Effectiveness of mechanical traction as a non-surgical treatment for carpal tunnel syndrome compared to care as usual: study protocol for a randomized controlled trial

BACKGROUND: Carpal tunnel syndrome (CTS) is a common condition (prevalence of 4%) where the median nerve is compressed within the carpal tunnel resulting in numbness, tingling, and pain in the hand. Current non-surgical treatment options (oral medication, corticosteroid injections, splinting, exercise, and mobilization) show limited effects, especially in the long-term. Carpal tunnel release (CTR) surgery is effective in 70 to 75% of patients, but is relatively invasive and can be accompanied by complications. In an observational study, mechanical traction proved to be effective in up to 70% of patients directly after treatment and in 60% after two years follow-up. This randomized controlled trial (RCT) will examine the effectiveness of mechanical traction compared to care as usual in CTS. METHODS/DESIGN: Patients diagnosed with CTS will be recruited from an outpatient neurology clinic and randomly assigned to the intervention group (mechanical traction) or the control group (care as usual). Participants in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. Primary outcome is symptom severity and functional status, which are measured with the Boston Carpel Tunnel Questionnaire (BCTQ). Secondary outcomes are quality of life (WHOQOL-BREF), health related resource utilization, and absenteeism from work. Outcomes will be assessed at baseline, and at 3, 6, and 12 months after inclusion. Linear mixed effect models will be used to determine the change from baseline at 12 months on the BCTQ, WHOQOL-BREF, absenteeism from work and health related resource utilization. The baseline measurement, change from baseline at three and six months, as well as duration of symptoms until inclusion, age, gender, and co-morbidity will be included as covariates The Pearson’s correlation coefficient will be generated to assess the correlation between depression and anxiety and treatment outcome. DISCUSSION: Since current non-surgical treatment options are not effective long-term and CTR is relatively invasive, there is a need for an effective and non-invasive treatment option. Mechanical traction is a safe treatment option that may provide a good alternative for the usual care. Considering the prevalence of CTS, the study is of great clinical value to a large patient population. TRIAL REGISTRATION: Clinical Trials NL44692.008.13 (registered on 19 September 2013)

Online mindfulness-based intervention for women with pregnancy distress:Design of a randomized controlled trial

Background:  Psychological distress during pregnancy is common: up to 20% of the childbearing women experience symptoms of depression and anxiety. Apart from the adverse effects on the woman herself, pregnancy distress can negatively affect pregnancy outcomes, infant health, postpartum mother-child interaction and child development. Therefore, the development of interventions that reduce pregnancy distress is very important. Mindfulness-based interventions (MBIs) show promising positive effects on pregnancy distress, but there is a need for randomized controlled trials with sufficient power. Trials on online MBIs, which are readily accessible and not expensive, also show positive effects on stress reduction in non-pregnant populations. Moreover, specific working mechanisms of MBIs remain unclear. The aim of the current study is to test the effectiveness of an online MBI in pregnant women with pregnancy distress, as well as exploring potential working mechanisms. Methods:  The current study is a randomized controlled trial with repeated measures. Consenting women with elevated levels of pregnancy distress will be randomized into an intervention group (MBI) or control group (care as usual) around 12 weeks of pregnancy, with an intended sample size of 103 women in each group. The primary outcome, pregnancy distress, will be assessed via questionnaires at baseline, halfway through the intervention and post intervention in both intervention and control group, and after 8 weeks follow-up in the intervention group. Secondary outcomes are mindfulness skills, rumination and self-compassion, which are also seen as potential working mechanisms, and will be assessed via questionnaires before intervention, halfway through the intervention, post intervention and after 8 weeks follow-up in the intervention group. Tertiary outcome variables are obstetric data and will be collected from the obstetric records for both intervention and control group. Analyses will be based on the intention-to-treat principle. Multilevel regression models for repeated measures (mixed models) will be used to evaluate changes in primary and secondary outcome variables. Tertiary outcomes will be compared between groups using independent t-tests and Chi Square analyses. Discussion:  The trial is expected to increase knowledge about the effectiveness of online MBIs during pregnancy in women with pregnancy distress and to evaluate potential working mechanisms.

