Spinal manual therapy in infants, children and adolescents: A systematic review and meta-analysis on treatment indication, technique and outcomes.

BACKGROUND: Studies on effectiveness and safety of specific spinal manual therapy (SMT) techniques in children, which distinguish between age groups, are lacking. OBJECTIVE: To conduct a systematic review of the evidence for effectiveness and harms of specific SMT techniques for infants, children and adolescents. METHODS: PubMed, Index to Chiropractic Literature, Embase, CINAHL and Cochrane Library were searched up to December 2017. Controlled studies, describing primary SMT treatment in infants (<1 year) and children/adolescents (1-18 years), were included to determine effectiveness. Controlled and observational studies and case reports were included to examine harms. One author screened titles and abstracts and two authors independently screened the full text of potentially eligible studies for inclusion. Two authors assessed risk of bias of included studies and quality of the body of evidence using the GRADE methodology. Data were described according to PRISMA guidelines and CONSORT and TIDieR checklists. If appropriate, random-effects meta-analysis was performed. RESULTS: Of the 1,236 identified studies, 26 studies were eligible. Infants and children/adolescents were treated for various (non-)musculoskeletal indications, hypothesized to be related to spinal joint dysfunction. Studies examining the same population, indication and treatment comparison were scarce. Due to very low quality evidence, it is uncertain whether gentle, low-velocity mobilizations reduce complaints in infants with colic or torticollis, and whether high-velocity, low-amplitude manipulations reduce complaints in children/adolescents with autism, asthma, nocturnal enuresis, headache or idiopathic scoliosis. Five case reports described severe harms after HVLA manipulations in four infants and one child. Mild, transient harms were reported after gentle spinal mobilizations in infants and children, and could be interpreted as side effect of treatment. CONCLUSIONS: Based on GRADE methodology, we found the evidence was of very low quality; this prevented us from drawing conclusions about the effectiveness of specific SMT techniques in infants, children and adolescents. Outcomes in the included studies were mostly parent or patient-reported; studies did not report on intermediate outcomes to assess the effectiveness of SMT techniques in relation to the hypothesized spinal dysfunction. Severe harms were relatively scarce, poorly described and likely to be associated with underlying missed pathology. Gentle, low-velocity spinal mobilizations seem to be a safe treatment technique in infants, children and adolescents. We encourage future research to describe effectiveness and safety of specific SMT techniques instead of SMT as a general treatment approach.

Common Manual Therapy Practices in the Netherlands for Infants With Upper Cervical Dysfunction: A Prospective Cohort Study.

OBJECTIVE: The purpose of this study was to describe common clinical practices of manual therapists (MTs) in the Netherlands for infants with indications of upper cervical dysfunction (UCD). METHODS: A prospective observational cohort study was conducted to gain insight into characteristics, reasons for seeking care, and common clinical practice for infants (<27 weeks) with indications of UCD, referred to MTs. Pre- and posttreatment self-reported questionnaires were used to collect data from parents and MTs. Parents reported on infant characteristics and perceived effect of treatment. Manual therapists reported on diagnostics, therapeutic procedures, and outcomes. RESULTS: Between 2006 and 2007, data regarding 307 referred infants (mean age: 11.2 weeks) were collected by parents and 42 MTs. The most frequent reasons for seeking care were positional preference, restlessness, and/or abnormal head position. Manual therapists observed active, spontaneous, and provoked mobility and passive upper cervical mobility. Of the 307 infants, 295 were diagnosed with UCD based on positive outcomes on the flexion-rotation test and/or lateral flexion test. After treatment with mobilization techniques, positive outcomes on the flexion-rotation test decreased from 78.8% to 6.8%. For the lateral flexion test, the positive outcomes decreased from 91.5% to 6.2%. All parents perceived positive treatment effects. No serious adverse events were reported during this study. CONCLUSIONS: This is the first study to describe common clinical practice for infants referred for manual therapy. Infants with UCD were treated mainly with upper cervical mobilization techniques, and the greatest perceived effect was observed after approximately 2 treatment sessions.

