Chronic Pelvic PainNCT07820176

CPP Among Somali Women in Norway: SCED

A study testing Multimodal physiotherapy in people with Chronic Pelvic Pain, run by Kristiania University College at 1 site in Norway.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Chronic pelvic pain (CPP) in women is a condition associated with negative cognitive, behavioral, sexual and emotional consequences. Although multimodal physiotherapy is recommended for women with CPP, it is unclear whether evidence can be adopted to Somali women living in Norway. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Chronic Pelvic Pain
What is being tested?: Multimodal physiotherapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteNorway
Study dates: Sep 2026to Dec 2031
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

Biological females, aged between 18 and 45 years
Chronic pelvic pain symptoms >3 months
Moderate to severe pain intensity (≥4/10)
Somali background and currently residing in Norway
Able to understand simple Norwegian
Able to perform physical activity of low to moderate intensity
Able to travel to physiotherapy appointments for participation
Able and willing to give informed consent to participate.

Who cannot join

Surgery during the past 12 months and any medical conditions that would interfere with the ability to participate
Severe pathology (malignancy)
Pregnancy, as well as childbirth within the last 12 months and breastfeeding
Severe psychiatric disorders
Exercising regularly including pelvic floor muscle training (PFMT) more than once per week.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Madeleine Lyngmo Johansen, PhD Student contact

+47 47381177

madeleine.lyngmojohansen@kristiania.no

Merete Kolberg Tennfjord, PhD contact

+47 98663431

meretekolberg.tennfjord@kristiania.no

Norway1 site

Different physiotherapy clinics in South-Eastern Norway
Oslo
Merete K Tennfjord, PhD, +4798663431, meretekolberg.tennfjord@kristiania.no

Other trials in Norway

About this study

Official title: Chronic Pelvic Pain Among Somali Women Living in Norway: Effect of Self-management Strategies Assessed Through a Single-case Experimental Design

This study aims to evaluate a culturally adapted multimodal physiotherapy intervention consisting of pain education, physical activity, pelvic floor muscle training, and self-management strategies among Somali women with CPP.

The study uses a single-case experimental design with a nonconcurrent randomized multiple baseline. The design allows each participant to serve as their own control while all participants receive the intervention. Repeated quantitative outcome measures will evaluate changes in pain-related outcomes, perceived change in condition, treatment satisfaction, quality of life, health literacy, and self-efficacy. Qualitative interviews will explore feasibility and acceptability of the intervention, and the participants' experiences of chronic pelvic pain, and understanding and management of their own health.

Read the detailed description

Single-case experimental design (SCED) with repeated measurements structured into a nonconcurrent randomized multiple baseline design is the method of this study.

The study is divided into pre-intervention, baseline (Phase A), the intervention period (Phase B), post-intervention and follow-up.

Pre-intervention is the time period before baseline (Phase A). During this timperiod the participants will fill out the first questionnaire package.

Phase A is the baseline phase before initiation of the intervention. During this phase, pain-related outcomes and overall health (EQ VAS) will be measured repeatedly. There are three possible baseline lengths (4, 5, or 6 weeks) and the participants will be randomized to one of the baseline lenghts.

Phase B is the multimodal physiotherapy intervention, which starts immediately after the baseline period (intervention starts in week 5, 6, or 7, depending on the baseline length) and lasts for six months (24 weeks). The intervention consists of two parts. During the first two months (Phase B1), participants receive weekly physiotherapy sessions that include pain education and general physical activity, consisting of exercises targeting strength, mobility, balance, and endurance. During the following four months (Phase B2), participants receive physiotherapy sessions every other week. They continue with pain education and general physical activity, while pelvic floor muscle training and education on pelvic anatomy are introduced during this phase. Participants receive a total of 16 physiotherapy sessions during Phase B.

Throughout the intervention period (Phase B), participants will be encouraged to perform home-based exercises weekly as part of a self-management approach, supported by training diaries and individualized follow-up from women's health physiotherapists.

