EndometriosisNCT05091268
Effect of Physical Activity and Pain Education on Endometriosis-associated Pain
A study testing Exercise in people with Endometriosis, run by University Hospital, Akershus at 1 site in Norway.
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)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteNorway
- Study dates
- 15 Feb 2022to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Physical Activity and Pain Education on Endometriosis-associated Pain A Randomizes Controlled Trial With a Multimodal Interdisciplinary Group Approach
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).
Read the 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.
- Conditions
- Endometriosis
- Being tested
- Exercise
- Keywords
- endometriosis, women's health, pelvic floor, physical activity, pain education, quality of life
- Medical subject headings
- Endometriosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise |
| Pain education group | No intervention | No further follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and after 4 months and 12 months
Secondary outcomes (10)
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: Measured at baseline and after 4 months and 12 months
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: 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: 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: 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: 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: 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: 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: 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: 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: Measured at baseline and after 4 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start15 Feb 2022
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Fysiofondet, Kristiania University College, Oslo University Hospital
- Responsible party
- Principal investigator, Merete Kolberg Tennfjord, University Hospital, Akershus
- Investigators
- Merete Kolberg Tennfjord, Phd, Study director, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091268
- Sponsor's protocol ID
- 2019/28494(REK)
- Other IDs
- 2019
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within reasonable request, anonymised data could be shared with other researchers. Data from training diaries and transcripts from qualitative interviews will not be shared.
Publications
Gabrielsen R, Tellum T, Bo K, Engh ME, Tennfjord MK. Effect of pain management, supervised exercise, and pelvic floor muscle training on sexual function in women with endometriosis: A randomized controlled trial. Acta Obstet Gynecol Scand. 2026 Jul 22:10.1111/aogs.70318. doi: 10.1111/aogs.70318. Online ahead of print.
PubMed 42483830Gabrielsen 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.
PubMed 41006088Kvale 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.
PubMed 40686285Tennfjord 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.
PubMed 39261815
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physical Activity and Pain Education on Endometriosis-associated Pain A Randomizes Controlled Trial With a Multimodal Interdisciplinary Group Approach
- ClinicalTrials.gov ID
- NCT05091268
- Acronym / sponsor ID
- 2019/28494(REK)
- Conditions
- Endometriosis
- Keywords
- endometriosis, women's health, pelvic floor, physical activity, pain education, quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Fysiofondet, Kristiania University College, Oslo University Hospital
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseAll 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. |
| Pain education group | No intervention | –No further follow-up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAll 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 | Behavioural | Exercise group |
Primary outcome
Endometriosis associated pain
Time frame: Measured at baseline and after 4 months and 12 months
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.
10 secondary outcomes
Level of physical activity
Time frame: Measured at baseline and after 4 months and 12 months
Pelvic floor muscle maximal contraction and resting tension
Time frame: Measured at baseline and after 4 months
Sexual function and sexual pain
Time frame: 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
Pain with urination
Time frame: Measured at baseline and after 4 months and 12 months
Bowel function
Time frame: Measured at baseline and after 4 months and 12 months
Health economy and related quality of life
Time frame: Measured at baseline and after 4 months and 12 months
Fear of movement
Time frame: Measured at baseline and after 4 months and 12 months
Pain with defecation
Time frame: Measured at baseline and after 4 months and 12 months
General pain
Time frame: Measured at baseline and after 4 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 42483830Gabrielsen R, Tellum T, Bo K, Engh ME, Tennfjord MK. Effect of pain management, supervised exercise, and pelvic floor muscle training on sexual function in women with endometriosis: A randomized controlled trial. Acta Obstet Gynecol Scand. 2026 Jul 22:10.1111/aogs.70318. doi: 10.1111/aogs.70318. Online ahead of print.
- Derived from this study: PubMed 41006088Gabrielsen 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.
- Derived from this study: PubMed 40686285Kvale 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.
- Derived from this study: PubMed 39261815Tennfjord 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.
- Individual participant dataSharing planned: Yes. Within reasonable request, anonymised data could be shared with other researchers. Data from training diaries and transcripts from qualitative interviews will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Kolberg Tennfjord, Phd study director
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Endometriosis, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometriosis associated pain (time frame: Measured at baseline and after 4 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05091268, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.