Effectiveness of Pelvic Physiotherapy in Children With Functional Constipation Compared With Standard Medical Care.

BACKGROUND & AIMS: Functional constipation (FC) is a common childhood problem often related to pelvic floor muscle dysfunction. We compared the effectiveness of pelvic physiotherapy (PPT) vs standard medical care (SMC) in children with FC. METHODS: We performed a multicenter randomized controlled trial of 53 children (age, 5-16 y) with FC according to the Rome III criteria, at hospitals in The Netherlands from December 2009 to May 2014. Group allocation was concealed using a central computer system. SMC consisted of education, toilet training, and laxatives (n = 26), whereas PPT included SMC plus specific physiotherapeutic interventions (n = 27). Results were obtained from written reports from the subjects' pediatricians and parents. The primary outcome was absence of FC, according to Rome III criteria, after a 6-month follow-up period. Secondary outcomes were global perceived effect (range, 1-9; success was defined as a score ≥ 8), numeric rating scales assessing quality of life (parent and child; scale, 1-10), and the strengths and difficulties questionnaire (SDQ). RESULTS: Treatment was effective for 92.3% of the children receiving PPT and for 63.0% of the children receiving SMC (adjusted odds ratio for success of PPT, 11.7; 95% confidence interval, 1.8-78.3) (P = .011). Significantly more children undergoing PPT stopped using laxatives (adjusted odds ratio, 6.5; 95% confidence interval, 1.6-26.4) (P = .009). Treatment success (based on global perceived effect) was achieved for 88.5% of subjects receiving PPT vs 33.3% of subjects receiving SMC) (P < .001). PPT also produced larger adjusted mean differences, before vs after treatment, in numeric rating scales to assess quality of life: an increase of 1.8 points for parents (P = .047) and 2.0 points for children (P = .028). Results from the SDQ did not differ significantly between groups (P = .78). CONCLUSIONS: In a randomized controlled trial of children with FC, PPT was more effective than SMC on all outcomes measured, with the exception of findings from the SDQ. PPT should be considered as a treatment option for FC in children 5-16 years old. Dutch Clinical Trial Registration no: NL30551.068.09.

Biofeedback in Partial Weight Bearing: Usability of Two Different Devices from a Patient's and Physical Therapist's Perspective.

BACKGROUND: Partial weight bearing is frequently instructed by physical therapists in patients after lower-limb trauma or surgery. The use of biofeedback devices seems promising to improve the patient's compliance with weight-bearing instructions. SmartStep and OpenGo-Science are biofeedback devices that provide real-time feedback. For a successful implementation, usability of the devices is a critical aspect and should be tested from a user's perspective. AIM: To describe the usability from the physical therapists' and a patients' perspective of Smartstep and OpenGo-Science to provide feedback on partial weight bearing during supervised rehabilitation of patients after lower-limb trauma or surgery. METHODS: In a convergent mixed-methods design, qualitative and quantitative data were collected. Usability was subdivided into user performance, satisfaction and acceptability. Patients prescribed with partial weight bearing and their physical therapists were asked to use SmartStep and OpenGo-Science during supervised rehabilitation. Usability was qualitatively tested by a think-aloud method and a semi-structured interview and quantitatively tested by the System-Usability-Scale (SUS) and closed questions. For the qualitative data thematic content analyses were used. RESULTS: Nine pairs of physical therapists and their patients participated. The mean SUS scores for patients and physical therapists were for SmartStep 70 and 53, and for OpenGo-Science 79 and 81, respectively. Scores were interpreted with the Curved Grading Scale. The qualitative data showed that there were mixed views and perceptions from patients and physical therapists on satisfaction and acceptability. CONCLUSION: This study gives insight in the usability of two biofeedback devices from the patient's and physical therapist's perspective. The overall usability from both perspectives seemed to be acceptable for OpenGo-Science. For SmartStep, overall usability seemed only acceptable from the patient's perspective. IMPLICATION: The study findings could help clinicians to decide which biofeedback device is appropriate for their given situation and provide information for future development of biofeedback devices.

Biofeedback in Partial Weight Bearing: Validity of 3 Different Devices.

