Hand therapy or not following collagenase treatment for Dupuytren's contracture? Protocol for a randomised controlled trial.
ABSTRACT: BACKGROUND:Dupuytren's contracture (DC) is a fibrotic hand condition in which one or more fingers develop progressive flexion deformities. Quality of life is diminished due to disabling limitations in performing everyday activities. For DC patients treated with collagenase, referral for subsequent hand therapy is inconsistent. It is unknown whether subsequent hand therapy is beneficial compared to no therapy. The purpose of this study is to determine whether hand therapy improves DC patients' performance of and satisfaction with performing everyday activities one year after collagenase treatment. METHODS:We will conduct a randomised controlled trial with two treatment groups (hand therapy vs. control) of DC patients who have received collagenase treatment. DC patients with contracted metacarpophalangeal joint(s) (MCPJ) (hand therapy, n =?40; control, n?=?40) and those with proximal interphalangeal joint(s) (PIPJ) involvement (hand therapy, n?=?40; control, n?=?40) comprise two subgroups, and we will study if the treatment effect will be different between both groups (n =?160). Patients with a previous injury or treatment for DC in the treatment finger are excluded. Hand therapy includes oedema and scar management, splinting, movement exercises, and practice of everyday activities. The main outcome variable is patients' performance of and satisfaction with performing everyday activities, as assessed with the Canadian Occupational Performance Measure. Secondary outcomes are DC-specific activity problems, as assessed with the Unité Rhumatologique des Affections de la Main scale, and active/passive flexion/extension of treated joints and grip force using standard measuring tools, and self-reported pain level. Demographic and clinical variables, degree of scarring, cold hypersensitivity, number of occupational sick-leave days are collected. Self-reported global impression of change will be used to assess patient satisfaction with change in hand function. Assessments are done pre-injection and 6?weeks, 4?months, and 1?year later. Standard univariate and multivariate statistical analyses will be used to evaluate group differences. DISCUSSION:This study aims to assess whether hand therapy is beneficial for activity-related, biomechanical, and clinical outcomes in DC patients after collagenase treatment. The results will provide an objective basis for determining whether hand therapy should be conducted after collagenase treatment. TRIAL REGISTRATION:This study has been registered at ClinicalTrials.gov as NCT03580213 (April 5, 2018).
Project description:To compare collagenase injections and surgery (fasciectomy) for Dupuytren's contracture (DC) regarding actual total direct treatment costs and short-term outcomes.Retrospective cohort study.Orthopaedic department of a regional hospital in Sweden.Patients aged 65 years or older with previously untreated DC of 30° or greater in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints of the small, ring or middle finger. The collagenase group comprised 16 consecutive patients treated during the first 6 months following the introduction of collagenase as treatment for DC at the study centre. The controls were 16 patients randomly selected among those operated on with fasciectomy at the same centre during the preceding 3 years.Treatment with collagenase was given during two standard outpatient clinic visits (injection of 0.9 mg, distributed at multiple sites in a palpable cord, and next-day finger extension under local anaesthesia) followed by night-time splinting. Fasciectomy was carried out in the operating room (day surgery) under general or regional anaesthesia using standard technique, followed by therapy and splinting.Actual total direct costs (salaries of all medical personnel involved in care, medications, materials and other relevant costs), and total MCP and PIP extension deficit (degrees) measured by hand therapists at 6-12 weeks after the treatment.Collagenase injection required fewer hospital outpatient visits to a therapist and nurse than fasciectomy. Total treatment cost for collagenase injection was US$1418.04 and for fasciectomy US$2102.56. The post-treatment median (IQR) total extension deficit was 10 (0-30) for the collagenase group and 10 (0-34) for the fasciectomy group.Treatment of DC with one collagenase injection costs 33% less than fasciectomy with equivalent efficacy at 6 weeks regarding reduction in contracture.
