Osseointegration of minimally invasive sacroiliac joint fixation implants-A human retrieval study.

Minimally invasive sacroiliac joint fusion has become increasingly prevalent and is described to reduce pain and improve function. In some patients, pain can recur several months after primary surgery. Lack of early implant osseointegration might be a cause of pain and hence an indication for revision surgery. Triangular titanium implants are the most documented implant for minimally invasive sacroiliac joint fusion. There is, however, no knowledge of how triangular titanium implants osseointegrate in humans and whether fusion is induced over the sacroiliac joint. During planned revision surgery due to recurrent pain, six triangular titanium implants were retrieved from six different patients at median 9 months from primary surgery. All six implants were scanned using microcomputed tomography. The presence or absence of bone in-growth, on-growth, and through-growth of the implants was evaluated as an indication of implant osseointegration. Three of six implants showed no or minor signs of osseointegration. Of the three remaining implants, one showed partial osseointegration and two implants showed high degrees of osseointegration. This study showed that triangular titanium implants can osseointegrate into host bone in humans. When osseointegration occurs, triangular titanium implants can give fusion across the sacroiliac joint.

The effect of minimally invasive sacroiliac joint fusion compared to sham operation: a double-blind randomized placebo-controlled trial.

Background: Minimally invasive fusion of the sacroiliac joint as treatment for low back pain may reduce pain and improve function compared to non-operative treatment, although clear evidence is lacking. The aim of this trial was to evaluate the effect of minimally invasive sacroiliac joint fusion compared to sham surgery on sacroiliac joint pain reduction. Methods: In this double-blind randomized sham surgery-controlled trial patients with clinical diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection were included at two university hospitals in Sweden and Norway. Patients were randomized by the operating surgeon at each site to minimally invasive sacroiliac joint fusion or sham surgery. The primary endpoint was group difference in sacroiliac joint pain on the operated side at six months postoperatively, measured by the Numeric Rating Scale (0-10). Un-blinding and primary analysis were performed when all patients had completed six months follow-up. The trial is closed for new participants and was registered at clinicaltrials.gov: NCT03507049. Findings: Between September 1st, 2018 and October 22nd, 2021, 63 patients were randomized, 32 to the surgical group, 31 to the sham group. Mean age was 45 years (range 26-63) and 59 of 63 (94%) patients were female. The mean reduction in the operated sacroiliac joint from baseline to six months postoperative was 2.6 Numeric Rating Scale points in the surgical group and 1.7 points in the sham group (mean between groups difference -1.0 points; 95% CI, -2.2 to 0.3; p = 0.13). Interpretation: This double-blind randomized controlled trial could not prove that minimally invasive fusion of the sacroiliac joint was superior to sham surgery at six months postoperative. Funding: Sophies Minde Ortopedi supported a clinical research position for Engelke Marie Randers. Region Stockholm supported the cost for the Swedish ethical application and a clinical research appointment for Paul Gerdhem.

Airway clearance physiotherapy and health-related quality of life in cystic fibrosis.

OBJECTIVE: Airway clearance physiotherapy is recommended in cystic fibrosis, but limited evidence exists to suggest how much treatment is enough. As a secondary analysis of a prior study investigating the safety, efficacy, and participants' perceptions of a novel airway clearance technique, specific cough technique (SCT) compared to forced expiration technique (FET), we aimed to evaluate whether the intervention was associated with changes in health-related quality of life (HRQoL). METHODS: We conducted randomised, controlled individual trials with six adults (N-of-1 RCTs). Each trial included eight weeks of treatment, twice a week, using saline inhalation in horizontal positions, one with SCT and one with FET, in random order. Efficacy was measured by sputum wet weight (g) after each session. Perceived usefulness and preference were self-reported at the end of the study. Lung function was assessed at baseline and at the end of study. HRQoL was measured using the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at baseline (week 1) and at completion of the study (week 8). Individual HRQoL scores (0-100) were coded and analysed using CFQ-R Software Program, version 2.0. RESULTS: Patient-reported outcomes were completed by all subjects. Individual CFQ-R-Respiratory Symptoms Scores (CFQ-R-RSS) showed a positive change, meeting the minimal important difference (MID) ≥ 4 points in five participants and a negative change in one individual. A strong correlation (r = 0.94 (p<0.01) was found between total sputum weight (g) and the positive changes in CFQ-R-RSS, and between changes in lung function and CFQ-R-RSS (r = 0.84 (p = 0.04). CONCLUSION: The airway clearance intervention was associated with clinically meaningful changes in patient-reported symptoms on the CFQ-R in the majority of the participants. This finding warrants further investigation regarding treatment, duration and frequency. A long-term study may reveal beneficial effects on other clinically meaningful endpoints, such as pulmonary exacerbations, high-resolution computed tomography scores and HRQoL. TRIAL REGISTRATION: The study was registered in ClinicalTrials.gov, under the number NCT0 1266473.

