Balloon Expulsion Test Does Not Seem to Be Useful for Screening or Exclusion of Dyssynergic Defecation as a Single Test.
ABSTRACT: Balloon expulsion test (BET) is regarded as a screening tool of dyssynergic defecation (DD). However, some patients with normal BET results may be treated effectively by biofeedback training. This study aims to validate BET as a single screening test.Two hundred and thirty-two patients who were diagnosed with functional constipation or irritable bowel syndrome with constipation who underwent anorectal manometry (ARM) and BET at Seoul National University Hospital were enrolled. We evaluated the validity of BET based on ARM and electromyography (EMG) during biofeedback training.If BET ≤ 1 minute was defined as normal, sensitivity and negative predictive value (NPV) of BET in predicting paradoxical contraction based on ARM findings were 71.4% and 13.9%. If BET ≤ 3 minutes was defined as normal, sensitivity and NPV were 35.2% and 6.6%. Specificity and positive predictive value (PPV) of BET ≤ 3 minutes criteria were 84.8% and 93.3%. Same analysis was conducted in 107 patients who underwent EMG during biofeedback training. With 1-minute criteria, sensitivity and NPV of BET were 70.3% and 14.3%. With 3 minutes criteria, sensitivity and NPV of BET was 38.6% and 8.8%. Specificity and positive predictive values were both 100.0%.Based on either ARM or EMG during biofeedback training, sensitivity was at most 71.4% and NPV was less than 15.0% irrespective of whether BET was within 1minute or within 3 minutes. BET seems to have a limitation as both a screening test for dyssynergic defecation and a simple assessment to rule out the necessity of biofeedback training.
Project description:Although biofeedback therapy is effective in the short-term management of dyssynergic defecation, its long-term efficacy is unknown. Our aim was to compare the 1-year outcome of biofeedback (manometric-assisted pelvic relaxation and simulated defecation training) with standard therapy (diet, exercise, laxatives) in patients who completed 3 months of either therapy.Stool diaries, visual analog scales (VASs), colonic transit, anorectal manometry, and balloon expulsion time were assessed at baseline, and at 1 year after each treatment. All subjects were seen at 3-month intervals and received reinforcement. Primary outcome measure (intention-to-treat analysis) was a change in the number of complete spontaneous bowel movements (CSBMs) per week. Secondary outcome measures included bowel symptoms, changes in dyssynergia, and anorectal function.Of 44 eligible patients with dyssynergic defecation, 26 agreed to participate in the long-term study. All 13 subjects who received biofeedback, and 7 of 13 who received standard therapy, completed 1 year; 6 failed standard therapy. The number of CSBMs per week increased significantly (P<0.001) in the biofeedback group but not in the standard group. Dyssynergia pattern normalized (P<0.001), balloon expulsion time improved (P=0.0009), defecation index increased (P<0.001), and colonic transit time normalized (P=0.01) only in the biofeedback group.Biofeedback therapy provided sustained improvement of bowel symptoms and anorectal function in constipated subjects with dyssynergic defecation, whereas standard therapy was largely ineffective.
Project description:BACKGROUND:Office-based biofeedback therapy is effective for constipation with dyssynergic defecation, but must be performed by skilled staff, is only available in selected centres, and requires multiple visits. The efficacy of home-based biofeedback therapy is unknown. We compared clinical and subjective outcomes with home-based and office-based approaches. METHODS:In this randomised controlled trial, eligible patients were adult outpatients (age 18-80 years) who met the Rome III criteria for functional constipation and who had been referred to a tertiary-care centre after non-response to routine management, and who had dyssynergic defecation. Patients were randomly assigned according to a schedule generated in advance by the study biostatistician, in permuted blocks of four, to receive office-based or home-based biofeedback therapy. Office-based biofeedback comprised therapist-guided pelvic floor training for six sessions over 3 months (visits every 2 weeks). Home-based biofeedback comprised 20 min self-training sessions twice per day, in which a self-inserted probe was used to provide visual feedback via a handheld monitoring device of anal sphincter pressure and push effort. Patients recorded in diaries the time of each defecation attempt, stool consistency, straining effort, feeling of incomplete evacuation, need for digital assistance with stooling, and satisfaction with bowel function, from 1 week before enrolment to the end of follow-up. Treatment responders were defined post hoc as those with normalisation of dyssynergic defecation and an increase in the number of complete spontaneous bowel movements per week by 3 months. Cost outcomes calculated from health-care costs and loss of salary were assessed from hospital billing and medical records and questionnaires. Primary outcome measures were the presence of a dyssynergic pattern during attempted defecation, balloon expulsion time, the number of complete spontaneous bowel movements per week, and satisfaction with bowel function, assessed by intention to treat (non-inferiority) and per protocol. This trial is registered with ClinicalTrials.gov, number NCT03202771. FINDINGS:Of 300 patients screened we enrolled 100, from Jan 7, 2005, to Jan 31, 2010. 