Project description:Background and purpose - Few prospective studies have reported the long-term effect durability of collagenase injections for Dupuytren disease. We assessed the 3-year treatment outcome of collagenase injections and predictors of recurrence.Patients and methods - We conducted a single-center prospective cohort study. Indication for collagenase injection was palpable Dupuytren's cord and active extension deficit (AED) ? 20° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint. From November 2012 through June 2013, we treated 86 consecutive patients (92 hands, 126 fingers). A hand therapist measured joint contracture before, 5 weeks, and 3 years after injection. The patients rated their treatment satisfaction. Primary outcome was proportion of treated joints with ? 20° AED worsening between the 5-week and 3-year measurements. We analyzed predictors of recurrence.Results - 3-year outcomes were available for 83 of the 86 patients (89 hands, 120 treated fingers). Between the 5-week and 3-year measurements, AED worsened by ? 20° in 17 MCP (14%) and 28 PIP (23%) joints. At 3 years, complete correction (passive extension deficit 0-5°) was present in 73% of MCP and 35% of PIP joints. Treatment of small finger PIP joint contracture, greater pretreatment contracture severity, and previous fasciectomy on the treated finger were statistically significant predictors of recurrence. Treatment satisfaction was rated as very satisfied or satisfied in 59 of 87 hands. No long-term treatment-related adverse events were observed.Interpretation - 3 years after collagenase injections for Dupuytren disease, improvement was maintained and treatment satisfaction reported in two-thirds of the treated hands, with no adverse events. Complete contracture correction was achieved in 3 of 4 MCP joints, but in only a third of the PIP joints.
Project description:INTRODUCTION:Dupuytren's contracture (DC) is a chronic fibroproliferative disorder of the palmar fascia which leads to flexion contracture in one or more fingers. There is no definitive cure for DC, and treatment aims at relieving symptoms by releasing the contracture using percutaneous or operative techniques. METHODS AND ANALYSIS:We planned a prospective, randomised, controlled, outcome assessor-blinded, three-armed parallel 1:1:1, multicentre trial comparing the effectiveness and cost of (1) collagenase clostridium histolyticum injection followed by limited fasciectomy in non-responsive cases, (2) percutaneous needle fasciotomy followed by limited fasciectomy in non-responsive cases and (3) primary limited fasciectomy during short-term and long-term follow-up for Tubiana I-III stages DC. We will recruit participants from seven national centres in Finland. Primary outcome is the rate of success in the treatment arm at 5 years after recruitment. Success is a composite outcome comprising (1) at least 50% contracture release from the date of recruitment and (2) participants in a patient-accepted symptom state (PASS). Secondary outcomes are (1) angle of contracture, (2) quick disabilities of the arm, a shoulder and hand outcome measure (QuickDASH), (3) perceived hand function, (4) EQ-5D-3L, (5) rate of major adverse events, (6) patient's trust of the treatment, (7) global rating, (8) rate of PASS, (9) rate of minimal clinically important improvement, (10) expenses, (11) progression of disease, (12) progression-free survival, (13) favoured treatment modality, (14) patients achieving full contracture release and >50%?improvement and (15) patient satisfaction with the treatment effect. Predictive factors for achieving the PASS will also be analysed. ETHICS AND DISSEMINATION:The protocol was approved by the Tampere University Hospital Institutional Review Board and Finnish Medicine Agency. The study will be performed according to the principles of good clinical practice. The results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03192020; Pre-results.
Project description:In POINT X, a study designed to reflect clinical practice and patient treatment choices, 254 European patients received open-label collagenase for Dupuytren's contracture. The most severely affected joint was treated first in 74% of patients. In total, 52%, 41%, 7%, and 1% of patients selected the little, ring, middle, and index finger, respectively; 79% had one or two joints treated. Only 9% of patients (n = 24) received 4 or 5 injections. The mean improvement in total passive extension deficit (TPED) was 34° on day 1, improving further by day 7 to 42°. This secondary improvement was maintained by day 90 and month 6. The mean number of injections/joint was 1.2 for the metacarpophalangeal joint and 1.25 for the proximal interphalangeal joint. Median time to recovery was 4 days; the mean improvement in hand function was clinically relevant as measured by the Unité Rhumatologique des Affections de la Main (URAM) score. In total, 87% and 86% of patients and physicians, respectively, were very satisfied or satisfied with treatment at month 6, although correlation between TPED and patient satisfaction was weak (Spearman -0.18, 95% CI -0.32 to -0.06). Collagenase was well tolerated, with 10 (3.9%) patients experiencing severe adverse events. As a real-world study, the POINT X findings can be generalized to the at-large population.
