Chronic Pelvic Pain
Conditions
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
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.
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.
Interventions
BEHAVIORALMultimodal 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.
Sponsors
Kristiania University College
Oslo Metropolitan University
Norwegian Fund for Postgraduate Training in Physiotherapy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity in chronic pelvic pain | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Literacy | Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Perceived change in chronic pelvic pain | Assessed immediately after completion of Phase B (post-intervention), and at 12-month follow-up | 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. |
| Treatment satisfaction | Assessed immediately after completion of Phase B (post-intervention) | 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. |
| Psychological distress (anxiety and depression symptoms) | Assessed at pre-intervention (before Phase A), immediately after completion of Phase B (post-intervention), and at 12-month follow-up | 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. |
| Experiences of chronic pelvic pain and the multimodal physiotherapy intervention | Immediately after completion of Phase B (post-intervention), with an optional follow-up interview at 12-months follow-up | 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). |
| Physiotherapists' experiences of delivering the multimodal physiotherapy intervention | Immediately after completion of Phase B (post-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. |
Countries
Norway
Contacts
CONTACTMadeleine Lyngmo Johansen, PhD Student
CONTACTMerete Kolberg Tennfjord, PhD
PRINCIPAL_INVESTIGATORMerete Kolberg Tennfjord, PhD
Kristiania University College
Outcome results
None listed