Prevalence of Antenatal Depressive Symptoms and its Associated Factors among Pregnant Nepalese Women with and Without Low Back- and/or Pelvic Girdle Pain.

BACKGROUND: Pregnant women with health problems have shown higher odds of depressive symptoms. Evidence suggests a co-morbid relation between pregnancy-related low back pain and/or pelvic girdle pain and the risk of depression. The aims were to investigate the prevalence of symptoms of depression among pregnant Nepalese women in general and among pregnant Nepalese women with low back pain and/or pelvic girdle pain and to identify factors associated to symptoms of depression. METHODS: A cross-sectional study using standardized condition-specific questionnaires with response from 1284 pregnant Nepalese women. Multivariate logistic regression analysis determined variables associated with symptoms of depression. RESULTS: Twenty-one percent of the women presented with moderate to high symptom level of depression, compared to 29% of the women with low back pain and/or pelvic girdle pain. Low education, living without husband, no rest during work, higher self-reported disability, higher pain intensity and symptoms of pelvic organ prolapse were associated with higher odds of symptoms of depression among the women with low back pain and/or pelvic girdle pain. For the total sample, fetching water and having symptoms of low back pain and/or pelvic girdle pain and living without husband were associated to symptoms of depression. CONCLUSIONS: Twenty-one percent of the pregnant women reported moderate to high symptom level of depression. The proportion of women with symptoms of depression was significantly higher among the women categorized as having low back pain and/or pelvic girdle pain. Our findings highlight the need to address both emotional and physical needs among pregnant Nepalese women.

The effect of minimally invasive sacroiliac joint fusion compared with sham operation: study protocol of a prospective double-blinded multicenter randomized controlled trial.

Background and purpose - The sacroiliac joint is increasingly recognized as a cause of pain in 15-30% of patients with low back pain. Nonoperative management is not always successful and surgical treatment with fusion of the joint is increasingly recommended. According to the literature, minimally invasive fusion reduces pain and improves function compared with nonoperative treatment. It is, however, unclear to what extent the placebo effect influences these results. Patients and methods - The trial is designed as a prospective multi-center, double-blind, randomized shamsurgery controlled trial with 2 parallel groups. 60 patients with a suspected diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection are included according to the trial inclusion criteria. Patients are randomized with a 1:1 allocation into 2 groups of 30 patients each. The primary end-point is group difference in sacroiliac joint pain intensity on the operated side at 6 months postoperatively, measured by the Numeric Rating Scale. The main objective is to examine whether there is a difference in pain reduction between patients treated with a minimally invasive fusion of the sacroiliac joint compared with patients undergoing a sham operation. Results - Unblinding occurs after the completed 6-month follow-up. The primary analysis will be performed when all patients have completed 6 months' follow-up. Follow-ups are continued to at least 2 years postoperatively. Data from the different groups will be compared based on the "intention to treat" principle.

Pregnant women's experiences with a pelvic floor muscle training program in Nepal.