Post-intervention is the time period six months after baseline (Phase A) and immediately after intervention (Phase B). During this timperiod the participants will fill out the second questionnaire package and participate in individual interviews. The physiotherapists delivering the intervention will also participate in individual interviews.

Follow-up assessments will be conducted 12 months after baseline (Phase A). At this timperiod the participants will fill out the last questionnaire package and a second optional individual interview.

Outcomes are measured repeatedly within the baseline and intervention phases, allowing each participant to serve as their own control and enabling evaluation of changes following intervention initiation.

Pre-intervention, post-intervention, and follow-up questionnaire assessments will include outcomes related to health literacy, quality of life, function, self-efficacy, perceived change in condition, treatment satisfaction, and mental health symptoms.

Conditions: Chronic Pelvic Pain
Being tested: Multimodal physiotherapy
Keywords: Single-Case Experimental Design, Physiotherapy, Women's Health Physiotherapy, Women's Health, Migration Health, Chronic pain, Pain, Health Literacy, Quality of life, Physical activity, Pain education, Behavioral Therapy, Therapeutics, Rehabilitation, Chronic pelvic pain, Vulvodynia, Visual analysis
Medical subject headings: Chronic Pain, Pain, Motor Activity, Vulvodynia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multimodal physiotherapyBehavioural
Also called Physiotherapy, Pain education, Rehabilitation, Exercise therapy
The intervention consists of a multimodal physiotherapy program including physiotherapist-guided exercises, a home exercise program performed three times per week, and pain education.
The intervention is based on a standardized protocol with individualized adaptations according to each participant's symptoms, functional level, and progression.
All participants receive the same core intervention components.

Study groups in NCT07820176
Study group	Role	What they receive
Multimodal physiotherapy	Experimental	Participants will complete a randomized multiple baseline phase of 4, 5, or 6 weeks before receiving a multimodal physiotherapy intervention. The intervention includes pain education, general physical activity, and pelvic floor muscle training with guidance and individualized adaptations based on participant needs by a physiotherapist, including a home exercise program performed up to three times per week. The same core intervention components will be delivered to all participants. Receives: Behavioral: Multimodal physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain severity in chronic pelvic pain
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for severity of pain today. For each scale, 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores indicate greater symptom burden.
Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up.
The participant can choose to use the Norwegian or the Somali version of the question.
Measured: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.
Chronic pelvic pain-related distress
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for distress of pain today. For each scale, 0 indicates "no distress" and 10 indicates "extreme pain-related distress". Higher scores indicate greater symptom burden.
Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up.
The participant can choose to use the Norwegian or the Somali version of the question.
Measured: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.
Chronic pelvic pain-related interference
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for interference of pain today. For each scale, 0 indicates "no interference" and 10 indicates "inability to perform activities". Higher scores indicate greater symptom burden.
Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B).
It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up.
The participant can choose to use the Norwegian or the Somali version of the question.
Measured: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.

Secondary outcomes (10)