Study Design Controlled laboratory study to assess criterion-related validity, with a cross-sectional within-subject design. Background Patients with orthopaedic conditions have difficulties complying with partial weight-bearing instructions. Technological advances have resulted in biofeedback devices that offer real-time feedback. However, the accuracy of these devices is mostly unknown. Inaccurate feedback can result in incorrect lower-limb loading and may lead to delayed healing. Objectives To investigate validity of peak force measurements obtained using 3 different biofeedback devices under varying levels of partial weight-bearing categories. Methods Validity of 3 biofeedback devices (OpenGo science, SmartStep, and SensiStep) was assessed. Healthy participants were instructed to walk at a self-selected speed with crutches under 3 different weight-bearing conditions, categorized as a percentage range of body weight: 1% to 20%, greater than 20% to 50%, and greater than 50% to 75%. Peak force data from the biofeedback devices were compared with the peak vertical ground reaction force measured with a force plate. Criterion validity was estimated using simple and regression-based Bland-Altman 95% limits of agreement and weighted kappas. Results Fifty-five healthy adults (58% male) participated. Agreement with the gold standard was substantial for the SmartStep, moderate for OpenGo science, and slight for SensiStep (weighted ± = 0.76, 0.58, and 0.19, respectively). For the 1% to 20% and greater than 20% to 50% weight-bearing categories, both the OpenGo science and SmartStep had acceptable limits of agreement. For the weight-bearing category greater than 50% to 75%, none of the devices had acceptable agreement. Conclusion The OpenGo science and SmartStep provided valid feedback in the lower weight-bearing categories, and the SensiStep showed poor validity of feedback in all weight-bearing categories. J Orthop Sports Phys Ther 2016;46(11):-1. Epub 12 Oct 2016. doi:10.2519/jospt.2016.6625.

A tailored exercise program versus general exercise for a subgroup of patients with low back pain and movement control impairment: Short-term results of a randomised controlled trial.

BACKGROUND: Exercise is an effective treatment for patients with sub-acute and chronic low back pain (LBP). Patients with a movement control impairment (MCI) can be diagnosed as a subgroup of patients with LBP. Unknown is which exercise intervention is most beneficial for this subgroup. This study assessed the short-term effect of a specific exercise program targeting movement control impairment versus general exercise treatment on disability in patients with LBP and MCI. METHODS: In a multicentre parallel group randomised controlled pragmatic trial, patients with sub-acute and chronic LBP were included. Further inclusion criteria were disability of ≥5 points on the Roland-Morris Disability Questionnaire and ≥2 positive tests out of a set of 6 movement control impairment tests. A total of 106 patients were randomly assigned to either tailored movement control exercise intervention (MC, n = 52) or a general exercise intervention (GE, n = 54); both 9-18 individual treatment sessions, over a maximum of 12 weeks. The primary outcome was disability measured with the Patient Specific Functional scale (PSFS). Secondary outcome was the Roland-Morris disability scale (RMDQ). Measurements were taken pre- and posttreatment. RESULTS: No significant difference was found following the treatment period. Baseline-adjusted between-group mean difference for the PSFS was 0.5 (SD = 0.5; p = 0.32) in favour of MC exercises. The Roland-Morris Disability Questionnaire revealed a significant, but not clinically relevant, between-group difference of 2.0 points (SD = 0.8; p = 0.01). CONCLUSION: Disability in LBP patients was reduced considerably by both interventions. However, the limited contrast between the two exercise programs may have influenced outcomes.

Effect of manual versus mechanically assisted manipulations of the thoracic spine in neck pain patients: study protocol of a randomized controlled trial.