BACKGROUND: In Nepal, pelvic floor disorders affect about 24% of the women in reproductive age whereof 10% suffer from pelvic organ prolapse (POP). Still, many do not seek health care. Strengthening exercises for the pelvic floor muscles for prevention and treatment of POP has shown strong evidence internationally, but for women in Nepal surgery is primarily offered. To amend this, a novel pelvic floor muscle training (PFMT) program for pregnant women was introduced. OBJECTIVE: To learn about how the PFMT-program was received by the participating women, their understanding of the importance of doing the exercises, and the constraints of daily life for performing the program. METHODS: A qualitative study design based on a sub-sample (N = 10) from a strategic sample (N = 235) who participated in the PFMT-program. Ten semi-structured in-depth interviews were interpreted according to a phenomenological analytical tradition. RESULTS: The 10 women were representative for the women who had participated in the PFMT-program with regard to urban residence, socioeconomic, and educational standing. The program was well received and compliance satisfactory. In line with the PFMT's learning outcomes, the women described risk factors, showed knowledge about the pelvic floor muscles, and understood the importance of doing the exercises. They had managed to fit the exercises into their busy daily routines. Meeting peers in exercise groups and understanding from family were positive factors for compliance. CONCLUSION: The Nepalese women appear interested in self-care and are making an effort to fit the exercises into their busy schedule. Although the communicative validity was satisfactory, the pragmatic validity cannot be generalized to women in rural areas and under less fortunate socioeconomic and educational circumstances.

Cross-cultural adaptation, reliability, and validity of a Chinese version of the pelvic girdle questionnaire.

BACKGROUND: The Pelvic Girdle Questionnaire (PGQ) is the only specific instrument designed to evaluate pain and activity limitations in pregnant or postpartum women with pelvic girdle pain (PGP). This study aimed to translate and culturally adapt the PGQ for Chinese patients and to verify the validation of the psychometric items of the PGQ in the Chinese population. METHODS: First, the translation and cultural adaptation process of the PGQ was conducted on the basis of international guidelines. Eighteen women suffering from PGP (11 pregnant women and 7 postpartum women) were enrolled in the pilot tests. Second, a total of 130 pregnant and postpartum women with PGP were enrolled to evaluate the validation of the psychometric items of the Chinese version. RESULTS: The calculated Cronbach's alphas demonstrated a high level of internal consistency for the Chinese version of the PGQ, ranging from 0.77 to 0.93. The convergent validity showed a high positive correlation between the PGQ total score and the Oswestry Disability Index (0.84) and Numeric Rating Scale (0.73) for pain intensity. Furthermore, a good discriminatory ability was found for the Chinese version of the PGQ for distinguishing women who needed treatment from those not (area under the curve [AUC] = 0.843, p < 0.001), but not for discriminating the pregnant and postpartum states (AUC = 0.488, p = 0.824). The results of test-retest showed good reproducibility for the total PGQ (ICC = 0.93), the PGQ activity subscale (ICC = 0.92), and the PGQ symptom subscale (ICC = 0.77). CONCLUSION: Our study presents the translation, validation and psychometric features of the Chinese version of the PGQ, showing good construct validity and discriminative power for assessing the consequences of PGP among pregnant or postpartum Chinese women.

Reliability, validity and responsiveness of pelvic floor muscle surface electromyography and manometry.

INTRODUCTION AND HYPOTHESIS: Vaginal surface electromyography (sEMG) is commonly used to assess pelvic floor muscle (PFM) function and dysfunction but there is a lack of studies regarding the assessment properties. The aim of the study was to test the hypotheses that sEMG has good test-retest intratester reliability, good criterion validity and is responsive to changes compared to manometry. METHODS: PFM resting tone, maximum voluntary contraction (MVC) and endurance were measured in 66 women with pelvic floor dysfunction. One assessment by manometry was followed by two testing sessions with sEMG at baseline. After 4 to 42 weeks of supervised PFM strength training, 29 participants were retested with both devices. RESULTS: Median age of the participants was 41 years (range 24-83) and parity 2 (range 0-10). Very good test-retest intratester reliability was found for all three sEMG measurements. The correlation between sEMG and manometry was moderate for vaginal resting tone (r = 0.42, n = 66, p < 0.001) and strong for MVC (r = 0.66, n = 66, p < 0.001) and endurance (r = 0.67, n = 66, p < 0.001). Following the strength training period, participants demonstrated increased MVC and endurance measured with manometry, but not with sEMG. A significant reduction in resting tone was found only with sEMG. CONCLUSION: sEMG is reliable and correlates well with manometry. However, sEMG is not as responsive as manometry for changes in PFM MVC and endurance. For measurement of PFM resting tone, sEMG seems more responsive than manometry, but this requires further investigation.