83 patients completed training (38 [76%] of 50 in the home-based biofeedback group and 45 [90%] of 50 in the office-based biofeedback group). 34 (68%) patients in the home-based group and 35 (70%) in the office-based group were classified as responders. All primary outcomes improved significantly from baseline in the two treatment groups (all p<0·0001). Home-based biofeedback therapy was non-inferior to office-based therapy for number of complete spontaneous bowel movements per week, satisfaction with bowel function, and balloon expulsion time in the intention-to-treat and per-protocol analyses, and for dyssynergia in the per-protocol analysis. No adverse events were reported. The median cost of home-based biofeedback therapy was significantly lower than that for office-based treatment (US$1081·70, IQR 794·90-1399·30 vs $1942·50, 1621·70-2369·00, p=0·009). INTERPRETATION:Home-based and office-based biofeedback therapy for dyssynergic defecation improved bowel symptoms and physiology with similar efficacy. A home-based programme could substantially broaden the availability and use of this treatment. FUNDING:National Institutes of Health.
Project description:OBJECTIVES:Biofeedback therapy, whether administered at home or in office settings, is effective for dyssynergic defecation (DD). Whether home biofeedback improves quality of life (QOL) and is cost-effective when compared with office biofeedback is unknown. METHODS:QOL was assessed in 8 domains (SF-36) at baseline and after treatment (3 months), alongside economic evaluation during a randomized controlled trial (RCT) comparing home and office biofeedback in patients with DD (Rome III). Costs related to both biofeedback programs were estimated from the hospital financial records, study questionnaires, and electronic medical records. A conversion algorithm (Brazier) was used to calculate the patient's quality-adjusted life years (QALYs) from SF-36 responses. Cost-effectiveness was expressed as incremental costs per QALY between the treatment arms. RESULTS:One hundred patients (96 female patients, 50 in each treatment arm) with DD participated. Six of the 8 QOL domains improved (P < 0.05) in office biofeedback, whereas 4 of the 8 domains improved (P < 0.05) in home biofeedback; home biofeedback was noninferior to office biofeedback. The median cost per patient was significantly lower (P < 0.01) for home biofeedback ($1,112.39; interquartile range (IQR), $826-$1,430) than for office biofeedback ($1,943; IQR, $1,622-$2,369), resulting in a cost difference of $830.11 The median QALY gained during the trial was 0.03 for office biofeedback and 0.07 for home biofeedback (P = NS). The incremental cost-effectiveness ratio was $20,752.75 in favor of home biofeedback. DISCUSSION:Biofeedback therapy significantly improves QOL in patients with DD regardless of home or office setting. Home biofeedback is a cost-effective treatment option for DD compared with office biofeedback, and it offers the potential of treating many more patients in the community.
Project description:<h4>Context</h4>Subacromial impingement syndrome (SIS) is associated with scapular dyskinesis, or imbalanced scapular muscle activity. Evidence has shown that feedback can improve scapular control in patients with SIS. However, it is unknown whether real-time video feedback or electromyography (EMG) biofeedback is optimal for improving scapular kinematics and muscle activity during a functional task.<h4>Objective</h4>To compare the effects of video and EMG feedback sessions on absolute muscle activity (upper trapezius [UT], lower trapezius [LT], serratus anterior), muscle balance ratios (UT/LT, UT/serratus anterior), and scapular kinematics (anterior-posterior tilt, external-internal rotation, upward rotation) in SIS participants during arm elevation and lowering.<h4>Design</h4>Randomized controlled clinical trial.<h4>Setting</h4>Research laboratory.<h4>Patients or other participants</h4>Overhead athletes who were diagnosed with SIS and who also exhibited scapular dyskinesis (N = 41).<h4>Main outcome measure(s)</h4>Three-dimensional kinematics and EMG were recorded before and after feedback training.<h4>Results</h4>Lower trapezius muscle activity increased (4.2%-18%, <i>P</i> < .011) and UT/LT decreased (0.56-1.17, <i>P</i> < .013) in the EMG biofeedback training group as compared with those in the video feedback training group. Scapular upward rotation during arm elevation was higher in the video group than in the EMG group after feedback training (2.3°, <i>P</i> = .024).<h4>Conclusions</h4>The EMG biofeedback improved muscle control and video feedback improved the correction of scapular upward rotation in patients with SIS.<h4>Trial registration number</h4>ClinicalTrials.gov: NCT03252444.
