Conservative management of idiopathic clubfoot: Kite versus Ponseti method. An accelerated Ponseti versus the standard Ponseti method: a prospective randomised controlled trial. Comparison of Ponseti and Kite's method of treatment for idiopathic clubfoot. Ponseti's vs. Kite's method in the treatment of clubfoot--a prospective randomised study. Comparison of Ponseti versus surgical treatment for idiopathic clubfoot: a short-term preliminary report. Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme. Comparison of the effectiveness of three manual physical therapy techniques in a subgroup of patients with low back pain who satisfy a clinical prediction rule: a randomized clinical trial. Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial. Short- and long-term outcome of constraint-induced movement therapy after stroke: a randomized controlled feasibility trial. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Participants in prospective, randomized clinical trials for resected non-small cell lung cancer have improved survival compared with nonparticipants in such trials.
To compare the long-term results of the Kite and Ponseti methods of manipulation and casting for clubfoot.
                42 patients (with 64 idiopathic clubfeet) were equally randomised to Kite or Ponseti treatments in the early weeks of life. 14 males and 7 females (34 clubfeet) were treated by the Kite method, whereas 13 males and 8 females (30 clubfeet) were treated by the Ponseti method. All the clubfeet were manipulated, casted, and followed up (for a mean of 3 years) by one experienced orthopaedic surgeon. The final results were compared.
                The success rates for the Kite and Ponseti treatments were similar (79% vs 87%). With the Ponseti method, the number of casts was significantly fewer (7 vs 10); the duration of casting required to achieve full correction was significantly shorter (10 vs 13 weeks); the maximum ankle dorsiflexion achieved was significantly greater (12 vs 6 degrees); and the incidence of residual deformity and recurrence was slightly lower.
                The Ponseti method can achieve more rapid correction and ankle dorsiflexion with fewer casts, without weakening the Achilles tendon. We conducted a prospective randomised controlled trial to compare the standard Ponseti plaster method with an accelerated method for the treatment of idiopathic congenital talipes equinovarus. The standard weekly plaster-change method was accelerated to three times per week. We hypothesised that both methods would be equally effective in achieving correction. A total of 40 consecutive patients (61 feet) were entered into the trial. The initial median Pirani score was 5.5 (95% confidence interval 4.5 to 6.0) in the accelerated group and 5.0 (95% confidence interval 4.0 to 5.0) in the standard control group. The scores decreased by an average 4.5 in the accelerated group and 4.0 in the control group. There was no significant difference in the final Pirani score between the two groups (chi-squared test, p = 0.308). The median number of treatment days in plaster was 16 in the accelerated group and 42 in the control group (p < 0.001). Of the 19 patients in the accelerated group, three required plaster treatment for more than 21 days and were then assigned to the standard control method. Of the 40 patients, 36 were followed for a minimum of six months. These results suggest that comparable outcomes can be achieved with an accelerated Ponseti method. The ability to complete all necessary manipulations within a three-week period facilitates treatment where patients have to travel long distances. The manipulation and corrective cast application for club foot was known to be done by Kite's method. The Kite's method of manipulation (center of rotation of malaligned foot and fulcrum on cuboid) was modified by Ponseti (fulcrum on head of talus). Recently, Ponseti's method has gained popularity and vastly improved results are reported. We report randomized controlled trial where manipulation of club foot was done by Ponseti's and Kite's method and correction evaluated by Pirani score to compare the outcome of treatment.