A core outcome set for research and clinical practice in women with pelvic girdle pain: PGP-COS.

BACKGROUND: Inconsistent reporting of outcomes in clinical trials of women with Pelvic Girdle Pain (PGP) hinders comparison of findings and the reliability of evidence synthesis. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials on the condition. The aim of this study was to develop a consensus-based COS for evaluating the effectiveness of interventions in PGP during pregnancy and postpartum for use in research and clinical practice. METHODS: A systematic review of previous studies on PGP and semi-structured interviews with women were undertaken to identify all outcomes that were reported in prior studies and that are relevant to those experiencing the condition. Key stakeholders (clinicians, researchers, service providers/policy makers and individuals with PGP) then rated the importance of these outcomes for including in a preliminary PGP-COS using a 3-round Delphi study. The final COS was agreed at a face-to-face consensus meeting. RESULTS: Consensus was achieved on five outcomes for inclusion in the final PGP-COS. All outcomes are grouped under the "life impact" domain and include: pain frequency, pain intensity/severity, function/disability/activity limitation, health-related quality of life and fear avoidance. CONCLUSION: This study identified a COS for evaluating the effectiveness of interventions in pregnancy-related and postpartum-related PGP in research and clinical settings. It is advocated that all trials, other non-randomised studies and clinicians in this area use this COS by reporting these outcomes as a minimum. This will ensure the reporting of meaningful outcomes and will enable the findings of future studies to be compared and combined. Future work will determine how to measure the outcomes of the PGP-COS. CORE OUTCOME SET REGISTRATION: This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 (http://www.comet-initiative.org/studies/details/958).

Trunk, pelvic and hip kinematics during the Stork test in pregnant women with pelvic girdle pain, asymptomatic pregnant and non-pregnant women.

BACKGROUND: Pelvic girdle pain is prevalent during pregnancy, and women affected report weight-bearing activities to be their main disability. The Stork test is a commonly used single-leg-stance test. As clinicians report specific movement patterns in those with pelvic girdle pain, we aimed to investigate the influence of both pregnancy and pelvic girdle pain on performance of the Stork test. METHODS: In this cross-sectional study, 25 pregnant women with pelvic girdle pain, 23 asymptomatic pregnant and 24 asymptomatic non-pregnant women underwent three-dimensional kinematic analysis of the Stork test. Linear mixed models were used to investigate between-group differences in trunk, pelvic and hip kinematics during neutral stance, weight shift, leg lift and single leg stance. FINDINGS: Few and small significant between-group differences were found. Pregnant women with pelvic girdle pain had significantly less hip adduction during single leg stance compared to asymptomatic pregnant women (estimated marginal means (95% confidence intervals) -1.1° (-2.4°, 0.3°) and 1.0° (-0.4°, 2.4°), respectively; P = 0.03). Asymptomatic pregnant women had significantly less hip internal rotation compared to non-pregnant women 4.1° (1.6°, 6.7°) and 7.9° (5.4°, 10.4°), respectively (P = 0.04) and greater peak hip flexion angle of the lifted leg in single leg stance 80.4° (77.0°, 83.9°) and 74.1° (70.8°, 77.5°), respectively (P = 0.01). Variation in key kinematic variables was large across participants in all three groups. INTERPRETATION: Our findings indicate that trunk, pelvic and hip movements during the Stork test are not specific to pregnancy and/or pelvic girdle pain in the 2nd trimester. Instead, movement strategies appear unique to each individual.

Cross-Cultural Adaptation and Validation of the Nepali Version of the Pelvic Girdle Questionnaire.