Health Literacy
Assessed using domains 2 (Having sufficient information to manage my health), 3 (Actively managing my health), 4 (Social support for health), and 8 (Ability to find good health information) of the Health Literacy Questionnaire (HLQ), comprising a total of 19 items.
Domains 2, 3, and 4 are rated on a 4-point agreement scale, while domain 8 is rated on a 5-point difficulty scale. Each domain is scored and interpreted separately according to the HLQ scoring guidelines.
The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Measured: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Health-related quality of life (EQ-5D-5L descriptive system)
Health-related quality of life will be assessed using the EQ-5D-5L descriptive system. The questionnaire measures five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels ranging from no problems to extreme problems/unable to perform the activity.
The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Measured: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Overall health (EQ VAS)
Overall health will be assessed using the EQ Visual Analogue Scale (EQ VAS) of the EQ-5D-5L. Participants rate their overall health today on a vertical visual analogue scale ranging from 0 (the worst health the participant can imagine) to 100 (the best health the participant can imagine).
The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Measured: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Patient-specific functional ability
Patient-specific functional ability will be assessed using the Patient-Specific Functional Scale (PSFS). Participants will identify three personally meaningful activities affected by chronic pelvic pain and rate their ability to perform each activity on an 11-point scale from 0 (unable to perform the activity) to 10 (able to perform the activity without difficulty). Higher scores indicate better functional ability. At the initial assessment, a brief interviewer-assisted process will be used to support participants in identifying relevant activities. Subsequent assessments will use the same individually selected activities. The participant can choose to answer in Norwegian or Somali.
Measured: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Self-efficacy for managing chronic pelvic pain
Self-efficacy for managing chronic pelvic pain will be assessed using a study-specific single-item question. Participants will rate their confidence in their ability to manage their pelvic pain independently in daily life on an 11-point scale ranging from 0 (no confidence in my ability to manage my pelvic pain independently) to 10 (very high confidence in my ability to manage my pelvic pain independently). Higher scores indicate greater perceived self-efficacy.
The participant can choose to use the Norwegian or the Somali version of the question.
Measured: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Perceived change in chronic pelvic pain
Perceived change in chronic pelvic pain will be assessed using a study-specific single-item question based on the Global Rating of Change (GROC) scale. Participants will rate how their pelvic pain has changed compared with the start of the study on an 11-point scale ranging from -5 (very much worse), 0 (no change), to +5 (completely pain-free). Higher scores indicate greater perceived improvement.
The participant can choose to use the Norwegian or the Somali version of the question.
Measured: Assessed immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Treatment satisfaction
Treatment satisfaction will be assessed using four study-specific single-item questions rated on an 11-point scale ranging from 0 (completely dissatisfied) to 10 (completely satisfied). Participants will rate their satisfaction with pain education, general physical activity, pelvic floor muscle training, and overall satisfaction with the intervention. Higher scores indicate greater satisfaction. The participant can choose to use the Norwegian or the Somali version of the questions.
Measured: Assessed immediately after completion of Phase B (post-intervention)
Psychological distress (anxiety and depression symptoms)
Psychological distress will be assessed using the Hopkins Symptom Checklist-5 (HSCL-5), a five-item self-report questionnaire assessing symptoms of anxiety and depression during the previous two weeks. Items are rated on a 4-point scale ranging from 1 (not at all) to 4 (extremely). Higher scores indicate higher levels of psychological distress. The participant can choose to use the Norwegian or the Somali version of the questionnaire.
Measured: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Experiences of chronic pelvic pain and the multimodal physiotherapy intervention
Individual semi-structured interviews will be conducted with participants receiving the intervention. Interviews will use open-ended questions, and interviews will be conducted in their preferred language when needed.
The interviews will explore experiences, perceptions, and acceptability of the intervention, including understanding and management of chronic pelvic pain, health literacy, and bodily and emotional experiences related to overall health and quality of life. The interview guide will be informed by relevant domains from the Health Literacy Questionnaire (HLQ) and inspired by questions from the Conversational Health Literacy Assessment Tool (CHAT).
Measured: Immediately after completion of Phase B (post-intervention), with an optional follow-up interview at 12-months follow-up
Physiotherapists' experiences of delivering the multimodal physiotherapy intervention
Individual semi-structured interviews will be conducted with physiotherapists delivering the intervention. Interviews will use open-ended questions and will explore the physiotherapists' experiences of delivering the intervention, including perceived feasibility, acceptability, and possibilities of implementation in clinical practice.
Measured: Immediately after completion of Phase B (post-intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2026Dec 2031