                Sixty feet in 38 patients, 22 with bilateral and 16 with unilateral clubfeet in children less than two years of age and without any prior manipulation or surgical treatment were randomly allocated to the Ponseti (30 feet) and Kite (30 feet) methods of manipulation. This process resulted in the right and left feet of the same patient in 12 bilateral cases being compared with one another (Paired analysis). In the remaining 10 bilateral cases, four patients had both feet treated by Ponseti and six had both feet treated by Kite (unpaired analysis). Finally, in 16 unilateral cases, 10 feet were allocated to the Ponseti and six to Kite methods of manipulation (unpaired analysis). Feet were followed up weekly for 10 weeks for change of cast and recording of hindfoot, midfoot and total Pirani scores. Correction was measured as a difference between hindfoot, mid foot and total Pirani scores weekly from weeks 1 to 10 and corresponding baseline scores. Absolute correction and rate of correction in (i) bilateral clubfeet treated by Ponseti's method on one side and Kite's method on the other side in the same patient were compared using paired Student's t test and (ii) patients with unilateral clubfoot (where either of the methods was used) or those with bilateral clubfoot (where both feet treated by either of the two methods on both the sides) were compared using difference between means (mean correction by Ponseti minus mean correction by Kite) for magnitude of difference and unpaired Student's t test (if data was normally distributed) or Mann Whitney U statistics (otherwise) for significance of difference.
                In 12 bilateral clubfeet, where one foot received Kite's method and the other Ponseti's manipulation, feet treated by Ponseti's technique showed faster rates of decrease in Pirani score (improvement) as compared to feet treated by Kite's method with the mean of difference between baseline and follow up scores showing significantly greater (P<0.05) difference from zero from fourth week onwards to up to 10 weeks. In unpaired analysis, both for unilateral or bilateral clubfeet, regardless of side, mean Pirani scores in Ponseti feet improved much faster than Kite feet but the difference achieved statistical significance only at the 10(th) week from the start of treatment.
                Hind foot, midfoot and total Pirani scores reduce much faster with Ponseti than the Kite's method of manipulation of clubfoot. In paired analysis the difference becomes statistically significant at fourth week and in unpaired analysis at 10(th) week from the start of treatment. Ponseti's and Kite's methods of conservative management in idiopathic congenital clubfoot were compared in a prospective randomised study consisting of 45 infants (67 feet) younger than 3 months, from March 2003 through February 2004. There were 36 and 31 feet that underwent treatment by Ponseti's and Kite's methods, respectively. After an average follow-up of 27.24 months in the Ponseti group, correction was achieved in 33 feet (91.7%), with only three patients requiring surgical management. There were seven relapses (21.1%), all of which were corrected conservatively. However, two of these required surgical intervention on showing a relapse again in the second year. In the Kite group, we achieved correction in 21 feet (67.7%) after an average follow-up of 24.8 months, with ten patients requiring surgical intervention. There were eight relapses of which only four could be corrected conservatively. We could also achieve correction in very severe feet (Dimeglio classification) in a significantly higher percentage using Ponseti's method, in significantly lesser time and with fewer casts. We are of the opinion that Ponseti's method is superior to Kite's method in achieving correction in idiopathic clubfeet in a relatively shorter period of time when used to treat young infants. The Ponseti method of treatment for congenital clubfeet has gained widespread clinical acceptance. We have used manipulation, serial casting, and surgery to treat congenital clubfeet for almost 3 decades. Considering the Ponseti method of treatment to replace our traditional treatment method, we conducted a randomized, controlled trial evaluating the short-term outcome of the two treatment protocols. We evaluated foot function and applied a standardized measure of health status for children with orthopaedic problems. Nineteen patients (28 feet) were included in the trial. Nine infants (12 feet) were assigned to the Ponseti treatment group, and 10 (16 feet) were assigned to a group with initial casting and posteromedial release at the age of 6 to 8 months. The minimum followup was 3.3 years (mean, 3.5 years; range 3.3-3.8 years). Outcome measures included the Functional Rating System of Laaveg and Ponseti, the Pediatric Outcomes Data Collection Instrument (PODCI), and standardized radiographic measurements. At last followup the mean Functional Rating score was higher in the Ponseti group. Passive dorsiflexion and passive inversion-eversion were better in the Ponseti group. PODCI scales were comparable and radiographic outcome measures were similar in both groups. This trial has documented a favorable short-term outcome for the Ponseti method when compared with a traditional treatment protocol. Level of Evidence: Level III, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. Previous research reviewed treatment success and whether the collective uncertainty principle is met in RCTs in the US National Cancer Institute portfolio. This paper classifies clinical trials funded by the UK HTA programme by results using the method applied to the US Cancer Institute trials, and compares the two portfolios.