OBJECTIVE: The purpose of this study was to translate, cross-culturally adapt, and assess the reliability and validity of the Pelvic Girdle Questionnaire (PGQ) in pregnant Nepalese women. METHODS: The cross-cultural adaptation process was conducted according to the Guillemin guidelines. Reliability and validity were assessed using cross-sectional design. The participants responded to questionnaires of sociodemographics, the Nepali version of the PGQ, the Oswestry Disability Index, the Patient-Specific Functional Scale, the 5-item version of the Edinburgh Depression Scale, and the Numerical Pain Rating Scale. The internal consistency was assessed with Cronbach's alpha. The test-retest reliability was calculated using the intraclass correlation coefficient and smallest detectable change. Construct validity was assessed by testing 9 a priori hypotheses that examine correlations between the PGQ activity and symptom subscales, and also among the PGQ subscales and Oswestry Disability Index, Numerical Pain Rating Scale, Patient-Specific Functional Scale, and 5-item version of the Edinburgh Depression Scale. Spearman and Pearson's correlation were used to assess the correlations. RESULTS: A sample of 111 pregnant women were included in the study. The Cronbach's alpha for the Nepali version of the total PGQ was good (α = 0.83), and the test-retest reliability was acceptable (ICC2.1, 0.72) with a measurement error of SDC95% 18.6 points. Seven of the 9 hypotheses found support, which confirms acceptable construct validity of the Nepali PGQ. CONCLUSION: The Nepali version of the PGQ is a reliable and valid tool for assessing pelvic girdle pain in pregnant Nepalese women.

The Swedish version of the pelvic girdle questionnaire, cross-cultural adaptation and validation.

Purpose: The aims of this study were to translate and culturally adapt The Pelvic Girdle Questionnaire to Swedish, and to evaluate the construct and discriminative validity.Materials and methods: A translation and cultural adaptation process was performed according to international guidelines. Pilot tests were conducted among 16 women during pregnancy and post-partum. Analysis of the construct and discriminative validity of the Swedish version of the Pelvic Girdle Questionnaire was performed in a sample of 177 pregnant women suffering from pain in the lumbo-pelvic area. Participants completed the Pelvic Girdle Questionnaire along with Oswestry Disability Index, numeric rating scales for pain intensity and for pelvic girdle pain concerns.Results: The Swedish version of the Pelvic Girdle Questionnaire showed high internal consistency with Cronbach's alphas between 0.82 and 0.96, good convergent validity with high correlations with the Oswestry Disability Index and the pain intensity numeric rating scale, whereas moderate correlation was shown between the concerns numeric rating scale and the other instruments as hypothesized. Receiver operating characteristic curves showed good discriminatory capacity for women in need of treatment.Conclusions: The Swedish version of the Pelvic Girdle Questionnaire has patient acceptability. It has good construct and discriminative validity for measurements of consequences of pregnancy-related pelvic girdle pain among Swedish speaking women.IMPLICATIONS FOR REHABILITATIONPregnancy-related pelvic girdle pain may be disabling and long-lasting, however treatable when identified.The Pelvic Girdle Questionnaire is the only condition-specific, reliability tested and validated questionnaire for pelvic girdle pain.The Swedish version of the Pelvic Girdle Questionnaire has patient acceptability, good construct validity for pelvic girdle pain among Swedish speaking women, and shows good discriminative capacity for women in need of treatment.

Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study.

INTRODUCTION AND HYPOTHESIS: Pelvic floor muscle training (PFMT) is internationally recommended for prevention and treatment of urinary incontinence (UI) and pelvic organ prolapse (POP). However, there is lack of knowledge about PFMT among pregnant Nepalese women. The objectives of this study were to develop a PFMT programme and to assess the feasibility of the programme. METHODS: A feasibility study was conducted to address aspects of the PFMT programme provided to pregnant women attending antenatal check-ups at Kathmandu University Dhulikhel Hospital. The women were recruited consecutively from June 2017 to April 2018. The PFMT programme consisted of attending a minimum of four supervised PFMT follow-up visits after inclusion to the programme and performing PFMT daily at home. Feasibility was assessed in terms of the recruitment capability, sample characteristics, data collection procedures, outcome measures, and acceptability (attendance to PFMT visits, PFMT adherence, participant experiences) of the programme. Data were collected using self-reported questionnaires. Educational material (video, leaflet, and exercise diary) was developed in Nepali. RESULTS: Among 253 women included, 144 (57%) attended four or more supervised PFMT visits. No significant differences were found in the symptoms of UI (0.89) and POP (0.44) between those attending and those not attending four PFMT visits. Half of the women adhered to 50-100% of PFMT daily at home. The supervised PFMT and the educational material motivated the women to daily PFMT. CONCLUSION: The PFMT programme was acceptable, at least to those living in the district of the study site. The results and experiences from the current study may guide implementation and future studies on the effectiveness of PFMT in Nepal.