Mechanical wrist traction as a non-invasive treatment for carpal tunnel syndrome: a randomized controlled trial

Abstract Background Carpal tunnel syndrome (CTS) is a common, compressive nerve-entrapment disorder with symptoms of numbness, paresthesia, and pain. Carpal tunnel release surgery is the only known long-term effective treatment. However, surgery is invasive and up to 30% of patients report recurrence or persistence of symptoms or suffer from post-surgical complications. A promising non-surgical treatment for CTS is mechanical wrist traction. The purpose of this study was to evaluate clinical outcomes following mechanical traction in patients with CTS compared to care as usual. Methods Adult patients (N = 181, mean age 58.1 (13.0) years, 67% women) with electrodiagnostically confirmed CTS were recruited from an outpatient neurology clinic in the Netherlands between October 2013 and April 2015. After baseline assessments, patients were randomized to either the intervention group (12 treatments with mechanical traction, twice a week for a period of 6 weeks) or “care as usual”. The main clinical outcome measure was surgery during 6 months’ follow-up. In addition, symptom severity was measured using the Boston Carpal Tunnel Questionnaire (BCTQ) at baseline, 3, and 6 months’ follow-up. Baseline characteristics and severity of CTS symptoms at follow-up were compared between the intervention and care-as-usual groups using a t test and χ 2 tests. Time to event (surgery) between the groups was analyzed using Kaplan-Meier survival analysis and Cox proportional hazards analysis. Results The intervention group had fewer surgeries (28%) compared to the care-as-usual group (43%) during follow-up (χ2 1 = 4.40, p = .036). Analyses of the survival curves revealed a statistically significant difference between the groups over time (log-rank test χ 2 1 = 6.94, p = .008). At 6 months’ follow-up, symptom severity and functional status scores had significantly decreased from baseline in both groups (p < .001) and the improvements did not differ between the two groups. Conclusions Mechanical traction is associated with fewer surgical interventions compared to care as usual in CTS patients. Reductions in patient-reported symptoms at 6 months’ follow-up was similar in both groups. The long-term effects of mechanical traction require further evaluation. Trial registration ClinicalTrials.gov, ID: NL44692.008.13 . Registered on 19 September 2013

Maternal cognitive function during pregnancy in relation to hypo‐ and hyperthyroxinemia

Objective:  To assess a possible relationship between maternal cognitive dysfunction during pregnancy and hypothyroxinemia, adjusted for major confounders. Background:  Thyroid dysfunction in general is associated with cognitive dysfunction. Cognitive dysfunction is common during pregnancy. Design:  Prospective follow‐up study from 12 to 32 weeks of pregnancy.Participants: 2082 healthy pregnant women. Measurements: Cognitive function, depression and sleeping problems were as‐sessed by self‐report questionnaires at 12, 22 and 32 weeks of gestation, higher scores reflecting more symptoms. FT4, TSH and TPO‐Ab were assessed at 12 weeks of gestation.Definitions: healthy (euthyroxinemia) control group: FT4 within 10‐90th percen‐tiles, without elevated TPO‐Ab titres and TSH within first trimester‐specific refer‐ence range (0.23‐4.0 mU/L). Hypothyroxinemia: FT4 1 SD > mean on the cognitive function scale. Results:  A total of 54 women showed hypothyroxinemia and 1476 women had eu‐thyroxinemia. At 12 weeks, multiple logistic regression showed that poor cognitive function was independently related to hypothyroxinemia: OR: 2.9 (95% CI: 1.6‐5.4), adjusted for depression (OR: 3.1; 95% CI: 2.7‐4.6) and sleeping problems (OR: 2.8, 95% CI: 1.9‐3.9). TPO‐Ab + women with hypothyroxinemia had the highest levels of cognitive dysfunction. Other cut‐offs of hypothyroxinemia (<5th or <10th percen‐tile with normal TSH) showed similar results. GLM‐ANOVA showed that throughout pregnancy women with hypothyroxinemia at 12 weeks had significantly higher cog‐nitive dysfunction scores compared with the healthy controls: F = 12.1, P = .001. Conclusions:  Women with hypothyroxinemia during early gestation are at risk for poor cognitive function throughout gestation, adjusted for depression and sleeping problems

