CPP Among Somali Women in Norway: SCED

NCT07820176 | Not Yet Recruiting

• 2 other identifiers: 941139335181
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Pelvic Pain

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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 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)

  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)

  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

  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

  Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up

Study Arms (1)

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.

Behavioral: Multimodal physiotherapy

Interventions

Multimodal physiotherapy BEHAVIORAL

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

Multimodal physiotherapy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Eligible participants are individuals who were assigned female at birth and who self-identify as women. Participation is limited to individuals meeting both criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kristiania University College: lead
• Oslo Metropolitan University: collaborator
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

Different physiotherapy clinics in South-Eastern Norway

Oslo, Norway

Location

Related Publications (10)

• 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/.

  BACKGROUND

• 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.

  PMID: 35342872 BACKGROUND

• 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.

  PMID: 27809815 BACKGROUND

• 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.

  PMID: 20046623 BACKGROUND

• 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.

  PMID: 32508258 BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 33239350 BACKGROUND

• 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.

  PMID: 39142363 BACKGROUND

• 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.

  PMID: 32965632 BACKGROUND

• 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.

  PMID: 29253607 BACKGROUND

Related Links

• Official project webpage providing background information and a description of the study design and objectives.

MeSH Terms

Conditions

Chronic Pain; Pain; Motor Activity; Vulvodynia

Interventions

Physical Therapy Modalities; Rehabilitation; Exercise Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Merete Kolberg Tennfjord, PhD

  Kristiania University College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine Lyngmo Johansen, PhD Student

CONTACT

+47 47381177; madeleine.lyngmojohansen@kristiania.no

Merete Kolberg Tennfjord, PhD

CONTACT

+47 98663431; meretekolberg.tennfjord@kristiania.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: September 15, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)