First posted15 Sep 2026
Study startSep 2026 (estimated)
Primary completionDec 2029 (estimated)
Study completionDec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Chronic Pelvic PainStudies 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: Not applicable
Intervention model: Single group
Model description: The study tests multimodal physiotherapy (pain education + increased physical activity) using a multiple baseline single-case experimental design (MBD SCED; N of 1). Each participant (n=20-30) serves as their own control with repeated measures: comprehensive surveys pre, post and at 12-month follow-up, plus brief measures 3×/week during baseline and intervention. Intervention onset is randomized to 4, 5 or 6 week baselines to create a staggered multiple baseline across participants, strengthening causal inference. Participant interviews post-intervention and at 12 months, and physiotherapist interviews post-intervention, explore experiences, acceptability and feasibility. Individual treatment effects will be estimated and pooled to produce an overall effect while preserving within-person comparisons. No separate control group. SCED is chosen because the intervention and chronic pain are complex, recruitment is challenging, and feasibility and individual variability are priorities.
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07820176
Sponsor's protocol ID: 941139
Other IDs: 335181
Status last verified: Sep 2026
First submitted: 12 Aug 2026
Last updated: 15 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared with other researchers due to concerns regarding participant confidentiality and the risk of re-identification. The study includes a small and culturally specific sample of Somali women living in Norway and collects sensitive health-related information, including repeated self-reported outcome measures and qualitative interview data. The combination of demographic characteristics, health-related information, and detailed personal experiences described in interviews may increase the possibility of identifying individual participants even after removal of direct identifiers. Data will therefore only be accessible to the research team and managed according to approved ethical and data protection procedures.

Publications

Engeler D, Baranowski AP, Berghmans B, Cottrell AM, Dütschler J, Flink I, Grzybowska IM, Parsons B, Petersen K, Pinto RA, Tidman V, Vyawahare B. EAU Guidelines on Chronic Pelvic Pain. European Association of Urology; 2021. Available from: https://uroweb.org/guideline/chronic-pelvic-pain/.
Manolov R, Moeyaert M, Fingerhut JE. A Priori Justification for Effect Measures in Single-Case Experimental Designs. Perspect Behav Sci. 2021 Mar 25;45(1):153-186. doi: 10.1007/s40614-021-00282-2. eCollection 2022 Mar.
PubMed 35342872
Gele AA, Pettersen KS, Torheim LE, Kumar B. Health literacy: the missing link in improving the health of Somali immigrant women in Oslo. BMC Public Health. 2016 Nov 3;16(1):1134. doi: 10.1186/s12889-016-3790-6.
PubMed 27809815
Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
PubMed 20046623
Wahl AK, Hermansen A, Osborne RH, Larsen MH. A validation study of the Norwegian version of the Health Literacy Questionnaire: A robust nine-dimension factor model. Scand J Public Health. 2021 Jun;49(4):471-478. doi: 10.1177/1403494820926428. Epub 2020 Jun 7.
PubMed 32508258
Engeler D, Baranowski AP, Berghmans B, Cottrell AM, Dütschler J, Flink I, Grzybowska IM, Parsons B, Petersen K, Pinto RA, Tidman V, Vyawahare B. EAU Guidelines on Chronic Pelvic Pain. European Association of Urology; 2021. Available from: https://uroweb.org/guideline/chronic-pelvic-pain/
Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, Carty C, Chaput JP, Chastin S, Chou R, Dempsey PC, DiPietro L, Ekelund U, Firth J, Friedenreich CM, Garcia L, Gichu M, Jago R, Katzmarzyk PT, Lambert E, Leitzmann M, Milton K, Ortega FB, Ranasinghe C, Stamatakis E, Tiedemann A, Troiano RP, van der Ploeg HP, Wari V, Willumsen JF. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020 Dec;54(24):1451-1462. doi: 10.1136/bjsports-2020-102955.
PubMed 33239350
Starzec-Proserpio M, Frawley H, Bo K, Morin M. Effectiveness of nonpharmacological conservative therapies for chronic pelvic pain in women: a systematic review and meta-analysis. Am J Obstet Gynecol. 2025 Jan;232(1):42-71. doi: 10.1016/j.ajog.2024.08.006. Epub 2024 Aug 13.
PubMed 39142363
Pathak A, Sharma S, Heinemann AW, Stratford PW, Ribeiro DC, Abbott JH. Development and assessment of a verbal response scale for the Patient-Specific Functional Scale (PSFS) in a low-literacy, non-western population. Qual Life Res. 2021 Feb;30(2):613-628. doi: 10.1007/s11136-020-02640-0. Epub 2020 Sep 23.
PubMed 32965632
Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
PubMed 29253607

Interested in taking part?

