Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.
Women's Health and Perinatology Research Group, Institute of Clinical Medicine, The Arctic University of Norway, Tromsø, Norway.
Scand J Pain. 2020 Oct 25;20(4):793-800. doi: 10.1515/sjpain-2020-0026.
Background and aims Women with chronic pelvic pain represent a heterogeneous group, and it is suggested that the existence of sub-groups can explain varying results and inconclusiveness in clinical trials. Some predictors of treatment outcome are suggested, but the evidence is limited. The primary aim of this study was to explore if selected pre-treatment characteristics of the participants in a recently conducted randomized controlled trial were associated with treatment outcome. Methods In this study secondary analysis of data collected in a randomized trial were conducted. The participants were women with chronic pelvic pain randomized to two different physical therapy treatments. Analyses in this study were performed for the whole group as a cohort. The primary outcome measure was change in pain intensity from baseline to 12 months, measured with the numeric rating scale (0-10). The women were asked to rate their mean pelvic pain intensity during the last 7 days. Based on previous research and on available variables from the randomized controlled trial four potential predictive factors were derived from the baseline data and assessed one by one in a linear regression model, adjusted for age and treatment group. The variables with strongest association (p < 0.10) with the primary outcome were further included in a multivariable linear regression model with backward selection, adjusted for age and treatment group. Results Fifty women (mean age 38.1, SD = 12.2) were included in the analysis. For these women the mean change in pain intensity was -1.2 points (95% CI -1.8 to -0.7) from baseline to 12 months. The multivariable regression model showed that pelvic pain duration of 6 years or more was associated with less decrease in pain intensity with a regression coefficient of 1.3 (95% CI 0.3-2.4). Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1). None of the women with main pain site other places than in the pelvis reported any pain reduction after physical therapy treatment, but due to the small numbers the predictor was not included in the regression analysis. Conclusions We identified that pelvic pain duration of 6 years or more was associated with less pain reduction, and that higher baseline pain intensity was associated with higher pain reduction after physical therapy treatment in this sample of women with chronic pelvic pain. For the variable main pain site other places than the pelvis the results are unsure due to small numbers. Implications Based on our finding of long pain duration as a negative predictor for pain reduction, we emphasize that early intervention is important. Many of the participants in our RCT reported pelvic surgeries or other treatments prior to referral for PT, and we suggest that referral to a non-invasive intervention such as PT should be considered at an earlier stage. In order to tailor interventions to the individual women's needs, thorough baseline assessments, preferably in a multidisciplinary setting, should be performed.
慢性盆腔痛的女性表现为一个异质群体,有人认为亚组的存在可以解释临床试验中不同的结果和不确定性。一些治疗结果的预测因素已被提出,但证据有限。本研究的主要目的是探讨最近进行的一项随机对照试验中参与者的某些治疗前特征是否与治疗结果相关。
本研究对一项随机试验中收集的数据进行了二次分析。参与者为慢性盆腔痛女性,随机分为两种不同的物理治疗方法。本研究的分析针对整个群体进行。主要的结局测量指标是从基线到 12 个月的疼痛强度变化,使用数字评分量表(0-10)进行测量。这些女性被要求在过去 7 天内平均疼痛强度。基于先前的研究和随机对照试验中可用的变量,从基线数据中得出了四个潜在的预测因素,并在一个线性回归模型中逐个进行评估,调整了年龄和治疗组的影响。与主要结局具有最强关联(p < 0.10)的变量进一步被纳入一个多元线性回归模型,采用向后选择法,调整了年龄和治疗组的影响。
本研究共纳入了 50 名女性(平均年龄 38.1,标准差为 12.2)。对于这些女性,从基线到 12 个月时疼痛强度的平均变化为-1.2 分(95%置信区间-1.8 至-0.7)。多变量回归模型显示,疼痛持续时间为 6 年或更长时间与疼痛强度降低较少相关,其回归系数为 1.3(95%置信区间 0.3-2.4)。基线疼痛强度与物理治疗后疼痛减轻程度较高相关,基线疼痛每增加一个标准差,疼痛减轻程度增加 0.6(95%置信区间-1.1 至-0.1)。没有主要疼痛部位在骨盆以外的女性报告在物理治疗后有任何疼痛减轻,但由于人数较少,该预测因素未被纳入回归分析。
我们发现,疼痛持续时间为 6 年或更长时间与疼痛减轻程度较低相关,基线疼痛强度较高与物理治疗后疼痛减轻程度较高相关,在这个慢性盆腔痛女性样本中。由于人数较少,主要疼痛部位在骨盆以外的结果不确定。
基于我们发现的疼痛持续时间长作为疼痛减轻的负预测因素,我们强调早期干预很重要。我们的 RCT 中的许多参与者在转诊到物理治疗之前报告了骨盆手术或其他治疗,我们建议应更早考虑转介到非侵入性干预措施,如物理治疗。为了根据个体女性的需求定制干预措施,应在多学科环境中进行彻底的基线评估。