BACKGROUND: Neck pain is a common musculoskeletal condition with a point prevalence of around 15% in males and 23% in females that often presents in physiotherapy practice. Physical therapy and/or manipulation therapy is generally the first management option for patients with mechanical neck pain. Physical therapists treat mechanical neck pain with a number of interventions including joint mobilization and/or manipulation, therapeutic exercises or education. However, manipulation of the cervical spine carries some risks. Treating the thoracic spine for neck pain is an alternative approach. Emerging evidence suggests that it may be effective for treating neck pain without the risks associated with cervical spine manipulation. A new electromechanical device has recently been developed and tested for delivering multiple high velocity, low amplitude thrust manipulations to the spine. This device incorporates both auditory and visual systems that provide real time feedback on the applied treatment. The objective of this study is to compare the short- and long-term effects of manual versus mechanically assisted manipulations of the thoracic spine for neck pain patients. METHODS/DESIGN: A 6-month, randomized controlled trial consisting of 54 patients with acute or chronic neck pain patients will be conducted. Patients with no signs of major pathology and with little or no interference with daily activities will be recruited. Three treatment sessions with 4-day intervals will be carried out. The patients will be randomly assigned to receive either manually performed manipulations or electromechanical manipulations at the thoracic spine. The primary outcome is pain intensity as measured by the Visual Analogue Pain Rating Scale. The secondary outcome measures are neck physical disability using the Neck Disability Index, quality of life measured by the European Quality of Life 5 Dimensions 5 Levels and patients' improvement using the Patient's Global Impression of Change Scale. DISCUSSION: It is expected that both interventions will improve neck pain. This would be a significant finding, as thoracic spine manipulation for neck pain does not carry the same risk of injury as cervical spine manipulation. In addition, the results may provide useful information about therapeutic options for health care providers and patients for the problem of neck pain. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88585962, registered January 2013.

Aquatic circuit training including aqua-cycling in patients with knee osteoarthritis: A feasibility study.

BACKGROUND: Aqua-cycling is easy to learn, acceptable, and safe for patients with knee osteoarthritis. It can therefore be an ideal component of aquatic circuit training. OBJECTIVE: To investigate the feasibility of a small group-based aquatic exercise programme including aqua-cycling. DESIGN: A feasibility study using quantitative (pre-post) and qualitative (cross-sectional) assessments. PARTICIPANTS: A volunteer cohort of 10 women and men, age range 46-77 years, with knee osteoarthritis. METHODS: Focus group interviews explored participants' experience with the training. Pre- and post-exercise knee pain, attendance, progression in training, and adverse events were registered. RESULTS: Seventy percent of patients attended all sessions. Focus groups revealed high levels of satisfaction with the selection of exercises, and participants valued the immediate pain relief experienced. Participants progressed well. However, aqua-cycling in an out-of-the-saddle position was too demanding for most participants. CONCLUSION: An aquatic circuit training that includes aqua- cycling is feasible for patients with knee osteoarthritis. Participants reported pain reduction and were positive about the diverse exercise programme. Aqua-cycling in a seated position is a safe and controlled type of movement.

Efficacy of a physical exercise training programme COPD in primary care: study protocol of a randomized controlled trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is recognized as a systemic illness with significant extra-pulmonary features, such as exercise intolerance and muscle weakness. Pulmonary rehabilitation has been shown to be very effective in counteracting these consequences in patients with more advanced COPD. However, limited data is available on the efficacy of a physical exercise training programme in patients with mild to moderate COPD in primary care. Furthermore, it is unknown if improved exercise capacity translates into enhanced daily physical activities. The aim of this paper is to describe the design of a randomized controlled trial to assess the efficacy of a physical exercise training programme in patients with mild to moderate COPD. METHODS/DESIGN: In this randomized controlled trial situated in the primary care setting, 102 patients with mild to moderate airflow obstruction (FEV1 ≥ 50% of predicted), dyspnoea and a physically inactive lifestyle will be randomized to an intervention or control group. The intervention group receives a 4-month physical exercise training programme at a local physiotherapy practice, which includes exercise training, resistance training, breathing exercises and advises on how to increase the level of physical activity. The control group receives usual care, i.e. advises on how to increase the level of physical activity and a sham treatment at a local physiotherapy practice of which no physiological training stimulus can be expected. Primary outcome is functional exercise capacity at 4-months measured on the six-minute walk distance. Secondary outcomes include peripheral muscle strength, physical activity in daily life, health related quality of life, Medical Research Council (MRC) dyspnoea score and patients' perceived effectiveness. Follow-up measurement will take place at 6 months after baseline. DISCUSSION: This will be one of the first studies to evaluate the efficacy of a physical exercise training programme in patients with mild to moderate COPD completely recruited and assessed in primary care. The results of this trial may give a unique insight into the potential of the implementation of an easy, close-to-home rehabilitation programme. TRIAL REGISTRATION: The Netherlands National Trial Register NTR1471.