Madeleine Lyngmo Johansen, PhD Student

+47 47381177

madeleine.lyngmojohansen@kristiania.no

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome

All Chronic Pelvic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Chronic Pelvic Pain Among Somali Women Living in Norway: Effect of Self-management Strategies Assessed Through a Single-case Experimental Design
ClinicalTrials.gov ID: NCT07820176
Acronym / sponsor ID: 941139
Conditions: Chronic Pelvic Pain
Keywords: Single-Case Experimental Design, Physiotherapy, Women's Health Physiotherapy, Women's Health, Migration Health, Chronic pain, Pain, Health Literacy
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Kristiania University CollegeUniversity, hospital or other
Collaborators: Oslo Metropolitan University, Norwegian Fund for Postgraduate Training in Physiotherapy
Study start: Sep 2026 (estimated)
Primary completion: Dec 2029 (estimated)
Study completion: Dec 2031 (estimated)
First posted: 15 Sep 2026 (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.

Detailed description

Single-case experimental design (SCED) with repeated measurements structured into a nonconcurrent randomized multiple baseline design is the method of this study.

The study is divided into pre-intervention, baseline (Phase A), the intervention period (Phase B), post-intervention and follow-up.

Pre-intervention is the time period before baseline (Phase A). During this timperiod the participants will fill out the first questionnaire package.

Follow-up assessments will be conducted 12 months after baseline (Phase A). At this timperiod the participants will fill out the last questionnaire package and a second optional individual interview.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study tests multimodal physiotherapy (pain education + increased physical activity) using a multiple baseline single-case experimental design (MBD SCED; N of 1). Each participant (n=20-30) serves as their own control with repeated measures: comprehensive surveys pre, post and at 12-month follow-up, plus brief measures 3×/week during baseline and intervention. Intervention onset is randomized to 4, 5 or 6 week baselines to create a staggered multiple baseline across participants, strengthening causal inference. Participant interviews post-intervention and at 12 months, and physiotherapist interviews post-intervention, explore experiences, acceptability and feasibility. Individual treatment effects will be estimated and pooled to produce an overall effect while preserving within-person comparisons. No separate control group. SCED is chosen because the intervention and chronic pain are complex, recruitment is challenging, and feasibility and individual variability are priorities.

Arm	Type	Receives
Multimodal physiotherapy	Experimental	Behavioral: Multimodal physiotherapyParticipants will complete a randomized multiple baseline phase of 4, 5, or 6 weeks before receiving a multimodal physiotherapy intervention. The intervention includes pain education, general physical activity, and pelvic floor muscle training with guidance and individualized adaptations based on participant needs by a physiotherapist, including a home exercise program performed up to three times per week. The same core intervention components will be delivered to all participants.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Biological females, aged between 18 and 45 years
Chronic pelvic pain symptoms >3 months
Moderate to severe pain intensity (≥4/10)
Somali background and currently residing in Norway
Able to understand simple Norwegian

Key exclusion criteria (5 listed)

Surgery during the past 12 months and any medical conditions that would interfere with the ability to participate
Severe pathology (malignancy)
Pregnancy, as well as childbirth within the last 12 months and breastfeeding
Severe psychiatric disorders
Exercising regularly including pelvic floor muscle training (PFMT) more than once per week.

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
Multimodal physiotherapyAlso: Physiotherapy, Pain education, Rehabilitation, Exercise therapyThe intervention consists of a multimodal physiotherapy program including physiotherapist-guided exercises, a home exercise program performed three times per week, and pain education. The intervention is based on a standardized protocol with individualized adaptations according to each participant's symptoms, functional level, and progression. All participants receive the same core intervention components.	Behavioural	Multimodal physiotherapy

