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Self-rated health, experiences and quality of life in regard to chronic pelvic girdle pain 10 years after delivery.

Research project At least 50 % of all pregnant women will develop different levels of PGP symptoms during pregnancy. Currently, the knowledge in respect of the long-term effect and life situation for women with chronic pelvic girdle pain is limited.

Pelvic girdle pain (PGP) is a common health problem during pregnancy. It is estimated that at least 50 % of all pregnant women will develop different levels of PGP symptoms during pregnancy. Even though the majority of women recover within three months after delivery, about 40 % of women still experience persistent symptoms. Currently, the knowledge in respect of the long-term effect and life situation for women with chronic pelvic girdle pain is limited. The aim of this project is to study risk factors and the long-term effects of persistent PGP as well as the experience of persistent PGP 10 years after delivery.

Head of project

Cecilia Bergström
Senior research assistant
E-mail
Email

Project overview

Project period:

2014-04-01 2016-11-30

Participating departments and units at Umeå University

Department of Clinical Sciences

Research subject

Clinical medicine

Project description

Background
Pelvic girdle pain (PGP) is a common health problem during pregnancy. It is estimated that at least 50 % of all pregnant women will develop some degree of PGP related symptoms during pregnancy (1). Around one third will develop a more severe form of PGP that disturbs the patient’s normal way of life (including working life and daily activities) during the pregnancy (1-3). The condition often occurs early in the pregnancy and is usually exacerbated in the latter part of the pregnancy (1, 2, 4). Even though PGP is a common complication of pregnancy, the underlying cause is still partly unknown(1). Biomechanical dysfunction of pelvic joints, hormonal factors, postural changes (4-6) and early menarche (7) have been postulated as causal mechanisms and risk factors of PGP during pregnancy include previous low back pain (LBP), hypermobility, overweight/obesity as well as low socioeconomic status (1). Furthermore, the risk for developing PGP during the next pregnancy has been estimated to 85-90 % (1, 2).
Historically there has been a lack of consensus concerning the diagnostic criteria of PGP. Recently, however, a European consensus proposal has recommended a battery of orthopaedic tests to assist in confirming a clinical diagnosis of PGP (1, 4). These include the P4 test (Posterior Pelvic Pain Provocation test), Patrick’s Fabere test, Gaenslen’s test, the modified Trendelenburg’s test and palpation tenderness of the ligaments and joints of the pelvis (4).
Despite the previous lack of clarity regarding cases, the prevalence of chronic pelvic girdle around 6 months post-delivery is estimated to range between 5-43 % (8-11). Noren et al (2002) observed that 5 % of all pregnant women or 20 % of pregnant women with LBP during pregnancy still experience symptoms three years after registered pregnancy (10). The prognosis for each particular patient, based on the clinical picture during pregnancy, has been shown to be difficult to determine with certainty.
Many women suffering from PGP experience difficulties with performing normal daily activities such as sitting for prolonged periods of time and/or getting up from sitting, turning around in bed, dress/undress, walking, lifting and carrying smaller weights (12, 13). Comparatively women with PGP often experience a greater degree of disability than those with non-specific LBP (10). For example, PGP sufferers are often forced to resort to the use of crutches or a wheelchair (13). Numerous women also experiences sexual difficulties due to pain. Research has found that 7 out of 10 women with PGP had an increased risk of unsatisfying sexual life during pregnancy compared to women without pain (14). Even though the majority of women that experiences PGP during pregnancy recover after about three months after delivery (15), an estimated 7 % still experiences persistent pain and disability (16). Currently, the knowledge in respect of the long term effect and life situation for women with chronic PGP is limited as there are relatively few studies concerning chronic PGP after pregnancy which has a longer follow-up than three months (8, 10, 15, 17, 18).
Chronic PGP constitutes a significant health problem for many women before, during and post-partum. It therefore stands to reason that the phenomenon be investigated both cross-sectionally and longitudinally.
Aim
The overall aim of this project is to study the risk factors and the long-term effect of chronic PGP as well as the experience of chronic PGP 10 years after delivery in women that has reported continuous or recurrent PGP at 12 months post-partum.
Specific aims
To observe women with a history of PGP during pregnancy and reported chronic PGP 12 months after pregnancy 10 years post-partum:
1) Evaluate current frequency of chronic PGP
2) Health outcome and medical rehabilitation history
3) Risk factors for chronic PGP 10 years after registered pregnancy
4) Quality of life, life processes, living habits, work situation, economic outcome, gynaecological and obstetric history, orthopaedic history and sick-leave pattern
5) The experience of women with on-going chronic PGP 10 years after registered pregnancy and its influence on family life, everyday life and working life
6) The experience of partner’s regarding the effect chronic PGP on the woman in relation to family life, everyday life and working life.