The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

BACKGROUND: Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking. METHODS/DESIGN: A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria. DISCUSSION: This section discusses the relevance of publishing the study design and the development of the presented physiotherapy protocol. It also addresses difficulties when interpreting the literature with regard to the effectiveness of biofeedback, potential confounding, and future research indications. To our knowledge, this article is the first to describe the design of a randomised controlled trial among children with constipation to assess the effect of pelvic physiotherapy as an add-on to standard medical care. TRIAL REGISTRATION: Current Controlled Trials NL30551.068.09.

The ClaudicatioNet concept: design of a national integrated care network providing active and healthy aging for patients with intermittent claudication.

INTRODUCTION: Intermittent claudication (IC) is a manifestation of peripheral arterial occlusive disease (PAOD). Besides cardiovascular risk management, supervised exercise therapy (SET) should be offered to all patients with IC. Outdated guidelines, an insufficient number of specialized physiotherapists (PTs), lack of awareness of the importance of SET by referring physicians, and misguided financial incentives all seriously impede the availability of a structured SET program in The Netherlands. DESCRIPTION OF CARE PRACTICE: By initiating regional care networks, ClaudicatioNet aims to improve the quality of care for patients with IC. Based on the chronic care model as a conceptual framework, these networks should enhance the access, continuity, and (cost) efficiency of the health care system. With the aid of a national database, health care professionals will be able to benchmark patient results while ClaudicatioNet will be able to monitor quality of care by way of functional and patient reported outcome measures. DISCUSSION: The success of ClaudicatioNet is dependent on several factors. Vascular surgeons, general practitioners and coordinating central caregivers will need to team up and work in close collaboration with specialized PTs. A substantial task in the upcoming years will be to monitor the quality, volume, and distribution of ClaudicatioNet PTs. Finally, misguided financial incentives within the Dutch health care system need to be tackled. CONCLUSION: With ClaudicatioNet, integrated care pathways are likely to improve in the upcoming years. This should result in the achievement of optimal quality of care for all patients with IC.

Joint-pain comorbidity, health status, and medication use in hip and knee osteoarthritis: a cross-sectional study.

OBJECTIVE: To determine the prevalence of joint-pain comorbidities in individuals with hip or knee osteoarthritis (OA) and to assess the differences in the characteristics of people with and without joint-pain comorbidities. METHODS: In this cross-sectional study, individuals referred to secondary care for treatment of hip/knee OA completed questionnaires to determine sociodemographic characteristics, disease-related outcomes, and joint-pain comorbidities. Joint-pain comorbidity was defined as pain perceived in a joint, other than the index joint, for more than half of the days in the preceding month. To compare differences in patient- and disease-related characteristics between participants with and without joint-pain comorbidities, we performed analyses of covariance and logistic regression. RESULTS: A total of 401 individuals, 117 with hip OA and 284 with knee OA, returned the questionnaire (82% response rate); the mean ± SD age was 58 ± 13 years and 58% of the responders were women. Fifty-eight percent of the participants reported symptoms in ≥1 other joint. Participants with joint-pain comorbidities were more likely to be women, less educated, and have more medical comorbidities. Individuals with joint-pain comorbidities reported unfavorable outcomes on pain, functioning, fatigue, distress, and health-related quality of life compared with patients without joint-pain comorbidities (P < 0.001 for all). Moreover, use of nonsteroidal antiinflammatory drugs (P = 0.038), opioids (P = 0.010), and supplements (P = 0.019) was higher in the group with joint-pain comorbidities. CONCLUSION: Our results indicate that individuals with joint-pain comorbidities represent a clinically relevant and large subgroup of people with OA of the knee or hip. We recommend addressing joint-pain comorbidities in both research and clinical practice.