Maternal cognitive function during pregnancy in relation to hypo‐ and hyperthyroxinemia

Objective: To assess a possible relationship between maternal cognitive dysfunction during pregnancy and hypothyroxinemia, adjusted for major confounders. Background: Thyroid dysfunction in general is associated with cognitive dysfunction. Cognitive dysfunction is common during pregnancy. Design: Prospective follow-up study from 12 to 32 weeks of pregnancy. Participants: 2082 healthy pregnant women. Measurements: Cognitive function, depression and sleeping problems were assessed by self-report questionnaires at 12, 22 and 32 weeks of gestation, higher scores reflecting more symptoms. FT4, TSH and TPO-Ab were assessed at 12 weeks of gestation. Definitions: healthy (euthyroxinemia) control group: FT4 within 10-90th percentiles, without elevated TPO-Ab titres and TSH within first trimester-specific reference range (0.23-4.0 mU/L). Hypothyroxinemia: FT4 1 SD > mean on the cognitive function scale. Results: A total of 54 women showed hypothyroxinemia and 1476 women had euthyroxinemia. At 12 weeks, multiple logistic regression showed that poor cognitive function was independently related to hypothyroxinemia: OR: 2.9 (95% CI: 1.6-5.4), adjusted for depression (OR: 3.1; 95% CI: 2.7-4.6) and sleeping problems (OR: 2.8, 95% CI: 1.9-3.9). TPO-Ab + women with hypothyroxinemia had the highest levels of cognitive dysfunction. Other cut-offs of hypothyroxinemia (<5th or <10th percentile with normal TSH) showed similar results. GLM-ANOVA showed that throughout pregnancy women with hypothyroxinemia at 12 weeks had significantly higher cognitive dysfunction scores compared with the healthy controls: F = 12.1, P =.001. Conclusions: Women with hypothyroxinemia during early gestation are at risk for poor cognitive function throughout gestation, adjusted for depression and sleeping problems

The Brabant study: design of a large prospective perinatal cohort study among pregnant women investigating obstetric outcome from a biopsychosocial perspective

BACKGROUND: Pregnancy is characterised by many biological and psychosocial changes. Adequate maternal thyroid function is important for the developing fetus throughout gestation. Latent class analyses recently showed three different patterns of change in thyroid function throughout pregnancy with different associations with obstetric outcome. Maternal distress during the pregnancy (anxiety and depression) negatively affects obstetric outcome. Pregnancy distress in turn may be affected by personality traits and attachment styles. Moreover, during the pregnancy, substantial social changes occur in the partner relationship and work experience. The aim of the Brabant study is to investigate the association between thyroid function trajectories and obstetric outcomes. Moreover, within the Brabant study, we will investigate how different trajectories of pregnancy distress are related to obstetric outcome, and the role of personality in this association. We will evaluate the possible role of maternal distress and attachment style on maternal-fetal bonding. Finally, we will study social changes in the perinatal period regarding partner relationship and well-being and performance at work. METHODS AND ANALYSIS: The Brabant study is a longitudinal, prospective cohort study of an anticipated 4000 pregnant women. Women will be recruited at 8-10 weeks gestation among community midwife practices in South-East Brabant in the Netherlands. Thyroid function parameters (TSH and fT4), thyroid peroxidase antibody and human chorionic gonadotrophin will be assessed at 12, 20 and 28 weeks gestation. Moreover, at these three time points women will fill out questionnaires assessing demographic and obstetric features, life style habits and psychological and social variables, such as depressive symptoms, personality, partner relationship quality and burnout. Data from the obstetric records will also be collected. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethical Committee of the Máxima Medical Center Veldhoven. Results will be submitted to peer-reviewed journals in the relevant fields and presented on national and international conferences