Project description:Depression and anxiety disorders are a major concern in western countries, and because these often have a negative affect on everyday life interventions based on activities in everyday life are needed. The Tree Theme Method® (TTM) is a client-centred occupational therapy intervention designed to increase the ability to cope with, and to enhance satisfaction with, everyday life, both at home and at work. The aim of this study was to compare the short term outcomes of the TTM intervention with regular occupational therapy treatment for people with depression and/or anxiety disorders.This randomised controlled trial included patients from three counties in Sweden. Men and women with depression and/or anxiety disorders, ages 18 to 65, were randomised to either TTM or regular occupational therapy. Assessment data were collected at baseline and the follow-up directly after completing the intervention. Non-parametric and parametric statistical methods were used.The questionnaires were answered by 118 patients at baseline and by 107 patients after completing the intervention. No significant differences in short term outcomes were found between the groups. Both groups showed positive significant outcomes regarding almost all aspects of activities in everyday life, psychological symptoms, and health-related and intervention-related aspects.Despite the lack of differences between the groups, the positive outcomes regarding activities in everyday life, psychological symptoms, and health-related aspects after completing the intervention indicates the need for further research on the long-term perspective of TTM compared to regular occupational therapy.Clinical Trials.gov: NCT01980381 ; registered November 2013.
Project description:Limited research has assessed patient preferences for treatment disposition and antibiotic therapy of acute bacterial skin and skin structure infection (ABSSSI) in the emergency department (ED). Understanding patient preference for the treatment of ABSSSI may influence treatment selection and improve satisfaction. A survey was conducted across 6 US hospital EDs. Patients with ABSSSI completed a baseline survey assessing preferences for antibiotic therapy (intravenous versus oral) and treatment location. A follow-up survey was conducted within 30-40?days after ED discharge to reassess preferences and determine satisfaction with care. A total of 94 patients completed both baseline and follow-up surveys. Sixty (63.8%) participants had a history of ABSSSI, and 69 (73.4%) were admitted to the hospital. Treatment at home was the most common preference reported on baseline and follow-up surveys. Patients with higher education were 82.2% less likely to prefer treatment in the hospital. Single dose intravenous therapy was the most commonly preferred antibiotic regimen on baseline and follow-up surveys (39.8 and 19.1%, respectively). Median satisfaction scores for care in the ED, hospital, home, and with overall antibiotic therapy were all 8 out of a maximum of 10. In these patients, the most common preference was for outpatient care and single dose intravenous antibiotics. Patient characteristics including higher education, younger age, and current employment were associated with these preferences. Opportunities exist for improving ABSSSI care and satisfaction rates by engaging patients and offering multiple treatment choices.
Project description:Antigen presenting cells (APC) are a heterogenous population, comprised of macrophages/monocytes (CD14+ cells), classical dendritic cells (CD141+DC and CD1c+ DC) and pDC. Upon stimulation, APC migrate from peripheral organs to lymph nodes, where they drive T cell specific lineage fate, that is towards immune activation or suppression. APC in human tissues remain poorly defined. Through our previous published data we have charactised APC within adult skin and blood. Here we extend these findings, by increasing the sample for skin CD14+ DC and CD1c+ DC and performing gene array analysis of adult spleen CD14+ DC, CD141+DC and CD1c+ DC. Once, we were confident we could clearly distinguish our populations (CD14+ cell, CD141+ DC and CD1c+ DC) of interest from other cells, we sorted FACS purified the cells and prepared them for gene array analysis. Through generating subset specific gene signatures and comparing CMAP scores we confirmed we had identified equivalent APC subsets across human adult skin and spleen. Overall design: APC were isolated from adult skin that was collagenase digeseted overnight by FACS. Adult spleen was collagenase digested for 1hr and the APC isolated by FACS. Gene expression analysis using total RNA from specific human APC subsets purified by FACS was performed.