Primary outcome

Pain severity in chronic pelvic pain
Time frame: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for severity of pain today. For each scale, 0 indicates "no pain" and 10 indicates "worst imaginable pain". Higher scores indicate greater symptom burden. Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up. The participant can choose to use the Norwegian or the Somali version of the question.
Chronic pelvic pain-related distress
Time frame: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for distress of pain today. For each scale, 0 indicates "no distress" and 10 indicates "extreme pain-related distress". Higher scores indicate greater symptom burden. Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up. The participant can choose to use the Norwegian or the Somali version of the question.
Chronic pelvic pain-related interference
Time frame: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.
Assessed using an 11-point Numeric Rating Scale (NRS; 0-10), we ask for interference of pain today. For each scale, 0 indicates "no interference" and 10 indicates "inability to perform activities". Higher scores indicate greater symptom burden. Measured up to three times per week during single-case experimental design phases: baseline (A) and intervention (B). It will also be measured once at different time points: pre-intervention, post-intervention and at follow-up. The participant can choose to use the Norwegian or the Somali version of the question.

10 secondary outcomes

Health Literacy
Time frame: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Health-related quality of life (EQ-5D-5L descriptive system)
Time frame: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Overall health (EQ VAS)
Time frame: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Patient-specific functional ability
Time frame: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Self-efficacy for managing chronic pelvic pain
Time frame: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Perceived change in chronic pelvic pain
Time frame: Assessed immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Treatment satisfaction
Time frame: Assessed immediately after completion of Phase B (post-intervention)
Psychological distress (anxiety and depression symptoms)
Time frame: Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up
Experiences of chronic pelvic pain and the multimodal physiotherapy intervention
Time frame: Immediately after completion of Phase B (post-intervention), with an optional follow-up interview at 12-months follow-up
Physiotherapists' experiences of delivering the multimodal physiotherapy intervention
Time frame: Immediately after completion of Phase B (post-intervention)

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 15 Sep 2026.
BackgroundEngeler D, Baranowski AP, Berghmans B, Cottrell AM, Dütschler J, Flink I, Grzybowska IM, Parsons B, Petersen K, Pinto RA, Tidman V, Vyawahare B. EAU Guidelines on Chronic Pelvic Pain. European Association of Urology; 2021. Available from: https://uroweb.org/guideline/chronic-pelvic-pain/.
Background: PubMed 35342872Manolov R, Moeyaert M, Fingerhut JE. A Priori Justification for Effect Measures in Single-Case Experimental Designs. Perspect Behav Sci. 2021 Mar 25;45(1):153-186. doi: 10.1007/s40614-021-00282-2. eCollection 2022 Mar.
Background: PubMed 27809815Gele AA, Pettersen KS, Torheim LE, Kumar B. Health literacy: the missing link in improving the health of Somali immigrant women in Oslo. BMC Public Health. 2016 Nov 3;16(1):1134. doi: 10.1186/s12889-016-3790-6.
Background: PubMed 20046623Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.
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Official project webpage providing background information and a description of the study design and objectives.Link provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to concerns regarding participant confidentiality and the risk of re-identification. The study includes a small and culturally specific sample of Somali women living in Norway and collects sensitive health-related information, including repeated self-reported outcome measures and qualitative interview data. The combination of demographic characteristics, health-related information, and detailed personal experiences described in interviews may increase the possibility of identifying individual participants even after removal of direct identifiers. Data will therefore only be accessible to the research team and managed according to approved ethical and data protection procedures.

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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.

Madeleine Lyngmo Johansen, PhD Student contact

+47 47381177

madeleine.lyngmojohansen@kristiania.no

Merete Kolberg Tennfjord, PhD contact

+47 98663431

meretekolberg.tennfjord@kristiania.no

Merete Kolberg Tennfjord, PhD principal investigator

Kristiania University College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal physiotherapy in people with Chronic Pelvic Pain, run by Kristiania University College 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 8 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Sep 2026. 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?

Contact Madeleine Lyngmo Johansen, PhD Student (+47 47381177, madeleine.lyngmojohansen@kristiania.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain severity in chronic pelvic pain (time frame: Assessed at pre-intervention, repeatedly throughout the 4-6 week baseline (Phase A) and 6-month intervention (Phase B), immediately post-intervention, and at 12-month follow-up.). The study lists 3 primary outcomes in all. 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 NCT07820176, which also lists 10 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 15 Sep 2026.