                Data on all completed randomised controlled trials funded by the HTA programme 1993-2008 were extracted. Each trial's primary results was classified into six categories; 1) statistically significant in favour of the new treatment, 2) statistically significant in favour of the control treatment 3) true negative, 4) truly inconclusive, 5) inconclusive in favour of new treatment or 6) inconclusive in favour of control treatment. Trials were classified by comparing the 95% confidence interval for the difference in primary outcome to the difference specified in the sample size calculation. The results were compared with Djulbegovic's analysis of NCI trials.
                Data from 51 superiority trials were included, involving over 48,000 participants and a range of diseases and interventions. 85 primary comparisons were available because some trials had more than two randomised arms or had several primary outcomes. The new treatment had superior results (whether significant or not) in 61% of the comparisons (52/85 95% CI 49.9% to 71.6%). The results were conclusive in 46% of the comparisons (19% statistically significant in favour of the new treatment, 5% statistically significant in favour of the control and 22% true negative). The results were classified as truly inconclusive (i.e. failed to answer the question asked) for 24% of comparisons (20/85). HTA trials included fewer truly inconclusive and statistically significant results and more results rated as true negative than NCI trials.
                The pattern of results in HTA trials is similar to that of the National Cancer Institute portfolio. Differences that existed were plausible given the differences in the types of trials -HTA trials are more pragmatic. The results indicate HTA trials are compatible with equipoise. This classification usefully summarises the results from clinical trials and enables comparisons of different portfolios of trials. Randomized clinical trial.
                The purpose of this randomized clinical trial was to examine the generalizability of 3 different manual therapy techniques in a patient population with low back pain that satisfy a clinical prediction rule (CPR).
                Recently a CPR that identifies patients with LBP who are likely to respond rapidly and dramatically to thrust manipulation has been developed and validated. The generalizability of the CPR requires further investigation.
                A total of 112 patients were enrolled in the trial and provided demographic information and completed a number of self-report questionnaires including the Oswestry Disability Questionnaire (ODQ) and the Numerical Pain Rating Scale (NPRS) at baseline, 1-week, 4-weeks, and 6-months. Patients were randomly assigned to receive 1 of the 3 manual therapy techniques for 2 consecutive treatment sessions followed by exercise regimen for an additional 3 sessions. We examined the primary aim using a linear mixed model for repeated measures, using the ODQ and NPRS as dependent variables. The hypothesis of interest was the group by time interaction, which was further explored with pair-wise comparisons of the estimated marginal means.
                There was a significant group x time interaction for the ODQ (P < 0.001) and NPRS scores (P = 0.001). Pair-wise comparisons revealed no differences between the supine thrust manipulation and side-lying thrust manipulation at any follow-up period. Significant differences in the ODQ and NPRS existed at each follow-up between the thrust manipulation and the nonthrust manipulation groups at 1-week and 4-weeks. There was also a significant difference in ODQ scores at 6-months in favor of the thrust groups.