Project description:One third of patients with acute stroke have aphasia. The majority receive speech and language therapy. There is evidence for a beneficial effect of speech and language therapy on restoring communication, but it is unknown whether and how efficacy of speech and language therapy is influenced by timing of treatment. We studied whether speech and language therapy early after stroke by way of intensive cognitive-linguistic treatment is more effective than no speech and language therapy in the Rotterdam Aphasia Therapy Study-3, a multicentre randomised single-blind trial.Stroke patients with first-ever aphasia were randomised within 2 weeks of onset to either 4 weeks of early intensive cognitive-linguistic treatment (1?h/day) or no language treatment. Hereafter, both groups received regular speech and language therapy. Primary outcome was the score on the Amsterdam-Nijmegen Everyday Language Test, measuring everyday verbal communication, 4 weeks after randomisation. Secondary outcomes were Amsterdam-Nijmegen Everyday Language Test at 3 and 6 months. The study was powered to detect a clinically relevant difference of four points on the Amsterdam-Nijmegen Everyday Language Test.Of the 152 included patients, 80 patients were allocated to intervention. Median treatment intensity in the intervention-group was 24.5?h. The adjusted difference between groups in mean Amsterdam-Nijmegen Everyday Language Test-scores 4 weeks after randomisation was 0.39, 95% confidence interval: [-2.70 to 3.47], p?=?0.805. No statistically significant differences were found at 3 and 6 months after randomisation either.Four weeks of intensive cognitive-linguistic treatment initiated within 2 weeks of stroke is not more effective than no language treatment for the recovery of post-stroke aphasia. Our results exclude a clinically relevant effect of very early cognitive-linguistic treatment on everyday language.
Project description:INTRODUCTION:There is no definitive cure for Dupuytren disease (DD), and recurrence of finger contractures after treatment is common. Surgical fasciectomy is considered the standard treatment method for recurrence, although associated with a high incidence of complications. Collagenase injection, a non-surgical treatment option, has been shown to be a safe and effective method; however, most studies regarding collagenase have involved first-time treatment. Collagenase efficacy in patients with recurrent DD beyond the immediate effect has not yet been determined. The aim of our study is to compare surgical fasciectomy and collagenase injection in treating recurrent DD. METHODS AND ANALYSIS:The study is a single-centre randomised controlled trial. Inclusion criteria are recurrence of DD in one or more fingers after previous treatment with fasciectomy or collagenase injection, a passive extension deficit ≥30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joint, and a palpable cord causing the recurrent contracture. A total of 56 patients will be randomised to either surgical fasciectomy or collagenase injection. A hand therapist blinded to patients' group allocation will measure range of motion at baseline, 3 months, 12 months, 24 months and 60 months. The primary outcomes are the total active extension deficit (MCP plus PIP) at 3 months and the proportion of patients with contracture worsening ≥20° in the treated finger joint at 2 years compared with 3 months. The secondary outcomes include changes in total active motion, active and passive extension deficit from baseline up to 5 years, scores on patient-reported outcome measures, adverse events and costs of treatment. ETHICS AND DISSEMINATION:Ethical approval has been obtained from the Regional Ethical Review Board, Lund University, Sweden(2017/623). The trial will be conducted according to the Helsinki Declaration of 1975, revised in 2000. The results of the trial will be disseminated as published articles in peer-reviewed journals. TRIAL REGISTRATION:NCT03406338; Pre-results.
Project description:Stroke leads to constant rehabilitation needs even at the chronic stage. However, although many stroke patients receive physical or occupational therapy in primary health care, treatment prescriptions do not generally specify therapeutic goals; in particular, participation is not established as an explicit therapeutic goal in the ambulatory setting. The primary aim of this study is to evaluate the efficacy of a therapy regimen for chronic stroke patients (modified 'constraint-induced movement therapy (CIMT) at home') with impaired hand or arm function with regard to the prerequisites of participation in everyday activities: a sufficient arm and hand function. 'CIMT at home' will be compared with conventional physical and occupational therapy ('therapy as usual').The study is a parallel cluster randomized controlled trial with therapy practices as clusters (n = 48). After written consent from the patients (n = 144), the therapists will be randomly assigned to treat either the intervention or the control group. Blinded external assessors will evaluate the patients using standardized outcome measures before and after the intervention, and six months later. The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are the motor activity log (quality of arm and hand use) and the Wolf motor function test (arm and hand function). These assessments are made four weeks post-treatment and relativized to baseline performance. Changes in primary outcomes will be analyzed with mixed models, which consider the hierarchical structure of the data and will be adjusted to the baseline measurements and sex. The primary analysis will be the comparison of the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints. To keep an overall significance level of 5%, the two endpoints will be tested at the significance level of 5% each in hierarchical order.A modification of the CIMT, feasible in the patients' homes (CIMT at home), appears to be a promising therapeutic approach in the ambulatory care of chronic stroke patients. With proven efficacy and practicality, a participation-oriented, stroke-specific treatment would be available in primary care.ClinicalTrials.gov NCT01343602.