An interventional study of Multimodal physiotherapy in Chronic Pelvic Pain, sponsored by Kristiania University College. Not yet recruiting at 1 site in Norway. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Kristiania University College · Not applicable, Interventional, and Treatment
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.
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.
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.
3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 2,388 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Kristiania University College is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Multimodal physiotherapy
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.
Also known as: Physiotherapy, Pain education, Rehabilitation, Exercise therapy, Pelvic floor muscle training
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.
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.
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.
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.
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.
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.
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.
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)
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.
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)
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
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
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).
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
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.
Time frame: Immediately after completion of Phase B (post-intervention)
Plan to share: 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.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kristiania University College