Project description:Dyssynergic defecation (DD) is a subtype of chronic constipation that responds to biofeedback therapy (BFT). Abdominal, anorectal, and stool symptoms are commonly reported by DD patients, but limited data exist to demonstrate the improvement of these associated symptoms to BFT. Aims to prospectively study the response of constipation and associated abdominal, rectal, and stool symptoms to biofeedback in a population with dyssynergia.Patients with DD as determined by anorectal manometry and balloon expulsion testing were included into the study. All patients completed a validated survey, the Personal Assessment of Constipation Symptom (PAC-SYM) questionnaire, before and following BFT. The PAC-SYM is a clinical tool to assess constipation-related symptom frequency and severity.Seventy-seven dyssynergic patients fulfilled the study requirements. Abdominal symptoms were present in up to 74% of patients with dyssynergia. PAC-SYM summation scores improved following completion of biofeedback by 48%, from 22.08 to 11.48 (P<0.001). The proportion of patients with at least moderate symptoms decreased in all 12 questionnaire items, including all abdominal symptoms, after completing BFT (46.8% to 14.3%, P<0.001).Abdominal symptoms are common in patients with dyssynergia. BFT improves both anorectal-related constipation symptoms and associated abdominal symptoms in patients with DD. Limitations of this study are observational design, lack of control group, and lack of long-term follow-up.
Project description:<h4>Background</h4>Chronic or recurrent musculoskeletal pain in the cervical and shoulder region is a common secondary problem after spinal cord injury (SCI), reported by 30% to 70% of individuals.<h4>Objective</h4>The purpose of this study was to investigate the effect of electromyographic (EMG) biofeedback training, in addition to a standard exercise program, on reducing shoulder pain in manual wheelchair users with SCI.<h4>Methods</h4>Fifteen individuals with SCI, C6 or lower, who were manual wheelchair users with shoulder pain were randomly assigned to 1 of 2 interventions. The Exercise group (n = 7) received instruction on a standard home-based exercise program. The EMG Biofeedback plus Exercise group (n = 8) received identical exercise instruction plus EMG biofeedback training to improve muscle balance and muscle relaxation during wheelchair propulsion. Shoulder pain was assessed by the Wheelchair Users Shoulder Pain Index (WUSPI) at baseline, at posttest 10 weeks after the start of intervention, and at follow-up 16 weeks after posttest.<h4>Results</h4>The number of participants per group allowed only within-group comparisons; however, the findings indicated a beneficial effect from EMG biofeedback training. Shoulder pain, as measured by WUSPI, decreased 64% from baseline to posttest for the EMG Biofeedback plus Exercise group (P = .02). Shoulder pain for the Exercise group decreased a nonsignificant 27%. At follow-up, both groups showed continued improvement, yet the benefit of EMG biofeedback training was still discernible. The EMG Biofeedback plus Exercise group had an 82% reduction in shoulder pain from baseline to follow-up (P = .004), while the Exercise group showed a 63% reduction (P = .03) over the same time period.<h4>Conclusions</h4>This study provides preliminary evidence that EMG biofeedback has value when added to an exercise intervention to reduce shoulder pain in manual wheelchair users with SCI. These findings indicate that EMG biofeedback may be valuable in remediating musculoskeletal pain as a secondary condition in SCI. This preliminary conclusion will need to be studied and verified through future work.
Project description:INTRODUCTION:Defecation is a complex process that can be easily disturbed. Defecatory disorders may be diagnosed using specialized investigation, including anorectal manometry (ARM) and the balloon expulsion test (BET). Recently, we developed a simulated stool named Fecobionics that integrates several tests and assesses pressures, orientation, and bending during evacuation. The aim was to evaluate the feasibility and performance of Fecobionics for assessing defecatory physiology in normal subjects. METHODS:Physiological expulsion parameters were assessed in an interventional study design. The 10-cm-long Fecobionics probe contained pressure sensors at the front and rear and inside a bag and 2 motion processor units. The bag was distended in the rectum of 20 presumed normal subjects (15 female/5 male) until urge to defecate. ARM-BET was also performed. Three subjects used +2 minutes to evacuate BET, and 1 subject had a high fecal incontinence score. Therefore, the normal group consisted of 16 subjects (13 female/3 male aged 25-78 years). RESULTS:All subjects reported that Fecobionics evacuation was similar to normal defecation. Fecobionics expulsion pressure signatures demonstrated 5 phases, reflecting rectal pressure, anal relaxation, and anal passage. Preload-afterload loop diagrams demonstrated clockwise contraction cycles. The expulsion duration for BET and Fecobionics was 16 ± 2 and 23 ± 5 seconds (P > 0.2), respectively. The duration of the Fecobionics and BET expulsions was associated (P < 0.001). The change in bending of Fecobionics during defecation was 40 ± 3°. DISCUSSION:Fecobionics obtained reliable data under physiological conditions. Agreement was found for comparable variables between ARM-BET and Fecobionics but not for other variables. The study suggests that Fecobionics is safe and effective in evaluation of key defecatory parameters.