Study design
The specific aims in this research project will be investigated through qualitative and quantitative methods.
Participants and method
Definition of chronic PGP
Today, chronic PGP is defined in accordance with positive diagnostic tests as well as pain upon palpation of the ligaments and joints of the pelvis (4). The pain can be continuous or recurrent. However, this study commenced in 2002 and at that point in time the above definition was not available. Instead pain drawings were used to describe pain location (19). Thus, pain drawings will be used to define chronic PGP 10 years after post-partum.
This current project is a long-term follow-up (10 years) of women with reported PGP during a registered pregnancy and reported chronic PGP 12 months after pregnancy. The primary data collection took place between 2002 and 2003 through a series of three questionnaires distributed to patients:
1) Shortly after delivery
2) Six months after delivery
3) 12 months after pregnancy.

The first questionnaire (Q1) was distributed between January 1st 2002 and April 30th 2002. It is a population based cross-over study at Norrland university hospital in Umeå and Sunderby hospital in Luleå, where LBP and PGP during pregnancy were investigated through a number of parameters. More than 70 % (n=639) of the participating women were considered to have developed LBP and/or PGP during the pregnancy.
The second questionnaire (Q2) were sent out six months after delivery to all of the 639 women who had reported LBP and/or PGP during the pregnancy (Q1), in which 43 % (n=200) reported residual PGP (11).
The third questionnaire (Q3) were sent out 12 months after delivery to those women that reported continuous or recurrent pain six months after delivery (n=200). This questionnaire show that only 19.3 % (n=34) of women were symptom free, 65.3 % (n=115) reported recurrent PGP and 15.3 % (n=27) reported continuous chronic PGP (not yet published data).
Four studies are planned in this project:
Study 1: Descriptive study of women with PGP
A fourth follow-up questionnaire (Q4) is to be sent out to all participants who reported PGP at Q1 (n=639). The questionnaire will include questions that investigates health outcomes after registered pregnancy, medical rehabilitation history, pain drawing, risk factors related to chronic PGP, quality of life, life processes, living habits, family situation, sexual life, breast feeding history, self-rated health, gynaecological and obstetric history, orthopaedic history, working situation, economic outcome and sick-leave pattern. The group of women with chronic PGP will be described with the above mentioned background variables where variance and standard deviation (SD) will be reported. Pattern of distribution of the material, i.e. normality assumption, may also be considered. The analysis will be divided in relation to current chronic PGP or no symptom of chronic PGP.
Study 2: Risk factors in regard to chronic PGP
In this study, material from the Q4 (n=639) will be used. There is a possibility to control for continuous and dichotomous variables in the analysis. Multiple regression analysis may be used to investigate variables that may predict future chronic PGP. One can expect that data regarding sick-leave may not be evenly distributed; where the group of women that is considered symptom free may have 0 days of sick-leave due to back problems. Therefore, non-parametric statistical analysis such as Mann-Whitney U test may be used together with Holm-Bonferroni test. Long-term sick-leave will be defined as >30 days and therefore, the sick-leave variable will be dichotomized into ≤30 and >30 days. To predict the relative risk (RR) for chronic PGP during the follow-up period a modified Poisson regression will be used.
Study 3: The woman’s experience of the consequences of chronic PGP regarding family-, daily- and working life
This qualitative study will investigate the woman’s experience of chronic PGP during the period between registered delivery and the interview in respect to its impact on family-, daily- and working life. An interview guide will be drawn up. Approximately 10-15 women will be asked to participate in the study. The data collection will be conducted through semi-structured in-depth interviews and will be analysed with the help of manifest and latent content analysis. Data will be collected until saturation has been reached; i.e. when no new essential information is added by additional interviews.
Study 4: The partner’s experience of the consequence of woman’s chronic PGP regarding family-, daily- and working life
A qualitative study where the partner’s experience of living together with a woman with chronic pain that could influence family-, daily, and working life for all parts of the family including the children. An interview guide will be drawn up. Approximately 10-15 partners, preferably partners to participants in study 3, will be asked to participate in the study. The mode of procedure regarding the data collection and the analysis will be the same as for study 3.
Inclusion criteria for study 3 and 4 are women with continuous or recurrent bothersome chronic PGP 10 years after registered pregnancy and that lives in the vicinity of Umeå or Luleå as well as their partners. Other inclusion criteria’s are <64 years of age, ability to read, wright and understand swedish.>
Exclusion criteria: current pregnancy, acute trauma within the 10-year follow-up period, any diagnosed disease such as cancer, serious infection, cauda equina syndrome, fibromyalgia, osteoporosis, vertebral fracture, diagnosed disc herniation and disc surgery, spinal stenosis and any on-going insurance claim.
Data analysis and interpretation
Bio-statistical and epidemiological analysis as well as baseline data will be described and comparisons will be made between the groups (chronic PGP/no chronic PGP) to test for similarities/differences (study 1 and 2). In all of the analyses, the IBM SPSS 19.0 software package will be used.
Variables of interest study 1 and 2:
Possible background variables:
• baseline data (i.e. age, risk factors for chronic PGP, marital status, sexual life, breast feeding history, occupation), mental wellbeing
• sciatica
• sick-leave
• previous LBP
• body mass index (BMI)
• physical activity