Prevalence and severity of low back- and pelvic girdle pain in pregnant Nepalese women.

BACKGROUND: Low back pain (LBP) and pelvic girdle pain (PGP) are commonly reported during pregnancy and are known to affect pregnant women's well-being. Still, these conditions are often considered to be a normal part of pregnancy. This study assesses the prevalence and severity of LBP and/or PGP among pregnant Nepalese women, as well as exploring factors associated with LBP and PGP. METHODS: A cross-sectional study with successive recruitment of pregnant women was conducted at two district hospitals in Nepal from May 2016 to May 2017. The data was collected using self-reported questionnaires. Univariate and multivariate logistic regression were used to assess the associations between independent variables and LBP and/or PGP. RESULTS: A total of 1284 pregnant women were included in the study. The reported prevalence of pregnancy-related LBP and/or PGP was 34%. Pain intensity was high with a mean score (standard deviation) of 6 (2). The median (25th-75th percentiles) disability scores according to the total Pelvic Girdle Questionnaire and Oswestry Disability Index were 20 (10-32) and 30 (21-38), respectively. Even though only 52% of the women believed that the pain would disappear after delivery, concern about LBP and/or PGP was reported to be low (median 2 (0-4) (Numeric Rating Scale 0-10)). In the final model for women with LBP and/or PGP the adjusted odds ratios were for body mass index (20-24, 25-30, > 30) 0.7 (95% confidence interval (CI), 0.44-1.21), 1.1 (95% CI, 0.66-1.83), and 1.5 (95% CI, 0.78-2.94) respectively, for pelvic organ prolapse symptoms 6.6 (95% CI, 4.93-8.95) and for women with educated husbands (primary or secondary, higher secondary or above) 1.1 (95% CI, 0.53-2.16) and 1.7 (95% CI, 0.84-3.47), respectively. CONCLUSIONS: Pregnant Nepalese women commonly report LBP and/or PGP. The women experienced low disability despite severe pain intensity and poor beliefs in recovery after delivery.

Kinematic and spatiotemporal gait characteristics in pregnant women with pelvic girdle pain, asymptomatic pregnant and non-pregnant women.

BACKGROUND: Walking difficulties are common among pregnant women with pelvic girdle pain. This cross-sectional study investigated the influence of pelvic girdle pain, pregnancy and speed on spatiotemporal and trunk, pelvic and hip kinematics during gait in the 2nd trimester of pregnancy. METHODS: Three-dimensional gait analysis at self-selected speed was performed in 25 pregnant women with pelvic girdle pain, 24 asymptomatic pregnant and 24 non-pregnant women. Linear mixed models were used to investigate between-group differences in gait variables. Adjustment for gait speed was included in the analysis. Correlations between speed and fear of movement, disability and pain were examined using Spearman correlation coefficient (rs). FINDINGS: Pregnant women with pelvic girdle pain walked 18% slower (estimated marginal means (95% confidence intervals) 1.18 (1.22, 1.24) meter/s) compared to asymptomatic pregnant women (1.44 (1.38, 1.50) meter/s) (P < 0.001). Moreover, with longer double limb support (5%, P = 0.04), shorter contralateral step length (3%, P = 0.03) and more restricted pelvic and hip kinematics (0.001 ≤ P ≤ 0.01) adjusted for speed. Only stance, double limb support and thoracic rotation (0.001 ≤ P ≤ 0.04) differed between asymptomatic pregnant and non-pregnant women. Speed was negatively correlated with fear of movement (rs = -0.63, P = 0.01) and disability (rs = -0.46, P = 0.03) in the pelvic girdle pain group. INTERPRETATION: Gait is primarily influenced by pelvic girdle pain and less by pregnancy. Pregnant women with pelvic girdle pain walked slower and with a more rigid gait pattern compared to asymptomatic pregnant women, presumably related to altered load transfer. Our results may assist clinical evaluation of pelvic girdle pain, as well as direct future research.