Is on-demand sacral neuromodulation in patients with OAB syndrome a feasible therapy regime?

INTRODUCTION: Sacral neuromodulation (SNM) of the lower urinary tract has proven to be safe and effective in patients with complaints of OAB syndrome who are not responding to conservative therapy. After 5 years of treatment the implanted system is still effective in 56-71% of patients. The loss of effect could be caused by adaptation of the nerve system to prolonged stimulation of the sacral nerves. MATERIALS AND METHODS: We set up a pilot intervention study. After a run-in period of 2 weeks patients were randomized into two groups: one group with on-demand neuromodulation (intervention group) and one group with continuous neuromodulation (control group). Patients in the intervention group were instructed to switch their INS off by default and to switch it on again when they felt recurrent symptoms, patients in the control group were asked to use their system as normally. RESULTS: After 2 weeks 10 out of 16 subjects reported a comparable symptom score during on-demand use of their neuromodulation system. Patients appreciated the comfort of being self-determent in the need for therapy. CONCLUSIONS: Possible benefits for patients could be: more autonomy, longer battery life of the implanted INS, decreasing the chance of adaptation by the nervous system.

PNE versus 1st stage tined lead procedure: a direct comparison to select the most sensitive test method to identify patients suitable for sacral neuromodulation therapy.

AIMS: To compare the patient's response rate to the Percutaneous Nerve Evaluation test (PNE) and the 1st stage tined-lead placement test (FSTLP) for sacral neuromodulation therapy (SNM). METHODS: Single center study on patients with refractory idiopathic overactive bladder syndrome (OAB) or non-obstructive urinary retention, screened with both PNE and FSTLP. Patients were followed prospectively and their response rate based on bladder diary after PNE was compared to that after FSTLP. More than 50% improvement in at least two relevant urinary symptoms was considered a positive response. A Wilcoxon paired test was done to compare the rates of the two screening options and logistic regression to determine possible associations. A follow-up was conducted to determine the long-term failure rate. RESULTS: One hundred patients were included (82 female, 69 OAB). The mean age was 55 years (SD 13). The positive response rate on PNE was 47%. FSTLP showed a 69% positive response rate, which was negatively related to age. The 22% gain in positive response was statistically significant (P < 0.001) and positively associated with female gender and younger age. All 69 patients with a positive response to FSTLP received SNM treatment. Failure rate after an average of 2 years was 2.9%. CONCLUSIONS: This study suggests that FSTLP may be a more sensitive screening method than PNE to identify patients eligible for SNM therapy, warranting randomized trials.

The effect of pulse rate changes on the clinical outcome of sacral neuromodulation.

PURPOSE: We evaluated the effect of pulse rate changes on the clinical response to and stimulation related pain symptoms of sacral neuromodulation treatment. MATERIALS AND METHODS: In this pilot study we evaluated the effect of 4 pulse rates, including 5.2, 10, 21 and 40 Hz, in patients with a suboptimal response to sacral neuromodulation. The effect of each frequency was evaluated during a 6-day test period. To avoid the carryover effect stimulation was discontinued for 24 hours between consecutive test periods. On the last 3 days of each test period a voiding diary and questionnaire were completed. Changes in the clinical response and pain symptoms were compared between the 4 pulse rates using multivariate analysis. RESULTS: Of the 50 patients included in the study 40 (80%) were female. Mean ± SD age was 55.5 ± 12.3 years. Of the patients 41 (82%) had overactive bladder symptoms and 9 (18%) were in chronic nonobstructive urinary retention. No significant difference was found in clinical outcome on the voiding diary and questionnaire between the pulse rates and none of the 4 rates was significantly related to sacral neuromodulation associated pain. However, individuals appeared to benefit from changing the pulse rate in terms of treatment efficacy and stimulation related pain. CONCLUSIONS: On the group level none of the 4 pulse rates appeared to have a significantly different effect on clinical outcome or sacral neuromodulation related pain. However, an individualized approach to optimize treatment efficacy by changing the pulse rate appears to be useful.

