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

NCT05091268 | Active Not Recruiting

• 1 other identifier: 2019/28494(REK)
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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).

Conditions

Endometriosis

Keywords

endometriosis; women's health; pelvic floor; physical activity; pain education; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Level of physical activity

  Measured at baseline and after 4 months and 12 months

• Pelvic floor muscle maximal contraction and resting tension

  Measured at baseline and after 4 months

• Sexual function and sexual pain

  Measured at baseline and after 4 months and 12 months

• Depression and anxiety

  Measured at baseline and after 4 months and 12 months

• Pain with urination

  Measured at baseline and after 4 months and 12 months

Other Outcomes (3)

• Body mass index

  Measured at baseline

• Satisfaction and experience with physical activity and pain management

  Measured after 4 months

• Satisfaction and experience with physical activity and pain management

  Measured after 4 months and 12 months

Study Arms (2)

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.

Behavioral: Exercise

Pain education group

NO INTERVENTION

No further follow-up

Interventions

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

Exercise group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study is on endometriosis which only affect women in fertile age
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Fysiofondet: collaborator
• Kristiania University College: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Lillestrøm, Nordbyhagen, 1478, Norway

Location

Related Publications (3)

• 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.

  PMID: 41006088 DERIVED

• 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.

  PMID: 40686285 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.

  PMID: 39261815 DERIVED

MeSH Terms

Conditions

Endometriosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Merete Kolberg Tennfjord, Phd

  University Hospital, Akershus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 25, 2021
• Study Start: February 15, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available from 2024 until 2031
• Access Criteria: Researchers in the field of endometriosis

Locations

NO (1)