The Timed Up & Go test in pregnant women with pelvic girdle pain compared to asymptomatic pregnant and non-pregnant women.

BACKGROUND: The Timed Up and Go (TUG) test, a standardized functional mobility test, has been proposed as a physical performance-based measure in pregnant women with pelvic girdle pain (PGP). OBJECTIVES: This cross-sectional study aimed to investigate physical function by the use of TUG in pregnant women with PGP compared to asymptomatic pregnant and non-pregnant women, and to identify factors associated with increased TUG. METHODS: In total, 25 pregnant women with PGP, 24 asymptomatic pregnant and 25 asymptomatic non-pregnant women participated. One-way analysis of variance was used to explore difference in TUG between the groups and multiple linear regression analyses to explore associations between TUG and potential explanatory variables. RESULTS: The time on TUG varied among pregnant women with PGP, and was significantly higher (mean (95% CI) 6.9 (6.5, 7.3) seconds) than for asymptomatic pregnant (5.8 (5.5, 6.0), p < 0.001) and non-pregnant (5.5 (5.4, 5.6), p < 0.001) women. In the total study sample, group, increased BMI and sick leave were significantly associated with increased TUG (p-values≤0.02). In pregnant women with PGP, pain intensity was the only significant clinical factor associated with increased TUG (p = 0.002). CONCLUSION: Pregnant women with PGP used longer time and showed larger variation in TUG than asymptomatic pregnant and non-pregnant women, this underpins that TUG targets activities relevant to PGP. Our results provide new knowledge about factors influencing TUG time. Importantly, multivariable analyses suggest that pain intensity should be considered when interpreting TUG time in pregnant women with PGP.

Evidence of stabilizing exercises for low back- and pelvic girdle pain - a critical review.

BACKGROUND: Pregnancy-related low back pain (LBP) and pelvic girdle pain (PGP) have been associated with an alteration in the strategy for lumbopelvic stabilization. Different core stabilization approaches exist, the evidence is however controversial. METHODS: This paper discusses how to improve the evidence of exercises for women suffering from LBP and PGP during and after pregnancy. Exercises should be understood in a context, where the bio-psycho-social perspective directs the prescription of exercises, targeting both psychological and physical factors. The type of exercise probably should be individually tailored to the needs and capability of the individual and it is not only about the most appropriate exercise, it is about dosage and delivery of the exercises, and it is about performance. To promote adherence the use of patient preferences, with self-defined movement goals, may be a motivational basis for behavior change. Communication skills may facilitate positive beliefs and provide a motivational foundation for empowerment, self-efficacy and for self-management. To learn by discovery where the patient learns through their own experiences, might motivate the patients to active engagement and to behavioral change. Adherence probably will increase when the patients understand the aim and the rationale behind the exercises they are prescribed. However, with high adherence to exercises that maintains an inappropriate motor pattern, LBP and PGP possibly could proceed into chronicity. CONCLUSION: Exercises need to be meaningful to the patient, relevant for daily activities, individualized according to patient preferences, guided and supervised to secure performance and quality.

Protocol for the development of a core outcome set for pelvic girdle pain, including methods for measuring the outcomes: the PGP-COS study.