Satisfaction and patient experience with sacral neuromodulation: results of a single center sample survey.

PURPOSE: We systematically assessed long-term satisfaction and patient experience with sacral nerve modulation therapy. MATERIALS AND METHODS: All patients who received sacral neuromodulation between 1990 and 2007 at our center and who still had the implant were included in the survey. All received a postal questionnaire regarding satisfaction and experiences with the system, such as side effects, complications, burden, impact on sexuality and defecation changes. RESULTS: Of the 275 questionnaires sent 207 were returned for a 75% response rate. The population was 83% female. Overall treatment was done for overactive bladder syndrome, nonobstructive urinary retention, combined overactive bladder and retention, and pelvic pain in 55%, 24%, 20% and 1% of patients, respectively. Overall satisfaction with sacral neuromodulation was high at 90%. No correlations were found between the satisfaction rate, and pretreatment age, gender, complaint type, sexual dysfunction or therapy duration. However, 56% of patients reported side effects, such as pain at the internal nerve stimulator site and due to stimulation. However, 89% of these patients did not seek further therapy. Of patients with additional defecation problems 47% experienced relief of complaints. CONCLUSIONS: This study shows a high satisfaction rate in patients with sacral neuromodulation. There was no relation between patient age, complaint type, therapy duration or side effects and the satisfaction rate. The number of side effects was limited but further analysis in prospective cohorts should identify patients who are likely to have side effects or stop sacral neuromodulation treatment.

Long-term results of sacral neuromodulation with the tined lead procedure.

PURPOSE: We present long-term followup data on the outcome of sacral neuromodulation using the tined lead procedure. MATERIALS AND METHODS: We conducted a single center study including all patients who received an implantable neurostimulator between 2002 and 2005 using the tined lead technique. Treatment efficacy was evaluated by comparing the data of a 3-day voiding diary filled out in May 2009 to the data before the onset of sacral neuromodulation treatment (baseline). Clinical success was defined as more than 50% improvement in at least 1 of the relevant voiding diary parameters. RESULTS: A total of 64 patients underwent implantation with an implantable neurostimulator using the tined lead procedure. Mean followup was 53 months (range 35 to 77). Five patients died of causes unrelated to sacral neuromodulation and they were not included in analysis. The implantable neurostimulator was removed from 7 patients and 3 stopped using the neurostimulator. Voiding diary analysis showed that 38 of 59 patients (64%) were successfully treated. There were 21 patients (33%) who underwent a surgical revision due to an adverse event and 1 (1.6%) who underwent lead revision because of suspected lead migration. CONCLUSIONS: Sacral neuromodulation with the tined lead procedure is a safe and effective treatment for patients with overactive bladder symptoms or urinary retention.

Injection therapy for subacute and chronic low back pain: an updated Cochrane review.

STUDY DESIGN: A systematic review of randomized controlled trials (RCTs). OBJECTIVE: To determine if injection therapy is more effective than placebo or other treatments for patients with subacute or chronic low back pain. SUMMARY OF BACKGROUND DATA: The effectiveness of injection therapy for low back pain is still debatable. Heterogeneity of target tissue, pharmacological agent, and dosage, generally found in RCTs, point to the need for clinically valid comparisons in a literature synthesis. METHODS: We updated the search of the earlier systematic review and searched the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE databases up to March 2007 for relevant trials reported in English, French, German, Dutch, and Nordic languages. We also screened references from trials identified. RCTs on the effects of injection therapy involving epidural, facet, or local sites for subacute or chronic low back pain were included. Studies that compared the effects of intradiscal injections, prolotherapy, or ozone therapy with other treatments were excluded unless injection therapy with another pharmaceutical agent (no placebo treatment) was part of one of the treatment arms. Studies about injections in sacroiliac joints and studies evaluating the effects of epidural steroids for radicular pain were also excluded. RESULTS: Eighteen trials (1179 participants) were included in this review. The injection sites varied from epidural sites and facet joints (i.e. intra-articular injections, peri-articular injections and nerve blocks) to local sites (i.e. tender-and trigger points). The drugs that were studied consisted of corticosteroids, local anesthetics, and a variety of other drugs. The methodologic quality of the trials was limited with 10 of 18 trials rated as having a high methodologic quality. Statistical pooling was not possible because of clinical heterogeneity in the trials. Overall, the results indicated that there is no strong evidence for or against the use of any type of injection therapy. CONCLUSION: There is insufficient evidence to support the use of injection therapy in subacute and chronic low-back pain. However, it cannot be ruled out that specific subgroups of patients may respond to a specific type of injection therapy.