Project description:Levator ani syndrome (LAS) might be treated using biofeedback to teach pelvic floor relaxation, electrogalvanic stimulation (EGS), or massage of levator muscles. We performed a prospective, randomized controlled trial to compare the effectiveness of these techniques and assess physiologic mechanisms for treatment.Inclusion criteria were Rome II symptoms plus weekly pain. Patients were categorized as "highly likely" to have LAS if they reported tenderness with traction on the levator muscles or as "possible" LAS if they did not. All 157 patients received 9 sessions including psychologic counseling plus biofeedback, EGS, or massage. Outcomes were reassessed at 1, 3, 6, and 12 months.Among patients with "highly likely" LAS, adequate relief was reported by 87% for biofeedback, 45% for EGS, and 22% for massage. Pain days per month decreased from 14.7 at baseline to 3.3 after biofeedback, 8.9 after EGS, and 13.3 after massage. Pain intensity decreased from 6.8 (0-10 scale) at baseline to 1.8 after biofeedback, 4.7 after EGS, and 6.0 after massage. Improvements were maintained for 12 months. Patients with only a "possible" diagnosis of LAS did not benefit from any treatment. Biofeedback and EGS improved LAS by increasing the ability to relax pelvic floor muscles and evacuate a water-filled balloon and by reducing the urge and pain thresholds.Biofeedback is the most effective of these treatments, and EGS is somewhat effective. Only patients with tenderness on rectal examination benefit. The pathophysiology of LAS is similar to that of dyssynergic defecation.
Project description:Recent evidence suggests the minimization of muscular effort rather than of the size of bodily sway may be the primary, nervous system goal when regulating the human, standing posture. Different programs have been proposed for balance training; none however has been focused on the activation of postural muscles during standing. In this study we investigated the possibility of minimizing the activation of the calf muscles during standing through biofeedback. By providing subjects with an audio signal that varied in amplitude and frequency with the amplitude of surface electromyograms (EMG) recorded from different regions of the gastrocnemius and soleus muscles, we expected them to be able to minimize the level of muscle activation during standing without increasing the excursion of the center of pressure (CoP). CoP data and surface EMG from gastrocnemii, soleus and tibialis anterior muscles were obtained from 10 healthy participants while standing at ease and while standing with EMG biofeedback. Four sensitivities were used to test subjects' responsiveness to the EMG biofeedback. Compared with standing at ease, the two most sensitive feedback conditions induced a decrease in plantar flexor activity (~15%; P < 0.05) and an increase in tibialis anterior EMG (~10%; P < 0.05). Furthermore, CoP mean position significantly shifted backward (~30 mm). In contrast, the use of less sensitive EMG biofeedback resulted in a significant decrease in EMG activity of ankle plantar flexors with a marginal increase in TA activity compared with standing at ease. These changes were not accompanied by greater CoP displacements or significant changes in mean CoP position. Key results revealed subjects were able to keep standing stability while reducing the activity of gastrocnemius and soleus without loading their tibialis anterior muscle when standing with EMG biofeedback. These results may therefore posit the basis for the development of training protocols aimed at assisting subjects in more efficiently controlling leg muscle activity during standing.
Project description:We present a 47-year-old right-handed woman with a 15-year history of writer's cramp who was provided with six sessions of cathodal transcranial direct current stimulation (tDCS) combined with observation of writing actions performed by a healthy subject and electromyographic (EMG) biofeedback training to decrease EMG activities in her right forehand muscles while writing for 30 min for 4 weeks. She showed improvement in dystonic posture and writing speed after the intervention. The writing movement and writing speed scores on a writer's cramp rating scale decreased, along with writing time. Our findings demonstrated that cathodal tDCS combined with action observation and EMG biofeedback training might improve dystonic writing movements in a patient with writer's cramp.