. | |
| 40686285 |
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Within reasonable request, anonymised data could be shared with other researchers. Data from training diaries and transcripts from qualitative interviews will not be shared.
The data will be available from 2024 until 2031
Researchers in the field of endometriosis
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| 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 |
| 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 |
| 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 |
| 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. Alternatives will be yes/no. questions will also cover if the symptom increases during menstruation with alternatives yes, no, sometimes, always | Measured at baseline and after 4 months and 12 months |
| 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 |
| Health economy and related quality of life | Electronically patient-reported assessment using health-related quality of life questionnaire (EQ5D). Higher scores indicating better health. Questions also include questions on health care utilisation with categories over the last 4 weeks. Three questions on quality of life will also be included measured on a scale (0-10). | Measured at baseline and after 4 months and 12 months |
| 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 |
| Pain with defecation | Electronically patient-reported assessment of pain prior to, during or after defecation (developed by urologists at Akershus University Hospital). Categories of answers. Alternatives will be yes/no. questions will also cover if the symptom increases during menstruation with alternatives yes, no, sometimes, always | Measured at baseline and after 4 months and 12 months |
| General pain | General pain will be assessed with a body map in addition to self-developed questions. Alternatives will be yes/no. questions will also cover if the symptom increases during menstruation with alternatives yes, no, sometimes, always | Measured at baseline and after 4 months and 12 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. |
| Measured after 4 months |
| 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 |
| Kvale C, Tokovska M, Tennfjord MK. Women with endometriosis: Experiences with pain management and views on optimal healthcare through the concept of health literacy. Womens Health (Lond). 2025 Jan-Dec;21:17455057251347085. doi: 10.1177/17455057251347085. Epub 2025 Jul 21. |
| 39261815 | Derived | Tennfjord MK, Gabrielsen R, Bo K, Engh ME, Molin M. Can general exercise training and pelvic floor muscle training be used as an empowering tool among women with endometriosis? Experiences among women with endometriosis participating in the intervention group of a randomized controlled trial. BMC Womens Health. 2024 Sep 12;24(1):505. doi: 10.1186/s12905-024-03356-w. |
| D000091662 | Genital Diseases |
| D001519 | Behavior |