Periconceptional folic acid use and the prevalence of positional plagiocephaly.

The incidence of positional plagiocephaly (PP) has increased during the last 2 decades in the Netherlands. Although this is generally solely attributed to the advice to put babies on the back during their sleep, other factors might be of influence. Because the advice to take folic acid (FA) was initiated in the same period as the sleeping advice, this study was undertaken to evaluate the effect of FA on PP. It is known that a daily intake of 400 microg of FA around the time of conception is advised in periconceptive women to prevent development of neural tube defects. The maximal daily dietary folate intake is considered to be 250 mg with a bioavailability of 50% to 70%. However, periconceptional women may take a multivitamin containing pteroylmonoglutamine in addition to a FA supplement (isolated pteroylmonoglutamine). Therefore, the daily intake of FA will exceed 1 mg daily, which is considered the upper limit of daily folate ingestion. Data from the "Maastricht Cohort and Intervention study about pregnancy related girdlepain" were used to study the amount of folate containing supplemental intake of all the 7526 women. In this study, women were prospectively questioned about their FA intake. The entire cohort, considered the control group, was compared with a subgroup of women within this cohort with children with PP, treated by a plastic surgeon, considered the PP group. Double use, defined as isolated FA preparations in addition to folate containing supplements (vitamins), was seen more frequently in women giving birth to children with PP. In the PP group, double use was seen in 33.3% of the women compared to 13.2% in the control group. Although no statistical analysis could be made because the PP group was too small, the use of too high dosages of FA might have an adverse effect in causing more PP. This article does not want to discuss the beneficial effect of FA during pregnancy. However, we observed a potential empirical relation between PP and FA double intake requiring attention in more extensive studies.

Passive movement therapy in patients with moderate to severe paratonia; study protocol of a randomised clinical trial (ISRCTN43069940).

BACKGROUND: Paratonia, a form of hypertonia, is associated with loss of mobility and with the development of contractures especially in the late stages of the dementia. Passive movement therapy (PMT) currently is the main physiotherapeutic intervention. General doubt about the beneficial effects of this widely used therapy necessitates a randomised clinical trial (RCT) to study the efficacy of PMT on the severity of paratonia and on the improvement of daily care. METHODS/DESIGN: A RCT with a 4-week follow-up period. Patients with dementia (according to the DSM-IV-TR Criteria) and moderate to severe paratonia are included in the study after proxy consent. By means of computerised and concealed block randomisation (block-size of 4) patients are included in one of two groups. The first group receives PMT, the second group receives usual care without PMT. PMT is given according to a protocol by physical therapist three times a week for four weeks in a row. The severity of paratonia (Modified Ashworth scale), the severity of the dementia (Global Deterioration Scale), the clinical improvement (Clinical Global Impressions), the difficulty in daily care (Patient Specific Complaints) and the experienced pain in daily care of the participant (PACSLAC-D) is assessed by assessors blind to treatment allocation at baseline, after 6 and 12 treatments. Success of the intervention is defined as a significant increase of decline on the modified Ashworth scale. The 'proportion of change' in two and four weeks time on this scale will be analysed. Also a multiple logistic regression analysis using declined/not declined criteria as dependent variable with correction for relevant confounders (e.g. stage of dementia, medication, co-morbidity) will be used. DISCUSSION: This study is the first RCT of this size to gain further insight on the effect of passive movement therapy on the severity of paratonia. TRIAL REGISTRATION: Current Controlled Trials ISRCTN43069940.