                The results of the study support the generalizability of the CPR to another thrust manipulation technique, but not to the nonthrust manipulation technique that was used in this study. In general, our results also provided support that the CPR can be generalized to different settings from which it was derived and validated. However, additional research is needed to examine this issue. We evaluated the short- and long-term efficacy of a brief cognitive-behavioral therapy (CBT) for chronic temporomandibular disorder (TMD) pain in a randomized controlled trial. TMD clinic patients were assigned randomly to four sessions of either CBT (n=79) or an education/attention control condition (n=79). Participants completed outcome (pain, activity interference, jaw function, and depression) and process (pain beliefs, catastrophizing, and coping) measures before randomization, and 3 (post-treatment), 6, and 12 months later. As compared with the control group, the CBT group showed significantly greater improvement across the follow-ups on each outcome, belief, and catastrophizing measure (intent-to-treat analyses). The CBT group also showed a greater increase in use of relaxation techniques to cope with pain, but not in use of other coping strategies assessed. On the primary outcome measure, activity interference, the proportion of patients who reported no interference at 12 months was nearly three times higher in the CBT group (35%) than in the control group (13%) (P=0.004). In addition, more CBT than control group patients had clinically meaningful improvement in pain intensity (50% versus 29% showed > or =50% decrease, P=0.01), masticatory jaw function (P<0.001), and depression (P=0.016) at 12 months (intent-to-treat analyses). The two groups improved equivalently on a measure of TMD knowledge. A brief CBT intervention improves one-year clinical outcomes of TMD clinic patients and these effects appear to result from specific ingredients of the CBT. Constraint-induced movement therapy (CIMT) is a method to improve motor function in the upper extremity following stroke. The aim of this trial was to determine the effect and feasibility of CIMT compared with traditional rehabilitation in short and long term.
                A randomized controlled trial.
                An inpatient rehabilitation clinic.
                Thirty patients with unilateral hand impairment after stroke.
                Six hours arm therapy for 10 consecutive weekdays, while using a restraining mitten on the unaffected hand.
                The patients were assessed at baseline, post-treatment and at six-month follow-up using the Wolf Motor Function Test as primary outcome measure and the Motor Activity Log, Functional Independence Measure and Stroke Impact Scale as secondary measurements.
                The CIMT group (n=18) showed a statistically significant shorter performance time (4.76 seconds versus 7.61 seconds, P= 0.030) and greater functional ability (3.85 versus 3.47, P= 0.037) than the control group (n=12) on the Wolf Motor Function Test at post-treatment assessment. There was a non-significant trend toward greater amount of use (2.47 versus 1.97, P= 0.097) and better quality of movement (2.45 versus 2.12, P=0.105) in the CIMT group according to the Motor Activity Log. No such differences were seen on Functional Independence Measure at the same time. At six-month follow-up the CIMT group maintained their improvement, but as the control group improved even more, there were no significant differences between the groups on any measurements.
                CIMT seems to be an effective and feasible method to improve motor function in the short term, but no long-term effect was found. Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty-one overweight or obese individuals (body mass index [BMI], 25-40 kg/m(2)) with biopsy-proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group (P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) (P = 0.05). Percent weight reduction correlated significantly with improvement in NAS (r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (>or=7%), compared with those who lost less than 7%, had significant improvements in steatosis (-1.36 versus -0.41, P < 0.001), lobular inflammation (-0.82 versus -0.24, P = 0.03), ballooning injury (-1.27 versus -0.53, P = 0.03) and NAS (-3.45 versus -1.18, P < 0.001).
                Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH. The survival of 78 patients with resected non-small cell lung cancer entered in prospective, randomized investigational trials is compared to that of a population-based group of control patients not included in such trials. The survival of trial patients is significantly better than that of controls (P less than 0.001). This survival advantage for trial participants is most apparent among late Stage I patients, and is observed after matching for known prognostic factors (i.e., primary tumor size, nodal status, tumor histology) and after adjusting in the analysis for age, sex, and the administration of radiation therapy. Several explanations for the improved outcome for trial patients are explored, including differences in preoperative evaluation, staging, surgical technique, placebo effects, and patient motivation. These results suggest the possibility that inclusion in these controlled cancer trials may have had an inherent advantage for all participants.
From the limited evidence available, the Ponseti technique may produce better short-term outcomes compared to the Kite technique. An accelerated Ponseti technique may be as effective as a standard technique. We could draw no conclusions from other included trials because of the limited use of validated outcome measures and lack of available raw data. Future randomised controlled trials should address these issues.