BACKGROUND: Pelvic Girdle Pain (PGP) is an important cause of disability and economic cost worldwide. There is a need for effective preventative and management strategies. Emerging studies measure a variety of outcomes rendering synthesis and translation to clinical practice difficult. A Core Outcome Set (COS) can address this problem by ensuring that data are relevant, useful and usable for making well-informed healthcare choices. The aim of this study is to develop a consensus-based PGP-COS, including agreement on methods (e.g. instruments) for measuring the construct outcomes in the COS for use in research and clinical practice. Furthermore, as there is uncertainty as to whether incorporating stakeholder interviews in addition to conducting a systematic review to determine an initial list of outcomes for the Delphi survey, or, whether using different rating scales in a Delphi survey impacts on the final COS, we propose to embed two methodological studies within the PGP-COS development process to address these questions. METHODS: The PGP-COS study will include five phases: (1) A systematic review of the literature and semi-structured interviews with 15 patients (three countries) to form the initial list of outcomes for the Delphi survey; (2) A 3-round Delphi including patients, clinicians, researchers and service providers; (3) A systematic review of methods for measuring the outcomes in the preliminary PGP-COS identified in the Delphi survey; (4) A face-to-face consensus meeting to agree on the final PGP-COS and methods for measuring the COS; (5) Global dissemination. To address the methodological questions, we will assess the number and type of outcomes, in the final PGP-COS, that were exclusively derived from the interviews. Secondly, we will randomise Delphi survey participants to either a 5-point or 9-point importance rating scale, and examine potential differences in 'important' ratings between the groups. DISCUSSION: There is currently no COS for measuring/monitoring PGP in trials and clinical practice. A PGP-COS will ensure that relevant outcomes are measured using appropriate measurement instruments for patients with PGP globally. CORE OUTCOME SET REGISTRATION: This PGP-COS was registered with COMET (Core Outcome Measures for Effectiveness Trials) in January 2017 ( http://www.comet-initiative.org/studies/details/958 ).

Cross-cultural Adaptation of the Pelvic Girdle Questionnaire for the Polish Population.

OBJECTIVE: The purpose of this study was to translate and culturally adapt the Pelvic Girdle Questionnaire (PGQ) into Polish to allow pelvic girdle pain (PGP) assessment in Polish women. METHODS: The translation process comprised 4 stages: forward translation, backward translation, committee review, and pretest. We then conducted a pilot study of the final version of the questionnaire in 49 women (mean age: 31.2 years, standard deviation: 3.74 years) who had PGP when pregnant or within a year postpartum. RESULTS: The internal consistency of the newly created questionnaire assessed with Cronbach's α was 0.916. CONCLUSION: The internal consistency of the process of translation and cross-cultural adaptation of the Polish version of the PGQ was satisfactory. The Polish version of the PGQ may be used both in clinical practice and for research among Polish women with PGP.

Reliability and Construct Validity of the Adapted Norwegian Version of the Early-Onset Scoliosis 24-item Questionnaire.

BACKGROUND: The Early-Onset Scoliosis 24-item Questionnaire (EOSQ-24) reflects issues important for patients with early-onset scoliosis (EOS) and their parents. The aim of this study was to translate the original EOSQ-24 into Norwegian and to evaluate the resulting questionnaire's reliability and construct validity. METHODS: The EOSQ-24 was translated using a forward-backward translation method, followed by an expert review. One hundred parents of a heterogenic group of patients with EOS answered the EOSQ-24 and scored Numeric Rating Scales (NRSs) to evaluate the children's general health, pain, and physical function. Two weeks later, 55 parents (55%) answered the retest questionnaire. Data quality, internal consistency, and test-retest reliability were assessed, including the minimal detectable change. Construct validity was evaluated by predefined hypotheses and correlations with NRS scores. RESULTS: There were considerable ceiling (19.0% to 63.0%) and floor effects (zero to 26.0%). The internal consistency was excellent (Cronbach α = 0.95). The minimal detectable change for the EOSQ-24 total score was 15.2 and ranged from 21.6 to 33.0 for the subdomains scores. The EOSQ-24 showed discriminate capabilities among patients with different etiology, treatment status, and severity of deformity. High correlations were found between the EOSQ-24 total score and the NRS scores for general health (r = -0.66), pain (r = -0.63), and physical function (r = -0.78). CONCLUSION: The Norwegian version of the EOSQ-24 has acceptable reliability and validity for measuring quality of life and caregiver burden among EOS children. The EOSQ-24 total score is acceptable for evaluation of these patients over time. LEVEL OF EVIDENCE: Level III, diagnostic study.