Outcome variables:
• self-rated health
• quality of life
• total days of bothersome chronic PGP
• number of episodes of recurrent bothersome pain

Questionnaires:
EQ-5D has formerly been validated on Swedish patients (20) and has been shown to work well for patients with musculoskeletal pain (21). NRS has been shown to be responsive in patients with chronic pain (22).
Interviews:
Manifest and latent content analysis will be used for the text analysis in the two qualitative studies (study 3 and 4). The interviews will be recorded and then transcribed verbatim into text. The text is then read through several times to get a feel for its entirety. Sentences and phrases that contain information that is relevant for the study will be picked out (meaning units). These meaning units will be condensed for the purpose of shortening the text but at the same time preserve the substance of the text (condensed meaning units). These condensed meaning units are then abstracted into codes. The codes are compared in regard of similarities and differences and then grouped into categories, which reflect the key message of the interviews. The categories make up the manifest part of the content analysis. Finally, themes will be formulated, where the latent substance (the underlying meaning) of the interview is evident (23). The analysis of study 3 and 4 will be done manually and the process of analysis is described previously.
Ethical aspects
Participation is voluntary. Information regarding the participation in the study will be done in connection to responding to Q4. All participants will receive written information about the study which gives a general overview of the study and a brief description concerning confidentiality. The information will be sent out as a supplement to Q4. All participants must sign an informed consent form. In connection with the recruitment of participants to the qualitative studies, both an oral and a written consent will be given to all eligible participants. Thereafter, the participants will give both their oral and written consent to participate in the study. All reporting of the results will be done with anonymized data to protect the participants’ identity.
Time plan
The preparations of the data collection will commence in the spring of 2013 after the project has gone through the ethical review process during the fall 2012. Women with chronic PGP 10 years after registered pregnancy and their partners are eligible to participate in the deep interview studies (study 3 and 4). The deep interviews will take place during the spring of 2013 and the aim is to capture the circumstances of life of women with chronic PGP and their partners. An overview of the project is presented below.

Expected results and importance
Chronic PGP impacts the individual, family unit and broader society. For the individual, chronic PGP has in impact on the general health and quality of life that is also likely affect other parts of life (i.e. working life and recreational activities). From a social perspective, chronic PGP is a significant rehabilitative problem with large associated costs. A paucity of evidence currently exists investigating chronic PGP from a longitudinal perspective, which the proposed study will help reduce. Additionally, data is available on all women from the time of delivery, which provides important data regarding prevalence, disability of chronic PGP as well as its long-term consequences. Due to the qualitative component of this project, the potential to contribute data, novel to this area of research is high.
The results will be published in different scientific journal such as European Spine Journal, BMC Musculoskeletal Disorders and BMC Women’s Health. The results will also be presented at different suitable international conferences. Furthermore, the results will also be incorporated in the education of midwifes, medical student as well as through lectures to other healthcare professionals.

References
1. Wu WH, Meijer OG, Uegaki K, Mens JM, Van Dieen JH, Wuisman PI, et al. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Sep 27(13):575-89.
2. Mogren IM, Pohjanen AI. Low back pain and pelvic pain during pregnancy: prevalence and risk factors. Spine. 2005 Apr 15;30(8):983-91.
3. Nilsson-Wikmar L, Pilo C, Pahlback M, Harms-Ringdahl K. Perceived pain and self-estimated activity limitations in women with back pain post-partum. Physiother Res Int. 2003;8(1):23-35.
4. Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819.
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